1. FDA Finalizes AER Guidelines
2. FTC Testimonial Advertising Changes are Coming…
3. Vitamin Lawyer Webinars
- Blog & News –
For your EU exports: “The European Food Safety Authority (EFSA) and European Commission have acknowledged for the first time that the July 31 deadline for publication of the first batch of health claim opinions will not be met. EFSA will now publish the first batch of 1024 claim opinions “by September” although a spokesperson was not able to confirm the exact date nor what effect this would have on the ultimate nutrition and health claims deadline of January 31, 2010.”
www. nutraingredients. com/Regulation/EFSA-First-article-13.1-health-claim-opinions-delayed-until-September-2009/
NEW VITAMIN LAWYER VIDEO
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www. youtube. com/watch?v=wWPvzpn0YgA
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Self-Shielding White Paper and Action Item
www. healthfreedomusa. org/?page_id=2752
Dr. Laibow deconstructs Codex’s pretensions
www. youtube. com/watch?v=Hyo_VjJSVFo
[Please note: all URLs in this memo are "broken" with spaces inserted after the www. to avoid the memo being treated as "spam" by certain email service providers.]
1. FDA Finalizes AER Guidelines (July 13, 2009)
The Natural Products Association issued the following statement –
“The final version is almost identical to the draft guidance on this topic (not to be confused with the labeling guidance, which still has areas of contention).
“The final guidance clarifies the agency’s expectations of the information the FDA expects to receive on a serious adverse event report (SAER). It also indirectly highlights the importance of having the appropriately trained personnel with some sort of medical expertise to receive and procure additional information around the submission and background of SAERs to the agency. This is becoming more and more significant, as adverse event records are being requested by the agency on inspection.
“The guidance addresses the major provisions of the AER act , specifically providing detail on reporting responsibilities, and elaborates and offers some clarification on the use of agreements between retailers and manufacturers to transfer the responsibility for submitting adverse event reports for the product to the manufacturer.”
Please note: “as adverse event records are being requested by the agency on inspection.” This is a clear warning that you need to be able to show that you’ve prepared in your Standard Operating Procedures for any Adverse Event reported to you about one of your products, even if no such report is ever made.
The final guidance is at: http:// edocket.access.gpo .gov/2009/pdf/E9-16702.pdf
2. FTC Testimonial Advertising Changes are Coming…
Here is the current status: with the new Administration, proposed FTC changes are not moving forward as rapidly as some feared last year. However, it is expected that the changes discussed below will become effective this year. FTC extended the comment period on testimonial rules changes earlier this year, stating:
"The Commission has extended the current public comment period related to proposed revisions of its Guides Concerning the Use of Endorsements and Testimonials in Advertising (Endorsement Guides)... In a Federal Register notice published on November 28, 2008, the Commission requested public comments... on proposed revisions to the Guide provisions addressing, among other things, consumer endorsements and disclosure of material connections between advertisers and endorsers."
Here is a summary of the proposed changes:
www2.ftc .gov/os/2008/11/P034520endorsementguides.pdf [this is an 86 page document]
These changes include several items relevant to testimonial advertising:
Primary rule remains the sanme: "endorsements must reflect the honest opinions or experience of the endorser, and may not convey any [express or implied] representation that would be deceptive if made directly by the advertiser"
"The Commission proposes one significant revision to this section of the Guides, the addition of a new Section 255.1(d) explicitly recognizing two principles that the Commission’s law enforcement activities have already made clear. The first is that advertisers are subject to liability for false or unsubstantiated statements made through endorsements, or for failing to disclose material connections between themselves and their endorsers. The second is that endorsers may also be subject to liability for their statements. The Commission has brought law enforcement actions against both expert endorsers and well-known personalities (i.e., celebrities) who have acted as endorsers..."
And: "A third new example illustrates the potential liability of advertisers who use bloggers to promote their products and of the bloggers themselves."
"The Commission’s proposed new Section 255.2(a) would state that an advertisement employing endorsements by one or more consumers about the performance of an advertised product or service will be interpreted as a representation that the product or service is effective for the purpose represented in the endorsement. Consumer endorsements convey not only that the advertised product or service worked for the consumers depicted in the advertisement, but also that it will work for others. This is the natural implication of an advertiser’s use of a consumer endorsement, and this view is supported by the consumer research conducted for the Commission."
"New Section 255.2(a) also states that an advertiser who uses consumer endorsements must possess and rely upon adequate substantiation to support efficacy claims made through endorsements, just as the advertiser would be required to do if it had made the representation directly. It also notes that consumer endorsements themselves do not constitute competent and reliable scientific evidence; anecdotal evidence about the individual experience of consumers is not sufficient to substantiate claims requiring scientific evidence."
"...renumbered Section 255.2(b), presently provides that an advertisement employing an endorsement reflecting the experience of an individual or a group of consumers on a central or key attribute of the product or service will be interpreted as representing that the endorser’s experience is representative of what consumers will generally achieve with the advertised product in actual, albeit variable, conditions of use."
The above section will be modified slightly to "... qualify the currently unequivocal language of renumbered Section 255.2(b) to state that “an advertisement employing an endorsement reflecting the experience of an individual or a group of consumers on a central or key attribute of the product or service will likely be interpreted as representing that the endorser’s experience is representative of what consumers will generally achieve with the advertised product in actual, albeit variable, conditions of use”"
The Commission is considering "requiring that atypical testimonials include disclosure of typical results..." [This would abolish the "results not typical" safe-harbor.]
Commenters "stressed the importance of “aspirational” testimonials in weight-loss advertising, consumers understand that the weight loss achieved by the testimonialist does not necessarily reflect the experience they will have using the product or program." Commission thought this could be allowable if carefully stated.
"As with all advertising, the fundamental question to be answered is whether, taken in its entirety, an advertisement that uses testimonials is likely to convey to reasonable consumers a message that is false or for which the advertiser does not have substantiation. The substantiation requirements for advertisements that convey performance claims are the same, whether the claim is made with or without the use of testimonials. Advertisers cannot use testimonials to convey claims they could not make through other means."
"...the Commission notes that such a change in the Guides would not mean that advertising using testimonials would be subject to stricter legal standards than other advertising – to the contrary, it would merely eliminate a safe harbor that has allowed advertisers to avoid the general requirement that they be able to substantiate all material claims conveyed by their advertising to reasonable consumers."
"The Commission does recognize that a revision of renumbered Section 255.2(b) calling for non-typical testimonials to be accompanied by disclosure of the results consumers generally achieve with the advertised product would increase costs for those advertisers who have not previously tracked consumers’ experiences with their products, and could present an impediment to the use of such testimonials by certain advertisers..."
"For example, an advertiser may use testimonials from a defined subset of users for which it can determine the typical results.” Or, “…given the Commission’s proposal to revise the Guides so that they no longer provide unequivocally that testimonials will convey typicality claims, the advertiser could write its ad in such a way that consumers would not take away the message that they can expect to achieve the same results as the testimonialist."
"Moreover, the Commission does not assume that the use of testimonials necessarily gives rise to typicality messages, and thus to a need for disclosures, regardless of the nature of the product. Advertisements that use testimonials to promote products for which consumers’ reactions are inherently subjective and their endorsements thus merely statements of personal opinion (e.g., restaurants or games) are less likely to convey typicality messages than ads using testimonials to make objective, quantifiable claims (e.g., pounds lost, money saved)."
"..the Commission now proposes to revise the renumbered Section 255.2(b) not only to provide that testimonials reflecting consumer experience on a key attribute of the product will likely be interpreted as representing that the endorser’s experience is representative of what consumers will generally achieve with the advertised product in actual, albeit variable, conditions of use, but also to provide that when testimonials do so convey, and the advertiser does not possess adequate substantiation for this representation, the advertiser should clearly and conspicuously disclose the generally expected performance in the depicted circumstances."
"Specifically, the new example clarifies that whether the person making the statement is speaking from a script, or giving the endorsement in his or her words, is irrelevant..."
[Side issue: under the new rules, an expert who gets a royalty may have to disclose that: "the Commission now proposes to revise the renumbered Section 255.2(b) not only to provide that testimonials reflecting consumer experience on a key attribute of the product will likely be interpreted as representing that the endorser’s experience is representative of what consumers will generally achieve with the advertised product in actual, albeit variable, conditions of use, but also to provide that when testimonials do so convey, and the advertiser does not possess adequate substantiation for this representation, the advertiser should clearly and conspicuously disclose the generally expected performance in the depicted circumstances."]
The existing Guide covers compensation to testimonial givers:
"However, when the endorser is neither represented in the advertisement as an expert nor is known to a significant portion of the viewing public, then the advertiser should clearly and conspicuously disclose either the payment or promise of compensation prior to and in exchange for the endorsement or the fact that the endorser knew or had reasons to know or to believe that if the endorsement favors the advertised product some benefit, such as an appearance on TV, would be extended to the endorser."
3. Natural Solutions Vital Connection Webinars with The Vitamin Lawyer
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.
Vital Connection University’s new webinar system is up and running. Here is how you can sign up under the new VC system:
www. healthfreedomusa. org/?page_id=2002
(this page links to VitalConnnectionUniversity.com).
Once at Vital University, at the top right you will find the Student Login.
Once you’re on that screen, take the steps to create a New Student Account.
Once created, login and browse through the Live Upcoming Courses or check out the Recorded Courses and you will find the ones that we have done in the past and the new webinar as well.
Other Webinar Archives [follow instructions above to reach these]
A. 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:
B. 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.
Sign up through link at: www. healthfreedomusa. org/?page_id=2002 – go to “How to Sign-up”
"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!
C. 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