FTC Appeals Ruling over Brain Supplement Prevagen

Editorial credit for FTC image: Andriy Blokhin / Shutterstock.com

The Federal Trade Commission (Commission) on Wednesday filed a notice of appeal to challenge a judge’s ruling in September to dismiss a lawsuit against Quincy Bioscience, the marketer of a dietary supplement (Prevagen) to improve memory in older adults.

The results of the appeal could provide further guidance for marketers of dietary supplements and others whose advertising practices are routinely policed by the Commission. The U.S. Court of Appeals for the Second Circuit is likely to examine whether Quincy Bioscience could rely on results from certain subgroups of a human clinical trial to substantiate its advertising claims.

Quincy Bioscience describes Prevagen on its website as “a dietary supplement that has been clinically shown to help with mild memory problems associated with aging." But regulators aren’t convinced the popular supplement actually provides the cognitive benefits advertised on television and other media.

In a complaint filed in January, the Commission and New York Attorney General Eric Schneiderman alleged that Quincy Bioscience and its founders violated state and federal advertising laws.

Largely at issue in the case: interpretation of a human clinical trial known as the “Madison Memory Study." The study failed to show any statistically significant results for the study population as a whole, although statistically significant results were identified among certain subgroups.

The lawsuit noted “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"; such analysis, regulators asserted, “greatly increases the probability that the statistically significant improvements shown are by chance alone."

U.S. District Judge Louis L. Stanton wasn’t persuaded. In granting the defendants’ motion to dismiss the federal claims, he determined the lawsuit neglected “to do more than point to possible sources of error but cannot allege that any actual errors occurred." The state law claims were dismissed without prejudice.

An FTC spokesman said the agency doesn't comment on pending litigation, and Madison, Wisconsin-based Quincy Bioscience did not immediately respond to a request for comment on the appeal.