Marketing Opinion Blog: Evidence of FTC\'s Preference for Human Clinical Trials as "Competent and Reliable" Substantiation

1. NMR News: Volume 3, Issue 2, February 2010
EVIDENCE OF FTC’S PREFERENCE FOR HUMAN CLINICAL TRIALS
AS “COMPETENT AND RELIABLE” SUBSTANTIATION
MARKETING OPINION BLOG
By: Latesha Richards, Marketing Coordinator
February 2010
At the October 2009 Council of Responsible Nutrition (CRN; Washington, DC) Annual
Symposium for the Dietary Supplement Industry, FTC director David Vladeck emphasized that
advertising substantiation will continue to be on the top of their agenda list moving forward into
2010.1 Additionally, they intend to aggressively enforce action against any company that falls
short of providing such substantiation, especially when it comes to using testimonials. Well, my
friends, FTC enforcement action is still in full swing, and might we say, the basis of their actions
has very telling implications.
Putting Omega-3’s Brain and Vision Claims into Perspective
Last week, the FTC sent warning letters to eleven (11) companies over the misleading
marketing claims of omega-3 supplements for children. These supplements claimed that their
products “boost”, “improve”, “enhance”, or “support” brain and vision function and development
in children. The reasoning for their warnings is not crystal clear at this point, but statements
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2. NMR News: Volume 3, Issue 2, February 2010
made by the FTC certainly give clues to their “current thinking” and preference on the issue. An
analysis of a similar case under investigation in October 2009 involving an array of children‟s
omega-3 gummy products may help to explain and shed light on this case.
The Proof is in Product-Specific Research
Northwest Natural Products (NNP), manufacturer and marketer of three lines of
children‟s omega-3 gummy supplements made claims deemed by the FTC to be misleading and
deceptive. These supplements included L‟il Critters Omega-3 Gummy Fish (“Gummy Fish”),
L‟il Critters Immune C plus Zinc and Echinacea (“Immune C”) and L‟il Critters Gummy Vites
(“Gummy Vites”). One of the products, “Immune C” claimed that “[it] boosts the immune
system and prevents or treats colds or other types of illness in children.”2
There are a couple of things wrong with and misleading about this claim. First, under
DSHEA law, dietary supplement claims cannot use words like “boost”, “prevent” or “treat” as
they are not intended to treat, diagnose or cure illnesses as pharmaceutical drugs are, and require
overwhelming scientific evidence to be deemed and approved as a new drug. Second, I isolate
“Immune C” for analysis unlike NNPs two other products because “Immune C”, as revealed in
the product name, contains multiple compounds namely omega-3, zinc and Echinacea.
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3. NMR News: Volume 3, Issue 2, February 2010
Although publically available evidence may overwhelmingly support the immune
function enhancement claim for zinc and Echinacea when used individually, the company did not
show concrete data that the combination of zinc, Echinacea, omega-3 and other ingredients are
effective for “boosting” immune system function, or “preventing” or “treating” immune system
illnesses. Thus product-specific randomized clinical studies are necessary to ascertain that.
In response to the investigation and to comply with the FTC Act, NNP acted swiftly to
change their product packaging, label, marketing claims on print ads and website, as well as
“clearly and conspicuously disclose the actual amount of DHA in gummy fish when making the
representation „with DHA‟ on the new product label.”2
Assuming that the non-disclosure of the quantity of DHA was one of the issues that FTC
had in this case, the FTC evidently considers claims highly suspect when ingredient quantities
have not been disclosed and there is a lack of specific evidence to support making such claims.
The scientific principle here is evident. Since the actual amount of DHA used in the formulation
is entirely unknown, it is not known whether or not the amounts have been increased from the
original amount present. Again, as publically available research is inconclusive and evidence
was not presented by NNP to conclude that the specific amount of DHA added is clinically
effective for building immune function, product-specific scientific research would be required to
determine that.
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4. NMR News: Volume 3, Issue 2, February 2010
Where Does the FTC Stand?
A Nutra-Ingredients article published on February 17, 2010 discussing the recent FTC
action mentioned that FTC‟s Devin Desmond said that the FTC is not ruling out the brain health
claims for omega-3 altogether, but questions the truthfulness of the claims for these particular
products since no product-specific proof was presented. Ms. Desmond went on to say that the
FTC needed to see evidence to back those claims, in the form of “product and population-
specific trials,” and that the FTC has a preference for human, randomized clinical trials.3
Conclusion
Although the exact reasoning as to why the warning letters were issued is not too clear,
what is clear is that the FTC requires “competent and reliable” scientific proof for any
marketing/advertising claims being made for dietary supplements. How they define “competent
and reliable” substantiation is still nebulous, but from these cases alone, one can postulate that
the FTC wants more than just one clinical study or borrowed science on individual ingredients.
Let‟s expect sometime in the near future that the FTC will offer clearer and more precise
guidance around what type of and how much scientific evidence they require.1 But what‟s pretty
telling from this case is that the FTC is moving towards a product-specific randomized clinical
trials approach as the most “reliable and competent” means of providing substantiation.
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5. NMR News: Volume 3, Issue 2, February 2010
To access FTC‟s February 16, 2010 press release, click here.
About NMR: Nutraceutical Medical Research, LLC (NMR) is a premiere contract research
organization dedicated to substantiating your product or ingredient claims and efficacy with
clinical research. We also provide medical writing services which include brochures, literature
reviews and journal publication. Our goal is to partner with natural product, cosmeceutical and
pharmaceutical companies to help them establish the efficacy and safety of their products using
evidence-based approaches.
Contact NMR at 1-914-220-8325 or email info@nutraceuticalmedicalresearch.com.
References
1. Federal Trade Commission Website. Priorities for Dietary Supplement Advertising
Enforcement: Remarks by David C. Vladeck, Director FTC Bureau of Consumer
Protection. Available at:
http://www.ftc.gov/speeches/vladeck/091022vladeckcrnspeech.pdf. Accessed February
23, 2010.
2. Engle, M. Northwest Natural Products – L’il Critters, FTC File No. 092-3153. U.S.
Federal Trade Commission (FTC) Website. 2010. Available at:
http://www.ftc.gov/os/closings/091030northwestclosingletter.pdf. Accessed February 18,
2010.
3. Starling, S. FTC Flags 11 omega-3 players but on what grounds? Asks CRN. Nutra-
Ingredients-USA Website. 2010. Available at: http://www.nutraingredients-
usa.com/Regulation/FTC-flags-11-omega-3-players-but-on-what-grounds-asks-
CRN/?c=7TLDqiJOf5XcPYv5GF4EoA%3D%3D&utm_source=newsletter_daily&utm_
medium=email&utm_campaign=Newsletter%2BDaily. Accessed February 18, 2010.
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