The supplement product’s extensive marketing campaign for memory benefits is based on “false and unsubstantiated claims,” according to the FTC.
Photo © iStockphoto.com/1905HKN
Prevagen, a brain-health supplement product that’s been marketed extensively on television and elsewhere for its memory benefits, may now be in hot water with the FTC. This morning, the FTC and New York Attorney General (NYAG) Eric T. Schneiderman charged the marketers of Prevagen with making “false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is ‘clinically shown’ to work.”
Prevagen’s national advertising campaign-which includes a TV spot explaining that the product’s active ingredient, apoaequorin, is derived from a protein found in jellyfish-frequently references a double-blind, placebo controlled study in which Prevagen use led to “rapid and dramatic improvement in memory for users of the product,” as depicted by a chart in the ads, FTC says. But according to the complaint released today by the agency, that study failed to show Prevagen worked any better than a placebo on any parameter of cognitive function.
“The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection, in a press announcement. “But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence.”
The federal complaint also notes that 30-pill bottles of Prevagen have been sold for prices ranging from $24 to $68, and are widely available at retailers including Walgreens, Amazon, CVS, and more. The defendants named in the complaint-including Prevagen manufacturer Quincy Bioscience (Madison, WI)-have made more than $165 million in product sales to date, according to the FTC.
“The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country,” says NYAG Schneiderman. “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.”
Response from Prevagen Manufacturer
Quincy Bioscience issued a response to the complaint this morning that claims the FTC’s allegations are “unfounded and inaccurate.” The company notes that neither the FTC nor the NYAG are suggesting Prevagen is unsafe, and the body of research behind Prevagen’s memory and cognitive-health benefits are more than sufficient to meet both the FTC and FDA’s necessary standard for the health claims in question.
“The sole dispute rests on the interpretation and analysis of the data, with the regulators attempting to hold the company to a standard that is unreasonable, scientifically debatable, and legally invalid,” Quincy Bioscience says. “Their experts simply disagree with ours over how to interpret the study results. The FTC should not be the arbiter in matters of scientific debate. We are proud of the work we have done to support Prevagen’s effects and believe our large body of evidence clearly satisfies the longstanding standard to support such claims.”
Additionally, Quincy Bioscience notes that the complaint was approved by just two FTC commissioners (out of a maximum of five), both of whom are Democrats. Two of the FTC commission seats are currently vacant, while the other filled seat is held by a Republican who did not participate in the complaint.
The firm claims it is “unprecedented for a complaint like this to be brought by only two sitting commissioners, let alone two commissioners from the same party,” and says “there is no reason for a short-staffed and lame-duck FTC to rush this complaint through.”
“Quincy Bioscience will vigorously defend ourselves,” the firm’s response concludes. “The Americans who rely on Prevagen to improve their lives deserve nothing less.”
Read more:
FTC Charges Journal Publisher OMICS Group with Deceiving Researchers
How Do FDA and FTC Regulate Ayurveda Products?
Herbalife Agrees to $200 Million FTC Settlement, Will Restructure Multilevel-Marketing Business
Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com
Senate Committee has released the text of 2024 Farm Bill, with changes to hemp regulations
November 19th 2024The U.S. Senate Committee on Agriculture, Nutrition, & Forestry has introduced the Rural Prosperity and Food Security Act, which will serve as the Senate’s draft for the 2024 Farm Bill.
NPA’s lawsuit against FDA on NMN stayed pending agency’s decision on citizen petition
November 6th 2024The court has granted a joint motion for stay filed by NPA and FDA, pending the agency's decision on the citizen petition asking FDA to reverse its stance on NMN's status as a dietary ingredient.