Thursday, June 24, 2010

06/24/10 - Internet Listings and Your Business

 
0.  Blogs & News
1.  Internet Listings and Your Business
2.  SPECIAL: New Private Vitamin Lawyer Webinar!
3.  Natural Clinical Trials Center
4.  Archived Vitamin Lawyer Webinars
5.  Vitamin Lawyer connections…
-----------------------------------------------------

0. Blogs & News –

Recent issues of this Memo have covered such topics as Trends in FDA Warning Letters; the new FTC testimonial Rule, final cGMP June 2010 effective date and the FDA Rule regarding “expiration” dates and “best if used by” dates.

Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net

www .DrRima .net -- Dr. Rima Recommends: new web site with information regarding the Dr. Rima Institute Wellness Center that is expected to open in Panama at the end of June.

And the latest from the Vitamin Wars: Is President Obama’s New “Preventative Health” Executive Order just another effort to impose Codex?
www. healthfreedomusa .org/?p=5604


[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]
--------------
NEWS – “The economic impact of the new European health claims regulation on the nutrition industry will become clearer within the next three months, when the results of an independent assessment are due to be released.
Commissioned by an industry coalition – the European Health Claims Alliance (EHCA) – the impact assessment will evaluate the potential effect that Article 13 of the regulation will have on the food sector.
It comes to fill a gap long lamented by ingredient and product manufacturing firms, which criticized the lack of an economic assessment on the introduction of the nutrition and health claims regulation.
“There has not been an impact assessment so far, and it’s something we’ve long been calling for, so it’s good that industry is taking the initiative in this case,” said Lorène Courrège, director of regulatory affairs at The European Federation of Associations of Health Products Manufacturers (EHPM).
“If a number of issues are not resolved, we’re concerned that many claims will be wiped out, and this will obviously have a negative impact on industry. If you can’t make a claim on a product, how do you market it, how do you communicate its benefits to consumers? Certainly, manufacturers will find alternative ways to communicate to their customers, but a number of products will be discontinued,” she told NutraIngredients.com this morning.”
The results of the impact assessment, which is being conducted by an independent expert, will be presented at the EHCA event on September 30 in Brussels. They will form the basis of what is hoped to be a “constructive debate” on the regulation.
Nutraingredients .com/content/view/print/309264
-----------------------------------------------------

1. Internet Listings and Your Business

I received this interesting information about local internet listings in an email -
“Local business listings began with a basic business directory more than a decade ago . Chances are, your business has a local listing wherever you have a physical address location.
Check it out --- go to Google, type in your company name. You'll probably see a map locating your business and an address. Of course you may find other information too.

Local business listings are treated passively by many businesses. But that could be a mistake. You've probably read that prospects have something specific in mind when they are shopping.

So try this test. Go back to Google, type in the name of a product or service your business provides plus your hometown. Did your business show up? If it did: congratulations. If it did not: you're missing a major marketing opportunity.

Times have changed

From a marketing standpoint, the use of local business listings has exploded with the increase of social media and mobile devices. Consumers not only use these interactive yellow pages to locate a business, product or service in their area; they are also posting reviews of those products and services.

Today, there are over 60 local business listing websites on the Internet in five different categories. They include the search engines, social communities, 411 websites (aka yellow page type websites), GPS websites and that age-old business directory.”

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

2.  New Vitamin Lawyer Webinar – Private for Your Company, via Internet…

I am offering a private, two hour internet webinar, with Powerpoint visual aids and ebook, about writing lawful natural product ad copy, specifically including the new FTC testimonial rule. I will do the presentation over the net and answer any questions from your staff. Email me if your company is interested.

Webinar covers:

DSHEA and Nutrient Claims
Three Levels of Allowed Claims
FDA Guidance on Claims Substantiation
Allowed and Disallowed Terms (detailed lists!)
Common Mistakes
New FTC Testimonial Rule
Varieties of Substantiation
Traditional Uses
Substantiation & Other Resources


Sample: Slide #4

“Dietary Supplement products are governed by a complex of statutes and regulations.  The primary source of marketing rules for nutrient claims is the Dietary Supplement Health & Education Act of 1994 (DSHEA).  This Act is now part of the Food, Drug and Cosmetics Act that empowers the Food and Drug Administration (FDA).  DSHEA codified the right of marketers to make certain kinds of Claims about Dietary Supplements while forbidding others.
In any event, allowable Claims must also be, under Federal Trade Commission (FTC) rules, “truthful and not misleading” which means, there must be a certain level of substantiation for any Claim a marketer wants to make. On the horizon are several layers of international regulations, including the controversial Codex Alimentarius’ Vitamin and Mineral Guidelines that may restrict international trade in supplements and their ingredients.”


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

3.  Natural Clinical Trials Center

Update: NCT now has a relationship with a National University that is very interested
in "breaking into" the nutrient clinical study market -- this is an opportunity to benefit from a university-level study at modest price. Obviously, the cost will be greater than the cost of a private clinical study at Dr. Rima's clinic, but, with our special relationship, we can keep the
costs down to a reasonable and affordable level. And, of course, you will have the assurance that the professionals at NCT are keeping close watch on the protocol and progress of the university study. The Natural Solutions Center in Volcan, Panama is expected to be opened by the end of May, so Clinical Trials can begin shortly thereafter. Check out the Videos and PPT Webinar on the Site! www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.

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

4. Archived Natural Solutions Vital Connection Webinars with the Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

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

5. Vitamin Lawyer Connections…

Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

Our new affiliation site: www .naturalhealthoptions .net
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

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

Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
http:// vitaminlawyerhealthfreedom.blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

Tuesday, June 8, 2010

06/08/10 - Kellogg Settles with FTC re Food Claims

 
0.  Blogs & News
1.  2010 Healthy Foods Report
2.  FTC Settles with Kellogg… model for the future?
3.  Natural Clinical Trials Center
4.  Archived Vitamin Lawyer Webinars
5.  Vitamin Lawyer connections…
-----------------------------------------------------

0. Blogs & News –

Recent issues of this Memo have covered such topics as Trends in FDA Warning Letters; the new FTC testimonial Rule, final cGMP June 2010 effective date and the FDA Rule regarding “expiration” dates and “best if used by” dates.

Access to the Vitamin Lawyer Webinars and more:
www .NaturalHealthOptions .net

www .DrRima .net -- Dr. Rima Recommends: new web site with information regarding the Dr. Rima Institute Wellness Center that is expected to open in Panama at the end of June.

[Please note: all URLs in this memo are "broken" with spaces inserted to avoid the memo being treated as "spam" by certain email service providers.]

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

1. 2010 Healthy Foods Report

http://nutritionbusinessjournal.com/healthy-foods/market-research/2010-Healthy-Foods-Report/index.html

“The healthy foods market in the United States kept pace with overall food industry growth in 2009, but this is far from good news. Annual growth rates continue to slip for healthy foods, which has seen its star dull and tarnish in the protracted economic malaise. Data does suggest, however, that we may have hit the bottom, and growth rates should improve modestly in coming years. As growth takes meaningful hold, healthy foods should increase its share of the total foods market, reaching 23% penetration by 2017. The trends toward natural and organic food and beverages as safer and healthier consumer choices remain particularly strong.

   * NBJ predicts that natural and organic foods will grow the fastest of any healthy foods categories in the next eight years—with growth of organic reaching nearly 10% in 2012—as product categories like organic fruits & vegetables and natural meat, fish & poultry sidle into the mainstream.
   * Functional and lesser-evil foods will lose market share to the natural and organic categories in the future, NBJ projects, though functional should retain about a quarter of healthy food sales over the next eight years
   * With a forecast compound growth rate of nearly 9%, organic foods is expected to be the biggest competitor in healthy foods for the future. Compound annual growth for the total healthy foods industry should hover above 5% for the next eight years, just outpacing the growth of its largest categories, functional and lesser-evil foods.

The total U.S. food market grew 1.6% in 2009, reaching $628 billion in sales, while healthy foods grew 1.8% to reach $143 billion in sales. Nutrition Business Journal includes four product categories in the healthy foods market—organic, natural, functional and lesser-evil foods. Market-standard and conventional foods make up an additional, catch-all category for the total foods results. This report contains detailed analysis of each healthy foods category, and the food and beverage product lines they include.” [Report available from NBJ]
------------------------------------------------------

2. FTC Settlement with Kellogg and Substantiation

The FTC’s media release says it all: “Under the original settlement order covering Frosted Mini-Wheats, Kellogg was barred from making claims about the benefits to cognitive health, process, or function provided by any cereal or any morning food or snack food unless the claims were true and substantiated. The expanded order against Kellogg prohibits the company from making claims about any health benefit of any food unless the claims are backed by scientific evidence and not misleading.”
Clearly the fears expressed that the FTC will use its new general rule powers to restrict food claims (assuming the final Wall Street “Reform” Act contains this new power) seems a more reasonable fear, since FTC appears to believe that the settlement with Kellogg is a model for the future of greater regulatory restrictions on commercial speech. In the future FTC will require “scientific evidence” (meaning clinical studies) for every food product. Every natural products company needs to begin to plan for the looming requirement that all claims be substantiated by testing the product before the claim is made.
www .npicenter. com/anm/templates/newsATemp.aspx?articleid=27504&zoneid=258
-----------------------------------------------------

3.  Natural Clinical Trials Center

Update: NCT now has a relationship with a National University that is very interested
in "breaking into" the nutrient clinical study market -- this is an opportunity to benefit from a university-level study at modest price. Obviously, the cost will be greater than the cost of a private clinical study at Dr. Rima's clinic, but, with our special relationship, we can keep the
costs down to a reasonable and affordable level. And, of course, you will have the assurance that the professionals at NCT are keeping close watch on the protocol and progress of the university study. The Natural Solutions Center in Volcan, Panama is expected to be opened by the end of May, so Clinical Trials can begin shortly thereafter. Check out the Videos and PPT Webinar on the Site! www .NaturalClinicalTrials .org

• New FDA and FTC regulations make your job harder than ever... Recent changes mean that your company MUST consider Clinic Tests, Studies and Trials:

• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements.
• These changes also mean you must not:
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"

• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.

The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Staff.

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

4. Archived Natural Solutions Vital Connection Webinars with the Vitamin Lawyer

Setting up a Student Account at VCU is free and relatively easy:

www. VitalConnectionUniversity. com

[1] Your Ministry, the Law and Alternative Practices
Held July 9, 2009:  This webinar is Archived. –
(approximately 2 hours)

A PowerPoint discussion with Counsel Ralph Fucetola JD about advanced health care practices, the ministry and the law. $49.95 - Includes eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169

[2] CAM Advanced Healthcare Practitioner SOPs

Held: May 6, 2009 – This Webinar is Archived.
(approximately 2 hours)

You can see my short introductory YouTube video at:
vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.html

Direct sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84

[3] Bringing New Natural Products to Market

Held: May 10, 2009 – This Webinar is Archived.
(approximately 2 hours)

What does it take to bring a new natural product to market? This webinar will cover the pitfalls and requirements. Especially in the current market, you need to do everything right to have a success… includes a useful eBook with forms.

Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102

"Your papers must be in order."

Are your ingredients "grandfathered" under DSHEA?
Have you filed your Structure and Function Claims Notices?
Do you have your SOPs (Standard Operating Procedures)
Is your web site Site Use Statement up-to-date?
Is your Substantiation Notebook ready?

Your papers need to be in order before the FDA inspection!

[4] Sustainable IRA

Held: Saturday June 13, 2009 – This Webinar is Archived.
(approximately 2 hours)

Sustainable Retirement Capacity - Protecting the Environment AND Your IRA/401 – At the Same Time! The Foundation Trustees lead you through an interesting slide presentation that will help you make important decisions about where you want to be in the event conditions in the US continue to deteriorate. Free Webinar ($25 donation suggested).  With eBook.

Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95

Each Webinar includes its own useful eBook of forms and other information that will help you better organize (includes full powerpoint presentation text and resources).

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

5. Vitamin Lawyer Connections…

Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be. My Skype handle is: vitaminlawyer

Our new affiliation site: www .naturalhealthoptions .net
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.

“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
www. powerpicturesinc. net/store.html

Follow me on Twitter - www. twitter. com/healthfreedomus

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

Ralph Fucetola JD
www .NaturalHealthOptions .net
www .vitaminlawyer .com
http:// vitaminlawyerarchives.blogspot .com
http:// vitaminlawyerhealthfreedom.blogspot .com
www .globalhealthfreedom. org

If you want to unsubscribe to this newsletter, please email me at ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.