In January, the Federal Trade Commission -- along with New York Attorney General Eric Schneiderman--filed a lawsuit against Quincy Bioscience, producers of Prevagen, a popular memory enhancement supplement, charging the company with false advertising, deceptive marketing, and unproven brain health claims that unfairly target vulnerable elders.
It is the latest in an ongoing series of regulatory actions targeting companies that market products or services in the rapidly growing cognitive health sphere.
Prevagen made a splash long before this new FTC action. The supplement contains an unlikely ingredient: apoaequorin, a calcium-binding protein derived from a bioluminescent species of jellyfish called Aequorea victoria. According to product descriptions, this protein, first identified and utilized by Quincy Bioscience, "has proven to uniquely support critical brain functions." The company advertised Prevagen as a tool to promote improved memory, word recall, and learning for people concerned with either the cognitive challenges associated with normal aging or who wish to support healthy brain aging.
But the FTC and the state of New York argue otherwise.
Accusation of Fraud
"The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country," said AG Schneiderman in a press release issued the day the complaint was filed. Schneiderman stated that it is unacceptable that Quincy targeted seniors with advertising for a supplement costing "more than a week’s groceries," and charged the company with pushing a product that "provides none of the health benefits that it claims."
Sold at major pharmacies across the country, a month’s supply of Prevagen costs between $24 and $68. Sales of the supplement have topped $165 million.
The complaint further states that Prevagen's marketers have violated both the FTC Act and New York state laws requiring that advertisements be truthful. In issuing the complaint, filed in the US District Court for Southern New York, the two government agencies intend to ban future false claims about Prevagen, impose civil penalties upon its makers, and obtain refunds for consumers who purchased it.
In response to the lawsuit, Quincy Bioscience released a statement describing the charges as "unfounded and inaccurate."
The company says it has, "amassed a large body of evidence that Prevagen improves memory and supports healthy brain function," referencing results from a randomized, double-blind, placebo-controlled study it sponsored and completed in 2011.
In that study, 211 participants ages 40-91 with self-reported cognitive difficulties received either a 10 mg capsule of Prevagen or a rice flour-based placebo daily for three months. Using several different screening tools, researchers measured participants' cognitive functioning across a variety of domains, including memory, working memory, verbal and visual learning, executive and psychomotor function, and attention. The data indicate that the Prevagen group experienced statistically significant improvements in some select brain health categories.
Based on these findings, Quincy Bioscience concluded that Prevagen "supports cognitive function in healthy, non-demented individuals."
The FTC has a very different interpretation. The lawsuit asserts that the company's study, "failed to show a statistically significant improvement in the treatment group over the placebo group" and that its "few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect."
The regulators are not the first to point out the shortcomings of this study. A 2015 column in Pharmacy Today, questioned veracity of the tests used to measure executive functioning. The Groton Maze Learning and the Groton Maze Recall tasks, among others, "are not validated tests like the Trail Making Test Part B," writes the column's author, Anne L. Hume, PharmD, FCCP, BCPS. Hume also points out that Prevagen's key ingredient, apoaequorin, is "unlikely to be absorbed to a signicant degree" in the body; "instead it degrades into amino acids" like other proteins.
Protection or Over-Reach?
According to Quincy Bioscience, the backlash from federal authorities against Prevagen is just, "another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours."
The new lawsuit is not Quincy's first tangle with regulators. In 2012, the Food and Drug Administration (FDA) sent a warning letter to the company questioning its marketing tactics and stating that its line of Prevagen supplements was, "being promoted for conditions that cause these products to be drugs," rather than supplements.
"The therapeutic claims on your websites...establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," the letter stated. As reported by CBS, the FDA continues to question Quincy’s marketing strategies today. In October and November, the Administration conducted inspections at two locations owned by Quincy’s parent company. The agency declined to provide further comment, stating that "the matter remains open."
Additionally, in 2015, Quincy Bioscience was the subject of a class-action lawsuit accusing the company of false advertising. The complaint states that Prevagen's "brain function and memory representations are false, misleading, and reasonably likely to deceive the public."
There's little doubt that Quincy's marketing campaigns crossed a regulatory line for dietary supplements, and it is not surprising that the company has incurred the wrath of the FTC, the FDA, and as a state attorney general with a strong record of action against the supplement industry.
But the move against Prevagen is not an isolated incident. Over the past few years regulators have been increasingly vigorous in clamping down on a wide range of products and services marketed for cognitive improvement, brain health, or prevention of dementia.
In 2014, the FTC filed a complaint against i-Health and Martek Biosciences Corporation (now a division of DSM), makers of the BrainStrong Adult dietary supplement, which contains the omega-3 fatty acid DHA. The agency charged the companies with falsely claiming they had clinical proof that BrainStrong could improve memory and prevent cognitive decline. In 2014, the companies agreed to settle the charges.
More recently, the FTC squelched Lumos Labs—the San Francisco company that markets the popular Lumosity cognitive fitness system—charging that Lumos had made false and misleading claims about the system’s ability to improve IQ, stave off age-related cognitive decline, and restore brain function following stroke.
At peak in 2015, Lumosity had engaged roughly 70 million people, many of whom were paying $15 per month for access to the system’s array of games to stimulate and strengthen various cognitive skills.
Last year, the company settled for $2 million, which will be used to refund more than 13,000 customer grievances.
Lumosity has actually been tested in a number of studies. While outcomes are mixed and there is no definitive evidence that this or any other brain training system can "prevent" Alzheimer's, there are several trials showing that Lumosity training increased alertness, enhanced neurocognitive plasticity, strengthened visual attention, and improved function across several cognitive parameters.
Neurocore Raises Questions
Another brain-training company--Neurocore Brain Performance Centers--has also come under scrutiny, not only for its marketing claims, but also for its ties to Betsy DeVos, the Trump administration's pick to head the nation's Department of Education.
At it's eight centers in Michigan and Florida (with plans for broader expansion), Neurocore claims to provide effective treatment for memory impairment, ADHD, depression, migraines, sleep problems and other neurological problems, using a combination of biofeedback, heart rate variability monitoring, and attention-conditioning exercises.
With a pitch that stresses, "Your brain isn't hard-wired; it can change," and a promise to "look past the label you've been given to scientifically diagnose the root of your issue," Neurocore says it can offer patients "a data-centric, drug-free brain training exercise program that optimizes your brain for a better life."
In a recent New York Times article, a number of prominent physicians and neuroscientists question Neurcore's claims as well as the science--much of it unpublished--that the company cites to support its methods.
The article also notes that a group of Democratic senators have raised questions about potential conflicts of interest arising from Mrs. DeVos' ownership stake in Neurocore. She and her husband are primary investors in the company, with holdings estimated to be worth between $5 million and $25 million, according to the Office of Government Ethics.
Children with ADHD, autism, anxiety, and other neurological conditions make up a large portion of Neurocore's clients, and the company has a history of marketing its services in Michigan schools--especially Christian schools--as a drug-free way of managing attention or behavioral disorders and improving academic performance.
The Neurocore system was developed by psychologist and theologian Timothy Royer, who ran the pediatric psychiatry department at Helen DeVos Children's Hospital in Grand Rapids. The hospital is named for Betsy DeVos' mother-in-law, the wife of Richard M. DeVos, Sr, co-founder of Amway, and a major Republican donor.
DeVos has stated that pending her appointment as Secretary of Education, she is leaving Neurocore's board of directors but will maintaining her investment in the company, though she plans to divest from many other companies in her family's portfolio.
The rising regulatory oversight of products and services marketed for neurological or cognitive health is blowing a chilly wind through a rapidly growing sector of the natural products industry. It serves as an important reminder that contrary to the common assertion that the industry is "unregulated"---there are in fact very clear federal truth-in-advertising rules. Moreover, there are federal and state agencies capable of enforcing them, though with the change in administration the future of the regulations and the agencies is in question.
The recent moves will likely prompt marketers to think very carefully about making memory or cognitive function claims.
But given that mainstream medicine has essentially nothing to offer to patients at risk of dementia, and little in the way of truly effective therapy for ADHD and autism, the targeting of brain health products seems a bit heavy-handed, and some observers question whether the FTC and the New York AG have moved from legitimate consumer protection to regulatory over-reach.
The FTC states that it "looks especially closely at advertising claims that can affect consumers’ health or their pocketbooks." For the moment, it is very clear that the agency considers memory improvement and brain health to be just such an issue.