FDA WARNING_LETTER - MyStart Health LLC - August 31, 2025

The FDA issued a warning letter to My Start Health, located at 254 Chapman Rd., STE: 208 #17801, Newark, DE, on September 9, 2025, following a review of their website in August 2025. The FDA identified that the website offers compounded semaglutide products with misleading claims, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the compounded products are equivalent to FDA-approved drugs, which they are not, thus misbranding them under the FDCA. The introduction of these misbranded products into interstate commerce contravenes section 301(a) of the FDCA.

The FDA mandates that My Start Health 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 to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions such as seizure or injunction. The letter also advises that if the company disagrees with the FDA"s findings, they should provide supporting information. The FDA warns that misbranded products may be detained or refused entry into the U.S., and international regulatory bodies may be notified.