FDA WARNING_LETTER - The hCG Drops, LLC

The FDA and FTC issued a Warning Letter to The hCG Drops LLC after reviewing its product labeling and website (thehcgdrops.com) for "Homeopathic hCG." The agencies found the product to be an unapproved new drug, violating sections 301 and 505 of the FD&C Act [21 U.S.C. §§ 331, 355]. It was also deemed misbranded under sections 503 and 301 [21 U.S.C. §§ 353, 331]. Specifically, the product is considered a drug due to its intended use for disease treatment and affecting body structure/function, and a "new drug" lacking general recognition of safety and effectiveness, with no FDA-approved application. Furthermore, HCG is not a recognized homeopathic ingredient, rendering the product ineligible for marketing under FDA's homeopathic drug enforcement policies (CPG 7132.15). The product is also a prescription drug under section 503(b)(1) due to its potential for harm (e.g., use with a very low calorie diet) and claims for conditions requiring medical supervision, yet its label fails to bear the "Rx only" symbol, constituting further misbranding under section 503(b)(4) [21 U.S.C. § 353(b)(4)]. The FTC also cited violations of the FTC Act, 15 U.S.C. § 41 et seq., for advertising that the product can prevent, treat, or cure human disease without competent and reliable scientific evidence. The company must respond to both FDA and FTC within fifteen working days, detailing corrective actions, prevention measures, and plans for distributed product, or face potential legal action, including seizure, injunction, and consumer restitution.