Have you seen an ad like this (we have, more times than we can remember): “Ever walk into a room and forget why? Spend extra time looking for your car keys or purse? Have trouble remembering names or faces?”

If the answer is yes, the dietary supplement Prevagen may be just what the doctor ordered.

That’s because Prevagen contains the active ingredient apoaequorin, a dietary protein originally derived from a species of jellyfish living in the Puget Sound. (Don’t worry—no jellyfish are harmed in the making of Prevagen.) According to Prevagen’s marketers, this dietary protein can help reduce common memory problems—now you remember where you put those car keys—that we begin to encounter all too often as we age.

Or maybe not.

On January 9, 2017, the Federal Trade Commission and New York State Attorney General filed a complaint in the Southern District of New York against the marketers of Prevagen as well as two officers of the company who were involved in the advertising and marketing of the product. The complaint alleges that the defendants violated the FTC Act and New York law by making false and unsubstantiated claims that Prevagen improves memory, offers other cognitive benefits, and is “clinically shown” to work. (Sales of Prevagen in the U.S. have totaled more than $165 million.) The complaint requests, among other relief, a permanent injunction, consumer refunds, and civil penalties of up to $5,000 for each violation of New York law.

As we have written elsewhere, curbing unsubstantiated cognitive improvement claims—especially in the dietary-supplement industry—has remained a top priority for the FTC and, increasingly, State AGs as well. Prevagen is only the latest target.

According to the complaint, the defendants make claims that Prevagen:

• improves memory;
• improves memory within 90 days;
• is clinically shown to improve memory within 90 days;
• reduces memory problems associated with aging;
• is clinically shown to reduce memory problems associated with aging; and
• provides other cognitive benefits, and is clinically shown to provide other cognitive benefits.

In substantiating these claims, the defendants relied primarily on a “double-blind, placebo-controlled human clinical study” called the Madison Memory Study. In this study, 218 participants took either 10 milligrams of Prevagen or a placebo, and then performed nine computerized cognitive tasks—which were designed to evaluate cognitive skills like memory and learning—over a period of ninety days.

The FTC and NY AG allege that when this study failed to reveal a statistically significant improvement for the Prevagen group on any of the nine tasks, the defendants’ 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” tasks, a methodology that “greatly increases the probability that some statistically significant differences would occur by chance alone.” These post hoc analyses, however, also largely failed to show a statistically significant improvement for the non-placebo group. “Given the sheer number of comparisons run and the fact that they were post hoc,” the FTC and NY AG argue, “the few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect.”

Despite these results, the defendants still touted the Madison Memory Study in their advertising for Prevagen, according to the complaint. For example, the following chart, which appeared in television ads and on defendants’ website, indicates that “[i]n a computer assessed, double-blinded, placebo-controlled study, Prevagen improved recall tasks in subjects.”

The complaint also notes that defendants omitted from this chart the data point for day 60—a day on which “the recall task scores of subjects taking Prevagen declined from day 30, and were slightly worse than the recall task scores of subjects in the placebo group.” Finally, although the supplement was touted as affecting the brain, the FTC alleged that the defendants had no evidence that the product when taken orally was able to penetrate the brain/blood barrier.

In light of the continued focus on policing unsubstantiated cognitive improvement claims, companies making such claims should be sure that they can back them up—or else risk hearing from the FTC or a State AG.

No jellyfish were harmed in the publication of this blog entry, at least not that we can remember.