Brain Supplement Manufacturer Seeks Judicial Confirmation Regarding Claim Substantiation

Prevagen is a dietary supplement that purports to support healthy brain function. Its manufacturer, Quincy Bioscience, is requesting that a federal appeals court affirm a lower court’s recent decision to dismiss dismissing a deceptive advertising lawsuit filed against the company by the Federal Trade Commission and the New York Office of the Attorney General.

The issue? How Quincy interpreted a double-blind, placebo-controlled trial. Quincy’s position, in part, is that it adhered to the FTC’s dietary supplement guidance vis-à-vis claim substantiation, and that statistically significant results exists amongst study population subgroups.

“We relied on the FTC’s own guidance for dietary supplement marketing claims and have backed our claims with a double-blind, placebo-controlled human study, as well as other evidence,” Quincy Bioscience has stated.

The FTC alleged that “the researchers conducted more than 30 post hoc analyses of the results looking at data broken down by several variations of smaller subgroups for each of the nine computerized cognitive tasks,” and that post hoc subgroup analysis “greatly increases the probability that the statistically significant improvements shown are by chance alone.” As a result, “the few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect.”

The lower court found that the FTC failed to plausibly allege that the representations at issue were false or unsubstantiated, and that “the Madison Memory Study followed normal well-accepted procedures, conducted a ‘gold standard’ double blind, placebo controlled human clinical study using objective outcome measures of human cognitive function using 218 subjects.”

Following dismissal, the plaintiffs filed an appeal with the U.S. Court of Appeals for the Second Circuit, arguing that the efficacy data relied upon was insufficient to support relevant advertising claims.

Quincy argues, that “[o]f the 218 older adults included in this ‘Madison Memory Study,’ two large and distinct subgroups comprising more than 76% of the study population had normal cognitive function or mild-to-moderate cognitive impairment.” Quincy also states that the “two large subgroups undisputedly saw statistically significant and clinically meaningful cognitive improvements after taking Prevagen.”

Quincy also argues that the FTC lacked the proper authority to initiate the lawsuit because it did not have a vote of at least three commissions to initiate the enforcement action, and that the claims fail because any attempt to preclude undisputedly truthful statements about the results of a “gold standard” randomized controlled trial would constitute an impermissible restraint on commercial speech” in violation of the First Amendment.

This matter is significant for a number of reasons, including, but not limited to, the nature and degree of “competent and reliable scientific evidence” necessary to support health-related efficacy claims, as well as whether advertisers can rely upon positive results from subgroup analysis.

Contact FTC advertising compliance and defense attorney Richard Newman at [email protected].

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Richard B. Newman

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