FTC\'s Preference For Human Clinical Trials Feb 2010


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

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FTC\'s Preference For Human Clinical Trials Feb 2010

  1. 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 1
  2. 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. 2
  3. 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. 3
  4. 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. 4
  5. 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. 5