United States: Time To Get Cognizant About The Basics For Brain Claims

Last Updated: October 16 2014
Article by Amy R. Mudge and Randal M. Shaheen

As we blogged from the NAD conference, (or at least we think we did) FTC Chairwoman Edith Ramirez named cognitive claims as an area of national advertising enforcement priority for the FTC.  These can be claims from foods or dietary supplements or learning products to boost the brain power in adults or kids.  This is not a new but a continued trend we have blogged about before.  Just last week the FTC announced a settlement with Word Smart requiring that in future the company have competent and reliable scientific evidence before making claims that its programs will help kids get better grades or improved SAT and ACT scores.  The definition in the order of what constitutes such evidence is the more general requirement that substantiation be based on well designed and well conducted tests or other analyses by experts in the field with results that are not outliers but generally agreed upon by the relevant scientific community.  Earlier this summer, the FTC entered into a settlement with the makers of a supplement for adults, Brain Strong, that promised improved memory, but in that case the order did require randomized controlled clinical trials of the product to support future claims.  While the state of the FTC's expected definition of competent and reliable evidence is up in the air, perhaps it is fair to say that for dietary supplements the FTC expects at least one RCT of the product at issue while for other products or plans, some lesser form of evidence may be acceptable if it is reasonable and reliable.

The NAD continues to apply the more general standard of competent and reliable scientific evidence in its cases, taking the position that standards imposed on companies under order are not necessarily the standards that should be applied to other companies, as well as continued reliable on business guidance the FTC has given and not rescinded that allows for a more general standard, including the Dietary Supplement Advertising Guide.  In a recent case involving the SmartX Premium Brain Supplement, the NAD gave a good roadmap to how it would evaluate the strengths of the science behind claims.

  • In this case, the advertiser did not rely on testing of its product but of testing for different ingredients it combined.  NAD was clear that the advertiser had to use caution to prevent giving an unsupported message that the product had been tested and instead make clear its claims were based on individual ingredient studies.  The NAD noted some ingredients when combined can have a synergistic or additive effect together but others can diminish in efficacy when combined.
  • Quality over quantity – one really good study will always win the day over multiple less reliable sources.
  • Animal or in vitro studies alone will typically not be sufficient to support claims of benefits for people.
  • Wiggle language like "designed to" to qualify performance benefits will not serve to reduce the substantiation burden.  Consumers takeaway a performance promise from such claims.
  • The target audience of the ads should be the test population in third party studies – for example, if you market to healthy adults, testing on sick children generally will not provide support.
  • Similarly studies should test the same amount of ingredient as is found in the advertised product.
  • Advertisers should not rely on abstracts of third party studies to support claims but for third party studies should have sufficient information to be able to assess the underlying data.

To avoid enforcement, Advertisers should use significant caution not just in reviewing support but also in fashioning these sorts of brain claims as they are meaningful to vulnerable audiences, parents seeking every advantage for their children, young people feeling the relentless pressure to succeed in a competitive world and adults seeking to make sure they continue to function productively with age.  And bookmark this blog post so you remember where to find it.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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