The marketers of the BrainStrong dietary supplement – which claimed to improve adult memory and prevent cognitive decline – reached a settlement with the Federal Trade Commission over charges their advertising was false and deceptive.

i-Health Inc. and Martek Biosciences Corp. sold the BrainStrong Adult supplement at major national retail stores and Web sites at a price point of $30 for a 30-day supply. But the defendants falsely claimed on television, the product’s Web site, and Twitter that they had clinical proof that the supplement contained Omega-3 fatty acid DHA that improved adult memory, the FTC alleged.

For example, product packaging stated: “Strengthen your brain and boost your short-term memory, naturally!” while one of the company’s television ads showed a woman walking into a room and forgetting why she is there. A voice-over informs the viewer that she is looking for her sunglasses that are on top of her head. A second voice then asks: “Need a memory boost? Introducing BrainStrong…Clinically shown to improve adult memory.”

“Supplement marketers must ensure that adequate scientific proof supports their specific advertising claims,” Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said in a statement about the deal. “When the results of a scientific study don’t match the hype, consumers are likely to be misled.”

According to the FTC, the problem with the defendants’ claims is that “memory” can refer to different concepts like episodic memory, procedural memory, and sensory memory. The defendant’s study only supported claims that DHA improved certain types of memory, not all variations of memory and cognition as promised.

Pursuant to the proposed administrative settlement (which covers dietary supplements, and foods or drugs that contain DHA or are promoted to prevent cognitive decline or improve memory), the defendants cannot make claims about the prevention of cognitive decline or memory improvement unless such claims are truthful and supported by human clinical testing.

In addition, claims about the health benefits, performance, safety, or effectiveness of such products must be supported by competent and reliable scientific evidence. Statements about clinical proof where none exists are prohibited.

To read the complaint and proposed administrative order in In the Matter of i-Health, Inc., click here.

Why it matters: The case demonstrated the continuing split among Commissioners about required substantiation for health claims. Commissioner Maureen Ohlhausen dissented from the three other members (new Commissioner Terrell McSweeny did not participate in the case). Ohlhausen took the position that the double-blind, placebo-controlled clinical study published in a peer-review journal was sufficient to support i-Health’s establishment claims and that the order imposed “an unduly high standard of substantiation” which “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 dietary 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 Chair Edith Ramirez and Commissioners Julie Brill and Joshua D. Wright did not “simply defer to the authors’ interpretations of the study results,” and conducted their own evaluation of the results to assess whether they substantiated i-Health’s advertising claims.