WASHINGTON—Two supplement marketers have agreed to settle charges of deceptive advertising for claiming that a dietary supplement containing an omega-3 Docosahexaenoic acid (DHA) will improve adults’ memory and prevent a decline in cognition, the FTC announced.
FTC also alleged i-Health, Inc. and Martek Biosciences Corp. falsely claimed they had clinical proof that the supplement BrainStrong Adult improves adults’ memory. Royal DSM owns both companies.
The proposed administrative settlement covers any dietary supplement, food or drug that is promoted to prevent cognitive decline or improve memory, or containing DHA, FTC said.
Claims made by the marketers under the proposed agreement must be truthful and supported by human clinical testing, the agency said. Market Biosciences and i-Health also cannot make claims about the health benefits, performance, safety or effectiveness of the products unless the claims are supported by competent and reliable scientific evidence, FTC added.
"Due to the FTC Consent Agreement not imposing any monetary penalties, nor requiring i-Health to significantly modify their record keeping and preservation requirements, as well as requiring a substantiation threshold that i-Health is comfortable with, we saw no need to further pursue this matter and are pleased that the Consent Agreement resolves the FTC's investigation," i-Health President and CEO Wes Parris said. "We commend the FTC for their diligence throughout this matter and thank them for their cooperation in facilitating our response to the investigation in a professional and practical manner."
Since at least March 2011, BrainStrong Adult was sold by the marketers for roughly $30 for a 30-day supply, FTC said. The product was sold at major retail stores including CVS Pharmacy, Walmart, Walgreens and Rite Aid, as well as online through drugstore.com and Amazon.com. Martek Biosciences Corp. and i-Health, Inc. also advertised the product on Twitter and at brainstrongdha.com, according to the agency.
“Supplement marketers must ensure that adequate scientific proof supports their specific advertising claims," said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, in a statement. “When the results of a scientific study don’t match the hype, consumers are likely to be misled
Adequacy of Study?
FTC Commissioner Maureen Ohlhausen, who voted in part against the agreement, said the agency’s action “imposes an unduly high standard of substantiation on a safe product."
According to Ohlhausen, the marketers offered to back up their claims with a “placebo-controlled, randomized, double-blind, parallel, multi-center, six-month, peer-reviewed, journal-published study of 485 subjects with statistically significant results."
The conclusions in the study “match up well with the ‘improves memory’ efficacy claim and the ‘clinically proven to improve memory’ establishment claim," Ohlhausen said in a dissenting statement. “Thus, I believe this study, in the context of other supporting studies involving DHA and memory, provides a reasonable basis for the ‘improves memory’ claim."
i-Health expressed a similar view that the study "provided statistically significant results demonstrating the benefits of DHA in maintaining and improving brain health in older adults and was not deceptive in its advertising of the BrainStrong Adult product."
But in a joint statement, FTC Chairman Edith Ramirez and Commissioner Julie Brill said the study only showed a modest improvement in “episodic memory," known in layman’s terms as “the recollection of specific personal events linked to a time and place." The study also failed to disclose any improvement in “working memory," which Ramirez and Brill defined as “the short-term mental manipulation of information, such as the ability to follow a story or discussion."
The FTC officials also noted the study failed to show meaningful improvements in episodic memory on two of three tasks that were measured. Finally, they indicated an improvement on one of the tasks was insignificant and would have only a trivial effect on consumers.
“We believe that reasonable consumers would likely be misled that BrainStrong will result in the kinds of real-life improvements depicted in i-Health’s advertising," Ramirez and Brill said.
In a separate statement, FTC Commissioner Joshua Wright pointed out the study did not evaluate all forms of human memory. He also said the results of the study “were inconsistent and insufficiently robust to support claims about noticeable improvement in everyday memory along the lines of the television ad."