HCG Diet Direct, LLC – FDA Warning Letter, Nov 28, 2011

The FDA and FTC issued a Warning Letter to HCG Diet Direct, LLC, for marketing "HCG Diet Homeopathic Drops" as an unapproved new drug and misbranded product. The product's labeling and website, www.hcgdietdirect.com, made claims such as "Ultimate Weight Loss & Metabolism Formula" and "Lose 26 lbs in 26 days™," which classify it as a drug intended to affect body structure or function.

The product is deemed a "new drug" because there's no evidence it's generally recognized as safe and effective for its intended uses, violating sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331 and 355]. Despite being labeled homeopathic, it does not meet the conditions of FDA's Compliance Policy Guide (CPG 7132.15) for homeopathic drugs, as HCG, Arginine, and L-Carnitine are not established homeopathic ingredients.

Furthermore, the product is a prescription drug under section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] due to its use with a very low-calorie diet requiring medical supervision. It is misbranded under section 503(b)(4) [21 U.