Slendid – FDA Warning Letter, Aug 31, 2025

The FDA issued a Warning Letter to Slendid on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Slendid offers compounded drug products, specifically semaglutide and tirzepatide, with misleading claims. These claims imply equivalence to FDA-approved products, which is false, leading to the drugs being misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). The introduction of these misbranded products into interstate commerce violates section 301(a) of the FDCA.

The FDA requires Slendid to take immediate corrective actions, including ceasing the use of misleading language on their website. Slendid 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 recurrence. Failure to comply may result in legal actions such as seizure or injunction.

Slendid is also advised to investigate the root causes of these violations and ensure compliance with all federal laws and FDA regulations. If Slendid believes their products are not in violation, they must provide supporting information. Non-U.S. entities are warned that misbranded products may be detained or refused entry into the U.S., and foreign regulatory bodies may be notified. Correspondence should clearly indicate it is a response to the Warning Letter.