Cerebral Health, LLC – FDA Warning Letter

On January 7, 2010, the FDA issued a Warning Letter to Cerebral Health, LLC, specifically addressing Douglas J. Phillips, II, Director of Research and Development. The letter stemmed from a December 2009 review of the company's websites (http://www.alzenia.com, http://memeron.com, and http://www.cerebralhealth.com).

The FDA determined that Cerebral Health's products, including "Alzenia Anti-Aging Brain Formula," "Alzenia with Huperzine A," "Memeron," "Synaptine," "Synaptine Blue," "Synaptine Elite," and "Neurotine," are promoted for conditions that classify them as drugs under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)]. The therapeutic claims, including personal testimonials, on the websites establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease, thus violating the Act.

Specific examples of disease claims cited include: "Huperzine A...as a treatment for Alzheimer's disease," "Green Tea helps prevent neurodegenerative brain conditions including Alzheimer's disease and Parkinson's disease," "resveratrol significantly reduced beta amyloid plaques, which are often associated with...Alzheimer's disease," "Coconut oil is