September 15, 2014

A Memorable Decision?

Seller Beware: Consumer Protection Insights for Industry

Forgetting is a normal part of life. Many people forget where they put their keys, when that meeting was scheduled, when to charge their cell phones, and so on. Memory jogs such as handwritten notes and reminders or alarms on devices often remedy this situation. Martek Biosciences Corp. and i-Health, Inc. marketed its BrainStrong supplement as clinically-proven to boost adult memory. On August 21, the Federal Trade Commission (FTC) adopted the final order to settle allegations that Martek and i-Health falsely claimed that BrainStrong would improve memory and prevent cognitive decline.

On June 9, 2014, the FTC issued a complaint, by a vote of 3-1, on the company's memory improvement claim and unanimously on the cognitive decline prevention claim (Commissioner McSweeny did not participate). The three opinions on the memory improvement claim expose an instructive divide among the Commissioners regarding how the Commission should assess and address efficacy claims based on scientific studies.

Chairwoman Ramirez and Commissioner Brill explained their view that the FTC should "assess the quality and reliability of the scientific evidence underlying the challenged advertising claims" rather than accepting them "at face value." Citing the FTC's guidance in the Dietary Supplements Guide, they concluded that the advertiser made broad claims that the supplement improves all forms of memory. Accordingly, because the advertiser's study looked only at episodic (ability to remember specific details or events) and working memory, such a broad, "all memory" claim was not substantiated. They also concluded that the study was insufficient to support even narrower claims for improving just episodic or working memory.

In his concurring opinion, Commissioner Wright explained that the study fails to substantiate either a broader "all memory" claim or a narrower episodic memory improvement claim. The broader claim fails, he reasoned, because the study was not designed to assess all types of memory, but was largely limited to episodic memory. While the study's episodic memory design was sound, he noted that the findings did not support an "improves episodic" memory claim either, because the study only found statistically significant results for one of three measures of episodic memory. Cognitive experts, however, generally accept the need for statistically significant results for all three to consider the results sufficient to show improved episodic memory.

Commissioner Ohlhausen dissented in part, taking a narrower view about the degree to which the Commission should independently assess the validity of a study and a broader view of the claims advertisers can support from a study's results. She wrote that the Commission's decision "imposes an unduly high standard of substantiation on a safe product." The study at issue was "well-conducted" and yielded "statistically significant results" that episodic memory improved. In Commissioner Ohlhausen's view, "[a]n improvement in episodic memory is an improvement in memory, and the claim accurately conveys the study's findings in consumer vernacular." She further observed that expert disagreement with the study's conclusions does not make it unreliable or make claims based on the study unsubstantiated.

The final adoption of this settlement should serve as a reminder that health claims based on scientific studies and clinical proof will be rigorously examined by the FTC. Businesses should remember that they will be responsible for all reasonable interpretations of an ad and that claims must align with the study's results. In addition, in a battle of experts, the FTC's experts generally have the upper-hand, so it is important to be on solid footing when it comes to defending the adequacy of a study's methodology and conclusions in support of a claim.

© Arnold & Porter Kaye Scholer LLP 2014 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.


Matthew Shultz
Matthew Shultz
Washington, DC
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