The Federal Trade Commission and New York's attorney general charged a company with fraud on Monday for selling a memory supplement based on a glowing jellyfish protein.
Makers of a product called Prevagen are falsely advertising it as a memory booster, and falsely claiming the product can get into the human brain, the charges claim.
But the company pushed back hard, insisting its product is safe and calling the FTC is a "lame-duck" federal agency with heads who are about to be replaced by the incoming administration of president-elect Trump.
It's the latest battle in an ongoing war between the federal government and the Wisconsin-based Quincy Bioscience. In 2012, the Food and Drug Administration filed a warning letter to Quincy, saying it was making medical claims for a product that had not gone through the formal drug approval process.
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"The Federal Trade Commission and New York State Attorney General have charged the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is clinically shown to work," the FTC said in a statement.
"The extensive national advertising campaign for Prevagen, including TV spots on national broadcast and cable networks such as CNN, Fox News, and NBC, featured charts depicting rapid and dramatic improvement in memory for users of the product."
The capsules, which sell for anywhere between $40 and $90 for a bottle, supposedly contain a protein called apoaequorin, which is made by some jellyfish that luminesce.
The company tried, but failed, to show it can help people, the FTC says.
"Defendants primarily rely on one double-blind, placebo-controlled human clinical study using objective outcome measures of cognitive function. This study, called the Madison Memory Study, involved 218 subjects taking either 10 milligrams of Prevagen or a placebo," the charge alleges.
"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."
Nonetheless, the company said the study did show the product works.
"Defendants, however, do not have studies showing that orally-administered apoaequorin can cross the human blood brain barrier and therefore do not have evidence that apoaequorin enters the human brain," according to the charge.
It doesn't actually matter, because Prevagen is marketed as a supplement.
The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, specifically exempts vitamins and supplements from FDA's pre-marketing scrutiny, although the agency can warn against products found to be dangerous.
And the FTC, as well as the Justice Department and state officials, can act against misleading marketing practices.
"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. "But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence."
The suit seeks to fine Quincy and force it to pay back consumers who bought the pills.
However, the company said it will fight the charges.
"We vehemently disagree with these allegations made by only two FTC commissioners. This case is another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours," it said in a statement.
"There is no reason for a short-staffed and lame-duck FTC to rush this complaint through."
Members of Congress often defend companies. The FDA has frequently complained that DSHEA allows supplement makers to sell useless and often harmful products to trusting consumers, but Congress has failed to revise the legislation.
The Alzheimer's Association didn't want to weigh in on Prevagen in particular but the organization's science officer Maria Carrillo noted that there's no product out there that's been proven to help memory.
"The Alzheimer's Association has serious concerns about people using dietary supplements as an alternative or in addition to physician-prescribed, FDA-approved therapies in an attempt to treat or prevent Alzheimer's disease or other dementias," she said.
"First and foremost, the effectiveness and safety are unknown. In addition, the purity of the product is unknown. Finally, dietary supplements can have serious interactions with prescribed medications. "