Prevagen, a popular dietary supplement marketed to an aging population with memory loss, is the target of a lawsuit filed by the FTC and New York Attorney General Eric Schneiderman.
The marketers of PrevagenQuincy Bioscience Holding Company, Inc. and related entitieshave made false and unsubstantiated claims in violation of the FTC Act and New York state laws, according to a 31-page complaint filed in New York federal court. The disputed claims relate to the product’s ability to provide cognitive benefits including memory improvement and whether it has been clinically shown to work, FTC announced in a news release.
“The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country," said Schneiderman, who has been a critic of the supplement industry, in a statement. “It’s particularly unacceptable that this company has targeted vulnerable citizens like seniors in its advertising for a product that costs more than a week’s groceries, but provides none of the health benefits that it claims."
State and federal authorities are seeking refunds for consumers who purchased the dietary supplement. Minus refunds, sales of Prevagen have totaled US$165 million from 2007 through mid-2015, and customers have paid anywhere from approximately $24 to $59 for a 30-day supply of regular strength pills, the lawsuit noted.
Prevagen, which has been sold at major retailers and advertised on national broadcast and cable networks, contains apoaequorina dietary ingredient that was purportedly obtained from a species of jellyfish, the lawsuit said. The supplement “has been clinically shown to help with mild memory problems associated with aging," and apoaequorin “is safe and uniquely supports brain function," according to Prevagen’s website.
Authorities, however, contend the marketers of Prevagen have exploited an elderly population and lack scientific evidence to support their cognitive function claims.
“Marketers say Prevagen’s active ingredientderived from a species of jellyfishcan get rid of excess calcium that builds up in the brain as we age," Lisa Lake, a consumer education specialist with FTC, wrote in a Jan. 9 blog, commenting on the lawsuit. “The TV ads for Prevagen even tout a clinical study and featured dramatic charts. But according to the FTC, that study actually found that Prevagen didn’t impact brain function as advertised, and the company doesn’t have evidence to back up its claims for memory or other cognitive benefits."
Company Defends Itself
Quincy Bioscience, a biotechnology company in Madison, Wisconsin, described the case against it as “another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours." The company pointed out only two FTC commissioners votedincluding FTC Chairwoman Edith Ramirez, a Democratauthorizing staff to file the complaint.
“It is unprecedented for a complaint like this to be brought by only two sitting commissioners, let alone two commissioners from the same party," the company said in a press release. “The FTC is supposed to be headed by five commissioners, representing a diversity of political backgrounds."
Commenting on Prevagen, Quincy Bioscience said it has amassed substantial evidence to show its product improves memory and fosters healthy brain function.
“This evidence includes preclinical rat studies, canine studies, human clinical studies, and most importantly, randomized, double-blind, placebo-controlled human clinical testing," the company said. “The type of testing has long been acknowledged by both the FTC and the FDA to be the ‘gold standard’ for scientific evidence."
At issue in the case is a study that included 218 individuals who took either Prevagen or a placebo. “The Madison Memory Study failed to show a statistically significant improvement in the treatment group over the placebo group on any of the nine computerized cognitive tasks," the lawsuit alleged.
Quincy Bioscience asserted the dispute relates to the interpretation of study results. “The FTC should not be the arbiter in matters of scientific debate," the company said.
On the Prevagen website, Quincy Bioscience has written a letter to its customers, disclosing that it is defending itself against allegations that the product does not work as advertised. The lawsuit was filed Jan. 9 in the U.S. District Court for the Southern District of New York.
“We firmly contend that these allegations are not true, and we intend to vigorously defend ourselves in court," the company advised its customers.
This is not the first time Quincy Bioscience has attracted regulators’ attention. The company was the subject of an FDA warning letter in 2012. Among other observations, FDA alleged the company neglected to tell it about "adverse events like seizures, strokes, and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with the use of Prevagen products."