FDA WARNING_LETTER - Longevity Plus, LLC - July 31, 2010

The FDA issued a Warning Letter to Longevity Plus on October 12, 2010, following a July 2010 review of their website, www.longevityplus.com. The FDA determined that Longevity Plus's products "Beyond Chelation Improved," "EndoKinase," "Viral Defense," and "Wobenzym-N 200ct" are promoted with therapeutic claims that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). These claims, found on Longevity Plus's website and a linked site, www.gordonresearch.com (operated by Longevity Plus consultant Garry F. Gordon, MD), suggest the products are intended for the cure, mitigation, treatment, or prevention of diseases such as cancer, heart disease, strokes, blood clots, hypertension, influenza, herpes, hepatitis C, autoimmune diseases, and various inflammatory conditions.

Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act. Marketing new drugs without prior FDA approval, as required by section 505(a) of the Act, is a violation. The letter states that the listed violations are not exhaustive and that other products on their website also make unlawful disease treatment and prevention claims. Longevity Plus is required to take prompt action