Wednesday, December 24, 2008

12/24/08 - Doctors Recommend Dietary Supplements

 
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

Tuesday, December 16, 2008

12/16/08 - Testimonials Continue at Risk

 
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

Thursday, December 4, 2008

12/04/08 - Supplement Market Growth

 
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

Saturday, November 8, 2008

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

 
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

Tuesday, October 21, 2008

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

 
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

Thursday, September 18, 2008

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

 
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

Friday, August 29, 2008

08/29/08 - Credit Card Data Security Rules

 
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

Tuesday, August 12, 2008

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

 
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

Thursday, July 24, 2008

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

 
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

Tuesday, June 24, 2008

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

 
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

Friday, June 6, 2008

06/06/08 - Weight Control Supplements Attacked

 
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

Friday, April 25, 2008

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

 
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.

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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.

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

Tuesday, April 15, 2008

04/15/08 - FTC Health Claims Crackdown

 
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
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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.]
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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.”

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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.

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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

Saturday, March 8, 2008

03/08/08 - Substantiation Resource

 
Vitamin Lawyer Update Memo: March 8, 2008

This issue:
1. Substantiation Resource
2. Has the DS Industry Reached “Maturity”?
3. AER SOP
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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.]
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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.
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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