Expert Aesthetics – FDA Warning Letter, Aug 31, 2025

The FDA issued a warning letter to Erasing Age, located at 1551 US Hwy 287 N. Frontage Rd., Mansfield, TX, on September 9, 2025, following a review of their website in August 2025. The inspection identified significant violations related to the marketing of compounded drug products, specifically semaglutide and tirzepatide. These products were promoted with claims suggesting equivalence to FDA-approved drugs, which is misleading and constitutes misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA highlighted that compounded drugs are not FDA-approved and that the claims made on Erasing Age"s website falsely implied otherwise. This misrepresentation violates section 301(a) of the FDCA, which prohibits the introduction of misbranded drugs into interstate commerce.

The FDA has mandated that Erasing Age take immediate corrective actions, including ceasing the use of misleading language. The company is required to 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.

Erasing Age must ensure compliance with all federal laws and FDA regulations. The FDA also warned that misbranded products may be detained or refused entry into the U.S. if the company operates internationally. Correspondence should be directed to compoundinginspections@fda.hhs.gov with a clear subject line indicating a response to the warning letter.