Wednesday, October 28, 2009

10/28/09 - Making Claims in a Changing Regulatory Market

0.  Blog & News – "Stop the Shot" Litigation
1.  Making Claims in a Changing Regulatory Market
2.  FTC Changes Testimonial Rules – Are Your SOPs Ready?
3.  Vitamin Lawyer Webinars

Blog & News – EU Approves Plant Sterol Claims
www. foodnavigator. com/content/view/print/265330

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Coming soon…

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www. healthfreedomusa. org/?p=3686

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1. Making Claims in a Changing Regulatory Market

A recent emailing from Nutraingredients gives us useful insight about the current regulatory market:

“Making substantiated claims in a changing regulatory environment
There are many challenges facing companies due to regulations, with stricter health claim regulation looking set to make the marketing environment stricter in Europe than in North America. Increasingly the biggest issue facing marketers is how to overcome the lack of trust most consumer have in products...

77%, of European consumers do not believe that manufacturers' health and nutrition claims are trustworthy and this acts as a strong inhibitor to future growth, subsequently product claims need to be more specific and clearer for consumers to understand. A crucial mistake to avoid is offering too many claims for one product, progressively manufacturers need to assess whether they offer more "positive" than "negative" nutrition in their portfolios.”

It's time to review all your claims... can you substantiate them? Are you ready to obtain appropriate Clinical Studies of your product -- not just rely upon published literature about your ingredients... that's no longer sufficient!

Both the FDA's cGMPs with the emerging requirement for Clinical Trials of the actual product and the FTC's revision of the testimonial rules to, in essence, require you to do the clinical testing needed to establish what the "typical results" of your product might be before advertising with testimonials, leads to a growing understanding that clinical testing is becoming a necessity to remain in business.

The problem I've found is that it is very difficult to find competent third parties to conduct such tests. The market is beginning to respond and if you are interested in having clinical trials of your products, please contact me with "CLINICAL TRIAL" in the subject line.


2.  FTC Changes Testimonial Rules – Are your SOPs Ready?

Here is what the FTC announced Monday: “Under the revised Guides, advertisements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect. In contrast to the 1980 version of the Guides – which allowed advertisers to describe unusual results in a testimonial as long as they included a disclaimer such as “results not typical” – the revised Guides no longer contain this safe harbor.

“Celebrity endorsers also are addressed in the revised Guides. While the 1980 Guides did not explicitly state that endorsers as well as advertisers could be liable under the FTC Act for statements they make in an endorsement, the revised Guides reflect Commission case law and clearly state that both advertisers and endorsers may be liable for false or unsubstantiated claims made in an endorsement – or for failure to disclose material connections between the advertiser and endorsers. The revised Guides also make it clear that celebrities have a duty to disclose their relationships with advertisers when making endorsements outside the context of traditional ads, such as on talk shows or in social media.”

The Vitamin Lawyer is available to guide you through the changes in your advertising practices made necessary by these changes. If you need a revised SOP for Testimonials, let me know.

Clearly, if you want to use testimonials that are anything other than general and bland, you would need to be able to substantiate what typical users experience. The “gold standard” of substantiation is, with health products, a double-blind, placebo-controlled third party clinical study with biomarkers before and after. For some testimonial claims it might be possible to get by with an after-market randomized survey of your customers to find out what their typical experiences are. In either case, the instructions to the people doing the clinical study or the people doing the market survey are critical. The instructions and questions you put to the professionals will control the responses you get. For example, a couple weeks ago I helped a client’s experts rework their clinical study report language so that it focused on nutrient benefits, not medical benefits.

My basic approach to dealing with the new testimonial rules is to consider what Disclaimer can be substituted for the former “safe harbor.” I think the rationale behind Thompson v. Western States Medical Center (535 U.S. 357) applies, “…if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown….”

Thus, I believe we can construct usable interim Disclaimers that companies can use as they transition to substantiated testimonials. Remember, the law has always been that a testimonial is a claim subject to substantiation, not proof of your product or service’s typical results.

www .ftc .gov/opa/2009/10/endortest.shtm


3. 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:

[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).


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

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