FDA Prevagen Concerns Aired

From 2007 to 2016, Quincy Bioscience’s Prevagen posted dramatic sales increases, even as FDA regulators were raising many questions about the product and the company’s manufacturing processes and even as adverse event reports mounted. A Wired investigative report says three million people are estimated to have bought Prevagen since its 2007 launch. Sales reached $165 million by mid-2015 and the company claims the product is “a best-selling branded memory supplement in chain drug stores across the United States.”

While company officials have said that Prevagen is “safe and effective,” Wired says that for years FDA officials have been questioning the company’s claims. “Multiple FDA inspections, most of which have not been reported before, found significant issues with Quincy’s manufacturing processes, complaint handling, and the quality control testing that was supposed to ensure its products were safe,” the report says.

Wired says that apart from a 2012 Warning Letter, FDA has not publicly indicated concerns about Prevagen. And in 2018 the agency determined that the company had addressed the violations listed in the Warning Letter.

A Quincy spokesman told Wired that “Prevagen has been thoroughly tested and has GRAS (generally recognized as safe) status. FDA issued a close-out letter to Quincy Bioscience which FDA only issues when, based on its evaluation, a company has taken corrective action to address the issues identified in the Warning Letter to FDA’s satisfaction.”

The article says that Prevagen “shows how a dietary supplement can thrive on the market for years despite accumulating dozens of violations and raising alarm among government regulators, all unbeknownst to most consumers. Critics say FDA does not police the $40 billion supplement industry effectively, leaving Americans at risk. Even leaders of some of its largest trade associations say they are unhappy with FDA’s failure to enforce the law.”