In 2007, a Wisconsin-based company, Quincy Bioscience, launched a product called Prevagen. It contains one main ingredient, apoaequorin, a protein originally isolated from bioluminescent jellyfish off the coast of Washington state.
After years of scrutiny over the science behind the supplement, the company once again finds itself at the center of a legal fight.
Quincy has marketed Prevagen for its supposed ability to improve memory and support brain function. But consumer groups, physicians, and government agencies have all vigorously disputed these health claims. In late 2024, a jury largely decided in favor of the Federal Trade Commission (FTC) and the New York Attorney General, who had teamed up to sue Quincy Bioscience in federal court, finding that the company’s claims were not supported by science, had a tendency to deceive, and, in some cases, were materially misleading.
The company appealed the trial judge’s order requiring it to remove all challenged marketing statements from its promotion of Prevagen. A press release on the company’s website states that the order “is based on a misreading of the law and science supporting the advertising statements.” (MedShadow placed several interview requests with Quincy Bioscience via email, phone, and an online contact form, but received no reply. A list of the facts and views relating to Quincy that appear in the article was also sent to the company for comment; again, there was no reply.)
In late February 2026, a panel of federal judges heard oral arguments in Quincy’s appeal. Both sides are awaiting the decision.
Despite the ongoing litigation, Prevagen is, by all appearances, a commercial success. According to the FTC, the supplement had already generated more than $165 million in sales by 2017, and it remains widely available through major retailers like CVS and Walgreens. In the past few years, it has sponsored top U.S. sports bodies, including U.S. Figure Skating, USA Track and Field, and USA Gymnastics. On YouTube, advertisements for the product currently run with the tagline, “for your brain.”
“It is heartbreaking to watch my patients — who are in a very vulnerable position — spending their money on supplements like Prevagen, which have breathtaking advertising budgets and little rigorous science to back up their claims,” wrote Carolyn Fredericks, M.D., a neurologist at Yale Medicine, in an email. Fredricks pointed to a 2019 JAMA editorial warning that dietary supplements marketed to boost brain health had become a $3.2 billion industry despite lacking strong evidence.
“It is heartbreaking to watch my patients — who are in a very vulnerable position — spending their money on supplements like Prevagen, which have breathtaking advertising budgets and little rigorous science to back up their claims.”
“Among my patients, Prevagen is the best known of these by far,” she wrote.
Prevagen offers a good case study in how companies can use regulatory loopholes to circumvent the Food and Drug Administration’s review, says Jensen Jose, regulatory counsel for the Center for Science in the Public Interest. In the dietary supplement market, he added, those loopholes have created what he describes as the “wild west.”
The Origins of Apoaequorin
In the summer of 1961, a steady stream of bioluminescent jellyfish floated past the side of a dock each morning and evening at Friday Harbor in Washington state. A research team collected the invertebrates by the thousands, hoping to better understand the chemistry behind their glow. One of the researchers, a chemist named Osamu Shimomura, went on to identify two key proteins. One of them, green fluorescent protein (GFP), became a widely used tool in biomedical research. The other one, which he named aequorin, emits blue light when it binds to calcium. It contains two main components, including apoaequorin, the ingredient later marketed in Prevagen.
Quincy Bioscience was founded to develop apoaequorin-based products that “help support brain function in aging,” writes the company’s co-founder, Mark Underwood, in a slim book called The Brain Health Guide, published by his company. According to Quincy Bioscience’s website, the company’s headquarters was initially located in University Research Park, an affiliate of the University of Wisconsin-Madison, in 2004. During that time, “a partnership was formed with the laboratory of James R. Moyer, Jr., Ph.D.,” a neuroscientist who now studies brain aging at the University of Wisconsin-Milwaukee.
While Dr. Moyer told MedShadow that Quincy Bioscience has funded some of his research examining apoaequorin’s effects in rodents, he added, “I have nothing to do with Prevagen.”
Although Quincy Bioscience’s website does not currently explain the mechanism by which Prevagen might help the brain, Underwood’s book claims that the product uses apoaequorin to supplement certain proteins that decline with age. (This statement is followed by a disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”)
The Calcium Theory
In 2013, Dr. Moyer and a team of researchers from the University of Wisconsin-Milwaukee and Quincy Bioscience jointly published a paper examining whether apoaequorin could protect rat brain cells under experimental conditions meant to simulate a stroke. To test that idea, the researchers infused the protein directly into the animals’ brains.
During a stroke, the authors wrote, brain cells are exposed to excess calcium, a process that contributes to cell death. Because apoaequorin binds to calcium, the researchers theorized, it might help shield vulnerable cells from damage.
There’s merit to this approach, says Ksenia Kastanenka, Ph.D., an assistant professor of neurology at Harvard Medical School who studies the role of calcium in Alzheimer’s disease. Theoretically, if apoaequorin binds with the calcium in the brain, it could buffer some of the negative effects of stroke, she says.
But when it comes to Prevagen, there’s a big caveat.
The rats used in the 2013 study had apoaequorin delivered directly to their brains. A pill or capsule goes through the stomach, where it’s likely to be digested. And even if it makes it through the stomach, says Dr. Kastanenka, the apoaequorin still needs to cross the blood-brain barrier, “which is really hard to cross.”
The rats used in the 2013 study had apoaequorin delivered directly to their brains. A pill or capsule goes through the stomach, where it’s likely to be digested. And even if it makes it through the stomach, says Dr. Kastanenka, the apoaequorin still needs to cross the blood-brain barrier, “which is really hard to cross.”
Dr. Moyer said he has since begun testing oral administration of apoaequorin in rodents. When asked if he thinks Prevagen benefits the brain, he said, “it might,” but added that he’s reserving judgment until his studies are complete and published.
The FTC’s legal complaint took a firmer stance, asserting that the company’s own safety studies “show that apoaequorin is rapidly digested in the stomach and broken down into amino acids and small peptides like any other dietary protein.”
How ‘P-Value Hacking’ Created A Legal Complaint
Before the rat study was published, Quincy Bioscience had already begun testing Prevagen in a clinical trial involving more than 200 people known as the Madison Memory Study, which was ultimately published in 2016. Participants were randomly selected to receive either a placebo or Prevagen. But the findings did not show a statistically significant difference between the two groups.
Those findings are “proof positive” that Prevagen had no beneficial effect, says David Seres, M.D., a former professor of medicine at Columbia University Medical Center who served as an informal advisor to the government on the case.
The researchers, however, did not conclude that Prevagen was ineffective. Instead, they returned to the data, conducted additional analyses that lumped participants into smaller subgroups, says Dr. Seres, and reported improvements in some of those groups. But the memory-rating scale that the researchers used is validated — meaning rigorously vetted — only for use as a whole, he explained. The scale was never designed to be broken down into subgroups.
Additionally, scientists frown upon this kind of post hoc approach, known as p-value hacking, because it invites researchers to fiddle with their data until they reach their desired finding. “P-value hacking, also known as data dredging, data fishing, data snooping, or data butchery, is an exploitation of data analysis in order to discover patterns which would be presented as statistically significant, when in reality, there is no underlying effect,” states the Embassy of Good Science, a wiki-based platform run by researchers and devoted to research integrity.
The government raised this point in its legal complaint: “Given the sheer number of comparisons run and the fact that they were post hoc, the few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect.”
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Photo: Shutterstock
Which raises a question: How did a substance with so little scientific evidence to support it get on the market in the first place?
Loopholes That Helped Put Prevagen on the Market
When a company makes a chemical, puts it in a capsule, and then sells it for health benefits, “that’s called a medication in common terminology,” says Pieter Cohen, M.D., an associate professor of medicine at Harvard Medical School and a physician at Cambridge Health Alliance in Massachusetts. Yet here in the U.S., he continues, “there’s all sorts of loopholes to avoid calling it a medication and avoid the need to get it approved by the FDA.”
By law, companies seeking to bring a new drug to market must first prove that their product is safe and effective. This typically requires a series of high-quality clinical trials in which the drug is tested as a treatment for a specific disease. Such trials can take years and are often quite costly. The bar for supplements, meanwhile, is much lower.
In a JAMA editorial titled “The Supplement Paradox: Negligible Benefits, Robust Consumption,” Cohen describes how a 1994 dietary supplement law generally presumes supplements are safe unless the FDA detects evidence of harm.
But even under that more permissive framework, Prevagen appears to have posed unusual regulatory problems.
Reporting by WIRED writer Chiara Eisner in 2020 found that the FDA repeatedly balked at Quincy Bioscience’s attempts to classify Prevagen as a dietary supplement. For one thing, the agency noted, Quincy’s apoaequorin is produced synthetically, and not part of the current food supply, so it would require FDA approval as a “new dietary ingredient.” […] Furthermore, the company was making claims that Prevagen could prevent and treat disease. These two things taken together, Eisner reported, prompted the agency to view the supplement as an unauthorized drug.
But Quincy Bioscience found an alternative route: It started selling a shake with synthetic apoaequorin. Thus, apoaequorin became, at least from a regulatory perspective, a food ingredient.
The Food Ingredient Workaround
In 1958, Congress added an amendment to the Federal Food Drug and Cosmetic Act, stipulating that food additives should be subject to pre-market approval by the FDA. Lawmakers carved out an exception, however, for substances “generally recognized as safe” (GRAS). This designation was initially designed for common products like vinegar and pepper, says Jose. But because the amendment doesn’t clearly define how substances qualify as GRAS — and because formal premarket review of new food additives can be slow and resource-intensive — many companies began opting to self-affirm GRAS status using their own research instead.
This approach creates a route for a food ingredient to be marketed as a supplement, even in the absence of regulatory review, Jose explains.
Under dietary supplement law, food ingredients don’t need to go through an FDA review. “The theory is there’s already a premarket review system for food chemicals,” says Jose. But once companies decide that their products are GRAS, they can bring them to market as foods, bypassing the FDA review required for new dietary supplements. “And look, we don’t need to worry about the FDA anymore,” Jose quips.
But once companies decide that their products are GRAS, they can bring them to market as foods, bypassing the FDA review required for new dietary supplements. “And look, we don’t need to worry about the FDA anymore.”
Cohen and Jose are both advocates for GRAS reform, which is currently on the legislative agenda in some states. Bills in New York, New Jersey, Pennsylvania, and California, for example, would require companies to share evidence to justify their determination that their product is generally recognized as safe. (The California bill goes a step farther, Jose noted, requiring premarket review.)
The federal government has also signaled support for reform. In March, the Department of Health and Human Services issued a press release calling for stricter FDA scrutiny. In an email to MedShadow, HHS spokesperson Andrew Nixon wrote, “For far too long, the GRAS loophole has allowed ingredients to enter the food supply without meaningful transparency or FDA oversight.” The department, he added, is “committed to ensuring that all ingredients added to the food supply are backed by rigorous science and safety and are introduced through transparent processes.”
Why Prevagen Remains on Shelves Despite Legal Blow
In late 2024, a New York jury found that 8 statements used in the marketing of Prevagen lacked “competent and reliable scientific evidence,” according to a memorandum and judgment signed by the federal judge who presided over the trial.
These statements included “Prevagen improves memory,” “Prevagen reduces memory problems associated with aging,” and “Prevagen is clinically shown to provide other cognitive benefits, including but not limited to healthy brain function, a sharper mind, and clearer thinking.”
The Marketing Claims Challenged in Court
Claims challenged in court included statements that Prevagen:
* Improves memory
* Is clinically shown to improve memory
* Improves memory within 90 days
* Is clinically shown to improve memory within 90 days
* Reduces memory problems associated with aging (ruled materially misleading)
* Is clinically shown to reduce memory problems associated with aging (ruled materially misleading)
* Provides other cognitive benefits, including but not limited to healthy brain function, a sharper mind, and clearer thinking
* Is clinically shown to provide other cognitive benefits, including but not limited to healthy brain function, a sharper mind, and clearer thinking
The judge ordered Quincy Biosciences to “immediately remove” all of the statements from their marketing.
The overall verdict was a bit confusing, though, says Laura Smith, legal director for Truth in Advertising, a group that has been heavily involved in investigating Prevagen for over a decade. Although the jury found all of the challenged statements to be unsubstantiated by “competent and reliable scientific evidence and that all eight had a “tendency to deceive, it found only the two associated with aging to be “materially misleading.” As mentioned above, Quincy Bioscience has appealed the ruling on several grounds, including that it shouldn’t have to remove all 8 of the statements when only 2 were found to be misleading.
In a press release, the company emphasized that the case did not concern the safety of its product. A Quincy spokesperson said that the federal court’s order was “based on a misreading of the law,” as well as a misunderstanding of the company’s business practices and of the science it claimed supported its advertising statement. However, while the company disagreed with the decision, it stated it has “already started to transition its marketing campaign for Prevagen.”
At the moment, Prevagen advertisements are running with a slogan that simply says, “for your brain.” In promotional videos, people talk about the supplement in decidedly vague terms: One woman describes it as a confidence-booster, for example.
Some Prevagen marketing videos seem to suggest the product should be taken for years. A man identified only as Robert says he has taken the supplement for “at least 8 years.” On Amazon, a one-month supply costs $37.95, bringing the cost of his long-term use to roughly $3,650.
“After more than a decade of telling consumers this product improves memory, changing the slogan to ‘for your brain,’ is more of a cosmetic shift than a meaningful correction, especially when the target audience is older adults concerned about cognitive decline,” says Smith. Millions of Americans have Alzheimer’s dementia, she notes, and the global market for brain health supplements has been valued at more than $8 billion.
“After more than a decade of telling consumers this product improves memory, changing the slogan to ‘for your brain,’ is more of a cosmetic shift than a meaningful correction, especially when the target audience is older adults concerned about cognitive decline.”
Supplement makers are watching what’s happening with the lawsuit, she continued, “and the message to the industry should not be that deceiving America’s elderly is a successful and profitable business model.”
What Actually Supports Brain Health
There are evidence-based steps people can take outside of supplements to support brain health and lower their risk of disease. Dr. Kastanenka points to sufficient sleep. Individuals with sleep impairments are at increased risk for developing Alzheimer’s later in life, she says, but her research with animals shows that good sleep can slow the disease’s progression. Exercise is helpful, too. According to a 2023 meta-analysis, exercise interventions were associated with measurable improvements in cognitive function, particularly in older adults.
A healthy diet, staying away from processed foods, can help, too.
Fredricks points to a 2024 report in The Lancet that included a host of additional steps a person could take to reduce their risk, including staying cognitively and socially active, quitting smoking and alcohol, and keeping blood pressure at acceptable levels.
Performing complex tasks may help as well, says Seres, noting that a 2025 review found an association between ballroom dancing and delayed memory impairment.
But despite their appeal, Seres emphasizes that supplements marketed for brain health have not been shown to provide any meaningful clinical benefit.
This story will be updated as Quincy’s appeal moves forward and once a decision is issued.