FTC’s Substantiation Bar: i-Health Inc. and Martek Biosciences (June 2014)

The FTC’s June 9, 2014, consent order for i-Health Inc. and Martek Biosciences bans the companies from making any product claims of improving memory or preventing cognitive decline unless the company has “competent and reliable scientific evidence” comprising “human clinical testing that is sufficient in quality and quantity, based on standards generally accepted by experts in cognitive science, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall be randomized, double-blind, and placebo-controlled; and be conducted by researchers qualified by training and experience to conduct such testing.” However, the FTC does not specify how many trials are needed.

One Commissioner described the MIDAS study Memory Improvement with Docosahexaenoic Acid Study (MIDAS), which the companies used as evidence, as well conducted, but said that “its results were inconsistent and insufficiently robust to support claims about noticeable improvements in everyday memory...”

But not all of the Commission agreed. Commissioner Maureen K. Ohlhausen dissented with the rest. She wrote that the FTC’s complaint against BrainStrong “imposes an unduly high standard of substantiation on a safe product,” and that the MIDAS study did adequately substantiate the claims. Also, she wrote this:

This unduly high standard not only risks denying consumers useful information in the present but may also, in the long term, diminish incentives to conduct research on the health effects of foods and supplements and reduce the incentives of manufacturers to introduce such products. The majority’s approach may ultimately undermine an efficient and reliable competitive market process and make consumers worse off.

FTC Requirement: Human studies (but doesn’t specify number of studies)

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Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com

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