FDA WARNING_LETTER - The HCG Institute - August 31, 2025

The FDA issued a warning letter to The HCG Institute on September 9, 2025, following a review of their website in August 2025. The inspection revealed that the company was marketing compounded drug products, including semaglutide, with misleading claims. Specifically, the website suggested that their compounded semaglutide products were equivalent to FDA-approved medications, which they are not. This misrepresentation violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), leading to the products being misbranded and unlawfully introduced into interstate commerce under section 301(a) of the FDCA.

The FDA highlighted several misleading claims on the website, such as assertions that the compounded semaglutide was "clinically proven" for weight loss and comparable to FDA-approved products like Ozempic. The agency emphasized that compounded drugs are not FDA-approved and any implication otherwise is false and misleading.

The HCG Institute is required to take immediate corrective actions, including ceasing the use of misleading language. They must respond within 15 working days with a written plan detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions, including product seizure or injunction. The FDA also warned that misbranded products could be detained or refused entry if the company operates outside the U.S. Correspondence should be directed to the Office of Compounding Quality and Compliance.