FDA WARNING_LETTER - Hcg-miracleweightloss.com

On November 28, 2011, the FDA and FTC issued a Warning Letter to Mr. Greg Grimshaw of hcg-miracleweightloss.com regarding "HCG Extra Weight Loss Homeopathic Drops." The product was deemed an unapproved new drug and misbranded, violating sections 301, 505, and 503 of the Federal Food, Drug, and Cosmetic Act (the Act). The FTC also cited unlawful advertising under the FTC Act for unsubstantiated claims.

The product's website claims, such as "Lose up to 30 lbs in 30 days!" and "HCG resets your hypothalamus gland," classify it as a drug intended to affect body structure or function, and a "new drug" not generally recognized as safe and effective. No FDA-approved application exists for this product, making its marketing a violation.

Although labeled homeopathic, the active ingredient HCG (human chorionic gonadotropin) is not listed in the Homeopathic Pharmacopeia of the United States (HPUS), thus not qualifying it as a homeopathic drug under FDA's Compliance Policy Guide (CPG 7132.15). Furthermore, HCG Extra Weight Loss Homeopathic Drops is considered a prescription drug under section 503(b)(1) of the Act due to its use with a very low-calorie diet requiring medical supervision. Its label's failure to bear the "Rx only