Prevagen under FDA investigation
Posted on behalf of Janet, Jenner & Suggs on Apr 08, 2012 in Legal
Please Note: My Advocates is only providing information and not handling Prevagen cases. Contact the FDA about any concerns.
Class-Action Lawsuit Filed Against “Memory Supplement” Marketers
In January, 2015, a class-action suit was against Quincy Bioscience (QB) LLC the manufacturer of Prevagen. The company claims that the product works by re-supplying memory-related proteins that decline as people age. The lawsuit charges:
- The product cannot work as advertised because its only purported active ingredient, apoaequorin (a protein), is completely destroyed by the digestive system and transformed into common amino acids no different than those derived from other common food products.
- The amount of amino acids Prevagen adds to the user’s intake are trivial in comparison to normal dietary intake
- Claims that clinical tests demonstrate that Prevagen will improve memory and support healthy brain function, sharper mind, and clearer thinking are false. (Note: QB’s “clinical trials” were conducted in-house and did not have independent verification.)
- Studies touted in Prevagen’s marketing campaign “if they exist at all, are, on their face, so seriously flawed that they demonstrate nothing regarding Prevagen.”
FDA Announces Investigation of Prevagen (April 2012)
A supplement called Prevagen, which has helped propel its manufacturer, Quincy Bioscience, into the ranks of fastest-growing companies in the U.S., shows evidence of serious side-effects and should be marketed and regulated as a drug, says the U.S. Food and Drug Administration.
Anyone taking Prevagen should check with their doctor in light of the FDA’s disclosures about this so called “brain vitamin.”
Side Effects Reported, Then Ignored
In a warning letter, the FDA accused the company of not reporting to the government “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.” Reports about the supplement to the company have also included chest pain, tremors, fainting and other serious symptoms, the FDA says.
In fact, the company received more than 1,000 incidents and product complaints about Prevagen between May 2008 and December 1, 2011, and only investigated or reported two events, the letter says.
The FDA is waiting for the company’s response. It could seek legal action to halt the manufacture and marketing of Prevagen.
So-Called “Brain Vitamin” is Actually a Drug
“Prevagen” is hyped as a “brain vitamin” that can dramatically improve such things as learning, short-term memory and word recall. It is sold through major retailers, including CVS Pharmacy and Walgreens. The company’s website says Prevagen does not carry any serious side-effects.
The ingredient in Prevagen is apoaequorin, which is found in a certain kind of jellyfish. But because the company manufactures a synthetic form of apoaequorin, the supplement is a drug, the FDA says. As a drug, the company must perform studies to show it is both effective and safe, and the company must follow drug labeling and marketing regulations.
This is another example of the blurry line between supplements and drugs and how consumers can get caught in the middle. The supplements industry makes a fortune through exaggerated or false promises. Clearly, the safety of Prevagen needs to be proven before it is offered to the public and should be sold as a drug, not a vitamin.