FDA WARNING_LETTER - Quincy Bioscience Manufacturing Inc. - December 22, 2011

The FDA issued a Warning Letter to Quincy Bioscience Manufacturing Inc. for marketing Prevagen products (Prevagen, Prevagen Extra Strength, Prevagen Professional) as unapproved new drugs and misbranded drugs.

The FDA reviewed the company's websites in August 2012 and determined that therapeutic claims, such as "protects the brain cells from death" and testimonials about improving Alzheimer's and head injury memory loss, establish the products as drugs intended for disease treatment or prevention under 21 U.S.C. § 321(g)(1)(B). Additionally, the company sponsored clinical trials for apoaequorin without an Investigational New Drug (IND) application, violating 21 U.S.C. §§ 331(d) and 355(a) and 21 CFR Part 312.

The FDA also found that the synthetically produced apoaequorin in Prevagen products is not a "dietary ingredient" as defined by 21 U.S.C. § 321(ff)(1), meaning the products do not qualify as dietary supplements. Since the products are unapproved new drugs, they are also misbranded under 21 U.S.C. § 352(f)(1) because they lack adequate directions for layperson use.

An inspection from October to December 2011 revealed the company failed to report