FDA WARNING_LETTER - natural medical supply, llc - November 28, 2011

On November 28, 2011, the FDA and FTC issued a Warning Letter to Natural Medical Supply, LLC, DBA HCG Complete Diet, regarding their products "Alcohol Free hCG Weight Loss Formula," "hCG Diet Pellets Weight Loss Formula," and "hCG Diet Drops Weight Loss Formula."

The FDA determined these products are unapproved new drugs, violating sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act), and are misbranded under sections 503 and 301. The FTC stated that advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence violates the FTC Act.

The products' labeling and website, www.hcgcompletediet.com, make claims such as "lose weight," "mobilize stored fat," and "loss of one to two pounds a day," which classify them as drugs intended to affect the body's structure or function. As "new drugs," they require FDA approval, which they lack.

Despite being labeled as homeopathic, the products contain human chorionic gonadotropin (HCG), which is not an established homeopathic active ingredient in the Homeopathic Pharmacopeia of the United States (HPUS). Therefore, they do not fall under the FDA's homeopathic drug enforcement policies.

Furthermore, these products are considered prescription drugs under section 503(b)(1) of the Act because they require medical