Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted October 24, 2012
Warning Issued to Memory Supplement Maker For Unapproved Drug Ingredient, Drug Claims and Unreported Adverse Events
Prevagen contains a synthetic version of the jellyfish-derived protein apoaequorin. The warning letter states that because this ingredient is not a vitamin, mineral, amino acid, herb, botanical or an extract or metabolite thereof, it cannot be a dietary supplement ingredient.
The FDA also cited Quincy Bioscience's failure to report adverse events and product complaints associated with Prevagen, including heart arrhythmias, chest pain, vertigo, tremors, and fainting, seizures and strokes.
Prevagen was promoted on the company's website for the treatment of head injuries, Alzheimer's disease and dementia, through customer testimonials and through statements made in a promotional video, which describes the product as the "first and only dietary supplement that…protects the brain cells from death."
For more information about this warning letter, use the link below.