The Prevagen Settlement & the Wild West of Brain Health Supplements

Dietary supplements are a $40 billion industry. Some 50,000 products on the mark claim to improve mood, energy, vitamin levels, brain function, overall health. Prevagen, which made millions of dollars off people living with cognitive decline by touting its abilities to improve memory, mental sharpness and clearer thinking, is facing the consequences of making claims that don’t stand up to science.

A nationwide class action suit that has been years in the making has reached a settlement that would benefit millions with the small gesture of compensation, and the larger precedent against false advertising by supplement makers. Last week, Quincy Biosciences and consumers asked a Florida federal court to approve the settlement, which would mandate changes to Prevagen’s label and partial refunds to as many as 3 million consumers.

Prevagen made more than $165 million in U.S. sales between 2007 and 2015. As Being Patient reported in September of 2019, a bottle of Prevagen may cost between $24.29 and nearly $70, depending on the type (Prevagen Regular Strength, Prevagen Extra Strength, Prevagen Professional) and where it is purchased. It is sold online, at health stores and at national chain pharmacies including Duane Reade, CVS and Walgreens.

Prevagen’s active ingredient is a dietary protein, apoaequorin, which was first discovered in glowing jellyfish. Multiple testimonies from scientists in the lawsuits against Quincy Biosciences made the point that when apoaequorin is digested, it changes into common amino acids, no different from those derived from any other dietary protein and that these proteins “cannot cross the blood-brain barrier to reach the brain or affect its functioning.”

In January 2017, the Federal Trade Commission and the Attorney General of New York State charged Quincy Bioscience with making false and unsubstantiated claims about the supplement, claiming that a third-party study — the Madison Memory Study — had “failed to show a statistically significant improvement in the treatment group over the placebo group on any of the nine computerized cognitive tasks,” but that Quincy Bioscience referenced Prevagen’s success based on that specific study in much of their advertising.

In 2018, the AARP Foundation filed a brief supporting the New York suit, stating that the makers of Prevagen were “deceiving millions of aging Americans” with their inaccurate claims that Prevagen could treat memory loss. The lawsuit was dismissed in September, but revived in February of 2019.

And at that point, it was one of four different nationwide class actions pending in South Florida, Missouri, New York and California. The front against Quincy hit a snag when a judge in a California lawsuit, one of several underway, deadlocked jury led to a mistrial in January. That lawsuit, however, was notable, because it was one of few false advertising class action suits to have made it all the way through trial and one of the only ones to get so far in federal court.

In other words, it was a battle long and hard fought. And the stakes were higher than just false claims from one company:

Because dietary supplements are not considered drugs, they are not strictly regulated by the Food and Drug Administration. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), it is illegal for supplements to claim they prevent, treat or cure diseases. However, they can declare that they aid certain health functions as long as they are backed by scientific evidence that substantiates that the claims are “true and not misleading.”

One obstacle for consumers in vetting and interpreting this evidence is that some nutrition companies, including supplements companies, have a history of “funding biased research to support their products.” Another obstacle for consumers is that while companies may cite real studies, they may choose to interpret the results differently than other members of the scientific community would, or to cite studies that other members of the scientific community feel are not credible: While a spokesperson on behalf of Quincy told Being Patient that the company “stands firmly behind the substantial evidence supporting the efficacy of Prevagen,” a January 2019 JAMA article co-authored by Joanna Hellmuth, a neurologist at the University of California San Francisco (UCSF) Memory and Aging Center titled “The Rise of Pseudomedicine for Dementia and Brain Health,” criticized Quincy for quoting studies that lack “sufficient participant characterization, treatment randomization and fail to include limitations.” MedpageToday went on to add that “in the case of Prevagen … there isn’t even a single study published in the peer-reviewed scientific literature [that supports the company’s claims].”

“Supplement manufacturers are legally allowed to make misleading claims that may not have the greatest degree of scientific integrity,” Hellmuth told Being Patient. While they cannot claim to treat specific diseases or conditions, they can make claims that they treat symptoms, and they are not required to demonstrate efficacy.

A massive settlement against Prevagen creates a legal precedent for action against supplement companies that violate consumer protection laws with false advertising.

The new settlement isn’t final — it is still subject to court approval — but upon approval, it would provide plaintiffs with partial refunds: with proof of purchase, a cash refund of 30% of the Quincy manufacturer suggested retail price (up to $70 for an individual claimant) and without proof of purchase but with a valid claim, a cash refund of $12.

People will still be able to purchase Prevagen — the intention of the suit is that they will be better informed of the alleged risks and benefits. When the settlement is finalized, Prevagen will also need to make changes to its label.

Learn more about Being Patient found when our reporters asked experts about Prevagen:

Does Prevagen, a Cognitive Health Supplement, Really Improve Memory?

CORRECTION: The requirements around supplement makers’ legal ability to claim certain benefits were clarified, and information about the scientific evidence supporting Prevagen’s efficacy was added.