Vitamin Lawyer eMemo Archives

12/24/08 - Doctors Recommend Dietary Supplements

2008-12-24T11:44:00.000-08:00

Vitamin Lawyer Update eMemo: December 24, 2008

This issue: Doctors Recommend Dietary Supplements

0. News - Defending the NSF / The Year Ahead
1. Doctors Recommending Dietary Supplements
2. Web Ring and Wiki for Advanced Health Care – Sign-up Now!
3. Standard Operating Procedures and Site Use Statements
4. Livron Labs Looking for Industry Partners
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0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Defending Natural Solutions Foundation
vitaminlawyerhealthfreedom.blogspot .com/2008/12/truth-is-our-defense-internet-attacks.html
And – www .healthfreedomusa .org/index.php?p=1694
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The Year Ahead… According to Nutraingredients.com

“The momentum of areas that have dominated in 2008 such as probiotics, omega-3s, superfruits and weight management remains strong and seem certain to continue registering fat blips on the commercial and consumer radar in 2009…Despite the ongoing frustration of scientific studies that ask of vitamins, minerals, antioxidants, herbs and other nutrients that which they were never meant to deliver – like curing cancer or treating severe depression – the year ahead looks promising for their use in an array of matrices from supplements to cosmeceuticals to functional foods and drinks… With the financial climate bringing closer scrutiny to business and personal budgets alike, there is an argument that sales of healthy foods and supplements may benefit because individuals place greater emphasis on maintaining wellness through dietary choices, rather than face often exorbitant costs in the medical system.”

www .nutraingredients .com/Industry/A-Nutra-eye-on-2009

[Please note: all URL web page links in this email are “broken” or incomplete, with the “http://” and/or “www.” separated and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. Doctors Recommending Dietary Supplements
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www. functionalingredientsmag .com/fimag/articleDisplay.asp?strArticleId=1974&strSite=FFNSite
Newly-released results from the 2008 "Life…supplemented" Healthcare Professionals Impact Study show for the first time which supplements specialist physicians are taking and recommending to their patients…
Orthopaedic specialists — Nearly three-quarters (73%) of orthopaedic specialists use dietary supplements…Nearly all orthopaedic specialists who take supplements recommend them to their patients (94%). Even 82% of orthopaedic specialists who do not take supplements still recommend them to their patients. In total, 91% of orthopaedic specialists recommend supplements to their patients. The top reasons include: bone health (75%), joint health (73%), musculoskeletal pain (53%) and overall health and wellness benefits (25%).
Cardiologists — More than half (57%) of cardiologists use dietary supplements. The top reasons they do so include: overall health and wellness benefits (32%), heart health (29%), lower cholesterol (20%) and energy (17%)… Among the 72% of total cardiologists recommending supplements, the top reasons for doing so include: lower cholesterol (58%), heart health (55%), maintain healthy cholesterol (36%), and overall health and wellness benefits (30%).
Dermatologists — Three-quarters of dermatologists use dietary supplements. The top reasons for this include: overall health and wellness benefits (42%); bone health (24%); skin, hair and nails (16%); heart health (15%) and anti-ageing (14%)…
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2. Web Ring and Wiki… Sign-up Working!
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In recent eblasts I told you all about the new Advanced Healthcare Web Ring and how it can help your Search Engine Status and push derogatory postings off the first page of Google and other Search Engines.

I’ve posted that information at: http:// tinyurl .com/5d6489

Now, after more beta testing the sign-up page is working! (With my special thanks to those of you sought to sign up and who communicated with me about problems!)

Take a look at the Web Ring at: www .healthcare-aware .com

And SIGN UP HERE: http: //healthcare-aware .com/subscribe/go.php?r=1&i=l0

[Please remember: all links here are “broken” so AOL etc doesn’t treat this email as “spam.”]

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3. Standard Operating Procedures and Site Use Statements
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures and for Site Use Statements. YOUR PAPERS MUST BE IN ORDER!

You can find much more information about these at:

SOPs - http:// tinyurl .com/2eu6yj

SUSs – www .siteusestatement .com
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4. Livron Labs looking for industry partners

A note from a mutual friend in the industry:

Dear Ralph - If you know of anyone who needs a fabulous, ethical supplements manufacturer, my supplier has extra capacity just now. Ask for "Gary Viole" , "Richard Viole" - Livron Vitamin Co. - Allendale, NJ 07401 - Tel: 201-236-1300. Thanks, KH

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Happy Holidays to All… and a Peaceful, Prosperous New Year
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

12/16/08 - Testimonials Continue at Risk

2008-12-16T11:43:00.000-08:00

Vitamin Lawyer Update eMemo: December 16, 2008

This issue: Testimonials Continue at Risk

0. News - Divesting the FDA
1. Testimonials Continue at Risk
2. For the New Year – New Attacks on Dietary Supplements?
3. Web Ring and Wiki for Advanced Health Care – Sign-up Now!
4. Standard Operating Procedures and Site Use Statements
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0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Divesting the FDA of Food Authority
vitaminlawyerhealthfreedom .blogspot .com/2008/11/divesting-fda-of-food-authority.html

[Please note: all URL web page links in this email are “broken” or incomplete, with the “http://” and/or “www.” separated and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. Testimonials Continue at Risk
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In recent discussions that I have had with attorneys who are experts in the field of FTC testimonial regulation, I was told that it appears FTC is ready to issue new regulations severely limiting testimonials unless they are backed by clinical data.

Meanwhile, Vitamin Retailer issued a report dated December 9, 2008 on testimonial regulatory actions. Some of that report is excerpted here: “This past month, the FDA and FTC brought charges against five natural product companies, alleging … improper claims … in website testimonials… The FDA and FTC are seeking hefty fines and other sanctions in part because these companies posted letters from satisfied customers on their websites. None of the customers claim outright to have been cured by the products, although the customers did share their personal experience of medical conditions that objectively disappeared after use of the products.

“Citizens For Health Chairman of the Board Jim Turner, who represents Daniel Chapter One, maintains that the FDA and FTC motion against his client ‘fails to distinguish between cynical con men who intentionally cheat vulnerable people, and persons of conviction who work diligently to comply with the law in their effort to help people.’”

Said the owner of Daniel Chapter One. “We are fighting to protect all Americans' rights in this issue, which include access to information and choice. We are planning a rally in Washington DC the week of April 23, 2009 to promote the Health Freedom Protection Act (H.R. 2117), the necessity of which is underscored by our case and others like it.”

Vitaminretailer .com/VRMnews/news/121008VRMNews.htm#nie1

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2. For the New Year – New Attacks on Dietary Supplements?
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Nutraingredients highlighted this comment: Pharmaceuticals versus dietary supplements

Next up is Lorraine Heller’s comment about GlaxoSmithKline's petition to the Food and Drug Administration (FDA) to ban dietary supplements from making weight loss claims… thousands of readers … clicked on “The GSK weight loss wake-up call”.

Lorraine argued that the issue was due to the inadequate or incomplete scientific substantiation, question marks over efficacy, health claim exaggeration, formula contamination and mislabeling that continue to dog the dietary supplements industry despite the best intentions of the 1994 Dietary Supplements Health Education Act (DSHEA) and Good Manufacturing Practice (GMP) regulations enacted last year.

“It's a situation that leaves industry open to the kind of attack GSK has mounted and drives the urgent need for it to get its house in order,” said the comment.

The Vitamin Lawyer will continue to keep you updated as this “citizen petition” goes through the FDA.

To read more: www .nutraingredients .com/Industry/2008-round-up-This-year-s-top-five-comments

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3. Web Ring and Wiki… Sign-up Working!
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In recent eblasts I told you all about the new Advanced Healthcare Web Ring and how it can help your Search Engine Status and push derogatory postings off the first page of Google and other Search Engines.

I’ve posted that information at: http:// tinyurl .com/5d6489

Now, after more beta testing the sign-up page is working! (With my special thanks to those of you sought to sign up and who communicated with me about problems!)

Take a look at the Web Ring at: www .healthcare-aware .com

And SIGN UP HERE: http: //healthcare-aware .com/subscribe/go.php?r=1&i=l0

[Please remember: all links here are “broken” so AOL etc doesn’t treat this email as “spam.”]

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4. Standard Operating Procedures and Site Use Statements
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures and for Site Use Statements. YOUR PAPERS MUST BE IN ORDER!

You can find much more information about these at:

SOPs - http:// tinyurl .com/2eu6yj

SUSs – www .siteusestatement .com
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Happy Holidays to All… and a Peaceful, Prosperous New Year
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

12/04/08 - Supplement Market Growth

2008-12-04T11:43:00.000-08:00

Vitamin Lawyer Update eMemo: December 4, 2008

This issue: Final FDA Rule on Importing Dietary Products

0. News - Divesting the FDA
1. Supplement Market Growth
2. Bridging the Benefit – Ingredient Knowledge Gap
3. Web Ring and Wiki for Advanced Health Care – Sign-up Now!
4. Standard Operating Procedures and Site Use Statements
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0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Divesting the FDA of Food Authority
vitaminlawyerhealthfreedom .blogspot .com/2008/11/divesting-fda-of-food-authority.html

[Please note: all URL web page links in this email are “broken” or incomplete, with the “http://” and/or “www.” separated and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. Supplement Market Growth
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From NutraIngredients.com –

“The French food supplement market is enjoying heavy growth. Between 2000 and 2006, consumption of supplements doubled in France and should double again by 2012, according to Synadiet (National Dietetic Syndicate). This consumption is accompanied by an increase in self-medication across France.
With this heavy growth, French consumers are catching up with their European neighbors who are traditionally heavier consumers of supplements. To understand this boom, we should recall the generalization of the Health/Naturalness trend with a search for healthier lifestyles and a return to essential values. The reasoning is for a healthier lifestyle that includes prevention, a balanced diet, and a search for authenticity and naturalness in the products people consume. In fact, natural products are one of the five drivers of the European food supplements market and their consumers perceive them as safe and healthy.”

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2. Bridging the Benefit – Ingredient Knowledge Gap
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Another interesting article from Nutraingredients:

“Companies need to do more to link health benefits and those particular ingredients that deliver them to capitalise on consumer interest, according to research… [polling] consumers …found that while they were highly interested in brands that carried health benefits, they often failed to understand which ingredients delivered those benefits, nor how. Bone, heart and digestive health were the top three health concerns… In each case the health benefit was more important than the ingredient.
nutraingredients .com/Consumer-Trends/Bridging-the-benefit-ingredient-knowledge-gap/?c=gbrnO2ewSG3NYL%2FXgDb20g%3D%3D

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3. Web Ring and Wiki… Sign-up Working!
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In recent eblasts I told you all about the new Advanced Healthcare Web Ring and how it can help your Search Engine Status and push derogatory postings off the first page of Google and other Search Engines.

I’ve posted that information at: http:// tinyurl .com/5d6489

Now, after more beta testing the sign-up page is working! (With my special thanks to those of you sought to sign up and who communicated with me about problems!)

Take a look at the Web Ring at: www .healthcare-aware .com

And SIGN UP HERE: http: //healthcare-aware .com/subscribe/go.php?r=1&i=l0

[Please remember: all links here are “broken” so AOL etc doesn’t treat this email as “spam.”]

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4. Standard Operating Procedures and Site Use Statements
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures and for Site Use Statements. YOUR PAPERS MUST BE IN ORDER!

You can find much more information about these at:

SOPs - http:// tinyurl .com/2eu6yj

SUSs – www .siteusestatement .com
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

11/08/08 - FDA - Rule on Importing Dietary Ingredients

2008-11-08T11:42:00.000-08:00

Vitamin Lawyer Update eMemo: November 8, 2008

This issue: Final FDA Rule on Importing Dietary Products

0. News - Senator Obama, What About Change for Health Freedom?
1. New FDA Rule on Importing Foods (Including Dietary Ingredients)
2. Webinars: Reaching Out to Customers and Distributors
3. Web Ring and Wiki for Advanced Health Care – Sign-up Now!
4. Standard Operating Procedures and Site Use Statements
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0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

The President-elect and Change for Health Freedom
http:// vitaminlawyerhealthfreedom.blogspot .com /2008/11/president-obama-and-health-freedom.html

[Please note: all URL web page links in this email are “broken” or incomplete, with the “http://” and/or “www.” separated and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. New FDE Rule on Importing Foods – Including Dietary Ingredients
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Do you import any of your product ingredients? Do you import your finished product? Then you need to know about this: “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act…”

"The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of2002 (the Bioterrorism Act)"

http:// www.fda. gov /OHRMS/DOCKETS/98fr/FDA-2002-N-0233.pdf

Official publication date: 11/07/08 - 427 pages!!!!

pg 30: "Examples of food include fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods."

Note from the Vitamin Lawyer: I am reading the new regulations and will inform my retainer clients shortly about how these final rules might impact their purchases of raw materials from abroad. In general terms I will also discuss the Prior Notice Rule in future issues of this eMemo.

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2. Webinars: Reaching Out to Customers and Distributors
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I’m preparing a series of Vital Connections Webinar training seminars – www. vital-connections .com to further enhance the services I provide the Natural Products industry. The first of these will be entitled Ethics and Alternative Practices and will focus on the legal distinction between “treatment of disease” and “therapies that may benefit” as well as the various ethical considerations that may be important for Advanced Healthcare providers.

Webinars are an innovative use of New Media, combining PowerPoint Presentations with audio teaching that can be experienced “live” over the Internet and archived for future downloading. Here is what Vital Connections has to say about its services:

“Vital Connection is excited to have the opportunity to bring the latest evolutions in Holistic and Natural Health Education into your home. We have designed our education model so that it will give you the benefit of being able to take Online Courses that work with your schedule.

“We work cooperatively with the Holistic Community to present Professional Education and have the opportunity to learn in your home with Master Instructors. With this dedicated relationship we now are focused on empowering you with the most up-to-date information as soon as it is available!!!

“Through the education we provide; you will be able to complete your Continuing Education Units rapidly and in the most inexpensive way possible. Along with the Online Courses that we have available; look forward to receiving updates with the evolution of the education through FREE Webshops and Educational Material that will help to support your Natural Health Practice!!!”

You can contact Evan at info@vital-connections .com for further information. Tell him The VitaminLawyer.com sent you!

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3. Web Ring and Wiki… Sign-up Working!
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In r4ecent eblasts I told you all about the new Advanced Healthcare Web Ring and how it can help your Search Engine Status and push derogatory postings off the first page of Google and other Search Engines.

I’ve posted that information at: http:// tinyurl .com/5d6489

Now, after more beta testing the sign-up page is working! (With my special thanks to those of you sought to sign up and who communicated with me about problems!)

Take a look at the Web Ring at: www .healthcare-aware .com

And SIGN UP HERE: http: //healthcare-aware .com/subscribe/go.php?r=1&i=l0

[Please remember: all links here are “broken” so AOL etc doesn’t treat this email as “spam.”]

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4. Standard Operating Procedures and Site Use Statements
-----------------------------------------------

The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures and for Site Use Statements. YOUR PAPERS MUST BE IN ORDER!

You can find much more information about these at:

SOPs - http:// tinyurl .com/2eu6yj

SUSs – www .siteusestatement .com
-----------------------------------------------

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

10/21/08 - FDA, FTC Target Natural Products

2008-10-21T11:42:00.000-07:00

Vitamin Lawyer Update eMemo: October 21, 2008

This issue:

0. News
1. FDA and FTC Target Natural Products
2. Web Ring and Wiki for Advanced Health Care – sign-up now working!
3. Standard Operating Procedures and Site Use Statements
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0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

http:// vitaminlawyerhealthfreedom.blogspot .com/2008/10/no-forced-vaccination-rally.html
See a YouTube Video of the Vitamin Lawyer at the No Forced Vaccination Rally last week!

[Please note: all URL web page links in this email are “broken” or incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. FDA and FTC Target Natural Products
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Today, from my colleague Jim Turner, Esq, at Citizens for Health ( www citizens .org ):

“Companies barred from sharing customers' positive experience of their products

This past month, the FDA and FTC brought charges against 5 natural product companies, alleging that these companies have made improper claims about their natural dietary supplements. As most of you know, dietary supplement makers cannot legally claim that their products "cure" anything. The FDA and FTC give only drug companies permission to do that.

The twist in two of the cases is that the FDA and FTC are cracking down not just on claims, but also on the use of testimonials. These two "testimonial" cases involve Rhode Island company Daniel Chapter One and New Mexico-based Native Essence Herb Company. The FDA and FTC are seeking hefty fines and other sanctions in part because these companies posted letters from satisfied customers on their websites. None of the customers claim outright to have been cured by the products, although the customers did share their personal experience of medical conditions that objectively disappeared after use of the products. Are such testimonials medical claims? How far can a ban against testimonials go? Can the government ban consumers from sharing their personal health care experiences with one another in any forum?

Citizens For Health Chairman of the Board Jim Turner, who represents Daniel Chapter One, is concerned. The FTC and FDA attack against his client "fails to distinguish between cynical con men who intentionally cheat vulnerable people, and persons of conviction who work diligently to comply with the law in their effort to help people." You can read the full text of Turner's important analysis of this case here:

www .dc1pages .com/dc1freedom/index.php?option=com_content&view=article&id=46&Itemid=71 .”

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2. Web Ring and Wiki… Sign-up Working!
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In my last eblast I told you all about the new Advanced Healthcare Web Ring and how it can help your Search Engine Status and push derogatory postings off the first page of Google and other Search Engines.

I’ve posted that information at: http:// tinyurl .com/5d6489

Now, after more beta testing the sign-up page is working! (With my special thanks to those of you sought to sign up and who communicated with me about problems!)

Take a look at the Web Ring at: www .healthcare-aware .com

And SIGN UP HERE: http: //healthcare-aware .com/subscribe/go.php?r=1&i=l0

[Please remember: all links here are “broken” so AOL etc doesn’t treat this email as “spam.”]

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3. Standard Operating Procedures and Site Use Statements
-----------------------------------------------

The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures and for Site Use Statements.

You can find much more information about these at:

SOPs - http:// tinyurl .com/2eu6yj

SUSs – www .siteusestatement .com
-----------------------------------------------

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

09/18/08 - Your Customers, Best Lead Source

2008-09-18T11:41:00.000-07:00

Vitamin Lawyer Update eMemo: September 18, 2008

This issue:

0. News & Practice Notes
1. Mining for Leads: Your Customers are Your Best Source
2. Web Ring and Wiki for Advanced Health Care – closer and closer
3. Professional Practice Record Keeping SOP Available
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0. VL Blog News and Practice Notes; Fee Increase

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com
Dennis Kuchinich: Defending Our Right to Know – GMOs
vitaminlawyerhealthfreedom.blogspot .com/2008/09/dennis-kuchinich-defending-peoples.html

Weaponized Avian Flu: Current Estimate of Situation.3
Healthfreedomusa .org/index.php?p=965

URGENT! DIETITIANS MONOPOLY BILL IN NJ WILL STOP ALL ALTERNATIVES: vote on 09/25/08. Tell your state and national legislators to oppose all restrictions on Nutritional Free Speech: HealthFreedomUSA .org/index.php?p=1030
salsa.democracyinaction .org/o/568/t/1128/campaign.jsp?campaign_KEY=25929

Vitamin Lawyer.com Consultancy fees are increasing due to continuing dollar value declines. The new basic fee, starting September 1, 2008, will be $325/hr. Prepaid clients will receive the balance of their time at the original rates. Current clients receive the old rate until October 1st. Regular monthly retainer clients will be charged at $275/hr. and will continue to be permitted to use the Vitamin Lawyer Oversight Seal: http:// tinyurl. com/2cfoyb

“The value of the US and European natural (excluding organic) food and drinks market was worth $11.7bn in 2005 and it is expected to reach $19.2bn by 2010.” (from a Nutraingredients .com email)

“Ninety per cent of the 11,000 athletes in attendance at the Games of the 29th Olympiad used dietary supplements of some kind, according to the European Specialist Sports Nutrition Alliance (ESSNA). There was not a single supplement contamination case… So perhaps Beijing marks a turning point for the industry. Just as the Chinese capital’s hosting of the event boosted China’s public image (at least while it was on), so too has the supplements industry been given a lift by its clean Games performance….”

Nutraingredients .com/Industry/Dietary-supplements-win-Olympic-gold/?c=gbrnO2ewSG2xbUKNPtVBZw%3D%3D

“Companies that take advantage of the growing health and wellness market often don't do enough to tell consumers how to benefit from their products, says a brand-growth expert. Consumers are ‘looking for specific solutions that fit within the overall context of their lives’…"

Mediapost .com/publications/?fa=Articles.san&s=89814&Nid=46820&p=925781

[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. Mining for Leads: Your Customers are Your Best Source
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http://www.entireweb.com/newsletter/archive/2008/PRINT471.html
Excerpts: Entireweb Newsletter * September 2, 2008 * ISSUE #471

The Most Valuable Source for Leads

“…The Chief Marketing Officer (CMO) Council has just completed a study... The results of the surveys may not surprise you, but the contrasts of the responses provide a shocking insight into the sheer volume of missed opportunities. This is good news for you, because missed opportunities by others can create new opportunities for you…According to the survey results… most valued source of leads is from customer referrals.

54% Customer Referrals
14% E-Mail or Direct Marketing
8% Internet
7% Events
7% Leads from Vendors
3% Third Party Lead Generation Organizations
8% Other

Would you agree that the best leads come from the referrals of satisfied customers? Is it surprising that customer referrals were ranked as four times more powerful and valuable than E-Mail or Direct Marketing campaigns? Customer referrals were ranked nearly seven times more likely to result in sales and new business than leads derived the Internet…

With all of this insight, how did the same channel executives, distributors, resellers, and channel representatives respond to the survey by Chief Marketing Officer Council with regards to tactics for generating new leads in the coming year?

14% Plan to use Direct Marketing and E-mail campaigns
13% Plan to use Sales Brochures and collateral
10% Plan to focus on Tradeshows for lead generation
8% Will use Seminars to generate leads
7% Will rely on Print Advertising
7% Plan to use Public Relations and Article Placement
7% Plan to use the Internet and Online Advertising
6% Will revert to Telemarketing
6% Plan to invest in Internet Search Engine Marketing
5% Plan to engage customers in User Group Gatherings
4% Plan to rely on Yellow Page Advertising
4% Will experiment on the Internet with Blogs and Social Networking
3% Will use Online Directories
3% Will create Webcasts
1% Plan to use Content Syndication
2% Will try something completely different

The results of the survey regarding lead generation tactics for new business acquisition are hardly surprising. Very little has changed in the planning and tactics as conveyed by the survey response, and yet, the contrast in comparison to the most effective and valued leads is staggering. Even though 54% of respondents acknowledged that the most valued leads are based on customer referrals, the first mention of leveraging this goldmine occurs in the 4% of respondents that plan to engage customers in user group gatherings…. The Internet provides an exciting vehicle to be creative, showcase the brand, and communicate to a very large audience. However, is it targeting the most valuable audience by engaging the most valuable leads that come from customer referrals?

…So, how do you encourage and empower customers to grow this incredible pipeline of valued referrals? You ask them, of course. However, before you make such a bold request, your customers must know that you are fully engaged and obligated to their aspirations. When customers are assured that you are a trusted advocate, committed to customer satisfaction, they have the confidence to share referrals and recommendations. Once customer confidence is established and the relationship is mutually rewarding, then it is just a matter of creating the appropriate opportunity for referrals to occur. This can be as simple as asking for referrals… by engaging individuals in group gathering or discussions, leveraging the Internet or Advertising, or by collecting a powerful collage of testimonials… Actively and effectively mining the most valuable source for leads will give you an advantage over 95% of your competition.”

John Mehrmann is author of The Trusted Advocate: Accelerate Success with Authenticity and Integrity.

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2. Web Ring and Wiki for Advanced Health Care Update
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It is certainly the “Doldrums of Summer…” -- there were some continuing “glitches” since the last updates, but we now expect the Web Ring sign-up page to go live during late September. Below is a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature. I will also be sending a special Vitamin Lawyer Update eMemo in the next week or so which will have many more details about the Web Ring. Please watch for it.

You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!

Here is what one Web Ring company says about the benefits:

“WebRing offers a unique and effective means of searching, locating and navigating between web sites with similar themes. WebRing allows web site owners to group their sites together into ring communities, and provides a navigation tool that links web sites together called a NavBar. Linked sites not only eliminate the necessity of repetitive searches, but the NavBar also accumulates hits from all of the sites so that a hit to one site is a hit to all sites. Additionally, the NavBar acts as a link so your web site is linked to every other site in the community. So now your site is benefiting from higher search engine results because it has more hits and more links.”

If you are ready to sign-up, the beta form is here:
healthcare-aware .com/subscribe/go.php?r=1&i=l0

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3. Professional Practice SOPs
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM” practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients. The SOP has been amended to include the latest regulations regarding accepting credit cards for payments.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service. The SOP is being revised to reflect the new Data Security requirement of “a written policy for protecting the security of your customer…”

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

08/29/08 - Credit Card Data Security Rules

2008-08-29T11:41:00.000-07:00

Vitamin Lawyer Update eMemo: August 29, 2008

This issue:

0. News & Practice Notes; Fee Rate Increase
1. New Data Security Rules for Credit Cards Processing
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
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0. VL Blog News and Practice Notes

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Internet Abuzz: Avian Flu Weaponized?
www .healthfreedomusa. org/index.php?p=846

Practice Note: Data Security Rules Upgraded

I’ve worked with G. P. Nehra, Esq. regarding nutrient MLM issues and consider him a leading attorney in that world. The report from his office, below, is being shared with his permission. The five specific legal requirements coming into effect on 11.01.08 are being integrated into the Standard Operating Procedures Manual format maintained by the Vitamin Lawyer.com Consultancy. Regular retainer clients will automatically receive the updates. Others should email me with “SOP Update” in the subject line; there is a ½ hour fee for this service.

Vitamin Lawyer.com Consultancy fees are increasing due to continuing dollar value declines. The new basic fee, starting September 1, 2008, will be $325/hr. Prepaid clients will receive the balance of their time at the original rates. Regular monthly retainer clients will be charged at $275/hr. and will continue to be permitted to use the Vitamin Lawyer Oversight Seal: http:// tinyurl. com/2cfoyb

[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. New Data Security Rules for Credit Card Processing
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DATA SECURITY COMPLIANCE - 101

From G.P. Nehra Esq -- Prepared by Rick Waak

The Law Firm has had several inquiries about the announced November 1 effective date for compliance with new tighter data security requirements… [under] the Fair and Accurate Credit Transactions Act…

…[B]ecause of the way the rules affect the payment card industry, their impact covers a much broader segment, virtually all of the commercial world. … The biggest merchant account customers have long since been complying with the strictures of this Industry program as a condition of their using their payment card merchant accounts. Now it is time for smaller merchant users …

WHAT DOES THIS MEAN FOR YOU?

If you have or want to have a merchant account which enables you to accept and process payments from your customers or distributors by credit or debit card, you will need to do the following:

1. Establish a written policy for protecting the security of your customer (and employee) account data. The policy must include designation of employees responsible for carrying out the internal monitoring and security check procedures.

2. Determine what your merchant level will be. (based on number of expected transactions, i.e., Level 4 is 0-20,000 , Level 3 is 20,000-1 million, etc.). By accessing the web site at www. pcicomplianceguide .org you can get information and a chart to help make this determination, as well as other guidance that will tell you way more than you ever wanted to know about complying with the Payment Card Industry Data Security System.

3. Select and contract with an Approved Scanning Vendor (ASV). ASVs are industry certified contractors who conduct electronic scans of your data handling systems…

4. Download and complete periodically (as specified for your merchant level) a PCI DSS Self-Assessment Questionnaire.

5. Have the ASV conduct periodic (again, based upon your merchant level) network security scans.

The PCI compliance website, your ASV, your telecommunications vendor, and your merchant banks will all be able to help and advise you.

© Gerald P. Nehra 2008 - Permission to reproduce with attribution - www. mlmatty. com

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2. Web Ring and Wiki for Advanced Health Care Update
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It is certainly the “Doldrums of Summer…” -- there were some continuing “glitches” since the last updates, but we now expect the Web Ring sign-up page to go live during early September. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.

You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!

Here is what one Web Ring company says about the benefits:

“WebRing offers a unique and effective means of searching, locating and navigating between web sites with similar themes. WebRing allows web site owners to group their sites together into ring communities, and provides a navigation tool that links web sites together called a NavBar. Linked sites not only eliminate the necessity of repetitive searches, but the NavBar also accumulates hits from all of the sites so that a hit to one site is a hit to all sites. Additionally, the NavBar acts as a link so your web site is linked to every other site in the community. So now your site is benefiting from higher search engine results because it has more hits and more links.”

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3. Professional Practice SOPs
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM” practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service. The SOP is being revised to reflect the new Data Security requirement of “a written policy for protecting the security of your customer…”

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

08/12/08 - EU, Codex: Health Claims Substantiation

2008-08-12T11:40:00.000-07:00

Vitamin Lawyer Update eMemo: August 12, 2008

This issue:

0. News & Practice Notes:
1. Codex and EU: Health Claims Substantiation
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
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0. VL Blog and News and Practice Notes

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Weaponized Avian Flu Current Intelligence Estimate
http://www .healthfreedomusa .org/?p=755

Practice Note: How Not to Make Claims

I was recently asked to consult in a case where there might be an indictment for selling an “unapproved drug.” The product is a mix of a half dozen herbs with tea, a combination traditionally used to support normal immune function in case of influenza. The problem is: the product was advertised by an “off shore” distributor as “effective treatment for Avian Flu…” The US manufacturer made no such claims, but an off shore distributor did. Although the label was affixed off shore, the authorities want to impute the claim to the US entity, since the product was sold to Americans. This is another case where much trouble could have been avoided had the distributor structured the claims with attention to US permitted language in the first place. The US manufacturer never intended a “drug” use, but now needs to demonstrate that fact. Having your paperwork in order, including clear Standard Operating Procedures, good sales and purchase Records, can go a long way to demonstrating your legal intent.

[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. Codex and EU: Health Claims Substantiation
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Nutraingredients .com/Regulation/IADSA-keeps-pressure-on-Codex-over-science-for-health-claims/?c=gbrnO2ewSG3cp4pUuVpXUw%3D%3D

“August 11, 2008 (By Stephen Daniells) The International Alliance of Dietary/Food Supplement Associations (IADSA) is keeping up pressure on changing how health clams are substantiated by Codex. te science to substantiate health claims should bring together all studies, and putting too much emphasis on clinical trials is “not practical” …Professor David Richardson, scientific adviser to the UK Council for Responsible Nutrition (CRN) and IADSA - “Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials. These studies are, of course, important, but they provide only one source of information. All sources of scientific data have inherent limitations, hence the need to focus on the totality of the available data and weighing of the evidence.”

Codex agreed at the end of 2007 that its draft rules on health claims needs further work following concerns over what evidence should be required for scientific substantiation. And the calls for a wider consideration of the overall science by IADSA will keep up the pressure on Codex ahead of a review and redraft by a France-led working group, which will present its conclusions at the next Codex Nutrition Committee meeting in November 2008. …

In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods and drinks should be supported by science - and has caused uncertainty for the industry since coming into force in July because parts of the law have not yet been finalized… The text, as it currently stands, states that short-term human intervention studies in healthy subjects should be the prime source of evidence in claims substantiation…

“The scientific evidence to support the diet and health relationships for dietary guidelines and health claims for fruits and vegetables, and for whole grain cereals, are based mainly on human observational studies, not clinical interventions,” said Richardson. Sources of scientific evidence can include generally accepted authoritative information that has been verified and validated over time; human intervention studies; human observational or epidemiological studies; animal and in vitro studies, and traditional knowledge and experience of use. The scientific data that will be accepted for a health claim for botanical problems in EU law has also caused some concern. Lobbyists have called for the traditional use of a botanical to be acceptable as evidence and are opposed to clinical trials.”

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2. Web Ring and Wiki for Advanced Health Care Update
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There were some “glitches” since the last update, but we now expect the Web Ring sign-up page to go live this coming weekend. I will send you all a special link for The Vitamin Lawyer.com Consultancy clients and contacts. I know you will want to sign-up for this important new Internet feature.

You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). In previous issues of this Update eMemo I discussed the powerful search engine value of the Web Ring. In the near future I will be providing you with a detailed explanation about how the Web Ring can help your Online presence. I’ve been working on this project since last November, as some of you know. The wait will be worth it!

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3. Professional Practice SOPs
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

07/24/08 - Using Italics and Bold in Copy Writing

2008-07-24T11:40:00.000-07:00

Vitamin Lawyer Update eMemo: July 24, 2008

This issue:

0. News Notes: The Valley of the Moon Eco Community
1. Using Italics and Bold in Copy
2. Web Ring and Wiki for Advanced Health Care
3. Professional Practice Record Keeping SOP Available
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0. VL Blog and News Notes

Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com
US Takes Over Codex Commission Chair… agency consensus breaking…

Support Health Freedom: join the eAlert Newsletter at: www. HealthFreedomUSA .org

I’ve previously told you about The Valley of the Moon Eco Community, for investing, retiring or relocating off-shore in free and prosperous Panama. Please take a look at www. naturalsolutionsfoundation .org – there you will find links to The Valley of the Moon Eco Community information. Located in the beautiful, bountiful, temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation. Tax deductible donations for this project are gratefully accepted.

We are also seeking high-yield, short term (6 month) Angel Loans to provide the balance of the purchase funds for the first “finca” (farm) being purchased in the Valley. Panama’s strong banking sector does not provide funds to purchase property, but, once owned, routinely loans 80% of the purchase price of agricultural land at very low interest. Initial participants have contributed the 20% and the land contract is about to be signed, so we are reaching out to all our contacts for the next step. Let me know if you are interested.

Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!

[Please note: all URL web page links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. When to Use Italics and Bold in Copy
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Entireweb Newsletter * July 24, 2008 * ISSUE #460

“…Roman type is the straightforward, upright type we read everyday in our newspapers, magazines and books, and on our monitors. Italic is the 'handwriting' equivalent of whatever roman font we are reading… Bold type is roman or italic font that has been emphasized by thickening and making it darker than the surrounding text.

The question is: when should we use which version of a particular typeface - roman, italic, or bold? … It is obvious that for most copy the roman version of the chosen font should be used. …

Because the bold version of a font makes text stand out strongly, it is used for highlighting important words, phrases and sections. Thus headlines, decks and subheads set in bold will, along with pull-quotes and other tricks of the typesetter's art, provide the casual scanner with clues as to what your article or story is all about…

Bold however is too strong to be used, except very occasionally, within body text. To set off words from surrounding text is the main function of italics.

…Here's a sort of check-list…

[1] The names of ships and aircraft… This is the oldest when-to-use-italics rule…
[2] The titles of poems...
[3] Foreign words…
[4] The titles of books, newspapers, articles and stories…
[5] Latin phrases used to classify living things...
[6] Where a word is used as an example rather than for its meaning…
[7] For introducing new terms…. This is a neat solution to highlighting words that will probably be explained later.
[8] For the subjects of definitions…
[9] For mathematical symbols…
[10] For emphasis…
[11] To indicate a character's internal reflections in stories…
[12] Using a letter or number as a noun…

Of course, you don't have to follow these when-to-use-italics rules. However most of them are in current use because they do aid reader comprehension….”

Paul D Kennedy paulkpg@yahoo.ie - freelance writer of articles and stories - http:// www. writingservices. eu.
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2. Web Ring and Wiki for Advanced Health Care
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Yes, it is finally nearly here, after about a year of effort by a team of advanced Internet professionals. The ADVANCED HEALTH WEB RING and the ADVANCED HEALTH WIKI are now in the beta test stage.

You can get a sneak preview at: http:// healthcare-aware .com (for the Web Ring) and www .advancedhealthwiki .com (for the Wiki). Why do you want to know about these important innovations for nutritional and natural products purveyors, non-medical devices and advanced health care professionals, researchers, students and advocates?

Read Tim Bolen’s analysis of how “the other side took over” the Internet and you will understand why this initiative is so important. See: “The Six Components of the Quackbuster Operation” - http:// www .bolenreport .net/feature_articles/feature_article070.htm – learn how the skeptics, with their distorted views, outrank the best health care practitioners on major search engines.

Then you will understand this opportunity to take back the “high ground” of publicity for advanced health care (sometimes called “Complementary and Alternative Modalities – CAM)… and what this may mean for your company.

Within the next few weeks the Web Ring will be opened for membership. A near future issue of The Vitamin Lawyer Update will give you information on how to join. You will be among the first to have this opportunity. I have been telling a few of my clients, privately, about this important development… now you all know. And you found out first, here on the Vitamin Lawyer Update eMemo!

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3. Codex Approves 35 Food Standards
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The annual Codex Commission meeting just concluded in Geneva adopted 35 new food standards that may impact your businesses. These standards include, for example, sharply reducing the level of gluten allowed in “gluten free” products. You can read more at Nutraingredients.com.

Nutraingredients .com/news/ng.asp?n=86380&c=gbrnO2ewSG0lWhPfglxeag%3D%3D

My intrepid co-trustees of the Natural Solutions Foundation – Gen. Bert Stubblebine and Dr. Rima Laibow – were in Geneva. You can read their comments, and see a series of “as it happened” video reports at: www .healthfreedomusa .org/index.php?p=726

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4. Professional Practice SOPs
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The Vitamin Lawyer .com Consultancy offers standardized formats for various Standard Operating Procedures – for companies in the nutritional and natural products industry, as well as for advanced health care “CAM practitioners. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

06/24/08 - FDA "Cancer Cure" Warning Letters

2008-06-24T11:39:00.000-07:00

Vitamin Lawyer Update Memo: June 24, 2008

This issue:

0. Blog and Important News Notes
1. FDA Warning Letters – “Cancer Cures”
2. 97% of Nutrient and Health Claims Rejected in Europe!
3. Pharma Lobby Spends a Billion in a Decade…
4. Professional Practice Record Keeping SOP Available
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0. VL Blog and News Notes

Blog Update: http:// vitaminlawyerhealthfreedom .blogspot .com

Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org

The Valley of the Moon Eco Community – For those of you who are considering investing, retiring or relocating off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this Natural Solutions Foundation (Panama) zero-emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability. I am a trustee of the sponsoring private foundation.

Remember to check out: www. naturalsolutionsfoundation .org if you might be interested. And I know you might be interested!

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com or .org, to avoid this message being treated as “spam” by AOL or other services.]

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1. FDA Warning Letters – “Cancer Cures”

“The US Food and Drug Administration sent warning letters to 23 American companies and two foreign individuals for allegedly marketing a range of products fraudulently claimed to prevent and cure cancer… it had also warned North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves and creams, all sold under various names on the internet… contain[ing] ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.”

FDA says the following claims are “fraudulent:”
• "Treats all forms of cancer"
• "Causes cancer cells to commit suicide!"
• "80% more effective than the world's number one cancer drug"
• "Skin cancers disappear"
• "Target cancer cells while leaving healthy cells alone"
• "Shrinks malignant tumors"
• "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"

functionalingredientsmag. com/fimag/articleDisplay.asp?strArticleId=1771&strSite=FFNSite
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2. 97% of Nutrient and Health Claims Rejected in Europe
“23-Jun-2008 - The European Commission has culled its gargantuan nutrition and health claims list from more than 40,000 to 1500 as the health claims process moves closer to fruition in January, 2010. … [Some claims] were deemed inappropriate for want of supporting data or were making claims about foods or food supplements that were not legally available in the EU… The nutrition and health claims regulation was enacted last year and seeks to harmonize claims across the … EU's 27 member states…”

foodnavigator. com/news/ng.asp?n=86073&c=gbrnO2ewSG3%2BoFrFccmRkw%3D%3D
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3. Pharma Lobby Spends a Billion in a Decade…

Investigative report on the Public Integrity web site says Big Pharma spent more in 2007 ($186,000,000 – right, that’s nearly two hundred million dollars!) than in any previous year, but the past ten year total is approaching a billion dollars… all to convince Congress that this industry’s often dangerous products are… good for us?

publicintegrity. org/rx/report.aspx?aid=985
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4. Professional Practice SOPs

The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

You can see a list of the topics covered by the SOP at: http:// tinyurl. com/2eu6yj

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

06/06/08 - Weight Control Supplements Attacked

2008-06-06T11:39:00.000-07:00

Vitamin Lawyer Update Memo: June 6, 2008

This issue:
1. US and Japan Forming Health Food Alliance
2. Weight Control Dietary Supplements Under Attack
3. Professional Practice Record Keeping SOP Available
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Blog Update: NY to Mandate Forced Vaccine Pharma Profits
http:// vitaminlawyerhealthfreedom .blogspot .com

Support Health Freedom: join the eAlert Newsletter at: www. healthfreedomusa .org

And for those of you who are considering relocating some or all of your activities off-shore, and may be considering free and prosperous Panama, please take a look at www. naturalsolutionsfoundation .org – there you will find a link to The Valley of the Moon Eco Community web site. Located in the temperate highlands of Chiriqui Province, this planned zero emissions, off-the-grid community is built around the Songhai Principals of Passion, Perfection & Profitability.

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]

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1. US and Japan forming health food alliance

06-Jun-2008 (by Neil Merrett – “Two leading US nutrition groups are teaming up with a Japanese counterpart to combine their knowledge in a bid to meet both the domestic and international challenges facing the industry. … The Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the National Nutritional Foods Association of Japan (NNFA-J) yesterday agreed to work together to better deal with regulatory and research issues… ‘Emerging research is increasingly supporting the safety and benefits of supplements for maintaining good health and reducing the risk of chronic diseases," he stated. "Regulatory approaches in both countries should likewise reflect good science to help consumers make healthy decisions.’”

www. nutraingredients-usa. com/news/ng.asp?n=85762&c=gbrnO2ewSG3bTjEYx%2BWZAA%3D%3D

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2. Weight Control Dietary Supplements Under Attack

Dietary Supplements that support normal weight have been under increasing attack by both government and special interests. Even well-known weight loss brands such as TrimSpa® are failing (its parent company recently filed for bankruptcy).

Recently it seems that GlaxoSmithKline (GSK) will stop at nothing to rub out the competition when it comes to weight loss supplements. (No matter what your opinion is on weight loss supplements, this issue affects the vitamin industry as a whole.) GSK has petitioned FDA to classify all over-the-counter weight loss supplements as unapproved “drugs.” This means that mere overweight would be classified as a “disease” (as “obesity” is currently classified).

Furthermore, GSK hopes to remove any weight loss claims from dietary supplements. It should be noted that there is currently only one over-the-counter weight loss product with FDA approval: GSK’s alli®.

If FDA starts reclassifying normal conditions of life as “diseases” to protect the Pharmaceutical Industry, we may well see more dietary supplements threatened.
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3. Professional Practice SOPs

The Vitamin Lawyer .com Consultancy offers standardized formats for Standard Operating Procedures. The Professional Practice Record Keeping SOP describes record keeping standards for the practitioner who provides nutrients and natural remedies to his or her clients.

Contains the following topics:

1. Maintaining copies of all paid invoices
2. Maintaining regular back-up copies of client database.
3. Maintaining copies product ordered for resale records
4. Records of products ordered
A. Records showing that the products are manufactured in accordance with the marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing, packaging, and mislabeling
C. Reasonably necessary records of claimed “serious adverse events.”
5. Lawful written request for records; client objection
6. Record Types
(a) Research and other development records
(b) Records required by law to maintain for a certain period of time
(c) Comply with any published records retention or destruction policies and schedules
(d) Records relevant to litigation, or potential litigation
(e) Practitioner establishes retention or destruction policies
(f1) Tax Records
(f2) Employment Records/Personnel Records
(f3) Board and Committee Materials
(f4) Press Releases/Public Filings
(f5) Legal Files
(f6) Marketing and Sales Documents
(f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
(f9) Trade secret information
(f10) Contracts: final, execution copies of all contracts
(f11) Electronic Mail
(g) Notes, drafts and documents - no longer provide relevant
(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC) compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance
7. Practitioner Product Sales Record Keeping (in detail):
1. The Practitioner shall maintain order invoice copies
2. The Practitioner shall maintain back-up copies
3. The Practitioner shall maintain copies of records
4. Records of products
5. Record Availability
6. Report on FDA Form
7. Not construed by FDA as an admission

If you would like a copy of the Professional Practice SOP, please send me an email with “PP-SOP” in the subject line; I charge ½ hour for this service.

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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

04/25/08 - FTc and FDA Tactics to Limit Healthcare Free Speech

2008-04-25T11:38:00.000-07:00

Vitamin Lawyer Update Memo: April 25, 2008

This issue:
1. FDA to Require Data on Substantiation – Seeks Comments
2. FTC Unapproved Medical Claims Tactic: “Disgorgement”
3. Are Your SOPs in Order? AER SOP Available
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Blog Update: Co-creating the next wave in health freedom
http:// vitaminlawyerhealthfreedom .blogspot .com

Support Health Freedom: join the eAlert Newsletter at:
www. healthfreedomusa .org

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]

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1. FDA to Require Data on Substantiation – Seeks Comments

FDA is moving to upgrade the enforcement of the Claims Notice requirements by setting up a system to collect data on substantiation (heretofore, you had to have the data “on file” – now FDA seeks to collect that data.

“To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to baguilaz@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title, "Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act." Also include the FDA docket number found in brackets in the heading of this document. [Docket No. FDA-2008-D-00301 - formerly Docket No. 2004D-0466]…

“Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they chose to place a claim on their product's label. Gathering evidence on their product's claim is a one time burden; they collect the necessary substantiating information for their product as required by section 403(r)(6) of the act…

“The standard discussed in the draft guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature…

“FDA assumes that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established… FDA believes it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals…”

fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0030-n.pdf

Please note the new data production requirements are not yet in effect and I will let my list know as this develops further.
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2. FTC Unapproved Medical Claims Tactic: “Disgorgement”

FTC has been pursuing what is usually a criminal law tactic in its civil complaints against nutrient purveyors who make “medical claims” by demanding that the offender “disgorge” all of its gross sales income from such claims to the FTC, for, as stated in a Stipulation of Settlement offered one company earlier this month, “All funds paid pursuant to this Order shall be deposited into a fund administered by the Commission or its agents to be used for equitable relief , including but not limited to restitution, and any attendant expenses for the administration of such equitable relief. In the event that direct redress of consumer injury is wholly or partially impracticable or funds remain after the restitution is completed, the Commission may apply any remaining funds roe such other equitable relief (including consumer information remedies) as it determines…”

Conclusion: if you make unapproved medical claims, ALL the money that comes into your company from those claims will be taken by the government. You need to review and revise any such claims… contact me if you need my help.

-----------------------------------------------

3. Are your Papers in order? AER SOPs

The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.

If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.

-----------------------------------------------

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

04/15/08 - FTC Health Claims Crackdown

2008-04-15T11:38:00.000-07:00

Vitamin Lawyer Update Memo: April 15, 2008

This issue:
1. FDA Food Labeling Guide
2. FDA – FTC Health Claims Crackdown
3. Allowed Product Claims
4. Are Your SOPs in Order? AER SOP Available
------------------------------------------------------
Blog Update: My Blog has been unblocked
FTC Receives Truthful Vaccine Advertising Petition
http:// vitaminlawyerhealthfreedom .blogspot .com

Support Health Freedom: join the eAlert Newsletter at:
www. healthfreedomusa .org

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------
1. New FDA Food Labeling Guide issued April 3rd

Says FDA regarding its new food labeling guide, “The most frequently raised questions have been addressed using a ‘question and answer’ format. We believe the vast majority of food labeling questions are answered.” I’ve looked it over and find it cogent. www .cfsan.fda .gov/~dms/2lg-toc .html

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2. FDA – FTC Health Claims Crackdown
www .nutraingredients-usa .com/news/

Good advise from a “Beltway” industry lawyer, from NutraIngredients .com -

“Just because others do it, doesn't mean it's OK… FDA regulates product labels, whereas FTC regulates product marketing. However, both agencies have limited resources… they cannot stay on top of every new product launch…. Nevertheless - budgets allowing - the agencies will clamp down when misleading health claim use is brought to their attention. When this happens, companies are held responsible for their marketing, regardless of competitor activity…

“FDA and FTC both use science as a golden standard, and this is what any safety claims for a product or ingredient need to be based on…

“If a manufacturer highlights the fact that a product contains a particular ingredient, this is considered to be an implied claim that the ingredient will have some effect…

“Keep apprised of FDA/FTC enforcement actions… "Especially in some of the grayer areas, knowing the opinions expressed by the agencies in the context of enforcement actions will give you valuable information that you can use when deciding whether to launch a new product or tweak an existing one."

“…FDA and FTC have both stressed that they are particularly wary of 'miracle cures' or 'all-in-one' cures… High on the agencies' radars are claims to cure serious diseases, products targeting children, and weight loss. They also look out for 'patches', as dietary supplements cannot be topical - they must be ingested…

“Double Blind Placebo Controlled studies with Statistically Significant Results are key to substantiating claims… However, despite the need for caution, companies should not be scared to make claims that can be substantiated… Animal studies can be important for support, but they cannot stand alone as sufficient evidence to support the efficacy of a product. Human clinical studies are what hold the real weight, and any support from animal studies is an added benefit.

“Keep your customers happy… Customer complaints can also serve to alert regulatory agencies to the need for action. In addition, companies should be sure to keep their promises…if products make money back guarantees, then companies should be prepared to honor the promise...

“‘Getting the advice of a qualified lawyer or consultant before launching a product or an advertising campaign may not be cheap, but it can be money well spent, and end up saving you a lot in the long run.’”

Ivan Wasserman, Esq. who specializes on advertising and labeling issues in the food and dietary supplement sectors, was addressing industry members at Expo West in Anaheim, California this March.

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3. Allowed Product Claims
www .nutraingredients-usa .com/news/

Please note: a “health claim” as discussed below is one step up from the typical “structure and function” claim most marketers make. S&F claims can be made without prior FDA approval, not so with health claims. Here is what

“As defined by [FDA] health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.

“The use - and regulation - of health claims on products varies depending on which category these fall under: medical, or non-medical. The golden rule to using claims on foods, beverages and dietary supplements is to steer clear of implying in any way that these can prevent or treat a health condition, as they would then be classified as drugs.

Foods and supplements can carry two major types of health claims: Authorized health claims or qualified health claims… Examples of [authorized] claims would include:

* Calcium and the risk of osteoporosis
* Plant sterol/stanol esters and the risk of coronary heart disease
* Folic acid and the risk of neural tube defects

Authorized health claims can also be based on an authoritative statement from a scientific body of the US government or National Academy of Sciences… Examples include:

* Whole grain foods and risk of heart disease and certain cancers
* Potassium and the risk of high blood pressure and stroke…

Qualified health claims are those based on emerging evidence for the relationship between a food or supplement and a reduced risk of disease… this type of claim must include qualifying language to indicate that the evidence supporting the claim is limited… Examples include:

* Selenium and risk of certain cancers
* Walnuts and risk of coronary heart disease…

[Other types of claims include:] Structure/function claims on foods focus on the effects derived from the nutritive value of a food… Nutrient content claims characterize the level of a nutrient in the food, either directly or by implication.”

-----------------------------------------------

4. Are your Papers in order? AER SOPs

The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.

If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.

-----------------------------------------------
It’s been several weeks since my last VL Update Memo… we’ve been very busy, but I do expect to get back to one update every ten days or so. Thank you for your patience.

Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com

03/08/08 - Substantiation Resource

2008-03-08T11:37:00.000-08:00

Vitamin Lawyer Update Memo: March 8, 2008

This issue:
1. Substantiation Resource
2. Has the DS Industry Reached “Maturity”?
3. AER SOP
------------------------------------------------------
Blog Update: Healthcare vs the Illness Industry
http:// vitaminlawyerhealthfreedom.blogspot .com

Support Health Freedom: join the eAlert Newsletter at:
www. healthfreedomusa .org

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------

1. Substantiation Resource: Natural Standard Research

I’ve recently taken a look at a good source of substantiation information. If you think this may help your company, please contact Jason (contact info below) and tell him The Vitamin Lawyer sent you. He is knowledgeable and very helpful. I think this service may be quite useful for both substantiation and with Adverse Event Reporting.

“About The Natural Standard Research Collaboration

”The Natural Standard Research Collaboration provides high quality, evidence-based information on dietary supplements (including herbs, vitamins, and minerals), and functional foods to manufacturers. Natural Standard is the trusted professional reference of the National Institutes of Health and provides patient information to MD Anderson Cancer Center, Susan Komen Breast Cancer Foundation, The Mayo Clinic and Harvard Medical School.

”The Natural Standard Electronic Database

”The Natural Standard Database is an evidence based clinical database that will expedite and consolidate the literature retrieval process, assist researchers in new product development, promote safety and efficacy when labeling and marketing products, and assists in registering products or making structure function claims.

”Relevant Database Features:

”All available human studies provided with the level of evidence for each one are included (RCT, meta-analyses, systematic review, case reports, etc). Each clinical trial is rated for methodological quality with limitations discussed.

”Recommendations are made for future high quality studies. An ID program that allows users to search for related terms, substances, synonyms, foreign language terms, constituents, Latin terms and common names.

”Standardized grading criteria for effectiveness that is completely reproducible and based on the US Preventative Services Taskforce Sections that include anecdotal evidence, traditional uses, manufacturer reports, potentially biased publications, internet hearsay, popular opinion, and those that report controversy between secondary and primary data Brief safety summaries that includes maximum dose and duration as well as interactions with conditions Adverse, Effects/Precautions/Contraindications Interactions
Pregnancy/Lactation Data.

”Dosing/Toxicology section that provides brand names of products, dosing, frequency, duration, level of evidence, standardization and toxicology Mechanism of Action, Pharmacodynamics/Kinetics Evidence table and discussion of individual studies.
Brand names with ingredients Interactions cover herb/supplement, food, lab, name brand products, generic products, name brand drug and generic drug interactions Condition databases that allow user to compare effectiveness and include both conventional and integrative therapy treatment options News for product recalls, contaminants, and industry news RSS feeds,

”For more information please contact:
Jason Petralia
JPetralia@NaturalStandard.com
Director of Business Development
Natural Standard
www. naturalstandard .com”

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2. “Supplement Market Nears Maturity, Nutraceuticals Report
By Lorraine Heller

February 29, 2008 - The US, Europe and Japan will continue to drive the global nutraceuticals market, although growth in dietary supplements is expected to slow, according to a new report. Published by Global Industry Analysts, Nutraceuticals: A Global Strategic Business Report examines the leading markets for functional foods and dietary supplements, and the factors driving growth.

The report, which analyzes the past, current and future market dynamics over the period 2000-2010, projects "healthy growth" for the nutraceuticals market over the next few years, with global sales expected to reach $187bn by 2010.

Leading markets

According to GIA, the United States, Europe and Japan dominate the global market, with a combined share estimated at 86 percent last year... Primary reasons for the strength of these markets are the high-income levels of consumers, greater awareness and widespread preferences for specialty nutritional and herbal products, and trends promoting preventive medicine and self-treatment.

The US alone accounted for 37 percent of 2007 nutraceutical sales, but Asia Pacific is expected to emerge as the fastest growing market, boosted by the "robust" Chinese and Indian markets, and increasing economic prosperity, said the report.

Growth drivers

According to the report, rising consumer desire for leading a healthy life continues to drive sales of nutraceutical products… Other factors include an expanding elderly population, as well as escalating costs associated with healthcare, which is pushing the demand for self-medication and healthy foods.

Functional Foods

According to the report, functional foods constitute a fast moving segment in the nutraceuticals market, driven by the rising health awareness among consumers…

Supplements

Growth in the dietary supplements segment is expected to slow, as the category fast approaches maturity levels, said the report. This is particularly the case in developed regions…

Competition

As the global nutraceuticals industry continues to grow, competition will also increase. This will be driven by factors such as price, safety, efficacy, packaging and brand loyalty, said the report… nutraingredients-usa .com/news/printNewsBis.asp?id=83651”

My view is that the natural products / natural remedies / nutrition market will continue to experience significant growth as Baby Boomers seek to maintain and regain youthfulness.
-----------------------------------------------

3. AER SOP

The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.

If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.

-----------------------------------------------
Ralph Fucetola JD
www. vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com

02/27/08 - 2008 Supplement Tends

2008-02-27T11:37:00.000-08:00

Vitamin Lawyer Update Memo: February 27, 2008

This issue:
“Quackwatch” Exposed
Supplement Trends for 2008
Metabolic Syndrome
C&D Letters
FDA Gets Tough on Health Claims
Natural Solutions Panama ARC Project
------------------------------------------------------
Tim Bolen has exposed the “quackwatch” methodology used to attack CAM practitioners, nutrient and natural remedy purveyors. Please read my blog on this important issue.

vitaminlawyerhealthfreedom .blogspot.com/2008/02/tim-bolen-exposes-quack-anti-health.html

[Please note: all links in this email are incomplete, with the “http://” and/or “www.” removed and an extra space before the .com, to avoid this message being treated as “spam” by AOL or other services.]
------------------------------------------------------

Hartman outlines supplement trends for 2008 - By Lorraine Heller
nutraingredients-usa .com/news/ng.asp?n=83162&m=1NIU211&c=jegwylrviswtnqa

Feb-11-2008 - Healthy aging, balanced energy and inflammation are the three core health concerns that consumers try to address with dietary supplements,
according to a new report. The Hartman Group's Tinderbox on Trends 2008 draws its conclusions through ethnographic research, which includes consumer
interviews and observation in the home and in retail outlets. According to the research group, when a health concern presents itself, most consumers will first examine their diet. When food does not remedy the situation, they look to supplements, preferably from whole foods, to correct and balance their condition.

Supplements most popular with "leading-edge" or "core" consumers were those that addressed aging, energy and inflammation, said Hartman.

Although most supplement users are diligent when it comes to taking multi-vitamins, Hartman said that they tend to vary in their choice of supplements addressing
these three issues, either as they learn of new products, or as they shift focus from the one issue to another.

The group said consumers are "constantly searching for the latest supplement that may ease their condition or outperform a current supplement which is filling
nutritional holes missing from their diet".

Supplement use

Hartman divides supplement usage into three main categories: frequent, occasional and sporadic.

Frequent usage refers to those supplements that are taken on a daily basis in order to complement nutritional needs that are lacking from the diet. Ideally, consumers prefer 'daily' supplements to be sourced from whole foods sources.

These supplements are considered mainstays are taken daily and year-round as a preventative, said the group. Occasionally used supplements are those that are used to boost or alleviate a chronic condition or as a substitute for a prescription drug.

"Typically these supplements are taken from a few days to a week or until the bottle is finished. This demonstrates the core consumer's proactive approach to their
health," said Hartman.

Supplements that are sporadically used are those taken to alleviate an immediate health condition, or those that are tried for the first time. They are typically not taken in the long-term because consumers are unsure about their long-term use or possible side-effects.

Healthy mind and body

According to the report, consumers place a lot of emphasis on the balance between a healthy mind and body. Linked into this is the increasing search for natural methods to reduce low energy, sleep disturbances and anxiety. "Getting enough sleep, having sustained energy throughout the day and managing emotional ups and downs requires being present and truly paying attention to what their body and soul needs from day to day. When one element is out of balance, such as sleep or feeling blue, the whole person eventually needs tuning," said the report. "The core consumer looks to whole foods and the latest vitamin, mineral and herbal supplements in their quest for balancing mood, energy and sleep."

---------------------------------------------------------------

nytimes .com/2008/02/05/health/nutrition/05symp.html?_r=1&oref=slogin

"Researchers have found a correlation between drinking diet soda and metabolic syndrome — the collection of risk factors for cardiovascular disease and diabetes
that include abdominal obesity, high cholesterol and blood glucose levels, and elevated blood pressure... But the one-third who ate the most fried food increased their
risk by 25 percent compared with the one-third who ate the least, and surprisingly, the risk of developing metabolic syndrome was 34 percent higher among those
who drank one can of diet soda a day compared with those who drank none."

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nutraingredients-usa .com/news/ng.asp?n=83202&m=1NIU212&c=jegwylrviswtnqa
How to respond to a Cease & Desist Letter
By James F. Ewing, Michelle A. Flores, and Michel Morency

Feb - 12 -2008 - Legal experts form Foley & Lardner suggest a strategy to help nutraceuticals companies respond to an accusation of infringing patent rights.
The nutraceuticals market is dynamic and competitive. As such, your nutraceuticals company may be subject to enforcement of another's patent rights. Receiving a
Cease & Desist letter ('the Letter') accusing you of infringing the patent rights of another is an unwelcome notice that can create a sense of urgency akin to having
been just set ablaze.

Being subject to enforcement of another's patent rights, however, is not an uncommon occurrence for successful businesses in competitive markets such as the
nutraceuticals market. Such letters usually identify the granted Patent(s) by its number(s), assert ownership to the Intellectual Property, and detail your alleged infringing activities as well as conditions and deadlines that are to be met.

To avoid being burned in such circumstances, you may consider implementing a STOP, DROP and ROLL approach. STOP and objectively consider the claims.

Implementing the STOP, DROP and ROLL approach does not mean that you need to immediately stop your business activities upon receiving a Cease & Desist
letter. However, whether the Letter demands that you cease making, using, or selling a particular product or service, or merely suggests that you might be interested in licensing certain patent(s), you should stop to carefully consider the allegation, and refer it to knowledgeable Counsel.

Being placed "on notice" of another's patent rights, is a legally significant event where you have a duty to act. Proactively addressing the concerns or demands of a
patent owner serves to protect your company and mitigate exposure to possible damages and fees for alleged willful conduct.

'DROP a Line' to experienced patent counsel Your response to the Letter should be timely, well-considered, and strategic.

Before responding you need to engage the services of knowledgeable patent counsel. This may involve one or more individuals with expertise in patent prosecution
and enforcement matters who can render an opinion regarding whether your commercial product or activities may infringe the patent claims asserted against you
and/or assess the validity of these claims, and develop an appropriate response strategy.

Enforcement issues can be highly complex and a skilled patent counsel will provide essential guidance to address the issues and assess the risks and potential
commercial impact against your company. Be prepared to 'ROLL with the Punches'...

Simply ignoring a Cease & Desist letter will not make the issue go away and may result in increased costs and liability for the accused patent infringer. The STOP,
DROP and ROLL approach provides a strategy to minimize potential adverse impacts in these situations.

James F. Ewing, Michelle A. Flores, and Michel Morency are attorneys with Foley & Lardner LLP.

[Yes, The Vitamin Lawyer does have C&D formats for your use....]
-------------------------
FDA gets tough on rogue health claims
By Alex McNally
nutraingredients-usa.com/news/ng.asp?n=83501&m=1NIU225&c=jegwylrviswtnqa

25-Feb-2008 -

Two companies have signed an agreement that prohibits them from claiming any of their products can cure, treat, mitigate or prevent diseases after making
unauthorized health claims. The Food and Drug Administration said both Cherry Capital Services and Brownwood Acres Foods have a history of promoting unapproved claims, such as "chemicals found in cherries may help fight diabetes." The terms of the consent decree mean the firms have to remove drug and unauthorized health claims from their labels, brochures and websites....

Margaret Glavin, associate commissioner for regulatory affairs, said: "The FDA will not tolerate unsubstantiated health claims that may mislead consumers. The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."

...The US version of health claims was introduced a few years ago. Initially the legislation was beset by delays. Despite pledging that a response would be given to all claims submitted within 365 days, the FDA has exceeded this timeframe on a number of occasions. In one case the FDA was more than 300 days over an original
deadline for approval.

--------------------------------------

If you've been trying to reach me, you know I just got back from a quick trip to Panama. Awesome! Read on...

Natural Solutions Foundation in Panama was set up to research, educate and demonstrate natural solutions. Our shared vision is of an intentional community that links home sites (on a wonderful hillside with great views) with a natural wellness center/spa and organic+ farm and school, all on a 300 hectare (700+ acre) site that has never been farmed with chemicals. Currently, about ten acres are planted with organic coffee.

Our Panamanian legal entity is very flexible, combining the best aspects of a non-profit and a “private interest” entity that is allowed to form its own commercial enterprises. In keeping with the Songhai Principals, we see three “profit centers” for the project: the Wellness Center, the Organic+ Farm and School and what I call the Infrastructure Company, which provides transportation, communications, off-grid power, etc. to the center and farm school as well as the home sites. The Foundation will hold majority interest in the commercial entities, but there will be private investment opportunities.

The area is in the far north, by the Costa Rica border, against the 17,000 acre Amistad National Forest. Elevations vary from 3,000 to 5,000 feet above sea level. It is in the township of Santa Clara (Sacred Light) and is reached by modern road about an hour from the Vulcan eco-tourist area. The climate is year-round temperate (the woods look much like the woods of the US Northeast: similar evergreen, birch and other deciduous trees, deer and rabbits, but with coffee, banyan trees, plantains and howler monkeys too).

Gen. Stubblebine and Dr. Laibow have explored the area in recent months and I went there last week with a Natural Solutions supporter, guided by Kenneth Taylor, our Panamanian builder with experience in the area.

I am most impressed by Panama as a country where people have great hopes for the future... Panama City and the Canal area, where half of the 3 million population resides, is a very modern, thriving area with a huge building boom, very well developed banking and commercial sectors (the Singapore of the New World).

The Santa Clara area, to the far north, is pristine, flower filled and well connected to civilized amenities (international cuisine, locovore restaurants). It is becoming an eco-tourist center mostly because of the Vulcan Baru. The area is filled with ExPats from the US and Europe (20% of one town is American).

Land values are quite reasonable right now, but will not stay that way for long, as Americans and Europeans looking for more freedom than they can find at home, join the Panamanians in appreciating this land. Two hours away, in Boquete, land is bumping $100,000 per hectare (2.45 acres) – about 8 times our cost. Land taxes are very low and there is a 20 year tax holiday for new construction.

Because the land owners, who farm organically themselves, appreciate our vision, they are giving us a highly favorable financial arrangement and going far out of their way to work with us in a positive and helpful way. One of their sons, who lives on the land, would be ideal as a land manager for us. He is most amenable to that idea.

We are currently making arrangements to have the land surveyed, the soil and water tested and will be setting up preliminary meetings with architects to determine the number of building lots and areas. A generous donor has made that possible with a first gift for Panama.

We are now open for donations which, while fully tax deductible in the US, will allow the Natural Solutions Foundation to proceed with the development of our better than organic, advanced farming technology project complete with farm school for farmers from around the world -- teaching how to farm and feed communities while resisting the pressures of Big Agribiz is a central commitment of the Panama Project.

So is providing a free, beautiful, healthful and sustainable community for visionaries like ...YOU! Leasehold and ownership interests will be available.

If you are interested, just send an email to Ralph Fucetola - ralph.fucetola@usa.net - with "Panama" in the subject line or call 973-300-4594 to learn more about your place in the Panama Project! Before I became “The Vitamin Lawyer” I grew up on family construction projects and practiced construction law for fifteen years, being involved in housing, hotel, mall and commercial developments (including historical renovations) in northeast NJ.

I believe this site is ideal to develop and demonstrate natural solutions. It is the right country (friendly to Americans, natural health and organics) and the right natural area. We've looked for years for the best place to demonstrate natural solutions. In my humble opinion, this is the place!

You are invited to join our Panama Yahoo!Group forum where you will find many photos, copies of the organizing documents, skills database and much more:

http://tech.groups.yahoo.com/group/NSF-Panama/join

Natural Solutions Foundation is more than just talk: we are willing to walk our talk… and a beautiful walk up the mountain it will be!

Ralph Fucetola JD
vitaminlawyer .com
vitaminlawyerarchives .blogspot.com/

02/05/08 - SEO Strategies, Berries and Weight Management

2008-02-05T11:36:00.000-08:00

… VLUeM – 02.05.08 - VITAMIN LAWYER UPDATE e-MEMO

PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...

This issue: Privacy and Search Engine Optimization
_______________________________________________

1. Vitamin Lawyer Blogs and Factoid
2. Deep red and blue berry elements in weight management
3. Bio-Identical Hormones at Risk!
4. Important Yahoo!Groups Privacy Information
5. Top 10 Search Engine Optimization Strategies For Your Website!
6. VL Update eMemo Archive Blog
______________________________________________

1. Vitamin Lawyer Blogs & Factoids

New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/

Factoid: "01/02/2008 - The deadline for health claims to be submitted by member states to the European Commission passed yesterday, and among those passed on was the UK's 4,000 page dossier. The country's 3,931 page-long booklet, submitted by the Food Standards Agency (FSA), shows the scale of the task before the Commission and the European Food Safety Authority" As usual, relying on bureaucracy to rationalize the market is a near impossible task. Maybe they shoud have left it to market forces? nutraingredients.com/news/ng.asp?n=82966&m=1NIE201&c=jegwylrviswtnqa

This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________

2. Deep red and blue berry elements in weight management

From a study being published in Journal of Agricultural and Food Chemistry

http://www.nutraingredients.com/news/ng.asp?n=82855&m=1NIE129&c=jegwylrviswtnqa

"Purified forms of extracted anthocyanins from berries may decrease obesity, but the whole fruit doesn't produce the same benefits, suggests a new study with mice.
If the results can be translated to humans, anthocyanins extracted from blueberries and strawberries could find a role in the burgeoning weight loss and management market, estimated to already be worth $7bn (€5.2bn) globally.

"The recent findings that anthocyanins could possibly affect the development of obesity, at least in animal models, have generated considerable interest," explained the researchers, from USDA Arkansas Children's Nutrition Center and the University of Arkansas. "

______________________________________________

3. Bio-Identical Hormones at Risk!
From P2C2 - Patients and Professionals for Customized Care

http://iacprx.convio.net/site/PageServer?pagename=P2C2001secBHRTatRisk

"The FDA and Wyeth, a big drug maker, are trying to stop bio-identical hormone replacement therapy! Get involved and fight back!

Last week FDA decided to support a Wyeth campaign against compounded treatments and announced that it will "halt" compounding of hormone treatments that contain estriol. Estriol is a common and critical component of many bioidentical hormone therapies (including Bi-Est and Tri-Est) that meets standards that were established by Congress. If you are not sure if you are taking estriol, ask your doctor or pharmacist. Even if you don't take a medication with estriol, is your hormone or other compounded treatment next?

If FDA and Wyeth have their way, you will lose this access to vital treatment options. This action affects hundreds of thousands of women!"

______________________________________________

4. Important Yahoo!Groups Privacy Information Received from a Friend

If you belong to any Yahoo Groups read this notice - it is important!

Yahoo is now using something called "Web Beacons" to track Yahoo Group users around the net and see what you're doing and where you are going (similar to Cookies.)

Yahoo is recording every website and every group you visit.

Take a look at their updated privacy statement

1. http://info.yahoo.com/privacy/us/yahoo/details.html

2. About half-way down the page, in the section on Cookies, you will see a link that says "Web Beacons".

Click on the phrase "WebBeacons".

3. That will bring you to a paragraph entitled "Outside the Yahoo Network".

In this section you'll see a little "click here to opt out" link which will let you "opt-out" of their new method of snooping.

4. Once you have clicked that link, you are exempted.

Notice the "Success" message on the top of the next page.

Note: Be careful because on that page there is also a "Cancel Opt-out" button which, if clicked, will *undo* the opt-out. It appears after you have hit the opt-out button so is very confusing.

______________________________________________

5. Top 10 Search Engine Optimization Strategies For Your Website!

entireweb.com/newsletter/archive/2008/PRINT409.html
Entireweb Newsletter * January 29, 2008 * ISSUE #409

“Although the concept of search engine optimization can be somewhat complex, there are a number of basic search engine optimization techniques you can use to improve your organic search results…

1. Meta Tags. Meta tags are simple lines of code at the top of your web page programming that tell search engines about your page. Include the title tag, keyword stag, description tag, and robots tag on each page.

2. Create and update your sitemap. Developing a site map is a simple way of giving search engines the information they need to crawl your entire website. There are plenty of free software packages on the web that can help…

3. Ensure that all navigation is in HTML. All too often, navigational items are in the form of java script. Even though navigation technically still works in this format, it's not optimized. Create your navigation in HTML…

4. Check that all images include ALT text. Your image's alt text is spidered by search engines. If you're not including your keywords in alt text, you're missing out on a huge opportunity for improved search engine result placements…

5. Use Flash content sparingly. Content generated through java script or flash is a big no-no…

6. Make sure that your website code is clean. Keep in mind when optimizing a web page crawlers are basically only looking at your source code…

7. Place keywords in your page content. Search engines scan your website and web pages for keywords. Shoot for a keyword density of between two and eight percent…

8. Submit your website to search engine directories. It's always a good idea to let large search engine directories know that you're out there. Submit your website URL to directories like Google, Yahoo, and DMOZ.

9. Build links to your website. Consider building a link exchange program or create one-way links to your site using articles or forum posts…

10. Learn the basics. Learning to optimize your website for search engines takes time and patience…

Author: Michael Fleischner is a Marketing Expert and Search Engine Optimization Specialist - MarketingScoop.com
______________________________________________

6. VL Update eMemo Archive Blog

I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com

In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________

You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… 

And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com

For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...

Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
Attorney at Law in NJ, 1971 – 2006 / All Rights Reserved © 2008 . . .

01/25/08 - Web site cross promotion

2008-01-25T11:36:00.000-08:00

… VLUeM – 01.25.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...

This issue: saving your company from costly new FDA regulations…
_______________________________________________

1. Health Freedom Blog update
2. Cross-promotion of web sites
3. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/

Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite

The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”

eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join

If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .

This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. Entire Web on Cross-promotion of Web Sites
Entireweb Newsletter * January 22, 2008 * ISSUE #407
Easy Cross-Promotion Tactics

Cross-promotion is an easy, inexpensive method for generating more traffic and more revenue for your business and for the business of your promotional partners.

What could be better than a real win-win situation? With cross-promotion not only can you generate more customers and profit, usually for free, but you can help another entrepreneur do the same!

One simple example of good cross-promotion is swapping business cards with another business in your area. The idea is to find a related, yet non-competing operation, give them a stack of your cards to hand out and take a stack of their cards in exchange.

For example when I ran a local Web design company I swapped stacks of business cards with a nearby computer repair service. It made sense because both of us targeted small businesses, and nearly all small businesses today have computers in their office and a Website to promote their products and services. So often my customers would have an interest in a good computer repair service, and the repair shop's clients might be interested in somebody to build or re-design their Website.

It's easy to see how both parties stand to benefit in this arrangement. And the customers of both businesses also benefit!

Putting together a win-win cross-promotion on the Web is even easier, and here are a few examples of how you might do this:

Exchange Thank You Page Ads
Thank you or confirmation pages that prospects see after they make a purchase or register for a free mailing list are great places to post promotions. The people who see these pages are action takers, making them the ultimate target for a good advertisement.

You could place an ad for your cross-promotion partner on one or more of your thank you pages and have them do the same for you.

Unannounced Member Bonus
If you and your promotional partner run membership programs, you could place unannounced bonuses within one another's secure member areas. For instance, when members login to your site they could find a "free gift" from your partner, and be required to register at your partner's Website to receive access to their free gift; of course you would place a similar promotion in your promotion partner's member area.

Swap Autoresponder Messages
You could include an email in your automated message series promoting your partner's product or service, and they could reciprocate with an email for you. You could even promote as affiliates for one another so you both earn commissions in the process.

Cover Page Promotions
If you and your partner both produce digital information products such as e-books and special reports, you could swap promotions on the first page of your PDF products. This would provide both of you with quality exposure as your ads would be seen by the people who purchase and actually open digital products; so prospects generated by this measure are both buyers and action takers.

These four examples are just the tip of the iceberg. Once you sit down and really brainstorm about innovative ways to cross promote you might be amazed with what you come up with.

Both you and your promotional partner(s) stand to benefit, and neither of you will need to pay any advertising expense to generate new traffic and sales.

About the Author: Tim Whiston is a professional Internet marketer who enjoys his work. He has owned numerous Websites and ezines and has created hundreds of thousands of dollars in profits for his clients. Be sure to check out his free Information Marketing Course and Internet Marketing Tools.

http://www.entireweb.com/newsletter/archive/2008/PRINT407.html

______________________________________________

3. Upgrading the VL Update eMemo!

I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com

In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________

You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… 

And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com

For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...

Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .

01/18/08 - SOPs and FDA Regulations

2008-01-18T11:34:00.000-08:00

… VLUeM – 01.18.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...

This issue: saving your company from costly new FDA regulations…
_______________________________________________

1. Health Freedom Blog update
2. News Target targets FDA attacks on supplements… are your SOPs ready?
3. Food niche with potential
4. VL Memo Archives Blog - improved format for this Update eMemo!
______________________________________________

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/

Factoid: FDA just decided not to define the word “Natural” although petitioned to do so. Functional Nutrition Magazine also tells us that “Natural” was the favorite word last year for launching new food products, appearing on almost 2,500 of them. See: http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1553&strSite=FFNSite

The OneLook.com meta-dictionary defines “Natural” as: “adjective: existing in or produced by nature; not artificial or imitation… (used especially of commodities) in the natural unprocessed condition…”

eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join

If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .

This eMemo is being sent through my “back-up” Earthlink email address since AOL is still blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________
2. News Target targets FDA attacks on supplements – see SOP Alert! below.
“FDA Announces Plan to Eliminate Vitamin Companies by Byron Richards
“(January 15 - NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... very small …and …small dietary supplement manufacturers … will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)

”This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.

”Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.”
To read more: http://www.newstarget.com/022499.html
SOP ALERT FOR COMPANIES: Now more than ever, “your papers must be in order…” – The Vitamin Lawyer Consultancy has prepared formats for Standard Operating Procedures to allow small companies to comply with the new rules, including the new AER law, by maintaining the necessary records. Our SOP format is relatively short (about 20 pages) but does cover all the areas needed:
A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management
You can find out more at: http://tinyurl.com/2eu6yj
If you need the format, please email me at ralph.fucetola@usa.net and put “SOP” in the subject line. Typically, it takes an hour or two of my time to fine tune the format for you.
______________________________________________

3. Food niche with potential

Report pinpoints functional food niche with most potential - By Lorraine Heller

January 16, 2008 - Foods and drinks developed to address the specific health needs of consumers are expected to exceed category growth in the US functional food segment, according to a new report. Published by TSG, the study estimates that 'targeted foods', which currently make up 12 percent of the $60bn functional food segment, could grow to take a massive 25-35 percent share in 2012. This could bring up the total value of the sub-segment to between $55bn and $77bn over the next 13 years. Functional foods as a whole are projected to have a market value of $219bn by 2012.

TSG defines targeted foods are those functional foods that are designed to address specific health or disease conditions; specific physical or mental states; or specific age or gender needs. These, says the study, will grow "exponentially" as the functional foods markets continues its ascent into the mainstream.

"They will be the evolution of functional foods," TSG CEO Panna Sharma told NutraIngredients-USA.com.

Foods and beverages in this category include products that address: Digestive health, Celiac disease, Arthritis, Cancer prevention, Heart health

[Note from Vitamin Lawyer: some of these claims would not be allowed as Dietary Supplement claims.]

…[Other of these] products address: * Sports performance, * Beauty, * Skin care, * Libido, * Brain function

…TSG states: "Beverages will continue to drive innovation and early consumer adoption which will drive tighter alignment between functional ingredients and nutraceutical companies and the beverage community."

…"Global food and beverage giants will aggressively enter the market through acquisitions, alliances and select investments," said TSG.

For more –

http://www.nutraingredients-usa.com/news/ng.asp?n=82599&m=1NIU116&c=jegwylrviswtnqa
______________________________________________

4. Upgrading the VL Update eMemo!

I’m getting closer to the new version of the Update eMemo. I’ve begun to post earlier memos on a blogspot.com Blog. You can see it at: http://vitaminlawyerarchives.blogspot.com

In the future, you’ll receive a shorter weekly update email with links to Blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________

You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… 

And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com

For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider donating to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...

Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .

01/04/08 - FDA on AER Labeling

2008-01-04T08:35:00.000-08:00

… VLUeM – 01.04.08 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

PRIVATE MESSAGE: The purpose of the VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Private, privileged & confidential...

This issue: saving your company money…
_______________________________________________

1. Health Freedom Blog update
2. Web site titles and descriptions
3. The Electric Tree – savings and more
4. Guidance from FDA on AER labeling
5. Cost of foods… calorie
6. Coming next year: improved format for the VL Update eMemo!
______________________________________________

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Postings - http://vitaminlawyerhealthfreedom.blogspot.com/

Factoid: Nutrition Business Journal (nutritionbusiness.com) announced recently that the global nutrition industry has reached $226-billion annually. Other sources suggest the US share is about 50% -- so what portion of that $113 billion a year does your company earn?

eAlerts – STOP FORCED VACCINATION! A powerful new tool to stopped forced vaccination has been established by the Natural Solutions Foundation. You can join this open Yahoo!Group at: http://groups.yahoo.com/group/no-forced-vaccination/join

If you will be in the NYC area on January 26th and would like to meet with Gen. Stubblebine, Dr. Laibow and myself about ending forced drugging and vaccinations (they have a six hour stop over at JFK on their way to a Codex meeting in Africa) let me know; it will be a brunch or lunch meeting near the airport. And you can always join the Health Freedom eAlert list at: www.globalhealthfreedom.org .

This eMemo is being sent through my “back-up” Earthlink email address since AOL seems to be blocking my usa.net emails; however, please email me at ralph.fucetola@usa.net as I monitor that email all the time. If you have an AOL email address, please add my usa.net address to your permitted list.
______________________________________________

2. Web site advice from Entireweb Newsletter * January 1, 2008 * ISSUE #401 – entireweb.com

“How to Create Compelling Site Titles and Descriptions - There are many places in your HTML you can include keywords, but the Titles and descriptions are arguably the most important elements of your Web site… These places are …most important in terms of their ability to compel someone to visit your Web site. That is, after all, the ultimate goal of search engine positioning, isn't it? Not a lot of point in attaining a top ranking in a search engine if you are just going to call you site "Shop Here." …the Title tag has special relevance, because so many search engines use the title exactly as it appears on your page. …the title of the site is more important than the site description.

“Longer Titles are More Effective - Longer titles build a more compelling reason to visit a Web site. Because it takes a certain number of words to persuade someone to take action, logic dictates that longer sentences have more opportunity to create that compelling argument… People often scan headlines in brochures and magazines, even when they don't read all the information…

“People Don't Read Text, They Recognize Words - …Educators know that people glance at words and recognize the words by the shapes defined by the tops of the letters. …Since people recognize words because the tops of words vary in height and appearance, then sentences that start with just one capital letter and then lowercase letters are easier to recognize and get read faster… Words in all caps are hard to read…

Every little advantage helps you.” - Pamela Upshur - upshurcreative.com
______________________________________________

3. The Electric Tree = savings and corporate responsibility

Natural Solutions Foundation has been chosen as one of The Electric Tree’s 2008 Corporate Responsibility Designees. What does this mean to your business? If you are located in one of the currently covered states (NY, CT, MA. IL, MD, DE ) and choose to participate, with NO cost to you, The Electric Tree can save between 8 and 14% of your electric power bill… if you spend at least $2,000 per month or more on electricity and are willing to donate half your savings to the Foundation. This can be a “win – win” situation. It is very simple to do. If you have interest, please email me with Electric Tree in the subject line.

______________________________________________

4. FDA Guidance & AER Labeling
You can find a listing of FDA guidance documents for the vitamin industry at: http://www.cfsan.fda.gov/guidance.html

Among the new guidances published is a draft labeling guidance for the AER (adverse event reporting) system, with frequently asked questions. This document was finalized on January 2, 2008, as “Guidance for Industry: Questions and Answers Regarding, the Labeling of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act” - Docket No. 2007D-0491. It can be found at: http://www.cfsan.fda.gov/~dms/dsaergu2.html

Here is the summary of the label requirement: “the act requires the label of a dietary supplement being marketed in the United States to include a domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. If the label does not include the required domestic address or telephone number, the dietary supplement is misbranded.” FDA also “recommends that the label bear a clear, prominent statement informing consumers that the domestic address or telephone number is for reporting serious adverse events associated with use of the product.”

http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/07-6266.htm

Please note the distinction between “the act requires…” and FDA “recommends.” If a company voluntarily chooses to add language that the phone number or address on the label is there to report AERs, FDA does say “dual purpose” language such as “"To report a serious adverse event or obtain product information, contact..." would be acceptable.

And the FDA’s overall FAQs for AERs cam be found at: http://www.cfsan.fda.gov/~dms/dsaergui.html

That document also states: “Your submission will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported. Any serious adverse event report submitted to FDA, including any new medical information submitted as a follow-up to the initial report, is considered a safety report under section 756 of the FD&C Act (21 U.S.C. 379v) and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the serious adverse event.”

If you have any occasion to report an adverse event, you ought to have the report reviewed by The Vitamin Lawyer before submitting it.
______________________________________________

5. Cost of food, per calorie
Reuters reported on 01/02/08, “the average price of the lowest-calorie foods -- including green vegetables, tomatoes and berries -- increased by almost 20 percent over 2 years. In contrast, in the same time period there was a 2-percent dip in the cost of the most calorie-laden fare, such as butter, potato chips, cookies and candy bars… findings, published in the Journal of the American Dietetic Association, highlight a key obstacle to healthy eating. … They found that snack foods, sweets and fatty foods offered the most bang for a shopper's buck. Whereas the price of the lowest-calorie fruits and vegetables was more than $18.16 per 1,000 calories, the most calorie-rich foods cost $1.76 per 1,000 calories.”
______________________________________________

6. Upgrading the VL Update eMemo!

Coming early this year: this email update system will be replaced by a second, private blog, the Vitamin Lawyer Update Blog, to allow me to keep you up-to-date better than ever! You’ll receive a shorter weekly update email with links to blog articles that will be posted as the information becomes available… more timely information better indexed!
______________________________________________

You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… 

And do remember to check out the VLUeM Online Archives: http://tinyurl.com/rkneb
Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq
For an outline of typical cGMP SOP docs: http://tinyurl.com/2eu6yj
Vitamin Lawyer Oversight Seal: http://tinyurl.com/2cfoyb
For the latest on Adverse Event Reporting: http://www.aer-consultants.com
Vitamin Lawyer Health Freedom Blog: http://vitaminlawyerhealthfreedom.blogspot.com

For Health Freedom Issues: http://www.globalhealthfreedom.org - Please consider making an end-of-the-year donation to Natural Solutions Foundation - your help is needed to protect the natural products market from bureaucratic interference...

Wishing you and yours a joyous, prosperous, peaceful and free new year!

Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com – ralph.fucetola@usa.net
All Rights Reserved © 2008 . . .

12/14/07 - Saving Your Company Money

2007-12-14T19:13:00.000-08:00

… VLUeM – 12.14.07 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

This issue: saving your company money…
_______________________________________________

1. Health Freedom Blog update
2. Key food product trends
3. How do your email “click throughs” rate?

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/
NJ Tops Maryland in Compulsory Vaccination Stupidity

eAlerts – STOP COMPULSORY DRUGGING & VACCINATION! please go to: http://www.globalhealthfreedom.org and sign up for the eAlert list today! Better, please tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact…

Practice Note #1: FDA has brought together its various guidances on Food Defense and Terrorism. You can find this information at: http://www.cfsan.fda.gov/~dms/defguids.html

“FDA has simplified these documents by repackaging the information found in each guidance document into the new Food Defense Self Assessment Tool.”

Practice Note #2: It took a couple weeks of persistent emails to Google Adsense, but we just got Adsense to reject a paid ad by a competitor of a VitaminLawyer.com client where the competitor had purchased the client’s name to pass-off their inferior product as the real deal… I suspect deciding factors were that the client had her own name as one of her URLs and that it was a well-known name, not just a business phrase, thereby rising to the status of what the law calls a “famous mark.”
______________________________________________

2. Key food product trends

From an email: The 10 Key Trends for 2008 are:

“Key Trend 1: Digestive Health – a wellness issue and the biggest opportunity
Key Trend 2: Fruit and superfruit – the future of food and health
Key Trend 3: The marketing power of “naturally healthy”
Key Trend 4: Beauty foods – the newest niche
Key Trend 5: Weight management more about maintaining than losing
Key Trend 6: Mood food feels its way
Key Trend 7: A tipping point for the premiumisation of health
Key Trend 8: Healthy snacking for the “me” generation
Key Trend 9: Kid’s nutrition – connecting to multiple trends is crucial
Key Trend 10: Antioxidants - the new probiotics…

“Premiumization” has become a standard for healthy foods …which brands are able to command price premiums of 100%-800% over regular foods – and how they do it
Green tea, antioxidants, probiotics and fibres are the ingredients with the brightest futures
Omega-3 and plant sterols will continue to be niche ingredients
How packaging innovation is the biggest product differentiator…”
______________________________________________

3. How do your email blast “click throughs” rate?

What is the average click-through rate for email newsletters? I reproduce an excellent answer from Emaillabs.com:

Answer: The click-through rate is important because without it, you don't get conversions. However, there's no single benchmark click-through rate, because CTRs depend on many factors: whether you send to a business or consumer audience, the kind of mailing you send, how relevant it is to your audience, how often you send, your opt-in process, your use of personalization and segmentation and dozens of other factors. And most significantly, how many links you have in your email and if you are providing content such as articles, whether you include the entire article within the body of the email or you have a teaser or snippet that requires subscribers to click through to a Web site to read.

Beyond that, many companies calculate and report CTRs differently - using total rather unique clicks. Many subscribers will click on multiple links, which means that CTRs based on "total" clicks are typically about two times higher than those based on "unique" clicks..

That being said, below are some ranges for average CTRs for permission-based house lists. CTRs that we cite are based on unique clicks (only one click per person is counted) and are calculated as: unique clicks/emails delivered:

* B2B newsletters typically range from 5% to 15%. If yours are consistently below that level then among other things, you are probably providing content of little value to your subscribers. Or you may have most of the content within your email, not giving subscribers a reason or means to click-through to your site.
* B2C promotional emails often range from about 2% to 12%. Emails with less than a 2% CTR may be a result of over mailing and questionable opt-in processes.
* Highly segmented and personalized lists (B2B and B2C) are often in the 10% to 20% CTR range. Also, email messages with very strong content but sent to unsegmented lists, like many news or trend-type newsletters, are often in the 10%-15% range.
* Trigger or behavior-based emails (emails that are sent to a recipient based on some behavior they showed, such as clicking on a product link, visiting a specific Web page, etc.) are often in the 15% to 50% range.

If your emails are typically showing under say 2-3% CTRs, some of the causes likely include:

* Poor permission or opt-in processes. This includes pre-checked boxes, not making it clear what type of email they will be receiving, automatically adding someone to receive your email when they've actually signed up for something else such as a whitepaper, etc.
* Poorly written subject lines that do not direct and motivate recipients to take an action.
* Poor delivery rates. If a lot of your emails are getting blocked or filtered and you don't know it, your CTR will obviously be affected.
* Poor open rates. If few people open your email, fewer recipients have a chance to click.
* Poor design and layout. If they can't easily find where to click through or aren't motivated to by your layout - you've got trouble in River City.
* Lack of links. Quite simply, the more links the better. Make it so that readers are continuously stumbling over text and graphic links like they do signage in a retail store.
* No reason to click. If your newsletter has a single or multiple articles in their entirety, then don't expect them to click. You haven't given them any reason. If you are sending a promotional email and you don't include a deadline for the offer, or convey a discount, special offer, limited supply, etc., few people are probably going to take action.

emaillabs.com/FAQ/email_marketing_faq_1.html

12/07/07 - Insurance for Your Products

2007-12-07T19:14:00.000-08:00

… VLUeM – 12.07.07 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

This issue: saving your company money…
_______________________________________________

1. Health Freedom Blog update
2. Insurance for your products
3. The Electric Tree = savings and more
4. Bayer told to tone down vitamin claims
5. HOLIDAY DISCOUNT: VITAMIN LAWYER’S TIME FOR SALE!
6. Coming next year: improved format for the VL Update eMemo!
______________________________________________

1. Vitamin Lawyer Health Freedom Blog & Factoids
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

eAlerts – STOP FORCED VACCINATION! If you are on the Natural Solutions Foundation eAlert list you received an alert about the emergency health freedom advocates’ meeting in Tiburon CA I attended. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: http://www.globalhealthfreedom.org and sign up today! Better, please tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally.

And they’re getting the idea behind The Codex 2 Step:

"Although Codex is not a regulatory body, its decisions are used as a benchmark of discussion should trade disputes arise in the future, and while Codex does not have the same force of law as an EU directive or national legislation, it is used as a reference point for countries that are looking at revising or creating legislation."
nutraingredients.com/news/ng.asp?n=81841&m=1NIED05&c=jegwylrviswtnqa

For an 8 minute video of me explaining the Codex 2 Step, see: http://youtube.com/watch?v=rlmyvDnn2i0
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2. Insurance for your products

Obtaining product insurance has become increasingly difficult as FDA/FTC regulatory oversight has ratcheted up. I’ve worked with one particular agent here in NJ for nearly a decade and many of the Vitamin Lawyer clients have found his services reassuring. Here is the type of information that is needed for the application.

1) Description of all named insured person or entities
2) Financials – latest annual income statement and balance sheet.
3) 5 years of sales/receipts history
4) Product labels & brochures, reflecting ingredients in the products
5) 5 year currently valued company loss runs or “No Known Loss Letter.
6) Expiring program including carrier, limits, deductible, premiums, and term.
7) Does the insured have or plan on having any products containing Organ/Glandular Extracts, Ephedra, Colloidal Silver, Green Tea, Synephrine/Bitter Orange, Kava, Lobelia, Magnolia or Yohimbe products? If so what are the product names, what percentage of their sales is applicable to these products and how many milligrams go in the products? We will need these product names and labels

I have the 8 page application form available; please email me with “Insurance App” in the subject line.

The agent tells me that he spoke with the underwriters. “They are not willing to speculate on the impact [of the new Adverse Event Reporting law that goes into effect on December 22, 2007]. They aren't doing anything [with rates] at the moment, but will be following it over time to determine its impact. … "
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3. The Electric Tree = savings and corporate responsibility

Natural Solutions Foundation has been chosen as one of The Electric Tree’s 2008 Corporate Responsibility Designees. What does this mean to your business? If you are located in one of the currently covered states (NY, CT, MA. IL, MD, DE ) and choose to participate, with NO cost to you, The Electric Tree can save between 8 and 14% of your electric power bill… if you spend at least $2,000 per month or more on electricity and are willing to donate half your savings to the Foundation. This can be a “win – win” situation. It is very simple to do. If you have interest, please email me with Electric Tree in the subject line.

______________________________________________

4. Bayer told to tone down vitamin claims

December 5, 2007 - The National Advertising Division (NAD) of the Council of Better Business Bureaus is recommending Bayer Healthcare modify or discontinue certain claims surrounding its Vital and Sharp Mind supplement. NAD, the Federal Trade Commission and industry trade associations have been targeting the marketing claims of supplement makers. Because this move involves a large player in the health industry getting its knuckles rapped by a monitoring body, it could send out warning signals to smaller companies about being more careful in marketing their products… NAD found no fault with following its review are that Vital & Sharp Mind "supports memory, mental sharpness, and healthy brain function", as well as that it promotes "memory, concentration, and mental sharpness," and can "keep your mind vital and active." [But] … there was insufficient evidence to support the claim made in a television commercial that Vital & Sharp Mind could assist healthy adults in recalling a list of items that was recited moments earlier… this claim suggests the product can actually assist healthy adults in recalling a list of names that was recited moments earlier. The agency says this level of effectiveness goes beyond the general claim made by Bayer that the product "supports" memory and as such requires further scientific evidence…”

nutraingredients-usa.com/news/ng.asp?n=81855&m=1NIUD05&c=jegwylrviswtnqa
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5. Holiday Sale! Vitamin Lawyer Time for Sale…

It’s that time of year when your successful natural product business needs to expense out profits… So, why don’t you prepay The Vitamin Lawyer for consulting time good anytime in 2008? Here’s my special holiday deal: buy two hours at regular rate, $295/hr and get a third hour FREE… that’s a 33% savings! You can reserve as many hours as you’d like. We all know the dollar is tanking… that means all professional fees will be going up this coming year. Lock in 2007 discounted rates now! You can go to my PayPal page, http://tinyurl.com/yvdapx or email me with VL DISCOUNT in the subject line. And have happy holidays; prosperous new year!

______________________________________________

6. Upgrading the VL Update eMemo!

Coming next year: this email update system will be replaced by a second, private blog, the Vitamin Lawyer Update Blog, to allow me to keep you up-to-date better than ever! You’ll receive a shorter weekly update email with links to blog articles that will be posted as the information becomes available… more timely information better indexed!

11/29/07 - EU Court: Foods are not Drugs

2007-11-29T19:17:00.000-08:00

VLUeM – 11.29.07 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO

_______________________________________________
1. Health Freedom Blog update
2. Health Freedom victory in the EU
3. Herbs at a glance… NCCAM listing
______________________________________________

1. Vitamin Lawyer Health Freedom Blog
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/
The Tiburon Statement: No Forced Vaccinations!

eAlerts – STOP FORCED VACCINATION! If you are on the Natural Solutions Foundation eAlert list you received an alert the day before yesterday about the emergency health freedom advocates’ meeting in Tiburon CA this past weekend I attended. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: http://www.globalhealthfreedom.org and sign up today! Better, tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally.
______________________________________________

2. Victory for health freedom in the EU

As we’ve been saying for years, "Foods are not drugs..." Now says the European Court of Justice, about the German attempt to ban the importation of garlic capsules:

"Regarding the concept of a medicinal product by function, the Court stated that garlic capsules do not contain any substance other than natural garlic and have no additional effects, either positive or negative, compared to those derived from the consumption of garlic in its natural state. In contrast, a medicinal product must have the function of preventing or treating disease. Beneficial effects for health in general are not sufficient."

This rational and just decision, recognizing, as it does, that foods can have health benefits without that fact categorizing the food as a "medicine," is a major step toward more open and freer healthcare in Europe.

Congratulations to the Court of Justice!

nutraingredients.com/news/ng.asp?n=81424-european-botanical-forum-garlic-harmonisation-supplements
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3. Herbs at a Glance…

NACCAM – the National Center for Complementary and Alternative “Medicine” is publishing information about herbs, which can be found at: http://nccam.nih.gov/health/herbsataglance.htm

You may find this a useful resource to suggest some claims support. WARNING: the site uses the word “treat” inappropriately, confusing normal nutrient effects with treatment of disease… Maybe a US court needs to tell NACCAM what the EU high court just told Germany: food health benefits are not drug claims!

11/16/07 - AER on Your Labels?

2007-11-16T19:19:00.000-08:00

VLUeM – 11.16.07 - VITAMIN LAWYER WEEKLY UPDATE e-MEMO
_______________________________________________
1. Health Freedom Blog Update, Factoid
2. Best Practices Alert: AER on the label??
3. Evidence based healthcare
4. FDA food safety initiative
5. Healthcare professionals take vitamins!
______________________________________________

1. Vitamin Lawyer Health Freedom Blog
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

Supply Side West – Last week; industry association representative comments on the new AER law: “When questioned on the upcoming adverse events reporting (AER) bill, Seckman [NPA executive director] responded that when the legislation comes into effect at the end of the year, there will be an initial spike in incidences as reporting increases. However, he said this will then stabilize and eventually have a positive effect on the dietary supplement industry's image. "Then we will see that the baseline numbers will be low consistently," said Seckman. "We will then look to publicize this in industry."”

nutraingredients-usa.com/news/ng.asp?n=81338&m=1NIUN13&c=jegwylrviswtnqa

eAlerts - If you are on the Natural Solutions Foundation eAlert list you received an alert early this morning (I thinkwe sent it out about 6 AM…) about my foundation co-trustees, Dr. Laibow and Gen. Stubblebine at the Codex meeting. More about that meeting below. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: http://www.globalhealthfreedom.org and sign up today! Better, tell everyone on your elist to do the same! This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally. Imagine the impact if the list were One Million Health Freedom Warriors… ready to click their mousse for your right to sell and use high potency products!
______________________________________________

2. Best Practices Alert: AER on the label?

I’ve recently seen a few draft labels with statements like “We report all serious adverse events to the FDA.”

Please remove such statements! Mentioning "Adverse Event" might give customers the wrong idea... that they might have an “adverse event” with your product! I have read both the new AER law and the FDA guidance regarding same very carefully (just reread them to be sure) there is NO requirement for any mention of AER on the label!

The law is very specific that filing a serious adverse event report is not an admission of responsibility, but, if you mention AERs on your label, aren’t you admitting that you are selling a product that might harm a customer?

All the law does require is that you to have your company name and an address or phone number on the label. If The Vitamin Lawyer Consultancy reviews your labels, you know they will comply. For more information about the new AER law that goes into effect on December 22, 2007, please see: www.aer-consultants.com

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3. Evidence based healthcare

From Answer.com - answers.com/topic/evidence-based-practice

Evidence based practice (EBP) is an approach to care wherein professionals use the best evidence possible, i.e. the most appropriate information available, to make clinical decisions for individual patients. EBP promotes the collection, interpretation, and integration of valid, important and applicable patient-reported, clinician-observed, and research-derived evidence. The best available evidence, moderated by patient circumstances and preferences, is applied to improve the quality of clinical judgments and facilitate cost-effective care.

This involves complex and conscientious decision-making based not only on the available evidence but also on patient characteristics, situations, and preferences. It recognizes that care is individualized and ever changing and involves uncertainties and probabilities. Ultimately EBP is the formalization of the care process that the best clinicians have practiced for generations – from the country “Doc” who knew his patients to the practitioner who knew his patients over decades.

Evidence-based practice (EBP) develops individualized guidelines of best practices to inform the improvement of whatever professional task is at hand. Evidence-based practice is a philosophical approach that is in opposition to rules of thumb, folklore, and tradition. Examples of a reliance on "the way it was always done" can be found in almost every profession, even when those practices are contradicted by new and better information.

Evidence-based design and development decisions are made after reviewing information from repeated rigorous data gathering instead of relying on rules, single observations, or custom. Evidence-based medicine and evidence-based nursing practice are the two largest fields employing this approach. In psychiatry and community mental health, evidence-based practice guides have been created by such organizations as the Substance Abuse and Mental Health Services Administration and the Robert Wood Johnson Foundation, in conjunction with the National Alliance on Mental Illness.

This model of care has been studied for 30 year in universities and is gradually making its way into the public sector. It effectively moves away from the old “medical model” (You have a disease, take this pill.) to a “evidence presented model” using the patient as the starting point in diagnosis. EPBs are being employed in the fields of health care, juvenile justice, mental health and social services among others.

Key elements in using the best evidence to guide the practice of any professional include the development of questions using research-based evidence, the level and types of evidence to be used, and the assessment of effectiveness after completing the task or effort. One obvious problem with EBP in any field is the use of poor quality, contradictory, or incomplete evidence. Evidence-based practice continues to be a developing body of work for professions as diverse as education, psychology, economics, social work and architecture.

According to Norcross et al (2006) "the burgeoning evidence based practice movement in mental health attempts to identity, implement, and disseminate treatments that have been proven demonstrably effective according to the empirical evidence". However, Norcross et al (2006) also state that perhaps it is more useful to identify what does not work - discredited psychological treatments and tests, and has conducted survey research on discredited psychological treatments. Examples of discredited psychotherapies include: the use of pyramid structures, orgone therapy, crystal healing, past lives therapy, chiropractic manipulation, neurolinguistic programming and Erhard Seminars Training.
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4. FDA food safety initiative

HHS Unveils Plan to Strengthen, Update Food Safety Efforts
Plan uses integrated collaborative approach to meet demands of a global economy to protect American consumers

HHS Secretary Mike Leavitt today announced a comprehensive initiative by the Food and Drug Administration designed to bolster efforts to better protect the nation's food supply. The Food Protection Plan proposes the use of science and a risk-based approach to ensure the safety of domestic and imported foods eaten by American consumers.

"America's food supply is among the safest in the world, and we enjoy unprecedented choice and convenience in filling the cupboard. Yet, we face new challenges to meet both the changing demands of a global economy and consumers' expectations," Secretary Leavitt said. "This Food Protection Plan will implement a strategy of prevention, intervention and response to build safety into every step of the food supply chain."

HHS Deputy Secretary Tevi Troy and FDA Commissioner Andrew von Eschenbach, M.D., presented the Food Protection Plan at a press conference in Washington, D.C.

"FDA must keep pace with this transformation so that the safety of the nation's food supply remains second to none," said Commissioner von Eschenbach. "The Food Protection Plan calls for effective action before an outbreak occurs."

The Food Protection Plan, which focuses on both domestic and imported food, complements the Import Safety Action Plan delivered by Secretary Leavitt to the President earlier today that recommends how the U.S. can improve the safety of all imported products. This year, $2 trillion worth of goods will be imported into the U.S., and experts predict that amount will triple by 2015. The Import Safety Action Plan lays out a road map with short- and long-term recommendations to enhance product safety at every step of the import life cycle. Taken together, the two plans will improve efforts by the public and private sector to enhance the safety of a wide array of products used by American consumers.

Advances in food production technology, rapid methods of food distribution, and globalization have transformed supermarket shelves and restaurant menus, broadened the tastes of consumers, and challenged the existing food protection framework.

"Although our agency clearly needs to maintain and enhance its response capacity, the primary goal is to prevent contaminated food from ever reaching the consumer," said von Eschenbach.

The plan is premised on preventing harm before it can occur, intervening at key points in the food production system, and responding immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals. Taken together, these efforts will provide a food protection framework that ensures that the U.S. food supply remains safe.

To strengthen its efforts to prevent contamination, FDA plans to strengthen support of food industry efforts to build safety into products manufactured either domestically or imported. The FDA will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.

The plan's intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports.

The plan calls for enhancing FDA's information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency.

The Food Protection Plan's three core elements--prevention, intervention, and response--incorporate four cross-cutting principles for comprehensive food protection along the entire production chain:

* Focus on risks over a product's life cycle from production to consumption;
* Target resources to achieve greatest risk reduction;
* Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination); and
* Use science and employ modern technology, including enhanced information technology systems.

The Food Protection Plan is available at fda.gov/oc/initiatives/advance/food/plan.html.
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5. Healthcare professionals take vitamins!

The Council for Responsible Nutrition (CRN) has announced as part of the initial results from its survey of healthcare professionals that, contrary to industry belief, the sector is in fact both using and recommending dietary supplements.

"It reconfirms what we know: that supplements are very mainstream in the US," CRN vice president of communications Judy Blatman told NutraIngredients-USA. Industry repeatedly claims there is a perceived divide between its products and so-called mainstream medicine - but Blatman says this may not even be as prevalent as once thought and that the key now is to get healthcare professionals to talk more to their patients about the potential benefits of these products.

"We need to make sure that we as an industry are communicating with healthcare professionals and that they are communicating with their patients and getting accurate information," said Blatman… Perhaps even more surprising is that not only did the survey reveal that 72 percent of physicians use supplements… 85 percent recommend them to their patients…”

nutraingredients-usa.com/news/ng.asp?n=81401&m=1NIUN15&c=jegwylrviswtnqa

11/09/07 - Codex Meets; eMail Blasts

2007-11-09T19:21:00.000-08:00

VLUeM – 11.09.07 - VITAMIN LAWYER UPDATE e-MEMO

1. Health Freedom Blog Update, Factoid
2. Codex about to meet on health claims
3. How to improve your email blasts

1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

If you are on the Natural Solutions Foundation eAlert list you received an alert early this morning (I think I sent it out about 2 AM…) about my foundation co-trustees, Dr. Laibow and Gen. Stubblebine on their way to the Codex meeting. More about that meeting below. If you want to stay current on health freedom issues, you really need to sign up to the eAlert list - please go to: http://www.globalhealthfreedom.org and sign up today! Better, tell everyone on your elist to do the same. This list of several hundred thousand purveyors and consumers of natural products and remedies is having a powerful impact in Washington and internationally. Imagine the impact if the list were One Million Health Freedom Warriors… ready to click their mousse for your right to sell and use high potency products.

2. Codex about to meet on health claims

By: Alex McNally - Nov. 9, 2007 - Codex members are due to sit down and vote on a series of far reaching rules governing nutrient compounds in foods - and crucially discuss whether health claims should be based only on clinical studies. Although Codex is not a regulatory body, its decisions are used as a benchmark of discussion should trade disputes arise in the future, and while Codex does not have the same force of law as an EU directive or national legislation, it is used as a reference point for countries that are looking at revising or creating legislation.

In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods should be supported by science - and has caused uncertainty for the industry since coming into force in July. The Codex meeting… will vote upon whether scientific evidence should be based solely on clinical studies. This suggestion has come under fire from trade groups who say this would be "unfeasible."

nutraingredients.com/news/ng.asp?n=81247&m=1NIEN09&c=jegwylrviswtnqa

3. Better email blasts for your business

Entireweb always has good advice -- here is the entire article on email blasts

Entireweb Newsletter * November 6, 2007 * ISSUE #385 * www.entireweb.com

2 Dozen Ways to Improve Your E-Mail Marketing Results

I suppose I can title this article "25 Email Marketing Mistakes I've Made." But rather than focus on the negative, below I've outlined the best practices I’ve come to adopt over the years. Hope you find something here useful.

1. Diversify your Content: If your entire email focuses on one product, service, or topic, you risk alienating all but the few people who will be interested. Unless you have segmented your database based on previous behavior, do not send an email on only 1 topic. I consistently find that the click through rate increases in proportion with varied content.

2. Don't Stress about Spam Words: Many experts will tell you to avoid words like "free" or "sale". In my opinion, ISPs tend to be moving away from content based spam filtering in favor of reputation based filtering. In other words, your sending IP address and from email are more important than whether or not
your email contains certain words. Personally, I've used words like "free" in the subject line without any affect on delivery rates.

3. Make it Readable with Images Disabled: Always take into account the appearance of your email with images disabled. For email clients such as Outlook, this is now the default feature. Even popular web mails like Hotmail now disable images unless the sender is in the address book of the recipient.
The best tactic to create readable emails with images block as an alt description.

4. Create an Online Version: Always provide an online version of your email for users having trouble viewing images. I've calculated from emails I've sent in the past that around 5% of users will use this feature.

5. Remove Inactive Subscribers: Inactive subscribers are the most likely to get you in trouble by clicking the spam button. Consider automatically removing a subscriber that hasn't opened an email in several months.

6. Proofreading: Always have every email proofread by at least 2 detail oriented people. There's nothing more embarrassing than a typo in an email blast.

7. Monitor Replies: When you send out thousands of emails, you're bound to get a few replies. Occasionally, you'll get some good feedback from your subscribers. In addition, some people reply with unsubscribe requests.

8. Unsubscribe at Top: I know what you're thinking, "At the TOP!?" Yes, at the top. Lazy unsubscribers have a tendency to click the spam button instead scrolling down to find the unsubscribe link. By placing the link at the top, you might increase your unsubscribe rate, but that's better than an inflated spam complaint count.

9. Don't Over or Under Mail: If you send too much, you'll get deleted or marked as spam. Oddly enough, if you send once every 3 months you may have the same problem. Keep your brand top of mind for your customers by finding the perfect balance between over and under mailing.

10. Forward to Friend Feature: Many users automatically do this, but it doesn't hurt to ask. First time potential customers can be very open to a company when it is introduced by a friend or colleague.

11. Subscribe Feature for Forwards: Make it easy for potential new subscribers to subscribe if they receive your email as a forward. Include somewhere in the body a subscribe link.

12. White List Reminder: If you want your subscribers to add you to their white list or address book, you need to ask. Sure, not everyone will add you. However, those who do are likely the people who care most about receiving your emails and, therefore, you have the most to lose if your emails get flagged as spam.

13. Single Click Unsubscribe: I generally recommend keeping the unsubscribe as simple as possible. However, you may want to confirm the action if you place your unsubscribe at the top of every email in case users click the link on accident.

14. Privacy Policy: Always place your privacy policy at the bottom of every email. Assure customers that you obtained their email address in a legitimate fashion, and you will not sell their personal info.

15. Don't Rent Lists: Some may disagree on this, but I've never seen anything good come from a rented list. Don't risk your sender reputation with emails from questionable sources. If you want to reach a new audience, consider a joint venture with another firm in a similar but non-competing industry.

16. Develop your Brand: Remember that your emails will slowly build your brand in the minds of your subscribers. Even if they never click-through and make a purchase, be sure to keep a consistent and accurate corporate image with your email content.

17. Call to Action: Each section must contain a specific call to action that avoids vague phrases like "click here." You'll be surprised how an effective call to action button or link can improve your click through rate.

18. Mix Freebies with Products: Too much selling can burn people out. Engage your subscribers with useful, free content. For example, if you sell home theater equipment, send out an article on the explaining the benefits of newer technologies. When you provide additional value to your customers with
learning resources, they are sometimes even willing to pay more for your merchandise. In addition, strategies like this keep your brand top of mind.

19. Find Your "Tuesday": For the eCommerce sites I've worked with, Tuesday morning has always resulted in the best open, click-through, and conversion rates. However, every company is different.

20. Same Day, Same Time: Be consistent in the time you send your emails for two reasons. First, the ISPs see inconsistency as a possible spam flag. Spammers can care less when they send out mass emails. Second, your customers will begin to anticipate your emails at a certain time each week, possibly
increasing the likely hood of them opening and clicking through.

21. Keep the Good Stuff above the Fold: Remember that many email clients will obscure a large portion of your email unless the user scrolls down. Make sure the top 400 pixels are as engaging as possible. I can't tell you how many times I've had to send artwork back to the design department because the top
of the email failed to grab your attention.

22. A/B Test 1 Variable at a Time: It took me far too long to learn this. For years, I would change several factors in each successive email blast, but never could find that perfect mix. If you really want to find out what works, you can only change 1 variable. For example, should the subject line be short or long? Keep the same content and split your list in 2, sending half a longer subject and the other half a shorter one. Do not change any other variables!

23. 600 Pixel Width: Due to the limitations of many email clients, stick with a width somewhere between 500 to 600 pixels wide.

24. Experiment with Subject Lines: I wish there was a magic principle I can share with you about subject lines. Unfortunately, there isn't. The best we can do is test, test, and test again. Sometimes short subjects are better, sometimes long, sometimes intriguing, sometimes urgent, whatever works best for you. Here's a great article on email subject lines.

25. Begin Segmentation & Personalization Now: In a few years, email marketers that don't practice segmentation and personalization will be left in the dust. There are an endless number of ways to segment your email list. Some popular ways are by purchase behavior, geography, or ordering frequency.

As a long term strategy, I would also greatly encourage researching transactional and trigger based email marketing, as they tend to product much better open, click-through, and conversion rates. To learn more about eCommerce Email marketing, please visit the Palmer Ecommerce Marketing Blog.

Justin Palmer offers expert eCommerce consulting services and Do It Yourself search engine optimization lessons. In addition, Justin is the eCommerce director for C28.com, which sells Spiritual t-shirts and Witness wear.

11/02/07 - FDA Commissioner Warns Industry

2007-11-02T19:23:00.000-07:00

VLUeM – 11.02.07 - VITAMIN LAWYER UPDATE e-MEMO

Lots of ground to cover in this memo… important information…

1. Health Freedom Blog Update, Factoid & Client GMP Warning
2. Raising the RDA
3. Taking vitamins is good for you
4. Organic is better…
5. Warning from new FDA Commissioner to DS industry
6. SEO for small businesses

1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

“In the past, over-conservative government-sponsored [maximum level] standards have encouraged dietary complacency…” - Vitamin Safety Review Panel

Client GMP Warning: This just in: one of the Vitamin Lawyer clients reports receiving a request from his production people: “In the very near future we are going to need a copy of your stability study which substantiates your Exp [expiration] date. FDA requires that this be on file and available for review.” This particular client is wisely having his contract manufacturer laboratory retain samples to test every six months so he will have the data.

Please note that the FDA does not currently require the use of “expiration” or “best if used by” dates.

The new GMP Rule comments state: “if you use an expiration date on a product, you should have data to support that date... We recommended that you have a written testing program designed to assess the stability characteristics of the dietary supplement, and that you use the results of the stability testing to determine appropriate storage conditions and expiration dates… the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label (including a ‘best if used by’ date) should be supported by data.”

To get on to the Global Health Freedom eblast list, please go to: http://www.globalhealthfreedom.org

2. Raising the RDA

“The US Recommended Daily Allowance/Daily Reference Intakes are too low and most should be raised immediately, says an independent panel of physicians, academics and researchers. In a statement this week, the Independent Vitamin Safety Review Panel said: “Government-sponsored nutrient recommendations, such as the US RDA/DRIs, are not keeping pace with recent progress in nutrition research… In the past, over-conservative government-sponsored standards have encouraged dietary complacency. People have been led to believe that they can get all the nutrients they need from a 'balanced diet' of processed foods. That is not true. For adequate vitamin and mineral intake, a diet of unprocessed, whole foods, along with the intelligent use of nutritional supplements, is more than just a good idea: it is essential.”

orthomolecular.org/resources/omns/v03n10.shtml

3. Taking vitamins is good for you…

Knowledge of Heath, Inc. - nutritionj.com/content/pdf/1475-2891-6-30.pdf
Special Report: Dietary Supplement Fanatics Healthiest Of All - By Bill Sardi © 2007

“They may not be laughing at vitamin supplement fanatics much longer. According to an authoritative study just published in The Nutrition Journal, avid dietary supplement users who, on average, take 17 different supplements daily, were judged to be far healthier than adults who just take a single supplement such as a common multivitamin, or who don't take dietary supplements at all.…While more than half of U.S. adults take dietary supplements, nearly
half of these supplement consumers take only one type of supplement, most commonly an inexpensive multivitamin…Risk for disease was far lower among the multi-supplement users compared to non-users. Risk for diabetes was 73% less, coronary heart disease 52% less, and self-determined health status (report health status was rated as "good or excellent") 74% more often, compared to non-supplement users.

This study may dispel a common belief that a low-dose multivitamin may be sufficient to address essential nutrient shortages. Source: Gladys Block, et al, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study. The Nutrition Journal, 6: 30, 2007

4. Organic is better…

“The biggest study into organic food has found that it is more nutritious than ordinary produce and may help to lengthen people's lives. The evidence from the £12m four-year project will end years of debate and is likely to overturn government advice that eating organic food is no more than a lifestyle choice. The study found that organic fruit and vegetables contained as much as 40% more antioxidants, which scientists believe can cut the risk of cancer and heart disease, Britain’s biggest killers. They also had higher levels of beneficial minerals such as iron and zinc.”

timesonline.co.uk/tol/news/uk/health/article2753446.ece

5. Warning from new FDA Commissioner to DS industry

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), outlined what the agency claims is its science-based approach to regulating dietary supplements

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr. Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have
seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

The article continues: When DSHEA was passed a decade ago, there were about 4,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, which cannot be put on the market unless a high threshold of evidence about their safety and efficacy is met, and that, like foods, such dietary supplements should in general be given the benefit of the doubt as to safety. A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements and that there are about 29,000 such products on the market, with another 1,000 new products introduced each year.

altmedicine.about.com/cs/govtregulation/a/FDAPlan.htm

Are your papers in order? http://tinyurl.com/2eu6yj

6. Search Engine Optimization for Small Business Owners

Entireweb Newsletter * November 1, 2007 * ISSUE #384

Small business owners are often limited by small marketing budgets and manpower. But that doesn't mean they can't compete against larger businesses or websites when focused on search engine optimization. SEO is a basic marketing tool that everyone should use regardless of size...

What makes a keyword competitive? One way to determine the competitiveness of a search term is to simply type that search term into Google and notice the number of web pages that contain that search term. This number appears in the upper right-hand corner of the search results page and appears as, "Results 1 - 10 of about 228,000,000 for [your search term here]." ...From my perspective, when this number is less than 3 or 4 million, the particular search term would not be all that competitive in and of itself.

Determining just how competitive the search term is. There are a variety of methods to determine true keyword effectiveness (KEI, etc.)... In addition to the number of sites that contain your keyword, how well optimized are the top 3 sites that appear on the search result. You can determine this by:

1. Visiting the site and determining the Google PR of the page. This information is available by downloading the Google toolbar and looking in your browser. You will see a green bar and ranking (ex: PR5), which tells you how Google ranks this page/website with regard to popularity. Any site with a Google PR6 or better is well established and will be difficult to outrank in the near term.

2. Visit Google and type , "link:www.competitorwebsite.com". Be sure to replace 'competitorwebsite' with the website name you are researching... This will tell you how many sites are linking to this particular website. The larger the number the more difficult it will be to outrank.

3. Look at the website code. Simply visit the competitor's website and go to "View", "View Source". Look for the meta tags of "Title", "Description", and "Keywords"...

Using the above will give you a good sense of whether of not you can compete for given keywords...

About the Author: Michael Fleischner is an Internet marketing expert with more than 12 years of marketing experience... webmastersbookofsecrets.com

entireweb.com/newsletter/archive/2007/PRINT384.html

10/26/07 - EU Regs; CAM; GMPs

2007-10-26T19:26:00.000-07:00

VLUeM – 10.26.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update, Factoid & Client Notice
2. EU – taking over world food regulations?
3. CAM & Natural Products… perfect together…
4. Public support for CAM reimbursement
5. Fighting over GMP requirements
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1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

“With food supplements, we have an extremely cost effective and very safe tool to better public health.”
S. Hasslberger - newmediaexplorer.org/sepp/index.htm

Notice: Due to the continuing decline of the Dollar and increased costs, The Vitamin Lawyer Consultancy hourly rate has increased to $295 – the regular monthly retainer client rate remains $250 per hour, however.

To get on to the Global Health Freedom eblast list, please go to: http://www.globalhealthfreedom.org
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2. EU – taking over world food regulations?

Sepp Hasslberger’s Health Supreme Blog often has a very good knowledge of pending issues. He explores the claim that EU “Napoleonic Code” regulation of foods – including natural remedies, dietary supplements and functional foods – is being spearheaded by the European Union. The most serious problem from the viewpoint of the American wellness marketplace is the old legal distinction between “Code” countries, where whatever is not approved is prohibited, and Common Law countries, like the US, where whatever is not forbidden is allowed; the centuries-old struggle between free markets and mercantilism continues!

Sepp quotes one unnamed source: “One American official says flatly that the EU is ‘winning’ the regulatory race, adding: ‘And there is a sense that that is their precise intent.’ He cites a speech by the trade commissioner, Peter Mandelson, claiming that the export of ‘our rules and standards around the world’ was one source of European power. Noting that EU regulations are often written with the help of European incumbents, the official also claims that precaution can cloak ‘plain old-fashioned protectionism in disguise’.”

“Protectionism” is certainly not a friend of advanced healthcare and wellness companies, especially in our globalized world marketplace. Sepp’s article, on the dangers of “HARMonization” with Codex is a must read.

www.newmediaexplorer.org/sepp/2007/10/15/codex_alimentarius_will_eu_laws_become_world_standard.htm

And what would be the effect of the EU takeover on your business? On your vitamin use? Here is what one UK nongovernmental organization, ANH, noted in a report critical of the “science” behind upper limits: “upper levels being considered for nutrients such as beta-carotene could be exceeded by eating two carrots…”

nutraingredients.com/news/ng.asp?n=80871&m=1NIEO25&c=jegwylrviswtnqa
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3. CAM and Natural Products… perfect together…

From The Integrator Blog: Parallel Play or a Potent Alliance? Alternative Medicine Practitioners and the Natural Products Industry are Stronger Together - David Matteson, MPM, MURP, MS

"The Natural Products Industry (NPI) and the complementary and alternative medicine (CAM) industry are each in the midst of a major transformation. Their ability to learn how to 'play' together may be crucial to how well these industries grow and succeed over the next few years.

"There is a natural relationship between these two industries. Many policy makers and many consumers see them as flip sides of the same coin. Yet, these two industries have not really acknowledged their interconnectedness, let alone taken active steps to collaborate on their common political and market interests.”

theintegratorblog.com/site/index.php?option=com_content&task=view&id=368&Itemid=189
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4. Public support for CAM reimbursement

While I am no fan of licensing laws (‘A license is a limitation…”) An Iowa health reform poll shows 68% of voters want licensed CAM professionals covered in basic insurance benefits.

”A broad-ranging survey on health reform topics by the Gilmore Research Group found that 68% of voters believe basic health care benefits should include coverage for any licensed health care professionals.
Licensed professionals directly noted in the survey of 601 Iowa voters were ‘naturopathic physicians, acupuncturists and chiropractors.’ The survey was commissioned by Code Blue Now! - a national, non-partisan, not-for-profit citizen organization formed to build public consensus in health care policy. The Iowa population was strategically selected to have a maximum influence on the healthcare reform debate.”

theintegratorblog.com/site/index.php?option=com_content&task=view&id=365&Itemid=189
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5. Fighting over GMP requirements

The FDA’s new Good Manufacturing Practices will be phased in over two years, giving smaller companies some time to get ready… the most difficult area as been the new requirement for “100% Identity Testing” with many companies complaining that there may be no available lab tests that can determine identity where a product has a dozen or more ingredients, some in such low amount as to be nearly nano dilutions.

“The FDA (US Food & Drug Administration) published the final rule on Good Manufacturing Practices, known as GMPs, in June. The soon-to-be-implemented GMP legislation forms part of the 1994 Dietary Supplements Health and Education Act (DSHEA) and is set to provide standards specific to the industry for inspectors to check for purity, safety and legality in manufacturing. Both the Natural Products Association (NPA) and the American Herbal Products Association (AHPA) find fault with the fact that under the current GMPs, only supplement manufacturers, but not ingredient suppliers, can submit petitions for exemptions from 100 percent identity testing.”

It is expected that FDA will accommodate the needs of companies with specialized products that may not be susceptible to the required lab testing.

nutraingredients-usa.com/news/ng.asp?n=80939&m=1NIUO26&c=jegwylrviswtnqa

10/19/07 - AER Draft Guidance; Health Claims

2007-10-19T19:27:00.000-07:00

VLUeM – 10.19.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update & Factoid
2. A Case Study: how NOT to make claims
3. AER draft guidance issued
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1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

Vitamin D and Longevity - “Published in the September 10 issue of Archives of Internal Medicine, the meta-analysis examined 18 previously published studies which had suggested that deficiencies in vitamin D lead to a higher risk of death from cancer, heart disease and diabetes. However - given that these illnesses account for between 60 and 70 percent of deaths in high-income nations - the current analysis indicates the opposite. In fact, those individuals isolated from the studies who did take vitamin D had a seven percent lower risk of death than those who did not take it. "If the associations made between vitamin D and these conditions were consistent, then interventions effectively strengthening vitamin D status should result in reduced total mortality," wrote the researchers, hailing from the International Agency for Research on Cancer in France and from the European Institute of Oncology in Italy - nutraingredients-usa.com/news/ng.asp?id=79675
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2. FDA targets company making cancer treatment claims - By Clarisse Douaud

[VL comments: Here is a good example of how NOT to make claims!]

“In another move to prevent dietary supplements infringing on the territory of pharmaceuticals, the US Food & Drug Administration (FDA) has issued a warning to Zeo Health for three of its products…

“Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Instead, only ingredients not marketed in the US before October 1994 must be approved by FDA before being used in consumer products…

“Unlike, pharmaceutical drugs, dietary supplements are permitted few health claims… "The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," wrote FDA in a letter to the New York state-based company… FDA objects to …promotion …for cancer prevention and treatment. The agency highlights an example of phrasing to this effect as found on the company's website:

"The scientific community has recently had very positive results on the effect of Zeolite on certain types of cancers. In tests on a variety of tumor types, the treatment with Zeolite led to improvement of overall health status, prolongation of life span, and a decrease in tumor size." The insinuation that the supplement can prevent or treat cancer continues in the dosage information provided by Zeo Health.

"For prevention: As a nutritional supplement, take 2 capsules twice daily. As part of Cancer therapy: As a dietary supplement, take 6 capsules three times daily." [VL Notes: these directions are clearly “treatment” directions.]

“FDA also revealed that Zeo Health claims on its website that the supplement Esdifan is recommended for consumers with irritable bowel syndrome and Crohn's disease. "Esdifan is the most effective relief for diarrhea and bad stomach. Better than any drug on the market....," stated Zeo Health on its company website, according to FDA.

“In its website marketing, Zeo Health leapfrogs from cancer prevention to hangover cures in its product claims.

“The company claims that its Zeolite supplement absorbs toxins associated with alcohol before they make it into the organs: "ZEO absorbs the toxins from the alcohol before they are processed into your organs."

“FDA has urged Zeo Health to respond to its letter within 15 working days of receipt, advising the agency of the steps the company is taking to correct the violations. "Failure to do so may result in enforcement action without further notice." - nutraingredients-usa.com/news/ng.asp?n=78382-zeo-health-fda-warning-letter”
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3. FDA AER draft Guidance finally issued! Excerpts from the guidance:

“1. When do the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act become effective? -- The effective date for compliance with the requirements of this law is December 22, 2007.

2. What types of foods are covered by the Dietary Supplement and Nonprescription Drug Consumer Protection Act requirements? -- The requirements of this law only apply to dietary supplements. No other types of food are covered.

5. What is an "adverse event?" -- An "adverse event" is "any health-related event associated with the use of a dietary supplement that is adverse."

6. What is a "serious adverse event?" -- A "serious adverse event" is an adverse event that: Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

7. What is a "serious adverse event report?" -- A "serious adverse event report" is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States.”

The AER Consultants web site, www.aer-consultants.com will be analyzing form 3500A and will be providing assistance for companies to comply.

10/12/07 - Web Design Help; When to Patent

2007-10-12T19:28:00.000-07:00

VLUeM – 10.12.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update / Factoids
2. Contracting with your web designer
3. More on the Chinese ingredient crunch
4. Where are the FDA’s AER Regs?
5. When to patent?
6. Web Design Simple Mistakes and Golden Rules
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1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

Expanded and updated AER (Adverse Event Reporting) web site, with draft AER Guide:
http://www.aer-consultants.com

Factoids: “Food and ingredient prices are growing at a faster pace in China than anywhere else in the world”

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2. Contracting with your web designer

I've seen so many clients have awful problems with web designers!

Here's the issue from the designer's viewpoint:
http://reymendoza.blogspot.com/2006/01/web-design-contract-essentials.html

And this one from the company's perspective:
http://www.out-law.com/page-521

These together should give you a handle on the problem.

3. More on the Chinese ingredient crunch…

High energy and commodity prices have plagued companies at all levels of the food industry for the past few years.

Over the past couple of years alone major players such as CP Kelco, FMC Biopolymer, BASF, Novozymes, Cargill, Danisco and DSM, have all hiked up their prices for products ranging from vitamins E and B3, to sugar molasses and citric acid.

This month DSM announced a ten per cent price increase for all its citric acid, produced in Belgium, on a worldwide basis. The increase, which is effective immediately, was "due to cost increases in raw materials and in energy".

In the wake of "sharp increases" in raw materials, in September the firm further announced a 10 per cent rise in global prices for vitamin E supplies. Orafti pushed up prices of its Beneo fibre ingredient by six per cent.

Bio Springer also said rising costs and shrinking supply of sugar molasses were driving up the cost of yeast extract production, announcing a double digit price increase for its extracts as of next year. Sugar molasses are the main raw material for yeast extracts but over the past three years the cost of sugar molasses has risen by 10 per cent. Energy prices and the impact of the EU's sugar reform were blamed.

This summer Swiss biotech company Lonza announced a worldwide price hike of up to 12 per cent for vitamin B3 in a bid to pass-on increasing production costs…

For more see:
nutraingredients.com/news/ng.asp?n=80369&m=1NIEO08&c=jegwylrviswtnqa
ap-foodtechnology.com/news/ng.asp?n=80370-us-department-of-agriculture-dean-foods-wimm-bill-dann
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4. Where are the FDA’s AER Regulations?

Industry criticizes FDA for failure to act - where are the FDA regulations?
Companies turning to private experts for guidance.

10/09/07 - FDA must commit to AER guidance
Functional Ingredients Staff
functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1467&strSite=FFNSite

"The detailed data required under new adverse event reports (AERs) laws, need to be made transparent sooner rather than later, a major trade group has told the United States Food and Drug Administration. The Maryland-based American Herbal Products Association (AHPA) has requested what it considers an overdue guidance document to give the supplements industry a clearer idea of what is expected of them when the law kicks in on December 22. FDA guidance was expected on September 19 but has yet to see the light of day.

"AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS). The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."

"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."

For more information on private alternatives to meet the statutory requirements: www.aer-consultants.com
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5. When to patent.

This is a good background article on patenting: “Patently wise: what, how and where to patent” by Michel Morency and James Ewing

October 10, 2007 - Patent protection can be an effective tool for excluding competitors and generating revenues, if used wisely and married to a company's business strategy. Conversely, obtaining patents can quickly become an expensive and wasteful proposition if done haphazardly and not tied to an effective business strategy.

With the nutraceutical industry spending more and more resources on research and development, companies are turning to patents to protect their new products and investments. However, to get the most out of a patent, manufacturers need to familiarize themselves with the limits and potential of the process.

The first step in designing an effective patent strategy is to understand what a patent can and cannot do for the owner. A patent does permit the patent owner to exclude competitors from making, using, importing and selling the invention, as claimed in the patent.

The fact that a commercial product is described in the patent application is of no use if it is not covered by the scope of the claims. Accordingly, it is important to continuously monitor any claim amendments and any change to the product to ensure that the claims actually cover the final commercial product. A patent does not grant the patent owner the right to make, use, or sell the invention if doing so would infringe another party's patent.

Therefore, a patent strategy should always include a review of third party patents...

Finally, it is important to note that a patent can only be enforced in its country of origin… Obtaining patent protection in several countries can be a very expensive ordeal. The filing and translation costs alone can reach $10,000-15,000 per country. Costs of securing patent protection in a large number of countries can easily reach multiples of $100K or millions over the lifetime of the patents.

A common international patent strategy is to pursue patents in key developed health care markets including the US, Canada, Europe, Japan and Australia... A common misconception is that a company needs to obtain a patent in each and every country in which the product will be sold. A patent is not required to make, use, or sell in a given country; it is only useful to exclude competitors… Your patents are an important asset to your company…

Michel (Mike) Morency, Ph.D., LL.B., is a partner in Foley's Boston office… He can be contacted … via email at mmorency@foley.com - James F. Ewing, Ph.D., J.D., is senior counsel in Foley's Boston office… He can be contacted … via email at jfewing@foley.com

nutraingredients-usa.com/news/ng.asp?n=80483&m=1NIUO10&c=jegwylrviswtnqa
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6. Web Design - Simple Mistakes and Golden Rules

Excerpts from: Entireweb Newsletter * October 11, 2007 * ISSUE #378 * www.entireweb.com

Good web design … sticking to a small set of guiding principles and avoiding some very common mistakes…

1. Keep Everything Obvious - Don't Make Me Think… Visitors to a website expect certain conventions, breaking these is a great way of losing visitors. People expect to find the navigation at the top of a page or on the left hand side. Logos are mostly found on the top left. Much research has been conducted into how people view and use web pages. The good news is that you do not to know all of this; instead look at how larger companies such as eBay, Amazon, Google, Microsoft structure their pages and the language they use, then emulate them.

2. Limit Colours - A website using too many colours at a time can be overwhelming to many users… Limiting a palette to 2 or 3 colours will nearly always lead to a slicker looking design…

3. Be Careful With Fonts - The set of fonts available to all visitors of a website is relatively limited… It is advisable to stick to fonts such as Arial, Verdana, Courier, Times, Geneva and Georgia… Black text on a white background is far easier for the majority of people to read than white text on a black background. If you have large amounts of text then a white or pale background is far more user friendly. Always ensure that there is a good contrast between any text and its background…

4. Plan for Change - …The ability to add or remove content from a website is fundamental… Understanding how to use Cascading Style Sheets (CSS), avoiding unconventional layouts and complicated backgrounds will all help enormously.

5. Be Consistent - Again, don't make your visitors think! About how to use your site at least. If your navigation is at the top on your homepage, it should be at the top on all other pages too. If your links are coloured red ensure the the same convention is used on all sections…

6. Keep it Relevant - A picture is better than a thousand words but if the picture you took on holiday is not relevant to your Used Car Sales website then you should really replace it … If you can take something off of your web page without it adversely affecting the message, appearance or legality of your website you should do it without hesitation… Keeping your content focused will ultimately help your search-engine rankings.

7. Become a CSS Expert - Cascading Style Sheets should be any web designer's best friend. CSS makes it is possible to separate the appearance and layout of your page from the content. This has huge benefits when it comes to updating and maintaining your site, making your site accessible and making your site easy for search engines to read…

8. Avoid Complexity - Using standard layouts for your web page will save you development time and make your site easier to use…

The principles above all border on common sense and are well known to most people, yet so many sites continue to deviate away from them and suffer as a consequence. Following these principles will help you keep away from trouble, although it still doesn't guarantee it!

About the Author: Paul has worked as a programmer and in Web Design for over 15 years. morley-computing.co.uk - entireweb.com/newsletter/archive/2007/ISSUE378.html

10/05/07 - 7 Marketing Mistakes to Avoid; Oversight Seal

2007-10-05T19:29:00.000-07:00

VLUeM – 10.05.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update / Factoid
2. DHEA threatened again…
3. Do you sell in Europe?
4. Vitamin Lawyer Oversight Seal
5. 7 Marketing Mistakes to Avoid when Promoting your Business
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1. Vitamin Lawyer Health Freedom Blog –
New Posting - http://vitaminlawyerhealthfreedom.blogspot.com/

Factoid: "There are currently more than 194 million people with diabetes worldwide, set to exceed 333 million by 2025."

The price of Chinese produced Vitamin C has gone from $3.5 to nearly $20 since July.
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2. DHEA Threatened Again

“ ------ Original Message ------
From: news@naturesbotanicals.com
Subject: Action Alert--Stop Congress from Restricting Access to DHEA

Action Alert--Stop Congress from Restricting Access to DHEA

Your access to DHEA is in jeopardy! The Senate is considering a bill, S. 762, to classify DHEA as an anabolic steroid, adding it to the list of controlled substances and removing it from the market. H.R. 1249 is the companion bill in the U.S. House of Representatives. Your immediate help is needed to keep this safe and effective dietary supplement legal and accessible.

DHEA is not an anabolic steroid. It is a naturally occurring hormone that has a wide range of benefits, including maintaining muscle strength and strong bones, boosting immunity, and improving mood and sleep patterns. Further
studies suggest that DHEA may be helpful for such conditions as obesity, cancer and Alzheimers disease. DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family; for more information. – http://www.capwiz.com/nnfa/issues/bills/?bill=9492216 ”

We need your help to keep DHEA legal. Send a message to Congress asking your Senators and Representative to oppose S. 762 and H.R. 1249 and any amendment to restrict access to DHEA to minors. Congress should not restrict access to a dietary supplement that has given health to millions of Americans. Take action now!

If you want some background see my article on how I kept DHEA legal in 1995. http://www.lifespirit.org/dhealegal.html
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Index

3. Do you sell to Europe?

If people in Europe buy through your web site, you do. “The scope of the changes will not just affect food packaging, but any content including websites associated with the food.”

Innocent found guilty over antioxidant health claim
www.nutraingredients.com/news/ng.asp?n=80271&m=1NIEO03&c=jegwylrviswtnqa
By Alex McNally

10/03/2007 - UK's Innocent has been rapped on the knuckles for making a health claim about its smoothie having a high antioxidant content and detoxifying effect. The Advertising Standards Authority (ASA) said an advert by the firm, which claimed its fruit juice contained more antioxidants than the "five-a-day" portion, was not truthful or substantiated.

The verdict will come as a blow to Innocent and could set a precedent for other companies looking to make claims about antioxidant ability of fruit. It also adds the pressure on speeding up EU rules, which will require all health claims to meet a Commission-improved list. Although no official wording or accepted health claims have been approved, it seems that advertising regulators are already tightening up on health claims in preparation, and food companies should think carefully before making a health claim.

This is the second time in a week a company has come under fire for making a statement about a products' health or nutritional benefit. Last week the UK Tea Council was criticised for exaggerating the benefits of tea, and banned from making further claims about the drinks' antioxidant potential after running a series of adverts...

Under regulation (EC) No 1924/2006, which came into force in the UK from 1 July 2007, any food product claiming to have a health benefit must meet a list of European Commission-approved wording and be supported by scientific evidence.

Although the regulation came into force this month in the UK, the European Commission is not expected to agree a list of approved literature until the end of the year. The scope of the changes will not just affect food packaging, but any content including websites associated with the food.

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4. Vitamin Lawyer Oversight Seal
"The trademark Vitamin Lawyer Oversight Seal may only be displayed on a website if the owner of the website meets or exceeds specific standards. Displaying the Seal indicates:

1. The Website content has been reviewed for FDA and FTC regulation compliance by The Vitamin Lawyer.*
2. The Company’s cGMP (Current Good Manufacturing Practices) have been reviewed for government and industry standards.
3. The Company’s product labels are formatted and printed in conformity with FDA regulations.
4. The Company’s Internet advertisements comply with FDA/FTC regulations.
5. The Website’s content has been reviewed for clarity and appropriateness.

Subject to the Vitamin Lawyer Consultancy standard retainer agreement.

http://tinyurl.com/2cfoyb - Oversight Seal

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5. 7 Marketing Mistakes to Avoid when Promoting your Business

Entireweb Newsletter * October 2, 2007 * ISSUE #375
www.entireweb.com

Many people rush into business thinking it will be easy to run, but very soon they realize that it is not as easy as it looks. A successful business is a finely tuned machine. In order to keep your business running smoothly it is important to avoid making mistakes. Here are the 7 most common mistakes to avoid:

1. Not having clear objectives: Many business people start a business without clear objectives. They fail to set realistic goals for their marketing and consequently set themselves up for failure. It is important to make a list of goals and objectives based on a quarterly time line...

2. Neglecting to analyse your potential customers: Neglecting to analyse your potential customers is a dangerous mistake... When you do not analyse your customers wants and needs you do not know what products and services to develop for them. This will lead to targeting the wrong market and neglecting to understand your own niche market...

3. Not testing: By not testing your sales copy and places you advertise with split testing your advertising, you will be losing sales... If you do not test your ad copy and marketing promotions you will not have a proper idea of the ads and promotions that are pulling and what is not working...

4. Not budgeting: Budgeting is extremely important in business. Your business should never run out of money. This is especially true with your marketing and advertising ventures. It is important to have a monthly or quarterly budget for your marketing... Start small, test and then build on successes. This will allow you to always stay solvent and have enough for promotions.

5. Giving up too soon: Companies go out of business at an alarming rate these days. One of the reasons is that the owners give up too soon... You need to give your promotions at least 3 months before you decide to scrap them... As always, test all marketing tactics before you launch a larger promotion...

6. Poor sales copy: How often have you wanted a product but when you read the sales page you had serious doubts? Poor unprofessional ad copy will cost you sales...

7. Not screening your employees carefully...

The golden rule is to diversify. You should always use multiple forms of marketing promotions in your business. Do not just do one or two promotions and then wait for results. This will slow company growth and your business will stagnate...By avoiding these mistakes you will take your company to the success you deserve... So plan ahead and be careful not to make these common mistakes.

About the Author: Sean McPheat is a leading authority marketing consultant and helps businesses across the UK, Europe, US and the Middle East... www.seanmcpheat.com

09/28/07 - Vitamin Label Warnings; Functional Beverages

2007-09-28T19:30:00.000-07:00

VLUeM – 09.28.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. How to Avoid Alienating Search Engines
3. Vitamin Label Warnings
4. Functional Beverages… the future of supplementation?
5. Are your papers in order?
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1. Vitamin Lawyer Health Freedom Blog - New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

Does the FDA really want public comments?
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2. SE Tactics: How to Avoid Alienating the Major Search Engines
http://www.entireweb.com/newsletter/archive/2007/ISSUE373.html

Some more good advice from EntireWeb.com:

Each of the major search engines… have quality webmaster guidelines … prevent … manipulation of search engine rankings …. These webmaster guidelines change frequently … and those websites found engaging in these illicit practices are consequently dropped from the search engine rankings....

Being banned or dropped from the search engine rankings can have dire effects on your website traffic, online sales generation and site popularity…

If you wish to avoid alienating the major search engines then do not engage in the following SE tactics:

1. 'Cloaking' or sneaky redirects - displaying different content to the search engines than shown to your normal website visitors including hidden text and hidden links. …
2. 'Doorway' pages created specifically for the search engines that are aimed at spamming the index of a search engine…
3. Don't create pages that install viruses, Trojans or badware. 'Badware' is spyware, malware or deceptive adware…
4. Avoid using software that sends automatic programming queries to the search engines to submit pages or check rankings... you will be penalized for using it.
5. Don't load web pages with irrelevant words.
6. Don't link to 'bad neighborhood' sites who have: Free for all links pages, Link farms - automated linking schemes with lots of unrelated links, Known web spammers or the site has been dropped or banned by the search engines.
7. Avoid 'broken links' or '404 errors,' your site will be penalized for them.
8. Don't display pages with minimal content that is of little value to your site visitors.
9. Do not duplicate content unnecessarily.
10. Do not use pop-ups, pop-unders or exit consoles.
11. Do not use pages that rely significantly on links to content created for another website.
12. Do not use 'cross linking' to artificially inflate a site's popularity... multiple sites cross linking … together, if all sites are hosted on the same servers the search engines will pick this up and the sites will be penalized.
13. Do not misuse a competitors name or brand names in site content.
14. Sites with numerous, unnecessary virtual host names will be penalized.
15. Do not use techniques that artificially increase the number of links to your web pages ie. Link farms.
16. Display web pages with deceptive, fraudulent content or pages that provide users with irrelevant page content.
17. Using content, domain titles, meta tags and descriptions that violate any laws, regulations, infringe on copyrights & trademarks, trade secrets or intellectual property rights of an individual or entity….

About the Author: Rosemary Donald is an SEO Consultant with www.rank1websitemarketing.com - & author of the SEO ebook 'Insider Secrets of Rank 1 Websites'
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3. Vitamin Label Warnings…

In addition to the statutory FDA “…not evaluated…not intended…” disclaimer, here are some warnings for you to consider for your labels; please note that the AER warning may have to be modified when the final AER regulations are issued in the next couple weeks.

Product Warnings:

- Keep out of reach of children.
- Do not exceed recommended dose.
- Do not use if outer or inner seal is broken or damaged.
- If you have a serious adverse reaction to product, discontinue use
immediately, seek medical attention if necessary, and contact us.
- If you are undergoing treatment for a medical condition or if you are pregnant
or lactating, consult your physician when taking this product.

In addition to the above, you may need a Food Allergy Warning:

“The term “major food allergen” means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.”

That warning should read: ALLERGY WARNING: contains [list allergens].

Finally, there is a special warning for iron containing pills or capsules: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”
http://www.cfsan.fda.gov/~dms/secgiro2.html
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4. Functional Beverages… the future of supplementation?

Nutraingredients.com reports: “As part of its newsletter on equity research - Healthy Living Monthly … highlighted an increased consumer focus on health and wellness as a key driver of new trends… growth and innovation will stem from more alternative segments. There will as such be opportunities for functional beverage and ingredients manufacturers alike as these categories grow. But it depends on how they align their resources and efforts.

"The beverage industry has become a leading delivery vehicle for functional nutritional ingredients, is a major beneficiary of the convenience movement in the US, and is desperate, in our opinion, for any new ideas to offset the stagnant market for carbonated soft drinks," write the report's authors.

Canaccord Adams valued the US nonalcoholic beverage market at $100bn in 2005. Carbonated soft drinks (CSDs) take up the majority of this market, with a reported $64.7bn in sales. However, the analyst says growth in the nonalcoholic segment is coming from categories other than soft drinks as consumers move towards healthier options or, at least, options that are perceived as healthier.

The firm conjectures this interest in healthier beverages is in part due to the fact US consumers are increasingly overweight. An estimated 66 percent of adults in the US are either overweight or obese, based on results from the 2003-2004 National Health and Nutrition Examination Survey (NHANES). The rate of obesity more than doubled from the previous NHANES survey - increasing from 15.0 percent (1976-1980) to 32.9 percent (2003-2004).

In terms of recommending how manufacturers large and small ought to innovate in this market, the report repeatedly highlights the example of the rise of energy drink.

"The history of the energy drink category in the United States illustrates both the opportunities and the risks that exist as change occurs within the beverage industry," write the analysts.

While Canaccord Adams has identified emerging trends in the beverage market as being fortification, functionality, and a shift towards premium, "green" and organic products… For instance, instead of water, beverage manufacturers should now look out for 'enhanced' water.

"Don't buy commodity bottled water today, despite its enormous profitability," states the report. "It is late in the trend, and the early adopters are telling us that."

Waters fortified with healthy ingredients hold the biggest potential and are being cashed in on by the beverage giants. Coca-Cola this year forked out $4.1bn to acquire vitamin water company Energy Brands for the manufacture and marketing of new nutritionally enhanced vitamin water lines.

These fortified categories are the way of the future, according to Canaccord Adams… The analyst states that though dairy was once the bastion for beverage fortification, it has given way to alternative drink sources that come with perhaps less calories or fat.

http://www.nutraingredients-usa.com/news/ng.asp?n=80162&m=1NIU927&c=jegwylrviswtnqa
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5. Are your papers in order?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and let me know how if can help your company organize for future success!

09/19/07 - Eco Friendly Packaging; SOPs up to date?

2007-09-19T19:32:00.000-07:00

VLUeM – 09.19.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. More EU machinations
3. Eco-friendly packaging
4. Boomers and Dietary Supplements…
5. Are your SOPs up to date?
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SEPTEMBER 19: Fairfield, New Jersey, 7pm. Dr. Laibow, Gen. Stubblebine III, Ralph Fucetola (the Vitamin Lawyer), Prof. Murray Sabrin (spokesperson for Presidential candidate and US Congressman Ron Paul) and a spokesperson for Presidential candidate Dennis Kucinich are guest speakers at the Health Freedom vs. Health Tyranny Rally.

VFW Post 7925, 45 Plymouth Road, Fairfield, NJ. 937-227-9600.
Your Rights to Natural Health Care are in Jeopardy!

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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

Asking Congress to demand FDA reporting on AERs
--------------------------------------------------------

2. Does the situation in Europe portend developments here?

The FDA’s public policy of “harmonizing” with international regulations suggests so. Here is a report on what is happening in Europe, a potential market for many US dietary supplements and model for US regulators.

“…the harmonization process for EU food laws, including maximum mineral and vitamin levels, has "a long way to go" before completion. European Advisory Services (EAS) said the "vastly different national approaches" currently in place will continue to impact on companies launching onto the European marketplace. Manager of scientific and regulatory affairs Efi Leontopoulou also stressed the strategic importance of the evolving regulatory climate in non-EU countries such as Russia and Turkey, which she described as being "two complex but very promising markets for the food industry." She added that: "Bulgaria and Romania have recently joined the EU and this creates new market opportunities but also more challenges in terms of the harmonization process."

A lengthy wait is predicted due to the number or rules and complexity of the current situation, but EAS was unable to say how long this might take prior to publication. The warning means that uncertainty about what may or may not be imposed for minerals and vitamins will continue to spread through the industry. Some countries could suffer a blow if EU legislation were to proscribe the sale of high dose products or vice versa. In the UK, for example, high dose products account for 12 to 15 per cent of the £220m vitamin and mineral market and could experience trouble... Member states at the moment vary dramatically on maximum and minimum levels, which would come to an end once Europe-wide unification is imposed.

Yesterday NutraIngredients.com reported how lobbyists from Consumers for Health Choice have pleaded with the commission president José Manuel Barroso to not stay away from a heavy-handed approach to maximum levels. The setting of maximum levels forms part of the 2002 Food Supplements Directive, and the new with fortified foods regulation...

"Working with all of these different national legislations in Europe can be quite a minefield for companies, from issues such as the addition of nutrients to foods and the types of ingredients permitted in countries, to details on new product notification requirements and national approaches towards derogations for vitamins and minerals."

…A working party of Member States is expected to sit down and discuss maximum health claims next week, and the Commission is expected to propose a directive with actual figures in 2009.”

www.nutraingredients.com/news/ng.asp?n=79835&m=1NIE918&c=jegwylrviswtnqa
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3. Eco-friendly packaging

A recent issue of a nutrition industry magazine carried an interesting article on eco-friendly packaging. The two newest offerings are Polyactide (PLA) plastic bottles (made from corn and readily biodegradable) and Tetra Paks. The PLA is colorful, costs less than petroleum-based plastic and uses less energy to produce. The Tetra Paks, vaguely rectangular in shape, are mostly recyclable paper, but with a special aseptic process that allows liquids long shelf life without degrading the ingredients high temperatures, irradiation, etc.

Tetra Pak is at: www.tetrapak.com and you can Google “Polyactide bottles” for a number of links.

From “Design of the Times” September 2007 Nutrition Industry Executive – www.niemagazine.com

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4. Vitamins, minerals and boomers…

“Men and women over the age of 51 who regularly take dietary supplements are more likely to get adequate amounts of several vitamins and minerals than those who do not, a study suggests. Researchers writing in the Journal of the American Dietetic Association also found that a substantial portion of people in this age range do not get enough vitamins and minerals from their diet alone and the use of supplements is necessary. Not only do these results give the supplements industry a boost, but they could also help supplement providers in deciding which age group to target with marketing, as well as giving a clear indicator of what nutrients should be included… They concluded that a large "proportion of older adults do not consume sufficient amounts of many nutrients from foods alone. Supplements compensate to some extent, but only an estimated half of this population uses them daily…”

www.nutraingredients.com/news/ng.asp?n=79836&m=1NIE918&c=jegwylrviswtnqa

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5. Are your SOPs up to date?

With the imposition of new regulations this year, including the long-awaited Good Manufacturing Practices, are your Standard Operating Procedures up to date? Take a look at my standard SOP format outline at: http://tinyurl.com/2eu6yj and let me know how if can help your company organize for future success!

09/12/07 - FDA focus on saftety?

2007-09-12T19:33:00.000-07:00

VLUeM – 09.12.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. News bits… Vit. C shortage?
3. Reminder: Update Archives are at: http://tinyurl.com/rkneb
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1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/

Divesting the FDA and A Little History of Regulations

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From an FDA warning letter issued last week: "...FDA's focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions."
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2. News Bits…

From New Hope Media: Dietary ingredient shortage!
“Retailers may have to start charging their customers more for dietary supplements containing vitamin C by the end of the year as manufacturers are forced to pass on higher prices from suppliers. Prices for vitamin C are ballooning because of supply shortages out of China, the world's primary supplier, and the use of corn, a source of vitamin C for mass production, as a biofuel, said Ed Keenan, vice president of marketing at New York-based supplements manufacturer, FutureBiotics. Keenan said Chinese suppliers claim they are shutting down plants to remodel them to meet Western standards of production. China supplies about three quarters of the global vitamin C market. "What they've done is squeeze production. They're holding back in their production," Kennan said of the Chinese production companies. "The whole industry is going to be hit by a severe shortage."
http://www.functionalingredientsmag.com/fimag/articleDisplay.asp?strArticleId=1436&strSite=FFNSite

AHPA Speaks Out:
The American Herbal Products Association has submitted comments to the US Food and Drug Administration, urging it to assist the dietary supplement industry in complying with good manufacturing practices, adverse event reporting, and new dietary ingredient safety regulations. The Maryland-based association was responding to calls for input from the FDA's Center for Food Safety and Applied Nutrition. "The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice for manufacturing, packaging, labeling, and holding dietary supplements, which were released this past June, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports associated with dietary supplements and over-the counter drugs be submitted to the FDA, which goes into effect this December," AHPA stated.
NAC & Gambling:

“A common amino acid sold as a dietary supplement could help diminish pathological gambling addictions, according to a new study. Researchers at the University of Minnesota uncovered the link following an eight-week trial involving 27 people who were given increasing doses of N-acetyl cysteine. By the end of the pilot study, published in the September 15th issue of Biological Psychiatry, 60 percent of the participants reported having less urges to gamble. The potential significance of these findings is huge - given the widespread damage caused by addictive gambling.”

http://www.nutraingredients-usa.com/news/ng.asp?n=79705&m=1NIU912&c=jegwylrviswtnqa

Symbols of Harmonization?

“The US government yesterday concluded a hearing examining the implementation of a nation-wide food labeling system to provide consistent nutrition information on product labels. .. FDA this week held a two-day meeting to gather comments from industry, health groups, advocacy organizations and medical experts on the use of a labeling program similar to the UK's traffic light system. Indeed, a number of countries around the world have already instituted voluntary labeling systems for government-designed nutrition symbols. These symbol systems vary in their format. Some systems have detailed graphic illustrations that indicate the content of a number of selected nutrients, while others simply present a single icon indicating that a food is healthful, with further information available elsewhere, such as in booklets and web sites. In the US, the food and beverage industry has identified the need to spell things out simply for consumers..”

http://www.nutraingredients-usa.com/news/ng.asp?n=79708&m=1NIU912&c=jegwylrviswtnqa
And this, from Nutrition 21, indicating that the middlemen are moving into marketing as the new GMPs become effective.

“Nutrition 21, the developer of chromium-based Chromax, announced it has entered into definitive agreements to privately place shares and warrants to fund $17.75mn for marketing and retailing of its condition-specific products. The New York state-based company previously used its science portfolio to support branded ingredient Chromax's use in supplements. However, the company has opted for a change in direction and invested heavily in promoting Chromax directly as a finished supplement product through food, drug and mass retail outlets. The company is going to attempt to take the market by storm, because it says its products have the potential to be attractive to a wide variety of consumers.”

http://www.nutraingredients-usa.com/news/ng.asp?n=79678&m=1NIU912&c=jegwylrviswtnqa

3. Reminder: Update Archives at: http://tinyurl.com/rkneb

Here are some of the topics of recent Updates.

08.31.07 - More on cGMPs impact
08.17.07 - Web Site Mistakes - Speaking in NJ 09/19
08.17.07 - Superfooods Market to Double by 2011
08.03.07 - AER Regulations about to be issued.
07.21.07 - FDA Warning; current issues bulletpoints
07.17.07 - Another FDA guidance and a DC Road Trip
07.10.07 - cGMPs, TX AG, Codex degrades standards
06.28.07 - Randomized Clinical Trials; cGMPs posted
06.23.07 - cGMP Rule issued; ingredient testing...
06.07.07 - Summer of Decisions; Define your Market
05.31.07 - Ron Paul's Bill is the Answer to FDA Failings
05.16.07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs
05.11.07 - OMB approves cGMPs- S.1082 amend confirmed
05.03.07 - Responding to Net Attacks; Victory in Congress!
04.26.07 - SUS Page Updates

08/31/07 - More on cGMPs impact

2007-08-31T19:34:00.000-07:00

VLUeM – 08.31.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. More on the GMPs
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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

More News on Lobbying Congress to Divest FDA of Food Authority.
http://www.globalhealthfreedom.org
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2. More on GMPs

I’ve been reading the GMPs that were issued in June. You can read my initial blog on them at:
http://vitaminlawyerhealthfreedom.blogspot.com/2007_06_01_archive.html .

Meanwhile, a number of organizations have also been reviewing the new Rules and I’ve been reviewing what they are saying. AHPA (American herbal Products Association) has been part of the process from the start. Here are excerpts from a report they’ve prepared (my headings in ALL CAPS).

BACKGROUND: "…compared to the existing cGMP for conventional foods, which is expressed … in just under six thousand words, the final rule on dietary supplement cGMP will be codified in 21 CFR 111 in over sixteen thousand words."

"Publication of this final rule is the culmination of a process that was begun in 1995 with the submission to FDA of an “industry draft” by AHPA, CRN, NDMA (now CHPA), NNFA (now NPA), and UNPA. This draft was published as an advance notice of proposed rulemaking on February 6, 1997, and followed by publication of a proposed rule on March 13, 2003" The final rule was published June 22, 2007 and can be seen at: http://www.cfsan.fda.gov/~dms/dscgmps6.html

APPLIES TO: “The rule applies to all firms that manufacture, package, label or hold dietary supplements for sale in the U.S. and Puerto Rico, with the exception of retailers who hold dietary supplements “for the sole purpose of direct retail sale to individual consumers.” The final rule notes, however, that this retailer exception does not extend to “a warehouse or other storage facility for a retailer,” or to “a warehouse or other storage facility that sells directly to individual consumers.”

STRUCTURE OF RULE: The Rule is divided into 16 parts:

“Subpart A General Provisions (*)
Subpart B Personnel
Subpart C Physical Plant and Grounds (* as Buildings and Facilities)
Subpart D Equipment and Utensils (* as Equipment)
Subpart E Requirement to Establish a Production and Process Control System (*as Production and Process Controls)
Subpart F Production and Process Control System – Requirements for Quality Control
Subpart G Production and Process Control System **
Subpart H Production and Process Control System – Requirements for the Master Manufacturing Record
Subpart I Production and Process Control System – Requirements for the Batch Production Record
Subpart J Production and Process Control System – Requirements for Laboratory Operations
Subpart K Production and Process Control System – Requirements for Manufacturing Operations
Subpart L Production and Process Control System – Requirements for Packaging and Labeling Operations
Subpart M Holding and Distributing
Subpart N Returned Dietary Supplements
Subpart O Product Complaints
Subpart P Records and Recordkeeping”

* From the Food GMPs
** “Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement”

APPLIES TO SOME CAM PRACTITIONERS: "FDA also noted in the preamble to the final rule that it “would be appropriate to consider the exercise of our enforcement discretion, on a case-by-case basis, to determine whether to apply the requirements of this final rule” to health care practitioners, such as acupuncturists, herbalists, and naturopaths who are “adequately trained in their profession” and who provide supplements that they prepare in “one-on-one consultation[s].” The agency stated, however, that it is “not considering exercising our enforcement discretion with respect to practitioners who prepare batches of herbs and sell them to individual consumers without determining whether the dietary supplement is appropriate for each consumer’s needs in a one-on-one personal consultation, or those that prepare batches of a dietary supplement for which there is a known or suspected safety concern.”"

Since that’s written in bureaucratic “bass-ackwards” let’s make that clearer: IF you do individualized one-on-one counseling, the FDA does NOT expect you to meet GMPs; if you repackage ingredients without one-on-one consultations, you will be treated as a distributor and be required to meet GMPs.

I’ve also read the United Natural Products Alliance report on the GMPs. In general their analysis is similar to AHPA. Some points they note (quotes are from the FDA Rule comments):

PRODUCT COMPLAINTS: “The final rule defines product complaint…examples of product complaints are foul odor, off-taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a DS container, improper packaging, mislabeling or DS that are super potent, sub-potent or contain the wrong ingredient or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead)…”

QUALITY: “Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition and limits on contaminates and has been manufactured, packaged, labeled and held under conditions to prevent adulteration…”

GMP TRAINING: While FDA will not provide GMP training materials, “…paragraph, § 111.14(b)(2) requires you to make and keep documentation of training, including the date of training, the type of training and the persons trained.”

BATCH TESTING: “We are persuaded that as an alternative to testing each finished batch of product, we can allow for the use of a statistically sound sampling and testing program for finished batches of DS unless a manufacturer chooses to test every batch. Such a sampling and testing program is feasible when controls are implemented earlier than the final product stage in the manufacturing process. Controls include the use of a C of A from a qualified supplier for specifications other than the identity of a DI and the establishment and monitoring of in-process manufacturing controls.”

“We agree with the comments that if we reduce the requirements for testing at the finished batch stage, then it is critical that you determine whether components meet specifications. We address this issue in the following two ways: (1) Each manufacturer must confirm the identity of each component prior to use (you must test or examine DIs to verify the identity but may rely on a C of A to confirm the identity of components other than DS) and (2) Each company must confirm other required specifications for components prior to use, either by relying upon a C of A or by testing or examining the components.”

“Because of the critical importance of insuring the proper identity of DIs – they are the central defining ingredient of a DS – we are requiring each firm that uses a DI to perform its own testing or examination for identity of each DI prior to use. Firms may not rely upon a C of A provided by suppliers to determine the identity of a DI before use. … We believe that the minimum criteria that we are establishing for a C of A, together with the requirement that a firm relying on a C of A must qualify a supplier and periodically repeat that qualification process can prevent the problems that have occurred with faulty certificates in the past.”

“Under final § 111.75(a), a firm may rely upon a C of A from its supplier of a component provided that certain criteria are met which include the following: (1) The firm first qualifies the supplier by establishing the reliability of the supplier’s C of A through confirmation of the results of the supplier’s tests or examinations; (2) The C of A includes a description of the tests or examination method(s) used, limits of the tests or examinations, and actual results of the tests or examinations; (3) The firm maintains documentation of how it qualified the supplier; (4) The firm periodically reconfirms the supplier’s C of A; (5) The firm’s quality control personnel review and approve the documentation setting for the basis for qualification (and re-qualification) of any supplier.”

PRODUCT SPECIFICATIONS: “The requirement to establish specifications is not limited to when a manufacturer purports that its product possesses attributes of strength and composition on the label. One comment asks for guidance as to what constitutes an official or scientifically valid standard for specifications. We are not aware of any officially recognized standard for specifications… the manufacturer establishes the set of criteria to which a product should conform to be considered acceptable for its intended use. In general, a specification may include a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described.”

COMPLIANCE NOTIFICATION: “…an unqualified statement such as ‘produced in compliance with dietary supplement current good manufacturing requirements,’ without more, could suggest the product may be safe and effective or somehow superior to other DS products that are subject to the same CGMP requirements (id.) [and] would likely be considered misleading …, but that including language clarifying to consumers that all DS must be manufactured in compliance with CGMP requirements, and that such compliance does not mean that the DS is safe or effective, may be a way to cure that unqualified statement … Thus, we are not prohibiting voluntary statements on the DS label, provided that such statements are truthful and non-misleading…”

GMP & AER: And, despite the new AER law, “We continue to strongly recommend that firms that receive product complaints, that are not ‘serious adverse events’ notify us about any illness or injury, because, for example, we may have additional expertise or data that may be helpful in investigating the complaint or determining whether the problem applies to more than one product…We encourage you to include our recommendations in the written procedures that you develop for handling product complaints.”

CONCLUSION: Your bottom line: over the next three years, as GMPs become effective first for large firms, then in 2 years for medium firms (under 500 employees) and finally in three years for small (under 20 employees) individual firms will have to manage their compliance with the requirements. The Vitamin Lawyer Consultancy will be available to help.

STANDARD SOP: Expect my revised Standard Operating Procedures (for Dietary Supplement companies and for CAM practitioners) providing for phasing in the GMP requirements, to be available in the next month or so. I’ll let you know as soon as they are ready. You can see outlines of my pre-final rule SOPs at http://tinyurl.com/2eu6yj - these will be re-organized to fit the 16 GMP categories noted above. I estimate it will take 2 – 3 hours to customize the revised formats for each operating company responsible for GMPs.

08/17/07 - Web Site Mistakes - Speaking in NJ 09/19

2007-08-17T19:35:00.000-07:00

VLUeM – 08.17.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. Web Site Mistakes
3. Wiki Biased Editing Exposed
4. I’ll be speaking in NJ on September 19th
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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/

New link established to allow Health Claims comments to FDA! Comments end: 08/31/08.
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2. Entireweb Newsletter * August 14, 2007 * ISSUE #361 * entireweb.com

Excerpts from: Do You Make These Mistakes With Your Web Site?

“… no web site is absolutely perfect… But there are some basic web site mistakes …
- Not enough content. - …minimal information along with their contact information on their web sites … today's web visitors are looking for … lots of good quality content … build credibility for your business.
- Old or outdated content. - If you want visitors and search engines to pay attention to your web site, you need to keep adding new content and updating the existing information....
- Not being search engine friendly. - … in order to be included in the search engine databases.
- Not monitoring your site in the search engines. - … Monitoring your web site means that you can react to changes and take appropriate steps to make sure your site shows up in the search results and that web traffic keeps flowing.
- The site is built using Frames or Flash. - Not too many web sites still make this mistake…
Making your web site the best it can be is a very effective and affordable marketing option for most small businesses. Of all the other types of advertising and marketing that you do each year, your web site has the potential to be seen by more customers, can continue to promote your company perpetually through links, is always accessible to customers, and can instantly reflect changes and provide fresh information to draw people in….”
About the Author: Lauren Hobson is the Editor of Biz Talk Newsletter and the Five Sparrows Marketing Blog from Five Sparrows, LLC at www.fivesparrows.com/biztalk.
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3. Wiki Biased Editing Exposed

http://www.prisonplanet.com/articles/august2007/140807_wikipedia_credibility.htm

Has your company been the victim of derogatory Wikipedia postings?

Says PrisonPlanet.com: “The credibility of the online encyclopedia Wikipedia has taken another dive after a newly developed software program exposed how the CIA, corporations like Diebold and others routinely edit entries to bury criticism and manipulate the truth . . . Now a CalTech graduate student has developed a software tool that threatens to slam the final nail in the coffin of any credibility Wikipedia had left… Wikipedia Scanner -- the brainchild of CalTech computation and neural-systems graduate student Virgil Griffith -- offers users a searchable database that ties millions of anonymous Wikipedia edits to organizations where those edits apparently originated, by cross-referencing the edits with data on who owns the associated block of internet IP addresses," reports Wired News.”

"The Wikipedia Scanner (http://wikiscanner.virgil.gr/) also allows users to type in an IP range and find out which organizations are editing what pages on Wikipedia."

Adds PrisonPlanet: "Though Wikipedia's raison d'etre is obviously based around allowing users to edit the content, the checks to prevent abuse and organized partisan attack campaigns against certain subjects or ideas are non-existent and the absence of any kind of reasonable moderation is destroying Wiki's reputation. ... Wikipedia is fast becoming a complete anathema to reliable research and will see its wavering reputation as a trustworthy source for information quickly evaporate if it continues to allow itself to be abused by intelligence agencies, corporations and dedicated trolls."

Over the past two years we've noted that attempts to put positive postings on Wikipedia about alternative healthcare and natural nutrients has been met with attacks by "Quackwatch" types, even as the "official" Quackwatch sites and founders have been found by courts to be untrustworthy of belief. Will see over the next few months if Wikipedia is capable of reforming itself to regain its credibility.
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4. I’ll be speaking in NJ on September 19th - Here’s the flyer from NJNHP:

New Jersey Natural Health Professionals & Natural Solutions Foundation
Health Freedom vs. Health Tyranny: Your Voice Matters

September 19, 2007 7:00 p.m. - 10:00 p.m.
VFW Post 7925 - 45 Plymouth Road - Fairfield, New Jersey
973-227-9600

Guest Speakers:
Rima E. Laibow, MD
Founder Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army Ret.)
President Natural Solutions Foundation
Ralph Fucetola, JD
Best known as “The Vitamin Lawyer”
Professor Murray Sabrin
Spokesperson for Presidential Candidate & U.S.Congressman Ron Paul

For more information/reservations, please contact:
Sharan Woods, President
New Jersey Natural Health Professionals
Fairfield, New Jersey
973-882-0181

08/11/07 - Superfooods Market to Double by 2011

2007-08-11T19:36:00.000-07:00

VLUeM – 08.11.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Updates
2. Superfoods market to double by 2011
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1. Vitamin Lawyer Health Freedom Blog New Postings
http://vitaminlawyerhealthfreedom.blogspot.com/

AER Regulations Immanent… EU Backs off banning natural vitamins!!
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2. Superfoods market set to double by 2011 - Alex McNally

“Aug. 10, 2007 - The superfood and drink market is expected to almost double in the ten year period up to 2011, says a report published today, with soy products and exotic fruits leading the charge.

…Michael Hughes, market analyst and author of the report Super Food and Drinks: Consumer Attitudes To Nutrient Rich Products, said shoppers are actively seeking nutrient rich fresh, organic and functional food and drinks and turning their backs on foods high in fats, sugars and salts… Hughes said: "The trend towards 'positive nutrition' is well reflected by the recent popularization of superfoods, especially in the UK and US."

As a result, superfoods and drinks, like acai and goji berries, are seeing a surge in demand. Datamonitor defined superfoods for the purpose of the report as foods rich in "specific nutrients and phyto-chemicals (i.e. anti-oxidants) and are promoted as being able to improve health condition and/or disease prevention." A spokesperson told NutraIngredients.com that the definition includes both foods which are naturally high in nutritional value and those with added nutrition. This means it can include much of the functional food market. Many food and drinks associated with superfood status have also enjoyed healthy growth in the last five years and this - in part - can be attributed to this status, he added. Hughes said: "The popularization of superfoods means that many food and drinks now have a 'healthy-halo' which significantly influences consumer preferences."

Exotic, highly fashionable fruits such as acai berries, goji berries and pomegranates have all risen in popularity, with pomegranate currently one of the most fashionable superfood ingredients, the analyst said. In the period January 2005 to May 2007, there had already been a 500 per cent increase in the number of products using pomegranate as an ingredient compared to the period 1999 to 2004.

Hughes added: "Right now, pomegranate is the hot ingredient, but this is likely to be superseded given that new ingredients are being continuously touted. "Monitoring these developments will be vital if industry players are going to fully capitalize on the superfoods movement." … Green tea sales have grown substantially in the US. The market grew from €18m ($119m) in 2001 to €116m ($160m) in 2006… Datamonitor also identified an opportunity for manufacturers to respond to growing time constraints which are leading to people in Europe missing around 100 meals a years because they do not have time. The report suggests companies can take advantage of this by offering nutritionally enhanced snacks as a substitution for missed meals.

http://www.nutraingredients.com/news/ng.asp?n=78969&m=1NIE810&c=jegwylrviswtnqa

08/03/07 - AER Regulations about to be issued.

2007-08-03T19:38:00.000-07:00

VLUeM – 08.03.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. AER Regulations Immanent
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1. Vitamin Lawyer Health Freedom Blog New Posting
http://vitaminlawyerhealthfreedom.blogspot.com/
FDA enabling act delayed! Hope abounds…
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2. AER Regulations Immanent

This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.

www.nutraingredients-usa.com/news/ng.asp?n=78773&m=1NIU803&c=jegwylrviswtnqa

CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud

08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…"

07/21/07 - FDA Warning; current issues bulletpoints

2007-07-21T19:38:00.000-07:00

VLUeM – 07.21.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. Recent FDA Warning Letter
3. Bulletin Points: Current Regulatory Issues
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1. Vitamin Lawyer Health Freedom Blog New Posting

New posting on newest FDA draft guidance on Health Claims:

http://vitaminlawyerhealthfreedom.blogspot.com/

Dr. Laibow remarks that the guidance is “apparently in direct response to Dr. Ron Paul's Health Freedom Protection Act, HR 2117…” and offers a link to protest this to the FDA:

http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754

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2. Here are excerpts from a warning letter FDA issued a couple weeks ago

It shows us current thinking on “drug” claims for Dietary Supplements and gives a “text book” example of what claims not to make:

“This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at … and has determined that the products … are promoted for conditions that cause the products to be drugs under … the Federal Food, Drug, and Cosmetic Act (the Act) ... The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. … Examples [X} “…Cancer Prevention and Treatment” … "The scientific community has recently had very positive results on the effect of … on certain types of cancers. In tests on a variety of tumor types, the treatment with … led to improvement of overall health status, prolongation of life span, and a decrease in tumor size. Also, in local applications of … to skin cancer, it reduced tumor formation and growth." … "For prevention … As part of Cancer therapy"

*** [Y] The Hangover Preventive" … "When you drink alcohol, the body tries to break down the toxins.... These toxins are not fully broken down and cause damage to your organs. The side effects of this damage, we call a `hangover' such as headache and nausea, as well as other ill effects that we can't see (liver damage)…. absorbs the toxins from the alcohol before they are processed into your organs."

The above claims about individual products are supplemented by claims on your homepage about your products in general and by metatags you use to bring consumers to your website. Examples of the metatags include "cancer prevention," "toxin removal," and "Natural supplements that... are proven to inhibit cancerous tumor growth, and will even prevent hangovers.... Effective … cure." ***

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs"… New drugs may not be legally marketed in the U.S. without prior approval from FDA …. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

In addition, we note that your website states the following: "This form of [Y] is approved by the FDA as completely safe...." We have cited several examples in this letter to demonstrate that you are not in compliance with FDA requirements. Further, FDA has not reviewed the safety of [Y], nor its interactions with other substances. Therefore, the use of this statement to promote your products is false or misleading in that it implies FDA approval or sanction of your product and its purported uses. The false and misleading information misbrands your[Y] products ... ***

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. …Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.”

Students of the Vitamin Lawyer Red Flags Review School will readily see all the mistakes the marketer made… all the dangerous claims and over the line statements. A word to the wise…

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3. Some Bullet Points regarding current regulatory issues

* Since the last days of 2006 there have been a series of challenges to Health Freedom
o Adverse Event Reporting Act [December 2006]
o FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]
o USDA & Codex: Organic Standards Diminished
o Codex: Raising Toxic Levels, Mandating Irradiation
o Codex: GM (Genetically Modified) Labeling Failures
o FDA GMPs (Good Manufacturing Practices for Dietary Supplements)
o Senate & House adoption of FDA enabling bills [S.1082 & HR.2900]
[Only S.1082 contains DSHEA protection language]
o Failure of US House to consider Health Freedom Protection Act – HR.2117
[Although over 100,000 messages to Congress demanded protection]
* Now the FDA has directly challenged HR.2117 with a new draft guidance
“Evidence-Based Review System for the Scientific Evaluation of Health Claims”
o Citation: http://www.cfsan.fda.gov/~dms/hclmgui5.html
o Draft guidance document represents the agency's current thinking on
+ 1) the process for evaluating the scientific evidence for a health claim,
+ 2) the meaning of the significant scientific agreement (SSA) standard
+ 3) credible scientific evidence to support a qualified health claim.
* Ron Paul’s Health Freedom Protection Act (HR.2117)
Citation: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
o Health Claims must be allowed unless the FDA determines that –
+ (i) there is no scientific evidence that supports the claim;
+ (ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer

The opportunity should be clear: resubmit HR.2117 as the Health Freedom Restoration and Protection Act with language addressing each of the pending challenges noted above.

“It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07

07/17/07 - Another FDA guidance and a DC Road Trip

2007-07-17T19:39:00.000-07:00

VLUeM – 07.17.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Health Freedom Blog Update
2. Another FDA Guidance: Health Claims Substantiation
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1. Vitamin Lawyer Health Freedom Blog New Posting

The House passed the FDA enabling act last week and we visited Washington…

http://vitaminlawyerhealthfreedom.blogspot.com/2007/07/road-trip.html

Things are about to get very exciting as Dr. Ron Paul leads the way in countering recent attacks on Health Freedom by the FDA, Congress and Codex!

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2. New FDA Draft Guidance: “Evidence-Based Review System for the Scientific
Evaluation of Health Claims” - http://www.cfsan.fda.gov/~dms/hclmgui5.html

Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August.

Says the introduction: “This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act … and 3) credible scientific evidence to support a qualified health claim. … This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners … The specific topics addressed in this guidance document are: (1) identifying studies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”

This guidance attempts to impose a high standard on Health Claims. Dr. Ron Paul’s pending bill, the Health Freedom Protection Act, HR.2117 addresses this further FDA power grab by imposing the standard commercial substantiation requirement. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

This latest FDA Guidance needs further analysis and comments will be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency.

07/10/07 - cGMPs, TX AG, Codex degrades standards

2007-07-10T19:41:00.000-07:00

VLUeM – 07.10.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Aspartame, etc. now Dietary Supplements?
2. Texas AG and Testimonial Claims
3. More on the new cGMPs
4. Health Freedom Blog Update
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1. Codex, the World Food Code, continues to degrade food standards…

Rome 07.06.07 – “…the Codex General Standard for Food Additives (GSFA), which sets down the conditions for permitted food additives for all supplements, has now agreed the higher levels for castor oil, polysorbates, polyvinyl alcohol, acesulfame potassium, aspartame, cyclamates, neotame, saccharin, and sucralose. A US-led working group had been charged with drawing up a list of allowed additives and with setting levels based on technical justification and safety. The group had previously drafted lower than expected guidelines….”

http://www.nutraingredients-usa.com/news/ng.asp?n=78020&m=1NIU709&c=jegwylrviswtnqa

You can keep up with the Byzantine world of the Codex Mandarins at www.globalhealthfreedom.org

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2. “The Texas Attorney General last week charged supplement manufacturer Mannatech for illegally marketing using dubious claims and testimonials about the health benefits of its products.

”Mannatech, its owner and related entities were found in violation of the Texas Deceptive Trade Practices Act, which can result in civil penalties of $20,000 per violation, as well as going against the Texas Food, Drug, and Cosmetic Act, which can result in up to $25,000 per day, per violation.

”State judgments such as these can pick-up where the Federal Trade Commission - which is increasingly on the look-out for misuse of consumer testimonials - has not reached, or not yet reached.

”Mannatech has in particular been charged with encouraging salespeople to make use of misleading testimonials. … "With today's enforcement action, the Office of the Attorney General seeks to shut down an elaborate scheme to defraud innocent consumers across the nation," Texas Attorney General Greg Abbott said in a written statement.

”According to the Office of the Attorney General, exaggerated claims relating to the therapeutic benefits of Mannatech's dietary supplements and products were used to unlawfully mislead consumers with cancer, Down's syndrome, cystic fibrosis and other serious illnesses.”

http://www.nutraingredients-usa.com/news/ng.asp?n=78041&m=1NIU709&c=jegwylrviswtnqa

A word to the wise should be sufficient: Testimonials are not substantiation. Says the FTC in its Testimonial Guide,

“Endorsements must always reflect the honest opinions, findings, beliefs, or experience of the endorser. Furthermore, they may not contain any representations which would be deceptive, or could not be substantiated if made directly by the advertiser.”

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3. More on the new cGMPs

As I continue to read the 467 page Good Manufacturing Practices document recently issued by the FDA I will continue to send off “tidbits” that exemplify the spirit of the new regulations.

For example, from the Economic Impact section:

“We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business. …very small … and … small dietary supplement manufacturers … will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”

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4. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com

I just posted more information on the House and the pending FDA “revitalization” bill, based on contact from the office of a friendly Congressman.

06/28/07 - Randomized Clinical Trials; cGMPs posted

2007-06-28T19:42:00.000-07:00

VLUeM – 06.28.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. RCT (Randomized Clinical Trials) and nutrients
2. New cGMPs now available on net
3. http://www.vitaminlawyerhealthfreedom.blogspot.com
4. CRUSH media release: Silver Safety Standard
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1. RCT (Randomized Clinical Trials) and Nutrients

This article by Dr. Melton is cogent and worth reading. The article goes to the heart of the coming cGMPs – how will you substantiate the claims you make about your products? How will you prove the identity and quality of the ingredients? If you have the time to think about what your company will be doing in two years when the cGMPs become effective for small companies, this is something you need to think about… and, yes, you do need to start thinking now…

Clinical trials - gold standard or white elephant?

25/06/2007 - Randomised clinical trials are the ultimate. Forget what the observational studies tell us, if the RCT gives us an answer it must be the final word, right? Wrong.

The value of such trials for the food industry is undeniable, but too often nutrients are pulled out of context, following the same methodology as used for the testing of drugs.

But let's not forget that by following the drug model we are supplementing the diet with one or two nutrients, each at a single dose, for a set period of time. Can a time-constrained randomised trial really capture a lifetime of consumption with respect to chronic disease?

Randomised clinical trials work by randomly assigning a group of volunteers to receive an active compound, be it a drug or nutrient(s), or a non-active comparison, be it an inactive form of the active compound or a placebo. Observational studies, as the name suggests, observe a population and relate dietary intakes of food and nutrients to the occurrence of disease.

We need to consider the science as a whole and not blinker ourselves with results of one big clinical trial, regardless of how much money it costs and what universities were involved.

For food items that do not normally form part of the usual food chain, randomised clinical trials are the best of the best because such compounds can be tested and retested successfully.

Phytosterols, probiotics, or botanical supplements, for example, fit into this category.
Indeed, clinical trials on phytosterols have shown time and again that daily consumption of 1.5 to 3 grams of phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.

Studies looking at how these results transfer into real free-living populations have backed up the clinical trials, showing a stabilisation of cholesterol levels in certain populations.

So we know the benefit of clinical trials. But when we start using this approach for vitamins, minerals, antioxidants and other nutrients, we come a little unstuck.

Some may say that I'm over-reacting, but let's just look at the report published in the New Scientist magazine that slammed antioxidant supplements as myth.

Despite a vast body of observational/ epidemiological studies linking an increased dietary intake of antioxidants from fruits and vegetables to reduced risks of a range of disease, including cancer, cardiovascular disease and diabetes, when such antioxidants have been extracted and put into supplements, the results, according to RCTs, do not produce the same benefits and may even be harmful.

So the author of the article, Dr. Lisa Melton from the London-based registered charity, the Novartis Foundation, concluded that antioxidant supplements are too good to be true.

Is this really the answer or is it due to poor study design? Would a two-year trial of vitamin E, let's say, really produce a reduction in the risk of a chronic disease?

To illustrate this point further, we only need to go back to last year's Women's Health Initiative (WHI) trial that followed 18,176 post-menopausal women taking calcium (1000 mg) and vitamin D (400 IU) supplements. A similar population (N=18,106) was given a placebo. The subjects were followed for about seven years and the researchers reported that the supplements 'had no effect' on the risk of colorectal cancer.

None of the women had the cancer at the start of the study and colorectal cancer has a long latency period of 10 to 20 years, which begs the question - could we really have expected to see an effect?

We also need to remember that nutrients often work in synergy with one another and exert effects on multiple body tissues, unlike pharmaceuticals.

Additionally, many randomised clinical trials look at the effect of nutrients in diseased populations. Surely the damage of a lifetime's poor nutrition has already been done. When we obtain negative or null results from such trials, should we really be surprised?

The power of nutrients is in the prevention, not cure, of disease.

So what should we do? I don't pretend to have any answers. These are for ladies and gentlemen with infinitely bigger brains than me.

Realistically, there are no viable alternatives out there at present. Randomisation is the best way of limiting bias that creeps into every study, and controlling, specifically with placebo, is the best way to make comparisons.

For those times where randomised trials clearly aren't the best option, then we probably need to look at the observational studies and mechanistic studies in greater depth, and place more value on them.

The research community as a whole must work together to re-evaluate how to get the most from research into nutrition. Lots of different types of studies are out there. Let's make the most of what we already have.

Stephen Daniells is the Food Science Reporter for NutraIngredients.com and FoodNavigator.com. He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article please contact stephen.daniells'at'decisionnews.com
http://www.nutraingredients.com/news/ng.asp?n=77611&m=1NIE625&c=jegwylrviswtnqa

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2. FDA publishes Current Good Manufacturing Practices for Dietary Supplements

I’m reading them, but so can you, at: http://www.cfsan.fda.gov/~lrd/fr07625a.html (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA is taking us: “…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

We can hope there will be a change of Agency attitude when the Administration changes in about a year and a half; especially if the good doctor from Texas replaces the current Texan occupying the White House. I’ll provide more tidbits as I read the materials.

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3. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com

I just posted a link there to an 8 minute presentation I taped for Natural Solutions Foundation, for use with health-friendly delegates at next week’s Codex Commission meeting in Rome.

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4. CRUSH Silver Safety Standard

The Committee on the Responsible Use of Silver in Health (of which I am a member) is releasing the final version of its Silver Safety Standard (The “12 for 25 Rule). The media release will be posted on PRWeb shortly and can be seen at www.silverfacts.com or on my Blog.

06/23/07 - cGMP Rule issued; ingredient testing...

2007-06-23T19:43:00.000-07:00

VLUeM – 06.23.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. cGMP “Final Rule” Issued: all ingredients to be tested within 3 years!
2. Vitamin Lawyer starts Health Freedom Blog at Blogspot.com
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1. Excerpts from the FDA announcement follows. The terminology is fairly much what I had predicted in previous postings, focusing on “identity, purity, strength, and composition” – however, the enforcement procedures seem more extreme than had been predicted from the draft rule and may represent a further ratcheting of enforcement in general.

Announcement: “The U.S. Food and Drug Administration today (06/22/07) announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. ***

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. ***

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. ***

FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing … if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. ***

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with … less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

It is certainly time to make sure your Standard Operating Procedures meet the new standards, as those standards become effective. I will continue to monitor this situation and inform this email list as modified SOP documents are ready.

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2. Health Freedom Blog Upgraded

The Vitamin Lawyer has just started a Health Freedom Blog at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com – the earliest postings from my original health freedom blog at http://tinyurl.com/yo5t4t have been reorganized to start the replacement Blogspot blog. Additional material is added as available.

06/07/07 - Summer of Decisions; Define your Market

2007-06-07T19:45:00.000-07:00

VLUeM – 06.07.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Summer of Decision “Not Unreasonable…”
2. Entire Web: Define Your Target Market
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1. A Summer of Decision: Suggested Amendments to FDA "Revitalization" bill - "Not Unreasonable"

This is a summer of significant decisions in the Dietary Supplement and Natural Products marketplace.

Take Action: Natural Solutions: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344

Wellness Resources: http://capwiz.com/wellnessresources/issues/alert/?alertid=9773656&PROCESS=Take+Action

From Wellness Resources: "The Senate has recently passed bill S.1082, commonly known as the FDA Revitalization Act. ...the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use this legislation to undermine my access to safe and effective dietary supplements. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. ...members of Congress are not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with the following amendment, which will not in any way stop the FDA from identifying truly contaminated food that poses a risk to human health.

"Changes in Existing Law. The following provides a print of the existing statute or part or section thereof to be amended or replaced so as to delete the words “or unreasonable” (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):

"CHAPTER IV – FOOD - SEC. 402 (f) – (1) If it is a dietary supplement or contains a dietary ingredient that – (A) presents a significant [or unreasonable] risk of illness or injury under — (i) conditions of use recommended or suggested in labeling, or (ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:

"Changes in Proposed Bills Proposed amendment to S.1082 and HR.1561:

"The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use..."

My comment: it may seem small, but the words "not unreasonable" do have a big impact... and it is in the small space made by such words (or their deletion!) that Health Freedom has room to grow. This amendment, together with the wording of Dr. Paul's HR.2117, would go a long way toward protecting our access to truthful information about the health benefits of foods. Please note that S.1082 does not explicitly mention Dietary Supplements (except for the DSHEA Exemption Amendment adopted 94 to 0) so the suggested Emord Amendment would change existing law to be more protective of Dietary Supplements by attaching the change to the pending pro-FDA bill, the same parliamentary procedure that has been suggested with Dr. Paul’s bill.

One concern I do have with this amendment is that the recent Supreme Court Ephedra decision, not to review the appeals court upholding the Ephedra ban, effectively means that nearly any risk of illness may be considered "significant" and therefore, the amendment may not be strong enough. However, it may be possible to get it adopted… one step at a time!

This is an especially exciting time to be in the Dietary Supplement / Natural Products market. While stricter regulations seem on the way, scientific advances and ongoing clinical studies point the way to better and more effective products. The problem is not in the science or the production; the problem is in the politics. These products are generally recognized as safe when used as directed, like any food. We therefore need to reject the big government notion that tells us we will only be safe if bureaucrats have more control over us. That nostrum is provably wrong, as we see from the failure of government, with plenary power over approving drugs (as to efficacy and safety) to protect the public from what some estimate to be hundreds of thousands of unnecessary deaths each year from lawfully utilized prescription drugs.

The next few weeks, as the FDA “revitalization” bill is amended or not, and adopted, or not, will tell us a lot about the future of this market. Other important regulatory events are happening this summer as well: the FDA anti-CAM guidance may be finalized; the new Dietary Supplement “Good Manufacturing Practices” have been finalized and should be issued. And, as always, the FDA’s announced intent to “HARMonize” our freedoms to international rules (even where that decreases our access to safe products), operating through the North American Union, Codex and the new US/EU cooperation agreement, remains an ever present threat.

This will be a summer of rapid events; stay up to date, even between VLUeM Memos, by checking my Vitamin Lawyer Health Freedom Blog at: http://tinyurl.com/yo5t4t - updated every couple days; also http://www.globalhealthfreedom.org . . .

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Advertisement – Now more than ever - “your papers must be in order…” Check my SOP/GMP Information Web Page at: http://tinyurl.com/2eu6yj to learn what you need in order to stay on top of changing regulations.

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2. Defining Your Target Market

This Entireweb newsletter could be so useful to especially new companies that I am forwarding the entire piece…

> Entireweb Newsletter * ISSUE #340 - www.entireweb.com

> Define Your Target Market in 5 Easy Steps

> This report is designed for entrepreneurs, small business owners, independent contractors and anyone who needs to build relationships and develop leads or referrals in order to promote and increase their business.

> The information in this report is given based on the assumption that YOU know your product and service inside and out and you have already defined your business goals and have somewhat of a business plan in order.

> The next step would be to narrowly and clearly define your target market, your ideal prospect.

> Some people believe that their products or services would be perfect for everyone. For example, Mary Kay Cosmetics - no offense to my MK friends or other people in the health industry who say 'anyone with skin' needs a facial or 'anyone who has stress' need a massage. Then there are people in the home improvement industry who say, 'anyone with a house' needs my landscaping, my windows, my furniture or my loan, etc.

> For most small businesses however (1-5 employees or even more), I don't believe this is the most effective way to try to generate new leads and customers. If you determine the right target market to fit your business, you figure out the best ways to reach them AND if you figure out the best message to reach them with you will be spending your marketing dollars wisely. Business owners who don't plan ahead to figure out who their target market is before they open their doors end up spending a whole lot more money trying to figure it out by trial and error and that's expensive.

> Would you shell out $200 for a pair of shoes without trying them on? Plunge into a steaming bath without dipping a toe in first? Of course not-but people do the business equivalent every day. Many an entrepreneur has found out too late that nobody wants to buy hand-quilted Christmas stockings at $24.99 a pop, or that wealthy customers won't schlep to the unfashionable part of town for luxury stationery.

> The irony: Conventional market research is expensive (corporations regularly budget tens or hundreds of thousands of dollars for it), but no one needs it more than a startup entrepreneur. A couple of marketing blunders won't put a giant manufacturer out of business, but just one can sink an entrepreneur like a bolt of lightning.

> Defining Your Target Market

> Your "target customers" are those who are most likely to buy from you. Resist the temptation to be too general in the hopes of getting a larger slice of the market.

Try to describe them with as much detail as you can, based on your knowledge of your product or service and how it will benefit them.

> Step 1: Ask yourself some questions to get started

> 1. Are your target customers male or female?

> Figure 75-80% of your target customers would be which? If it's split, narrow it down another way but more than likely you can narrow down the gender.

> 2. How old are they?

> Give an age range of 10-20 years max, otherwise you might have two target markets. Remember, the marketing messages towards different age groups will be quite different most likely depending on your product or service.

> 3. Where do they live?

> Is geography a limiting factor for any reason? Can you narrow it down to specific zip codes or counties? The larger the geographical area you choose, the more people you will find but the less likely you'll be able to afford to market to all of them so narrow it down and expand out later.

> 4. What do they do for a living?

> You can get a mailing list by industry or profession and specific title for example.

> 5. What does their specific profession say about their lifestyle?

> Is it very busy with little time to shop? Would they be likely to be familiar with the internet for their shopping, researching, news and event information? Would they be commuting more in their car?

> 6. How much money do they make?

> This is most significant if you're selling relatively expensive or luxury items. Most people can afford a latte. You can't say the same of custom murals. Narrow this down to a specific range also and high enough that you will weed some people out or again, you'll have way too many people to afford to market to.

> 7. Are there kids in the household?

> What ages might they be? How many would there likely be? What does this say about their lifestyle - are they carpooling, or soccer parents where they are rarely home? Do they possibly eat out a lot or have less 'family' bonding time? Or are they empty nesters where they might spend more time at home watching television or reading?

> Step 2: Get specific

> What other aspects of their lives matter? Here are some examples to think about, see how your target market compares or how you can get more specific with them.

> * If you're launching a roof-tiling service, your target customers probably own their homes. In addition, they probably own homes with older roofs like shake roofs; you can get a list of homes by their age.

> * If you're a realtor, you might be interested in targeting first time homebuyers in which case you might find them to be likely to live in apartments or rentals of which you can get a list of those too.

> * If you're selling your own individual artwork but you can't create multiple paintings with the same picture, you may have to sell the unique pieces at local art shows rather than selling them online.

> * If you're planning to open a custom-tailoring shop and need busy executives to come for three fittings, you may need to limit it to your local area.

> * If you're a direct jewelry consultant needing women to gather for parties in someone's home, you'll want to go where many women meet like mom's groups, women's professional organizations, day cares or grocery stores.

> * If you're a business or life coach and want to coach only over the phone then you'll most likely want to do more online marketing and make sure to have a really top notch website since that's mostly what people are going to see for their first impression. You can network locally too but the more 'known' you are in person, the more people will want to do business with you in person.

> Step 3: Keep your mind open to any information

> Keep a list of primary research questions handy, such as:

> * Who influences your customers and how? Spouses, neighbors, peer groups, professional colleagues, children and the media can all affect buying decisions. Look for hints that one or more of these are a factor for you.

> * Why do they buy? Distinguish between the features and the benefits your product or service offers. Features describe what it is; benefits are what your customers get out of it. The latter is why your customers pay you. Are they looking for a status symbol, a savings in time or energy, a personal treat or something else?

> * Why should customers choose you and not your competition? What can you offer that the competition doesn't?

> * How do your customers prefer to buy? Many businesses benefit from the broader market provided by the Internet and mail order, while others do better with a physical presence. Don't assume you fall into one category or the other; customers may surprise you.

> Step 4: Identify Your Ideal or Favorite Client

> Think about your favorite client - who are they, name them, write down everything you know about them, their family status, age, sex, marital status, where they live, where they work, possible income level, their shopping characteristics.

> * Do they like to use coupons or shop on certain days?

> * Do they call you at the last minute to get something from you?

> * Do they value your service/product?

> * Is that type of client the most profitable type you have or the most non-profitable and you just like them?

> Step 5: Determine their profitability to your business

> Which type of clients will make you the most money, bring you joy and refer you tons of business? These are the types of clients you ultimately want, now where are they?

> Ask Yourself:

> * Who is the most profitable type of client? The one who will make you the most amount of money the fastest and with the least effort - do you like working with them? If not, you won't be totally happy with only this type of person, maybe you need a combination of the two.

> * How often will they be able to buy or consume your product or service? If they can only possibly purchase your services every 10-20 years (getting a new roof for example), do you never market to them again after the sale or do you heavily market to them after the sale by every means possible for at least 1 year to get all the referrals you could possibly get out of them in that time?

> * How likely are they to know others like them they can refer to you? Normally, very likely, in which case following up with them before, during and after the sale is huge - and if you don't ask for referrals in each stage of the sale continuously then shame on you.

> * What is really important to them when it comes to your product or service? Not what you think they should know or like, but actually what they care about, like, ask for, thrive on, are passionate about, etc. These are your target market's "Hot Buttons" and these are what you should be addressing in your headlines, letters and marketing efforts at all times because these are why the client would choose to buy.

> Defining your business' target market is absolutely critical to any small business. Everything you do in your marketing, advertising, design, publicity and networking will depend on who your target market is and what matters to them. Making decisions on your marketing and advertising without fully defining your target market or knowing them in depth could be detrimental to your business and you could be making some costly mistakes!

> About the Author: Katrina Sawa, Relationship Marketing Expert, helps entrepreneurs and independent consultants build their database of clients and prospects, determine the best ways to market their business to their target market, teach them how to network, develop follow up systems, marketing and advertising plans and find ways to get free or low cost publicity which all lead to more customers and increased sales! Visit her at http://www.ksawamarketing.com/.

05/31/07 - Ron Paul's Bill is the Answer to FDA Failings

2007-05-31T19:49:00.000-07:00

SPECIAL ...VLUeM – 05.31.07 - VITAMIN LAWYER UPDATE e-MEMO
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Ron Paul’s Health Freedom Protection Bill is the answer to the FDA’s failings…

Head of FDA wants to work more closely with Drug Companies...

Report from Gardner Harris - "May 30 - When Dr. Andrew C. von Eschenbach took over the Food and Drug Administration in 2005, the agency had a crisis over drug approvals that had missed or ignored dangerous side effects in Vioxx, antidepressants and other prominent medications. Dr. von Eschenbach promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety. But this month, The New England Journal of Medicine published a study suggesting that a major diabetes pill, Avandia, might increase the risk of heart attacks.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations. A House hearing is planned for June 6. Dr. von Eschenbach said in a briefing on Wednesday that his agency needed to collaborate more closely with drug companies.

’The point is that we need to look at the role of the F.D.A. in being a bridge to the future, not a barrier to the future,’ he said at his office here."

My question: is working closely with Drug Companies the solution... or the problem?

I suggest that a better solution would be promoting natural remedies without dangerous side effects; not putting up bureaucratic barriers to them. This
can best be done by allowing people access to truthful information about traditional, non-drug approaches; by letting natural product purveyors make
serious health claims... exactly what Ron Paul's Health Freedom Protection Act would do.

In the twelve hours since www.globalhealthfreedom.org sent an email blast seeking support for the Paul bill over 10,000 people have written their
congresspeople supporting the bill! We still need hundreds of thousands to move Congress.

Here's where to do it: http://tinyurl.com/3xwmjm or

http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754

Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!

05/16/07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs

2007-05-16T19:52:00.000-07:00

SPECIAL ...VLUeM – 05.16.07 - VITAMIN LAWYER UPDATE e-MEMO
EPHEDRA BAN CONTINUED: Risk - Benefit Analysis Comes to Herbs
The United States Supreme Court decided not to hear the Ephedra case appeal on May 13, 2007. This decision leaves standing the appeal court reversal of the Utah district court's voiding of the FDA's ban on the Chinese herb Ephedra. Take a deep breath! That means, in effect, a drug industry risk/benefit standard has been imposed on at least part of the Dietary Supplement industry. Instead of the standard of “safe if used as directed,” which is the standard that applies to all foods, herbs can now be subjected to the type of analysis that applies to drugs.

But not equally, as the Ephedra case shows. Let's take Aspirin for example: tens of millions use it daily; 1500 die each year. Apply Risk/Benefit Analysis: drug allowed. Another example: Viagra(R) - hundreds of thousands use it; hundreds are harmed yearly. Drug allowed. Now take Ephedra: at its height, 25,000,000 used it daily. Over ten years, there were 5 deaths that may have been associated with Ephedra abuse; not using it according to directions. Result: the herb is banned. To this observer, this does not appear to be equal treatment. Or based on science and reason.

According to NutraIngredientsUSA, "The most recent court ruling on Ephedra blurs the distinction between supplements and drugs and could force the industry to conduct clinical tests, says the Natural Products Association..." The "once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death. ... A year later the ban was successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor. ... Since then the pendulum has swung back and forth on appeal..." http://www.nutraingredients-usa.com/news/ng.asp?n=75628-pa-ephedra

Judge Campbell's reasoning, however has not been rejected by the Supreme Court, as it decided in its discretion, not to hear the case. Future cases asserting the same legal claim, that Congress intended Dietary Supplement law to be harmonized with food law, not drug law, could be further strengthened by steps the US Senate took last week to exempt Dietary Supplements when it approved enhanced powers for FDA.

In the 2005 case, Judge Tena Campbell held, “...the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…”

It is therefore incumbent upon Congress to protect this salutary policy and further enhance it, by writing a much stronger exemption for all foods and natural products into S.1082, the FDA Revitalization Act of 2007 when it comes before the House. Keep your mouse-tail twitching and stay tuned to get ready to bombard Congress with one simple demand:

"Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!"

Check www.globalhealthfreedom.org for further details.

To contact Congress:
http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344

05/11/07 - OMB approves cGMPs- S.1082 amend confirmed

2007-05-11T19:53:00.000-07:00

VLUeM - 05/11/07 - Vitamin Lawyer Update Memo
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1. New GMP Standards Cleared by OMB
2. Vitamin Lawyer Health Freedom Blog: DSHEA Exemption?
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1. New GMP Standards Cleared by OMB – as reported on the Internet
May 9th, 2007 – SEN. HATCH: DIETARY SUPPLEMENT GMPS FINALIZED
Completes Effort to Implement Key Aspect of DSHEA
>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”
>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing.
The GMPs are expected to be published within the next five weeks.
>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”

We are likely to get a look at the GMPs within the next few weeks. I will keep this elist informed of these developments, that I have long predicted. When the GMPs are issued, I will update the standard Vitamin Lawyer Consultancy SOPs (Standard Operating Procedures) to conform. My current formats are outlined at: http://tinyurl.com/2eu6yj
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2. Vitamin Lawyer Health Freedom Blog

The political situation, as it impacts Dietary Supplements and Alternative Practices is moving so fast that a couple of Update eMemos a month cannot keep up, so I’ve started a blog on these issues: http://tinyurl.com/yo5t4t - you need to be aware of the latest developments… and two of those are: (1) Dr Ron Paul, congressman from Texas and presidential candidate, called the draft FDA CAM guidance “an abuse of FDA power…” and (2) despite some confusion on the issue, we have written confirmation from Sen. Kennedy’s office that the Senate did approve SAmend 1022 (94 to 0), exempting DSHEA products from the Kennedy FDA enhancement bill (but, the broader exemption for all food and natural products needs to be added when the House considers the bill). More at www.globalhealthfreedom.org

Let Congress hear from you: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11344

05/03/07 - Responding to Net Attacks; Victory in Congress!

2007-05-03T19:54:00.000-07:00

05.03.07 - VITAMIN LAWYER UPDATE e-MEMO
PRIVATE MESSAGE: The purpose of the ...VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. Please take a look at www.vitaminlawyer.com – we have a new look and better indexing.
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1. Strategies for Responding to Net Attacks – Fake Ratings Sites
2. Strategies for Responding to Net Attacks – DoS Preparation
3. Health Freedom Issues: VICTORY IN CONGRESS TODAY!
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1. Strategies for Responding to Net Attacks – Fake Ratings Sites

Here is a copy of an email I just provided to one of my regular clients:

“There are several strategies that can be used to respond to fake "third party" sites that are actually competitor sites designed to denigrate competing products. These responses vary from mild to extreme; from inexpensive to very expensive.

But, before getting to those strategies, some preliminary issues may help understanding how far to go.

First, who actually owns the offending site? I searched the WhoIs database at NetworkSolutions.com and find a "private registration" through Network Solutions (NS is the original & "Cadillac" of the URL registrars). The problem is, the register does not have to cooperate without starting a lawsuit and serving a subpoena on it; one trick is to start a small claims action (which is relatively cheap) and issue the subpoena from that.

Second, does anyone actually see the offending site? I checked the Alexa.com rating for the offending site. It has worse than a 3,000,000th rating. Your rating is in the Top One Million. So this offending site may not be much of a problem. By the way, being in the Top One Million is a good thing!

Here are some options:

0. Create & promote a competing site with similar name & image to dilute the offending site's search engine status.
1. Legal letter from attorney to offender, sort of saying: “Cease & Desist your defamatory posting and stop using our trademark!” with copies to URL register and ISP.
2. Written complaint for unfair competition, false claims, to appropriate Attorney General Consumer Protection Agency; copy to offender.
3. Same as #2, but to Federal Trade Commission, if more of a federal issue situation.
4. Lawsuit in state court for unfair competition, trademark violations, etc.
5. Lawsuit in federal court under cyber protection laws (such as the Cybersquatting Act).”

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2. Strategies for Responding to Net Attacks – DoS Preparation

It takes a sophisticated opponent to engineer Denial of Service (DoS) attacks on a web site. Individual computers and even local networks have to be commandeered and turned to the nefarious task of massively requesting information from the attacked site, so it crashes under the assault. Since the attack is coming from many IP addresses, it is difficult to stop.

These are certain simple steps you can take, with your webmaster, to minimize the threat. The first step is to always have a mirror site on another server. Then, if attacked, the alternate site can take over until the attack stops. There is a certain way to code your site that can minimize the effect of a DoS attack. I acknowledge receiving this information from Mike Adams of www.newstarget.com – a great Internet source of information. For various reasons, I am not publicly releasing this information. If you would like to know more about this, please email me at ralph.fucetola@usa.net and put “DoS” in the subject line.

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3. Health Freedom Issues Continue to Reach 100,000’s

During the past 5 weeks we have seen an awesome outpouring of citizen protest against a growing list of FDA, congressional and international pressure on our health freedoms. Around 180,000 people sought to file comments with the FDA about the draft CAM guidance, before the comment period ended. At the same time, several troubling bills are wending their way through Congress and Codex, the UN food agency, continues to be a battleground. Commenting on this, Dr. Rima Laibow, MD, Medical Director of the Natural Solutions Foundation - www.globalhealthfreedom.org – recently stated on her blog:

"Right now the American Public is being whipsawed: first the dangerous FDA CAM Guidance (Complimentary and Alternative Medicine/Modalities) which threatens to turn all health practices into medicine which only physicians could practice and the foods and supplements supporting natural health into
unlicensed drugs – and, yes, there is a real danger to your health freedom despite a good deal of internet chatter to the contrary!) - and now the sudden advancement of Senator Ted Kennedy disastrous bill, S 1082 (“the FDA Revitalization Act of 2007”, plus the identical House bill) from Committee to the floor of the Senate for a vote in the immediate future without public hearings. It would be easy to succumb to “health freedom vigilance fatigue”, which is, I believe, exactly what the intended effect is supposed to be. There is even speculation that Senator Kennedy moved this bill forward so rapidly BECAUSE the American public responded so vigorously to the CAM Guidance and are presumed to be preoccupied with it."

You can keep up with the latest developments at the Health Freedom Blog: http://www.healthfreedomusa.org/index.php?page_id=219

VICTORY IN CONGRESS! And some very good news: Congress has accepted the following amendment to S.1082 - Enhancing Drug Safety and Innovation Act of 2007 - from Sen. Durbin. It appears that Congress heard our concerns! Hundreds of thousands of messages to FDA no doubt reverberated through the halls of Congress. The amendment was adopted with 94 out of 100 votes.

Sec. X08. Rule of Construction

Nothing in this title (or an amendment made by this title) shall be construed to affect--

(1) The regulation of dietary supplements under the Dietary Supplement Health and Education Act; or

(2) The adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

Like many victories in Congress, you hardly ever get everything you want. A leading supplement industry lawyer, J. Emord originally proposed exempting all "foods" from the new law (Counsel stated: "It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.") This approach would have offered even greater protection for natural products, but we are grateful that enough members of Congress heard the loud shout from the public and responded so quickly to at least protect DSHEA products -- the power of Internet politics at its best.

04/26/07 - SUS Page Updates

2007-04-26T19:55:00.000-07:00

04.26.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Dietary Supplement SUS page update
2. Vitamin Lawyer on Internet Radio this Friday
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1. Dietary Supplement SUS page update

One of the main services The Vitamin Lawyer Consultancy provides to its vitamin purveyor and alternative health care practitioner client base is to keep you updated with the latest changes in the Disclaimers and Disclosures that you need on your web site. Due to recent legal developments, I’ve modified my standard Site Use, Privacy, Disclosure, Disclaimer Statement by adding two new paragraphs. If you are using my format, you would add these after the section on food allergen labeling. The new clauses are:

"This Organization is in compliance with the terms of the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 and will make all required Adverse Event Reports (AER).

To the best of the knowledge of the Organization, none of our products are classified as “CAM” (Complementary and Alternative Medicine) Products and they are not labeled with claims to treat disease."

For more information about SUS contents, see: www.siteusestatement.com – if your web site needs a proper SUS, please email me with “SUS” in the subject line.

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2. Vitamin Lawyer on Internet Radio this Friday

I’ll be chatting with counsel Jim Turner on his Of Consuming Interest Internet Radio show this Friday, April 27th from 3 to 4 PM, EDT - www.prncomm.net - this is Gary Null’s internet radio network. Our prime topic will be Complementary and Alternative Modalities.

We will discuss the latest developments in the FDA anti-CAM guidance public outcry. To date, over 144,000 people have told the FDA , “We’re as mad as hell and we won’t take it any more!” While the FDA spin masters now assure us we have nothing to fear, lawyers in the field view the guidance as potentially dangerous to health care freedoms. We’re happy to take your questions and comments about this and the other pending attacks on health freedom, like CODEX, the NAU (Trilateral Cooperation Charter) and a bunch of bad bills recently introduced or threatened by the friends of Big Pharma in Congress. We will also focus on strategy going forward: how to deconstruct an agency that has confusing and conflicting authority and a record of mounting failure. It is sobering to realize that as many people die each year of properly prescribed, FDA approved, drugs, as have protested the anti-CAM guidance!

04/20/07 - Affiliate Programs, update on FDA anti-CAM guidance

2007-04-20T19:58:00.000-07:00

04.20.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Affiliate Program Upgrade: Higher Commissions!
2. FDA Anti-CAM Guidance Update: Hot Button Issue!
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1. Magnets for Wellness: Just a note to my clients with online businesses: BiomagScience has seriously upgraded its affiliation program: raising the commission rate from ten to 25% and the override (for sites that join through your site) from five to 10%! As I noted in past eMemos, joining affiliation programs is a quick way for you to bump up sales on your site; just remember to set up the html so the banner opens a new window, that way people don’t leave your site when the click through. You can join at: http://www.biomagscience.com/cmd.php?af=520607.

The “Body Electric” is also a body magnetic and the use of magnetism in self-help and as a therapy that may benefit normal structure and function is growing. Sports medicine, especially, is beginning to accept the benefits of magnetism in promoting healing and raising cellular energy levels. BiomagScience offers magnet products and clearly described protocols developed by the Foundation for Magnetic Science.

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2. FDA Anti-CAM Guidance Update: For those of you who have been trying to reach me with less success than usual, I apologize. I’ve been “riding a tiger” with the FDA’s proposed new controls on Complementary and Alternative Practices – over 90,000 comments have been generated to FDA in a bit over a week! This has been very controversial, with some observers suggesting the new “Guidance” does not represent a new power grab by FDA. Naïve, Naïve! Here is my latest commentary on the issue:

CAM Practices, Products and FDA Regulation: A Threat Assessment

The US Food and Drug Administration is a confusing and confused agency, charged with administering federal controls over foods, drugs and medical devices under a patchwork of laws and regulations that have drastically increased costs to American consumers and slowed health care progress, without demonstrable safety benefits. It is therefore inevitable that many actions taken by the agency are likely to do more harm than good. Such is the case with the proposed Complementary and Alternative “Medicine” (CAM) guideline that the agency proposed at the end of December, public comment period to extend through April 30th. You can go to http://tinyurl.com/2u7ghc to make your comments.

It is true the FDA anti-CAM guidance merely restates the existing law [as FDA sees it] -- that, if you intend to "treat disease" with a CAM product, that product (for example, says FDA, a “juice”) is a "drug." By codifying this in a guidance document, FDA is setting the stage for another push to control and restrict CAM practices. The FDA uses the term “CAM product” in the guidance, although Congress has never defined such a term. The agency seeks to create a “status” of being a certain type of product when all Congress has authorized is that the FDA can regulate certain products “intended” to “treat disease.” Of course, the responsible FDA Senior Science Advisor did say, in a very recent interview, this is not FDA’s “intent” and using “CAM Products” is just a matter of convenience. Of course, as good Americans, we should all believe exactly what the FDA tells us; trust the agency’s intent; shut up and take all our prescriptions.

In addition to telling us that a juice intended to “treat disease” would be a drug, a careful reading suggests even items used in religious healing ceremonies could now be subject to regulation as drugs or medical devices. Holy water, anointing oils, prayer beads, rosaries, sweat lodges and even religious paintings or icons could be classified as drugs or medical devices and essentially outlawed by the FDA. Does this sound absurd? Well, it is absurd!

Certainly, all this appears a bit less absurd if we are considering using an herb or dietary supplement to stay healthy. Says the FDA, if any supplement is used to treat a symptom, then it is a drug and will be regulated by the FDA, just like any prescription drug.

The FDA does give us a little hope -- the supplement will be exempted if it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." This is essentially the same standard used for substantiating drug claims. In 2004 the FDA gave us the standard for making claims about foods and dietary supplements: "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' Quite a difference! This is just one difference the anti-CAM guidance will codify. And after codification comes enforcement. All alternative practitioners should take note!

In other words, your freedom to use a dietary ingredient as therapy that may benefit a condition will be at the discretion of FDA “experts” who will determine whether to regulate it as “medicine.” Given the abysmal track record of FDA experts, this could be really bad news.

With so much latitude, I cannot predict just how far the FDA might go to restrict access to herbs, minerals and supplements, as well as other CAM products. Many pro-health freedom groups are offering their concerns too. For instance, one commentator, Jenny Thompson of the HSI Newsletter suggested, “…[FDA] could take a widely used supplement off the market if the label states a benefit; such as using lutein to reduce the damage from age-related macular degeneration, or using chondroitin and glucosamine to reduce joint pain, or using probiotics to address digestive problems - the list goes on and on…” The AAHF (American Association for Health Freedom is concerned that “the two biggest [problems with the guidance] are broadening the definition of “health claim” and the desire to pre-empt the states in the regulation of some health care issues”

The health freedom movement began to take notice of the pending anti-CAM guidance in late March. At the start of April, I assisted one group, Natural Solutions Foundation, to write its commentary to submit to the FDA, with emphasis on what we see as the important distinction between "treatment of disease" and its non-medical alternative, under AMA Ethics Code Opinion 3.04, "therapies that may benefit." The comments raised three demands:

1. A public hearing by the FDA before the finalization of the guidance.

2. Changing the title of the guidance to use the phrase “Complementary and Alternative Modalities” and not the prejudicial “Complementary and Alternative Medicine” as in the draft.

3. FDA recognize that “therapies that may benefit” are not the same as “treatment of disease” and do not have to be regulated as “medicine.”

The organization then alerted its elist and asked its supporters to also file comments with the FDA, supporting the group’s requests. We apparently touched a hot button issue; over the following week the buzz spread on the Internet

Propelled by this strong public support, I believe we now have an opportunity to turn this FDA "end run" around and use it to protect CAM practices. We are now seeking support from members of the US Congress to demand that FDA hold public hearings before making the guidance final. If FDA fails to hold such hearings, it would be time for Congress to step in, hold hearings, and propose legislation to protect CAM practices from FDA action that would deny Americans access to alternatives. With John Galt, we want to say, “Get out of my way!”

It has been settled law in this Country for over a century that medical regulations exist to protect the public, not to entrench licensed allopathic medicine to the detriment of all the evolving healing arts, which would refer to as “CAM practices” – though Traditional and Advanced Health Care might be a more appropriate term.

"The state has not restricted the cure of the body to the practice of medicine and surgery -- allopathy, as it is termed, -- nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to ours ystem as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind -- to allopathy, excluding homeopathy, osteopathy, and all other treatments -- might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly." North Carolina's Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p 582.

As NSF’s medical director, Rima Laibow, MD, has noted,

“Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, other invasive technologies of modern medicine, and un-manageable and unreasonable costs. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed.”

You can read more about this issue and add your comments to the FDA through the Natural Solutions Foundation, a non profit NGO at http://www.healthfreedomusa.org and submit your comments from the home page. Since the FDA Dockets Supervisor tells us her 9 member staff is overwhelmed -- apparently the system crashed and only about 102,000 of the over 245,000 people who have tried to post comments have succeeded so far – we have now made arrangements to email directly to the FDA and expect all future comments to get through, so if you did not succeed last week, please try again. The last time Americans got this mad about health freedom, we got DSHEA. This time, we will protect our complementary and alternative practices; our vitamins, herbs, minerals and healing arts. We are “mad as hell” and “we aren’t going to take it any more!”

04/07/07 - MLMs, AERs, SoPs, FDA on CAMs

2007-04-07T19:59:00.000-07:00

04.07.07 - VITAMIN LAWYER UPDATE e-MEMO
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1. MLM – Multilevel Marketing
2. Wanted: Testing for Supplements
3. Updated SoP Outline
4. AHPA on AERs
5. FDA to issue Guidance on CAM – comments requested!
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1. MLM Marketing

MLM Marketing, of which Online Affiliate Marketing is a subset, appears increasingly important in the Vitamin Industry, while, at the same time, every successful MLM seems to feature vitamin products. Here is what Wikipedia has to say about Multi-Level Marketing" -

"In a typical multi-level marketing or network marketing arrangement, individuals associate with a parent company as an independent contractor or franchisee and are compensated based on their sales of products or service, as well as the sales achieved by those they bring into the business. *** Multi-level marketing has a recognized image problem due to the fact that it is often difficult to distinguish legitimate MLMs from illegal scams such as pyramid or Ponzi schemes. MLM businesses operate legitimately in the United States in all 50 states and in more than 100 other countries, and new businesses may use terms like "affiliate marketing" or "home-based business franchising". However, many pyramid schemes try to present themselves as legitimate MLM businesses."

And what it says about "Pyramid Schemes" -

"A pyramid scheme is a non-sustainable business model that involves the exchange of money primarily for enrolling other people into the scheme, usually without any product or service being delivered. Pyramid schemes have existed for at least a century. *** There are other commercial models using cross-selling such as multi-level marketing (MLM) or party planning which are perfectly legal and sustainable."

It was in 1979 that the Federal Trade Commission (FTC) ruled in the case of In re Amway (93 F.T.C. 618) that MLM marketing was legal. Some of the largest marketing companies in the world use MLM systems to provide goods and services to the public. Some famous examples come to mind. Amway. Mary Kaye. Market America. Nikken. Shaklee or Tupperware. These companies market billions of dollars in products and services annually.

It can be fairly said that Multi-Level Marketing appears here to stay and has been strengthened by the rapid development of the Internet Market (for both ease of record keeping and direct online sales). While, in the past, there may have been some abuses by some companies, the continued participation by millions of people in MLM companies (around the world) and the rapid growth of online affiliate sales, shows strong market acceptance and a continuing role in the global economy.

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2. Wanted: Testing for Supplements – An important Nutraingredients commentary:

http://www.nutraingredients.com/news/ng.asp?n=75425&m=1NIE402&c=jegwylrviswtnqa

02/04/2007 - The dietary supplement industry needs an independent testing program that is recognizable to consumers in order to enhance the credibility of its products as well as encourage solid science and sourcing.

As it stands now, the industry lacks a familiar stamp of approval on labels that can let consumers know if the product in their hand stands out in any way from others on the shelf. This means companies that go the extra mile - those that invest heavily in research and development or oversee all sourcing of their ingredients - are not necessarily rewarded.

Many other consumer goods industries - such as dental products - have stamps of approval that can help point consumers to products with effective value-added ingredients, etc. The dietary supplement industry should apply a similar model, but with the added clout of a testing program behind the labels.

The obstacles frequently cited against this type of program are the cost of such an initiative, as well as what group or groups would assume the responsibility.

While the Natural Products Association, NSF International and US Pharmacopeia offer testing programs in the United States, they are either not yet wide enough in scope, or are not recognizable as label 'stamps of approval' to consumers.

The story in Europe is differs slightly with the finer points of the 2002 food supplements directive (especially vitamin and mineral) still to be hammered out. EU regulations. But even though industry may have its eye elsewhere, building consumer confidence in should always be a priority.

As such, a universal testing program would require an advertising campaign to familiarize consumers with the concept so that they know what to look for on product labels.

And once consumers start to look for stamps of approval on bottles, industry will be compelled to follow all the necessary steps to get such certification. This will also buffer the effect of allegations in the industry that target some companies and not others.

In January, American ConsumerLab.com allegedly found high lead content in certain supplement brands, including a multivitamin for women sold by The Vitamin Shoppe. Traces of dangerous compounds are a genuine concern for the industry and until one independent body tests decides what constitutes 'dangerous' levels, the charges made by businesses such as ConsumerLab.com will continue to scare consumers without providing any straight forward solution.

An independent testing program would also urge companies to become accountable for their ingredients and oversee the entire supply chain before their product goes to market. This could dissuade companies from relying on suppliers that contract from other suppliers in such a way that the end manufacturer has never even set foot in the facility where its product may have originated.

Also, any companies that cut their active ingredients with undeclared fillers would also be punished or, at least, would lose out on the bonus of certification.

Adulterated versions of relatively expensive ingredients such as hoodia gordonii or saw palmetto would become less easy for companies to proffer. Sold as an appetite-suppressant, cactus-like plant hoodia is sourced from South Africa, while saw palmetto for supporting prostate health is sourced and wild-harvested from Florida.

Consumers would finally know that what is on the label is what is really in the bottle.

However, none of this will come about until the majority of the industry is motivated enough to invest in its own long term livelihood instead of letting some companies take the easy way out while others invest in science and the consumer is caught somewhere in the middle trying to decide which product is legitimate.

Clarisse Douaud is a reporter with NutraIngredients-USA.com and has lived and worked in Canada, Ireland, Argentina and France. If you would like to comment on the piece, send an email to: clarisse.douaud'at'decisionnews.com

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3. SoP Outline Web Page

I’ve compiled the information presented in various Update eMemos regarding Standard Operating Procedures on the updated outline page at: http://tinyurl.com/2eu6yj

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4. AHPA on AERs

The natural products industry is starting to get ready for Adverse Event Reporting, as this article shows -

“4/4/2007 - The American Herbal Products Association has joined the ranks of trade associations preparing the dietary supplement industry to comply with impending adverse events reporting (AER) legislation... Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports. The AER legislation is set to come into practice by the end of 2007, meaning companies will have to have their reporting systems in place… Following the bill's passing at the 'eleventh hour' in December, the responsibility of informing industry was left in the hands of trade associations…. AHPA claims companies will be able to distinguish between a complaint and an adverse event.”

http://www.nutraingredients-usa.com/news/ng.asp?n=75506&m=1NIU404&c=jegwylrviswtnqa

More on AER services: www.aer-consultants.com

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5. FDA to issue Guidance on CAM – Comments requested!

The Food and Drug Administration is about to issue its “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” The “guidance” is just as bad as you imagine… however, first, they have to accept comments from the public on the proposal, and we hope to force a public hearing. Comments due by April 30th.

Guidance at: http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm

You can submit your comments through Natural Solutions Foundation at: http://tinyurl.com/2u7ghc

I helped write the NSF comments and would appreciate your support by submitting your comments in support of ours!
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Well, wish me a Happy Birthday – I was born this date in ’45.
Ralph Fucetola, JD - The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved

03/31/07 - Your FDA Compliance Notebooks, Affiliate Marketing

2007-03-31T20:03:00.000-07:00

VLUeM – 03.31.07 - VITAMIN LAWYER UPDATE e-MEMO
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1. Your SoP & Substantiation Notebooks & FDA Inspections
2. Grow Your Online Affiliation Program!
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1. Your SoP & Substantiation Notebooks & FDA Inspections

I’ve been asked what a Dietary Supplement marketer ought to have available for an FDA visit, in the event of a surprise agency inspection.

Ideally, you ought to have a couple loose leaf note books, (a) one entitled "Standard Operating Procedures Notebook" (or “SoP Notebook”) and (b) the other entitled “Substantiation Notebook.”

(A) The first Notebook should contain your:

(1) Operations Manual/SoPs and Employee Manual
(2) Formula sheets
(3) Label copies (with dates as to when they were in use)
(4) Literature copies (likewise dated)
(5) Copies of your Structure and Function Notices
(6) Insurance Policy binder page
(7) Certificate of Incorporation (or LLC Certificate of Formation)
(8) EIN and Bank Account number information

(B) The second Notebook contains information that substantiates the claims you are making. This Notebook should have a section for each product and each claim for the product, by ingredient.

(1) Abstract pages of scientific journal articles regarding the ingredients
(2) Clinical study reports about the ingredients and combinations of them
(3) Ethnographic reports on traditional uses
(4) Expert opinion letters

If you are ever visited by FDA, for one of their famous "surprise visits" having this stuff together so you can give them a copy would make them very happy.
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2. Grow Your Affiliate Program

The Vitamin Lawyer Consultancy does provide Affiliate Program Rules. Let me know if you want to establish an Affiliation Program.

Besides the right Rules, of course, you need the right software. One good program that I can recommend is the program used by BiomagScience.com for its online biomagnet sales program. It is a two step program, so, typically, you will see two banners from it on Affiliate web sites. One is for retail sales of biomagnets (for which you receive a sales commission), and the other is a “Become a Biomagscience Affiliate” banner, where another web site can join as an Affiliate, and your site earns an override on all retail sales through that site. If you go to the following page, you can see that banner: http://home.earthlink.net/~lifespirit23/support-lifespirit.htm .

But that’s just the start. After you have your web site and your affiliation program, you need to market it! If you do it right, you can expect very significant sales growth!

Here are excerpts from a piece through Add Me Newsletter about being an affiliate marketer.

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www.addme.com
How To Immediately Boost Your Affiliate Marketing Sa'les
By Titus Hoskins

Affiliate marketing is a very competitive field. Savvy affiliate marketers use every tactic they know to get the upper hand over their competition. It can mean the difference of whether or not they get that all important sa'le.

One of the best ways to boost your affiliate sa'les is to take full advantage of brand name recognition. … Popular brand names with popular trendy products sell the best.

If you're an affiliate marketer you must choose the products you promote with the utmost care; in many cases this is where you will determine the outcome of your marketing efforts…

As an affiliate marketer you can promote anything, why not choose the most popular brands and products. Just look for popular trends and join the bandwagon. Sure, the competition might be stiffer but the demand for these products will also be greater.

If you join affiliate networks like Commission Junction [or, for another example, eAffiliatez.com – rf] they will show you the companies with the highest sa'les volume in their system. Study this sa'les data before you pick your affiliate companies or products.

You can even use Google Trends to tell which products are popular and in which countries. Do some market research first and pick the most popular products to promote.

Many marketers keep an eye on their PPC (Pay Per Click) keywords for any surges in searches or impressions. A big jump could mean an increase in popularity for that product or company.

* Be Aware of “The Buzz” Factor …Certain brand names and products have buzz. …

* Can It Only Be Bought Online? … One of my most successful tactics has been to pick products or offers that are only available online. Dell products come quickly to mind. … Online coupons and exclusive deals also increases your affiliate sa'les. Look for these and display them along with your popular brands for they will increase your sa'les. Everybody loves a deal!

* Use Brand Names In Your Site Copy and PPC Advertising … You must always check with your affiliate company what rules they have about displaying brand names and trademarks on your site copy. Most companies will supply their affiliates with web content they can use for promotion.

Most Companies have strict rules prohibiting affiliates from using certain brand name keywords in their PPC advertising. Each company is different, so check before you proceed with any PPC campaigns.

However, one of the most effective ways for PPC advertising is to use the particular brand name and product name in your PPC ads. Savvy affiliate marketers have figured this one out long ago, it mainly has to do with finding the buyer at the right stage in their buying process. If they're looking a particular product ; they may already have their minds made up and are ready to buy…

* A Rose Is A Rose Is A Sa'le! … In conclusion… Keep your eyes peeled for popular trends and shifts in the marketplace so you can adjust your marketing to meet these new demands….

About the Author - The author is a full-time online marketer. For the latest and most effective web marketing tools try: Internet Marketing Tools - http://www.titushoskins.com/ © 2007 Titus Hoskins.

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Well, that’s all for now.

Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
http://www.vitaminlawyer.com
All Rights Reserved

03/16/07 - Making Claims, SoP Outline, Health Freedom Site attacked

2007-03-16T20:05:00.000-07:00

03.16.07 - VITAMIN LAWYER UPDATE e-MEMO

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1. Making Claims & New Dietary Supplements
2. Record Keeping SoP and Employee Manual – Online Outlines Available
3. Health Freedom Site Attacked
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1. MAKING CLAIMS & NEW DIETARY INGREDIENTS

Say your company needs a "DSHEA compliance" letter from The VitaminLawyer.com Consultancy about a new product. The threshold issue is whether the product is a "new dietary ingredient". We start by noting whether the product is found in the IBIDS data base. Then we check to see if similar products are found in the general FDA data base and look for references indicating whether FDA treats the product as a new dietary ingredient.

Journal abstracts showing the product being studied prior to the DSHEA "grandfathering" date of June, 1994 can be useful. Such information could show that the product was part of the food supply before the grandfathering date. This will negate the new dietary ingredient issue (which would have required prior FDA approval before marketing -- with proof of safety).

The other part of the DSHEA compliance issue has to do with the claims to be made for the product. If there are no claims being made, other than "a good source of [ingredient]" or "advanced bioavailable form of [ingredient]" (with substantiation for these claims, of course) then there would be no claim issues. Simple general “support of normal structure and function” claims are allowed. Even “immune system support” claims could be allowed:

"A “claim that a product "supports the immune system" is not specific enough to imply prevention of disease because the immune system has both structure/function and disease fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function."

Here is access to the FDA guidance: http://www.fda.gov/ohrms/dockets/98fr/98n-0044_gdl0001.pdf. Once these threshold issues are resolved, it becomes possible to provide a DSHEA compliance letter for use with potential distributors, online affiliates and joint venturers.

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2. RECORD KEEPING SoP AND EMPLOYEE MANUAL

SoP – Standard Operating Procedures – are an important part of cGMPs (current Good Manufacturing (Marketing) Practices. I’ve created a new web page with outlines of the contents of the SoP and EM documents - http://tinyurl.com/2eu6yj

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at: http://tinyurl.com/2eu6yj

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3. HEALTH FREEDOM SITE ATTACKED ON 03/12:

The websites of the Natural Solutions Foundation - www.globalhealthfreedom.org and www.healthfreedomusa.org – disappeared from the Internet within hours of the site exposing the genocidal agenda “the illness industry.” The sites are online again, but with a number of images and other information still missing. You can read the original article and the Internet attack at: http://www.healthfreedomusa.org/index.php?page_id=219

Here is what Dr. Laibow had to say in an email blast while the sites were down: “…our hosting company… locked our site with no reason given, no warning and no explanation. When I called to talk to someone about this I was told that the supervisor was "on leave," the manager was "not here," probably would not call me back when he got there, and that there was no one to talk to about the fact that my site was locked for no apparent reason at all. All this after 19 minutes and 45 seconds of international phone call holding. Why is our site blocked? Because, according to the technical services person, the site was locked in the computer with no explanation and can not be unlocked until I talk with the right person. Who is that? He does not know… The War on Freedom IS a War on Health Freedom… I wrote about the genocidal intent of the illness industry called Big Pharma in my latest email to you. Funny, immediately after that our site is mysteriously locked for no reason. Hmmmmm. Could it be that the Power Beast does not want you to know about these realities? Looks like it, doesn't it…”

As of today, the two parts of the site that still do not work, curiously, are the email sign-up and the Organics 4 U Shop. So no one can join or help support NSF*. Curious and curiouser… If you’ve chosen to be in this industry, you need to acknowledge its realities.

Ralph Fucetola JD
http://www.vitaminlawyer.com

* The Foundation can receive donations through PayPal, however.
You can PayPal to naturalsolution@optonline.net and the donation will go directly to the Foundation.

Also, do see Nutricide, now on YouTube at: http://video.google.com/videoplay?docid=-5266884912495233634&q=Nutricide

03/02/07 - More SoP, more attacks... Web 2.0

2007-03-02T20:06:00.000-08:00

03.02.07 - VITAMIN LAWYER UPDATE e-MEMO
--------------------------------------------------------
1. Record Keeping SoP and Employee Manual – Online Outlines Available
2. New Meta-Analysis Attacks Antioxidant Vitamins: Is it flawed? What to do?
3. Web 2.0 – What the Entrepreneur Should Know
---------------------------------------------------------

1. RECORD KEEPING SoP AND EMP MANUAL

[I was asked to repeat this information from previous eMemos. I’ve created a new web page with outlines of the contents of the SoP and EM documents -
http://tinyurl.com/2eu6yj ]

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the
industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing
Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and
shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler “Record Keeping SoP” version of my Standard Operating Procedures/Employee
Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For a bit over an hour of my
time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your
SoP.

You can now also take a look at the Tables of Contents of the Record Keeping SoP (actual document: 5 pages), the Standard SoP Manual (16 pages) and the Employee Manual (22 single-spaced pages) that I’ve posted at: http://tinyurl.com/2eu6yj

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2. FLAWED ANALYSIS – OR NEW APPROACH NEEDED FOR PRODUCTS?

Study alleges link between antioxidants and increased mortality.

“2/28/2007 - A meta-analysis of 68 randomized trials with antioxidant supplements has reported that vitamins A and E, and beta-carotene may increase
mortality risk by up to 16 per cent, but vitamin C did not have an effect on mortality and the antioxidant mineral selenium was associated with a nine per
cent decrease in all-cause mortality. … The pooled analysis, published in the Journal of the American Medical Association, could have significant
negative effects on the sale of antioxidant dietary supplements… The new pooled analysis has already drawn criticism from both inside and outside the
dietary supplements industry concerning the methodology applied, and the conclusions drawn. … The most prevalent criticism of the study has come from
the diverse nature of the studies pooled together, described by one industry expert as comparing "apples and oranges"… A wealth of epidemiological
evidence has linked dietary antioxidant intake to reduced risk of a wide-range of diseases, such as cancer and cardiovascular disease, but when such
antioxidants have been extracted and purified, or synthesized and put into supplements, the antioxidants, according to randomized clinical trials (RCTs),
do not always produce the same positive results. … [The meta-analysis] findings contradict the findings of observational studies… that antioxidants improve health.”

http://www.nutraingredients-usa.com/news/ng.asp?n=74582&m=1NIU228&c=jegwylrviswtnqa

The language used in the reports about the meta-analysis does appear carefully chosen to overstate the risks and understate the benefits. The bottom line for vitamin purveyors: (1) if these allegations begin to impact the market, consider substituting whole food sources of ingredients for extracts; (2) budget the funding needed for RCTs and (3) note the astoundingly positive results for Selenium: a 9% decrease in mortality. Think Whole Food Supplements!

[03/02 Update: Linus Pauling Institute blasts AMA fake meta-analysis: http://www.sciencedaily.com/releases/2007/02/070228172604.htm -- the Institute points out obvious flaws in the report and show the bias of the authors, who started with 815 trials, selected out 68 of them, ignored the most valid trials, and then manipulated the statistics to provide the preordained result. Voodoo science at its most obvious.]

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3. WEB 2.0 FOR “NEWBIES”

Excerpts from: Becoming the Spider: Next Generation SEO Tactics

"Just when you believed you had all your SEO tactics figured out, the web goes and changes on you. ... Web 2.0 changes the whole ballgame. It not only places the Internet user squarely in the middle of things, but it gives that user the means and power to create and manipulate data. Web 2.0 dramatically changes how we view and use the web. ... Just what exactly is Web 2.0? ...perhaps the simple definition can be found in the word "you"! Time magazine probably summed it up best by making reference to the "you" in user generated content. Web 2.0 is basically all the platforms that give us this brave new
user-powered interactive Internet, generally referred to as 'social media'. .. Web 2.0 can be seen or manifested in such sites as YouTube, MySpace,
Del.icio.us, Digg, Squidoo. ... Web 2.0 uses scripting languages such as Python, Perl PHP, RSS... to construct interactive platforms that websites can
use to create all this user-generated content. ... If you have used Google Earth, you will realize how powerful and revolutionary these new applications
can be, not to mention, they are a whole lot of fun. ... all webmasters should optimize their sites for this new Web 2.0 and take full advantage of all the
SEO possibilities presented by this brave new Internet. … Here are a few SEO suggestions you can try:

1. RSS/Blogging. You must place a blog and RSS feed on all your sites. This is a fairly simple procedure to do with free server-based programs... Having a
blog and RSS feed will place your site into the whole tagging process. Each category you create in your blog will be seen as a tag by such sites as
Technorati. RSS stands for 'Really Simple Syndication' and your RSS feeds will get your content distributed across the web. ...

2. Create some Google Juice! Join as many of these highly interactive sites as you can: MySpace, YouTube, Del.icio.us, Digg, Wikipedia ... my favorite is
Squidoo, where you can create Lenses on different topics that interest you. User driven content that's utilized by all the major social media sites. Of
course, link back to your sites in your posts and creations in these user-created content havens and watch your PR ratings go way up.

3. Use Interactive Scripts. Place interactive JavaScripts and platforms on your own sites. Have membership forums, polls, blogs, feedback forms,
user-contributions... to build unique content driven sites. Become the spider!

4. Tagging (Folksonomy). Be constantly aware of the tags (keywords) you're creating with your blogs and sites. This can have a very beneficial effect on
your traffic and rankings. Closely relate these tags to the content on your sites and build higher rankings in all the major search engines.

5. The Long Tail. Especially important for affiliate marketers, you need to cover special niches where there is less competition and content. These narrow
niches make up a large portion of the whole vast web, creating content in these unique areas will get your site included in the search engines a lot
quicker and keep them there a lot longer.

6. Holistic Web 2.0! Be constantly vigilant in placing your sites in the whole 'Interactive Game', building links and partnerships with the important
YouHubs: MySpace, Del.icio.us, YouTube, Digg, Squidoo... the more connections you have, the more your own sites will prosper.

"... Web 2.0 will play an ever increasing role in the development and evolution of the web. Make sure your sites are optimized and in the 'You'
game. Create blogs, RSS feeds, interactive forums, membership areas, user-generated content and truly make your sites interactive havens in their
own right. Just remember to tag everything and your sites will reap the benefits of this new Web 2.0 generated SEO gold rush. ... The author [Titus
Hoskins] is a full time Internet Marketer with numerous sites on the web, including two niche sites on Internet Marketing. His main site is
www.bizwaremagic.com ...”

Well, that’s all for now. Remember to check the SoP contents tables at: http://tinyurl.com/2eu6yj

Ralph Fucetola JD
http://www.vitaminlawyer.com

02/23/07 - Record Keeping SoP, attacks and opportunities

2007-02-23T20:08:00.000-08:00

02.23.07 - VITAMIN LAWYER UPDATE e-MEMO
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1. Harvard Joins Anti-Nutrient Crusade
2. The Future for Healthcare: $4.1 Trillion!
3. Record Keeping Short Form SoP
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1. HARVARD MEDICAL SCHOOL REPORT PERPETUATES ANTI-NUTRIENT LINE

The report speaks for itself, but do note how it is being used to create publicity for the idea of implicitly pre-market controls over nutrients, as though nutrients were not as safe as any other category of food.

“The report, "Vitamins and Minerals: What You Need to Know", gives consumer advice…Directed at the general public, the report could stir up the issue in the nutraceutical industry surrounding what body should give a stamp of approval for supplements, and whether an independent body is needed for such a purpose.

“"Choose products that bear the US Pharmacopeia Dietary Supplement Verification Program (USP-DSVP) mark, which indicates that the supplement manufacturer has complied with certain standards," says the report.

“Via its recommendations, the Harvard report is also critical of dietary supplements that go beyond the vitamin and mineral category.

“"Generally, if you're hoping for phytochemical benefits, you'll do better in the produce department than the supplement aisle," according to the report. "There is virtually no evidence that herbs and other nonvitamin ingredients added to supplements, such as echinacea, are essential for your health."

“The report questions another key area for the supplement industry - the benefit of different sourcing for vitamins in minerals.

“"It doesn't matter whether vitamin C is derived from organic rose hips or synthesized in large batches in a laboratory," says the report. "Your body will use the resulting product similarly."”

www.nutraingredients-usa.com/news/ng.asp?n=74406&m=1NIU221&c=jegwylrviswtnqa

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2. HEALTHCARE SPENDING TO INCREASE

FDA News reports today: “”Healthcare spending will continue to grow more quickly than the economy over the next decade … according to a report from economists at the Centers for Medicare & Medicaid Services (CMS). Healthcare spending in 2016 could reach $4.1 trillion, representing 20 cents out of every dollar spent, according to the report, which was published in Health Affairs. In 2006, healthcare spending was $2.1 trillion, the economists estimated. …

spending growth will reach 7.8 percent by 2009 because of accelerating medical price inflation and increases in pharmaceutical use. By 2016, health spending could be 19.6 percent of the gross domestic product, the report said.

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3. RECORD KEEPING SHORT FORM SoPs

A primary concern of small, leading edge dietary supplement purveyors is how to deal with the new wave of regulation that seems to be sweeping the industry. The first rule of bureaucracy is, “Are your papers in order?” Well, are they? In the context of current Good Manufacturing/Marketing Practices (cGMPs) your “papers” are the documentation of your business activities, from buying your products, through advertising, selling and shipping them. And then, dealing with customer issues, refunds, recalls, adverse event claims, etc., etc.

To make it as simple as possible, I’ve developed a shorter and simpler version of my 50+ page Standard Operating Procedures/Employee Handbook (SoP/EMs) that is made for smaller, Internet oriented dietary supplement and alternative therapy companies. For an hour of my time, I can customize the Record Keeping SoP format for your company, so you will know what documents you need to keep and for how long. Just email me at ralph.fucetola@usa.net with “Record SoP” in the subject line and I’ll let you know what information I need and how you can reserve the time for your SoP.

Well, that’s all for now.
Ralph Fucetola JD
http://www.vitaminlawyer.com

02/09/07 - FTC enforcement... Situational Selling

2007-02-09T20:10:00.000-08:00

02.09.07 - VITAMIN LAWYER UPDATE e-MEMO
The purpose of the ...VLUeM e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer.com Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own eList… ;)
And do remember to check out the ...VLUeM Online Archives: http://tinyurl.com/rkneb and my Online Seminar compilation of briefs and white papers: http://tinyurl.com/ua9lq .
This issue focuses on two areas: (1) FTC plans to police the vitamin market and (2) some more tips from Entire Web.

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1. FTC Enforcement Plans
2. Increase Conversion with Situational Selling
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1. FTC Enforcement Plans from Nutra Ingredients USA (article excerpts below)

http://www.nutraingredients-usa.com/news/ng.asp?n=74055&m=1NIU208&c=jegwylrviswtnqa

“2/8/2007 - The Federal Trade Commission has said that it will continue to prioritize policing dietary supplement marketing practices, thereby sending out a warning to companies making exaggerated or unsubstantiated claims. .

“The deceptive marketing of products that may affect consumer health and safety will continue to be an FTC priority,” said the FTC in its budget request summary submitted to Congress on February 5. “The FTC will focus on health care products, including dietary supplements.”

“The authority rang in the New Year with a $25m-clamp-down on parties behind the deceptive marketing of four major weight-control supplements: Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart. [The Vitamin Lawyer notes: none of my clients!] . . .

“Going forward, the FTC will continue its aggressive program by focusing its law enforcement on violations that create the greatest risks to consumer health.” . . .

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2. Increase Conversion with Situational Selling from EntrieWeb - www.entireweb.com (article excerpts below)

“. . . [R]eally good salespeople are trained to discover details about the customer before trying to pitch a particular item. A question like, "Hi, how are you? What sport do you play?" is a great opening line. It gets the customer to focus on a general topic, and then persuades him or her to narrow down the choices. And a focused customer is a buyer, not a browser.

“What does this have to do with your online sales? Plenty. Especially if you'd like to increase your conversion by 50 percent or more.

“You see, if you focus just on increasing traffic without increasing your profit per visitor, well, you're missing out on more money. Or more e-mail opt-ins. Or whatever it is that you do to monetize your site. Fewer clicks and more sales should always be the goal. You'll improve those two metrics when your site successfully gets visitors to focus right away on the homepage and then proceed directly to checkout.

“That's where the "situational sell" can be your super-cybersalesperson. On a website, you can give visitors a few choices that best describe their situation, and entice them to click on the description that puts them into a specific segment of the market.

“The situational sell is a way to pitch products and information strictly from the customer's point of view. If you're selling sports merchandise online, you would want to get customers to click on their favorite team right away, and then choose the item they want to buy. … Think of the situational sell as pre-qualifying your visitors, before they get a chance to wander aimlessly through your site. If you pre-qualify them, you can funnel them through the sales process a lot faster.

“One traffic school website who tried this tactic ended up increasing its email opt-ins by a whopping 60 percent! How did they do it? Instead of simply listing the names of the courses it offers, the website asks visitors what type of driver they are, literally. On the site you'll see 3 boxes in a row in the main body area. Each box contains a unique headline, a photo to illustrate the idea, and a description of services within the category.

“Box #1 contains the headline "New Driver?" and includes a picture of teenagers laughing and hanging out in a school parking lot. Box #2 carries the headline "Too Many Tickets?" and includes a picture of a driver getting a ticket. Finally, Box #3 has the headline "Trying to pass the state exam?" along with a picture of a recent immigrant holding paperwork.

“Under the headlines, a series of links appear. This is also a great place to include your top-tier keywords. Once a visitor clicks on one of those links, he or she is guided to a page specifically geared to sell products or services to their demographic

“The beauty in setting up a 'situational sell' website is that it's a very flexible way to market one type of product to a wide selection of site visitors.

“If you're selling e-books or informational products, there will be different features or advantages that you'll want to highlight, depending on the visitor. By segmenting your visitors first on your homepage, you can funnel them to specialized pitches.

“The situational sell sounds logical because it is logical. But in the day-to-day minutia of maintaining a website, the big details sometimes get lost in the shuffle. Take a fresh look at your homepage and give your visitors a fresh perspective. Try the situational sell. It will make your visitors comfortable, they'll feel as if you already understand their point of view, and you'll most likely be rewarded with higher conversions.”

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About the Author: Diane Metz writes about website marketing and development. She offers free, unique content to select websites. Her companies include Crown CD Manufacturing, which specializes in CD duplication and CD replication, for marketing, music, promotions and software - http://www.crowncd.com/ .

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I am happy to be able to bring you Diane Metz’ interesting piece on Situational Selling. I think it is a useful marketing concept that can help you design a stronger web site. The great genius of the Internet is its ability to connect people and information. The more you are able to link the right people with the right product the more likely you are to have a sale. So good luck on your web site optimization!

Well, that’s all for now.
Ralph Fucetola JD
http://www.vitaminlawyer.com

01/27/07 - New attacks on vitamins... and AER - DEATH by Medicine

2007-01-27T20:10:00.000-08:00

01/27/07 - VITAMIN LAWYER UPDATE e-MEMO
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Vitamin Lawyer on HealthRadio; Vitamin Shoppe under attack; DEATH by medicine

Vitamins are under major media attack -- again. A new Adverse Event Reporting Law has been signed by the President. These issues are so important for Dietary Supplement Purveyors, that I reproduce below most of the report from Nutraingredients-USA and devote this entire issue of my Update eMemo to the attack:
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The Vitamin Shoppe calls for independent testing procedures - By Clarisse Dou

1/26/2007- Following the withdrawal of its women’s multivitamin product - as a result of allegations of high lead content by ConsumerLab.com - the Vitamin Shoppe has expressed both its desire to get to the truth of the matter and for industry to devise new testing methods.

NutraIngredients-USA ran an article Wednesday on the Vitamin Shoppe's decision to withdraw its "Especially for Women" multivitamin. The decision was sparked by the highly publicized results of a study conducted by industry watchdog ConsumerLab.com that pinpointed 11 products - out of 21 tested - as not meeting their labeled contents and standards.

The Vitamin Shoppe… said… “Our industry badly needs an independent testing procedure that truly has the best interests of the consumer at heart…”

ConsumerLab said the Vitamin Shoppe’s multivitamin was contaminated with 15.3 micrograms of lead per daily serving. This is more than ten times the amount of lead permitted without a warning label in California – the only state to regulate lead in supplements – and several times the normal daily exposure to lead…

The Vitamin Shoppe has also stood by its assertion that its products are manufactured according to Good Manufacturing Practices (GMPs). “We have strict checks and record keeping requirements that follow "Good Manufacturing Practices" for food and all products delivered to our distribution facility.”

Draft current GMPs were published in 2003, but the final version of the guidelines are reported to still be going through a law-making process at the Office of Management and Budget.

“There is a proposed regulation for GMPs that are specific for dietary supplements that have been in discussion since 1995… “We regularly audit our contract labs to assure that they are complying with our educated best guess as to what these proposed regulations will entail and for the legally required compliance with food GMPs.”

Copyright - Unless otherwise stated all contents of this web site are © 2000/2007
http://www.nutraingredients-usa.com/news/printNewsBis.asp?id=73719
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So, what does this mean to the average vitamin company? These are the points to consider –

First: cGMPs are about to become a center of the attack on the industry.

Second: the attack continues, in different ways and places. Just a week ago Tuesday, the New York Times carried a major article attacking vitamins as potential poisons – my comments and those of Maury Silverman – prepared for my appearance last Saturday on HealthRadio - Dr. Alan Pressman, www.drpressman.com - are below:
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Date: Thu, 18 Jan 2007 03:26:45 PM EST
From: "Ralph Fucetola JD"
To:
Cc:

Subject: The Safety of Dietary Supplements

Well, Dr. Pressman, I looked at the NY Times propaganda piece.
http://www.nytimes.com/2007/01/16/health/16diet.html?ref=science

I'd be happy to appear on your show this Saturday. What strikes me is the extraordinary SAFETY of supplements -- one death in 60,000 complaints, for example, with many ten millions of users - 230 deaths in 23 years. Compare that to aspirin - 1,500 deaths per year, every year. Etc.

With the new Adverse Event Reporting law, we may get better statistics over the next few years. See: http://www.aer-consultants.com .

Among other failures, the Poison Control people are not collecting the right information. It has been suggested by some critics of such studies that often the adverse reaction is caused by the interaction with drugs and it is the drug that is to blame, not the food substance.

Maury Silverman recently wrote me (about implementing the new AER law):

"Implementing 'objectively' has been stated many times here, meaning to first identify concurrent use of foods and dietary supplements with drugs of any kind, be they prescription, OTC, or illegal/illicit/counterfeit.

"Once that is done on the MedWatch form your company now must fill out once a complaint comes to you that must be reported to FDA, the FDA should screen out drug-drug interactions & drug-nutrient interactions, (which are inherently drug problems). The current MedWatch form is very inadequate to gather this
information.

"This is important so that:

" (1) the dietary supplement ought not be blamed for a serious adverse event prompting a lawsuit against your company, or yourself since you are so
numerous on the record as disbelieving and/or being delusional on this matter.

" (2) The FDA can require labeling of the drug, for contra-indications, known drug-drug and/or drug-nutrient interactions. As drugs are so inherently
more dangerous than foods and dietary supplements, better labeling of drugs, first, is vital importance to the nutrition industry and the public health.

" (3) Drugs can be labeled for the nutritional deficiencies they cause. That goes also for alcohol, caffeine, and nicotine when poor nutrition is concurrent.

" (4) More 'E' can be put into the full implementation of DSHEA. This means more quality information from the nutrition community on how to avoid
adverse events, when there is concurrent usage with drugs.

"The problem is too often that the medical establishment does not educate or train its practitioners on nutrition and the healing qualities of natural products. They are more likely than not, drug salespeople. From when I was a youngster, I do remember that people grew up on food and good nutrition, not DRUGS.

"I suggest here that you look at the article in the October 9, 2006 issue of Archives of Internet Medicine titled: "Factors Associated with Dietary Supplement Use among Prescription Medication Users". (166: 1968-74, 2006)"

Allen, Thanks for the opportunity to respond to obvious BS.
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Third: The current attack on vitamins needs to be seen in light of AER – Adverse Event Reporting. AER implementation will be directly tied to these developments. And, a word to the wise: The new AER law is not concerned with the general propaganda that nutrients are not safe, as a class of food. Nutrients are generally recognized as foods, and foods are generally recognized as safe when ingested as directed. AER is concerned with specific batches of specific products and whether they are contaminated or otherwise unwholesome. AER may provide the ammunition to yet again prove nutrients safe.

Please review what we have to say about AER developments on the AER Consultants web page, www.aer-consultants.com – we will post information on developments there. AER Consultants will engage with the FDA on the issues that need to be covered by the AER regulations to protect the industry as well as the consumer. Your thoughts on that would be appreciated, so please let me know what you think needs to be included.

What can concerned citizens, health freedom activists, alternative practitioners and dietary supplement purveyors do to protect their access to wholesome, high potency nutrients? Stay informed! Be ready to make your views known. Support health freedom groups like www.healthfreedomusa.org - if you are in the industry, realistically analyze the situation and remember, “Management manages…”

And now for the counter-punch... DEATH by medicine:

Previously published by the Life Extension Foundation, Gary Null and several other healthcare professionals lay it out: government-approved, standard medicine is the single greatest CAUSE of preventable death in the USA. While we've known this for a while, it's useful to see the statistics all brought together in one article, especially now that Dietary Supplements and natural alternatives seem under heavy media attack.

http://www.lef.org/magazine/mag2004/mar2004_awsi_death_02.htm

Well, that’s all for now.

Ralph Fucetola JD
http://www.vitaminlawyer.com