Wednesday, November 25, 2009

11/25/09 - Sneak Preview: Natural Clinical Trials

0.  Blog & News – (sic) “Food Safety” Bill S.510 Delayed
1.  FTC Changes Testimonial Rules – Clinical Trials Needed
2.  Sneak Preview: New Web Site for Natural Clinical Trials Center
3.  Vitamin Lawyer Webinars

Blog & News – The “Food Safety” bill is delayed in the Senate after we generate about 150,000 emails in a couple days; changes have been made that meet some natural product industry concerns… but not all. See: www .healthfreedomusa .org/?p=4014

Sneak Preview: Natural Clinical Trials – www .NaturalClinicalTrials .org – see below!

Our new affiliation site: www .naturalhealthoptions .com
Do you have an affiliation program? We’d like to list it. If you don’t have one… 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
$11.95 – www. powerpicturesinc. net/store.html

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The Vitamin Lawyer's SOP Outline Page: http: //tinyurl. com/2eu6yj
Current SOP Project: CAPA: Correction and Prevention Analysis
Coming soon…

Health Freedom's volunteer lobbyist in Washington, Maury Silverman of the American Library for Health is seeking donations for his nonprofit institute. Donations will be tax deductible, and this is the Giving Season... Maury will volunteer to be your man in DC and provide you with useful information... great networker of information that creates progress (I can attest how useful he's been to our foundation and some of my clients). Donations: PO Box 7507 - Silver Springs MD 20907 [240-330-3420].

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

Here is what the FTC announced last month: “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.

One 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.

But this interim approach is just that: a stop gap. What you need is the necessary clinical trials, studies and tests to both substantiate your claims and show what “typical results” are. That’s the bottom line. See the next article: Natural Clinical Trials.

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


2.  New Web Site for Natural Clinical Trials Center
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.

Natural Solutions Foundation, founded in 2004, is an international NGO (Non Governmental Organization) focused on natural solutions. We are active and registered in several countries and a not for profit 501(c)(3) tax exempt organization in the United States. The Mission of the Foundation is to discover, develop, document, demonstrate and disseminate natural solutions to the issues which threaten our health, food and freedom, achieving and maintaining a healthy self, community and world.

Natural Solutions Foundation, since its founding, has pursued a vigorous program on many fronts, including the development of an advanced healthcare clinic in the beautiful, bountiful, temperate Highlands of Chiriqui Province, Panama -- the advanced healthcare Natural Solutions Wellness Center.

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.


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