Quincy Bioscience, maker of Prevagen, a range of "brain support" supplements that failed to show meaningful results in their sole trial, has been ordered by a federal court to cease claiming that their product improves memory or cognitive function. Here’s what to know about the Federal Trade Commission’s charges of false and deceptive advertising, the bad science Quincy used to prop up those misleading claims for nearly 20 years, and how unproven supplements like Prevagen could soon be a thing of the past. 

Prevagen, a brand of supplements containing a novel jellyfish protein called apoaequorin, has, from its first appearance on the market in 2007 through last week, been marketed as a memory aid that can show positive improvements in memory retention and brain function in just 90 days. This is an attractive pitch to aging consumers concerned about cognitive decline—an observation Quincy capitalized on by directing the vast majority of their Prevagen ads to older audiences. 

At long last, Prevagen’s “memory improvement” days are over. An injunction filed Dec. 6, 2024, the long-awaited ruling on charges first filed by the Federal Trade Commission and Attorney General of New York in 2017, forbids Quincy from making claims that Prevagen-branded products can improve memory or cognition, that Prevagen can show results within 90 days, and that Prevagen is “clinically proven” to work.

“Following seven years of hard-fought litigation, including a jury trial, we are pleased that the Court has ordered Quincy Bioscience to cease making claims about Prevagen that mislead Americans concerned about memory loss,” Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, wrote in a statement following the ruling. “Companies should take note and remember that health claims need to be backed up by reliable scientific evidence."

As of Dec. 12, the Prevagen website no longer bears promises of memory improvement, doesn’t appear to refer to any 90-day results, and no longer claims that the products are “clinically proven” to work.

Support for the FTC’s case against Prevagen

Consumer advocacy organization Truth in Advertising, Inc. (TINA), which first filed a complaint with the FTC about Prevagen in 2015 and has spent the nine years since investigating the supplement’s misleading marketing practices, wrote in a statement on Dec. 12 that “the impact of these changes may be diminished as Quincy has been aggressively marketing Prevagen as a memory-improvement tool for over a decade.” 

That’s a valid concern, given the company’s methods of targeting older consumers through multiple media channels with an array of appealing—though unsubstantiated and deceptive—memory-boosting claims. (More on that later.)  

Despite concerns, TINA writes that “the court order and the resulting marketing shift sends a strong message that health claims need to be backed up with competent and reliable scientific evidence.”

This decision favoring the FTC has been many years in the making. And while the FTC was working in court, the agency had the support of organizations like TINA and CSPI. In March 2018, CSPI and other public health groups submitted an amicus brief supporting the FTC and the State of New York in their enforcement action against the dietary supplement Prevagen for making misleading memory enhancement claims.

The amicus brief explained consumers’ vulnerability to claims made for products, such as dietary supplements, that they cannot independently verify, and addressed the significant problem of relying on results from a post hoc subgroup analysis of a clinical trial.

Prevagen’s predatory marketing tactics

The FTC calls its victory against Quincy “another win” in the agency’s “efforts to protect older Americans.” If you have seen an ad on TV or social media for a Prevagen product, you’re not alone. With heavy rotation on national cable and network news channels, national and local radio, Facebook, Instagram, and YouTube, Prevagen is everywhere people concerned about age-related disease (and many other people) might be. According to iSpot.tv, which tracks nationally aired TV campaigns, Prevagen has aired more than 2,000 commercials in the past 30 days. 

In response to viewers’ presumed concerns about “mild to moderate memory loss related to aging,” one recently aired ad calls Prevagen the “number-one pharmacist-recommended memory support brand.”

Another recent spot, which ends with the tagline “Prevagen: Healthier brain. Better life,” features a retired school counselor named Steve, who describes how he learned about Prevagen. (It was through yet another commercial.) In that ad, Steve likens Prevagen to a hearing aid or a new eyeglasses prescription; to him, the supplement is an assistive product that he says “makes sense.” 

Quincy has at other times claimed that Prevagen aids “healthy brain function,” can offer a “sharper mind,” and promotes “clearer thinking,” all concerns of aging consumers who are seeking a miracle cure for, well, aging. 

Consumers like Steve can be forgiven for believing that it “makes sense” to take a supplement that’s “clinically proven” to work—and so quickly—with no apparent side effects. That is, of course, exactly how Prevagen has been presented all along. It’s a claim so good it can only be untrue, but Quincy’s tactic of making Prevagen maximally appealing to people who are navigating age-related cognitive decline means it’s a claim that will likely go unexamined—at least long enough to sell a few more bottles.

Ads like these targeted at audiences who are less capable of discerning which claims are bunk have been effective: Quincy peddled at least $165 million worth of Prevagen products—priced then at  $16 to $69 per 30-day supply—under misleading, deceptive, or outright false claims between 2007 and 2015. That was nearly ten years ago; no publicly available estimates of Quincy’s Prevagen sales are available after that date.

“Quincy has been able to make false claims about Prevagen’s miraculous memory improvement and clearer, sharper thinking because it manipulated its research to show results it didn’t actually get in a trial. Then it introduced that unproven ingredient, a synthetic protein that human beings have never consumed before, to the food supply without ever attaining FDA approval for safety,” explains CSPI Regulatory Counsel Jensen Jose. “So millions and millions of dollars’ worth of Prevagen, a supplement that contains an ineffective, potentially harmful ingredient patented by Quincy, have been sold to vulnerable consumers who are manipulated into assuming the product has been tested and works.”

Unfortunately, that’s not the case, which is why the FTC and a jury agree that Prevagen’s claims are unfounded.

The fishy science behind apoaequorin

Apoaequorin is what Quincy calls the “active” ingredient around which all Prevagen products are developed. Prevagen uses a synthesized form of a protein that is naturally found in bioluminescent jellyfish.

In the one study Quincy conducted to test apoaequorin’s effectiveness in reducing memory loss related to aging, there were no statistically meaningful results; it didn’t do anything. So Quincy conducted 30 post hoc analyses of its data, pulled out three results that should have been the subject of further study, and claimed that apoaequorin was “clinically proven” to work “in 90 days” for “mild memory loss.”

Learn more: How can this memory supplement flunk its one trial and still be advertised as effective?

Quincy attempted to go through the premarket review process for new dietary supplement ingredients when it introduced apoaequorin, but failed twice. The FDA had significant concerns about the evidence Quincy used to support the safety of this chemical. Instead of pulling Prevagen from shelves, Quincy exploited the process to declare that apoaequorin is “generally recognized as safe,” or GRAS, for use in foods. Once Quincy had declared apoaequorin safe for its shake products (regulated as a food), it was free to use the new ingredient in dietary supplements.

Because the notice Quincy submitted is voluntary, FDA approval is not required. Quincy simply continued selling Prevagen products and asked the FDA to cease their evaluation of their voluntary GRAS notice for apoaequorin. And just like that, Quincy used the GRAS loophole to bypass the FDA’s dietary supplement premarket review. 

Despite FDA’s safety concerns, having no reliable scientific evidence showing that apoaequorin performed in any way, and mounting pressure from consumer advocacy groups, Quincy persisted in making unsubstantiated claims—and sales. The company sold as many as three million bottles of Prevagen between 2007 and 2016—the last year for which data is available—while consumer complaints and FDA concerns piled up.

Learn more: How supplements distort science to sell

CSPI’s work on supplement safety

Though Prevagen’s marketing ploys and research manipulation are notably predatory, Quincy is not the only manufacturer of supplements that promise much and do nothing. They’re also not the only company selling products with unknown ingredients with untested safety, efficacy, or risk. CSPI has been working for years to improve regulatory transparency around supplements, educate consumers about deceptive marketers of untested products like Prevagen and Balance of Nature, and make it harder for companies like these to market untested products with unsubstantiated claims.

“Despite the FDA questioning Prevagen’s safety multiple times, they continue to sell this potentially dangerous ingredient via the secret GRAS loophole. Our New York GRAS Transparency bill would require Prevagen to provide evidence justifying apoaequorin’s safety,” said Jose.

Dietary supplements are distinct from drugs in that, unlike prescription and over-the-counter medicines, they are subject to much of the same regulatory process as food and beverages. New York’s GRAS Transparency bill, S08615/A9295, would require companies to disclose to the state of New York when they use food chemicals that the company secretly self-determines are GRAS without notifying the FDA. 

This disclosure step, had it been in place before Quincy took Prevagen to market, would have prevented Quincy from being able to first introduce apoaequorin to a food product (as Prevagen-branded shakes), declare it safe to eat, then use it freely in Prevagen dietary supplements.

People deserve to know what’s in their food and dietary supplements, deserve to know when manufacturers are making unsubstantiated claims, and deserve to feel secure that supplement products are advertised for exactly what they do; without regulatory oversight, we never will. As long as the GRAS loophole exists as an option for food, beverage, and supplement manufacturers, it will be exploited—and so will consumers.