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
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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
Follow me on Twitter - www. twitter. com/healthfreedomus
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.]
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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
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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.
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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: 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).
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Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
www .globalhealthfreedom. org
