‘Clinically proven’ memory-boosting supplements like Prevagen don’t work. So how do they escape FDA crackdown?

Credit: ABC News
Credit: ABC News

Some popular supplements advertised on TV claim to be “clinically” proven, but in fact are not. Notably, the maker of Prevagen is embroiled in an ongoing legal battle with the Federal Trade Commission and the attorney general of New York state. 

The charges are that Prevagen claims of improving memory and supporting healthy brain function, including a “sharper mind” and “clearer thinking,” are false and unsubstantiated. 

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Prevagen’s main ingredient, apoaequorin, a protein isolated from the Aequorea victoria jellyfish, has no known role in memory or cognitive function. 

A 2016 independent review by the Alzheimer’s Drug Discovery Foundation said it was unlikely to have any benefits for brain health, noting that the one company-sponsored randomized controlled trial did not show that apoaequorin worked better than a placebo.

In 2012, the FDA sent Prevagen’s manufacturer a letter warning that the company was violating federal law, alleging that the active ingredient was a synthetic copy of apoaequorin that had never been part of the human diet or sold in supplements. The agency also documented 1,000 “adverse events” between 2008 and 2011, including chest pain, vertigo and seizures.

The bottom line is that the FDA is not authorized to review supplements for safety or effectiveness before they are sold to consumers, so buyer beware. 

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