FDA WARNING_LETTER - Dr. Rhonda Henry

The FDA issued a Warning Letter to Dr. Rhonda Henry on October 12, 2010, following a July 2010 review of her website, www.drhenry.com. The FDA determined that products "Pure Heart," "Melatonin," "Flaxseed Meal," "DHEA," and "Cardio Chelate (H-870)" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The therapeutic claims on the website, including those for preventing and reversing heart disease, boosting immunity, slowing tumor growth, regulating blood pressure, preventing cancer, and treating Parkinson's disease, establish the products as drugs intended for the cure, mitigation, treatment, or prevention of disease. The letter provides numerous examples of such claims for each product, as well as disease claims in personal testimonials and metatags (e.g., "diabetes," "arthritis," "depression").

Since these products are not generally recognized as safe and effective for their promoted uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. Marketing new drugs without prior FDA approval, as described in section 50