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
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Blog & News – EU Approves Plant Sterol Claims
www. foodnavigator. com/content/view/print/265330
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…
Dr Laibow and Gen Stubblebine on the way to Codex Meeting in Germany
Support their trip with a MONEY BOMB!
www. healthfreedomusa. org/?p=3686
[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. 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.
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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
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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
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