FDA WARNING_LETTER - Elite Health Center - August 31, 2025

The FDA issued a warning letter to Elite Health Center on September 9, 2025, following a review of their website, https://eliterapidfatloss.com, in August 2025. The inspection revealed that the company offers compounded drug products, including semaglutide, with misleading claims. These claims suggest that their compounded products are equivalent to FDA-approved drugs, which they are not. This constitutes a violation of sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded and illegally introduced into interstate commerce under section 301(a) of the FDCA.

The FDA has instructed Elite Health Center to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must submit a written response within 15 working days, detailing the steps taken to correct the violations and prevent their recurrence. Failure to comply may lead to legal actions such as product seizure or injunctions. The FDA also warns that if the company is based outside the U.S., their products may be detained or refused entry into the country. Elite Health Center is urged to ensure compliance with all federal laws and FDA regulations to avoid further enforcement actions.