FDA WARNING_LETTER - EvoLife Wellness - August 31, 2025

The FDA issued a warning letter to EvoLife Wellness on September 9, 2025, following a review of their website in August 2025. The inspection revealed that EvoLife Wellness offers compounded drug products, including semaglutide and tirzepatide, with misleading claims. These claims suggest equivalence to FDA-approved products, which is false, leading to the misbranding of these drugs 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 EvoLife Wellness to take immediate corrective actions, including ceasing the use of misleading language that misbrands the products. The company must submit a written response within 15 working days, detailing steps taken to address and prevent future violations, along with supporting documentation. Failure to comply may result in legal actions, such as product seizure or injunctions.

EvoLife Wellness is responsible for ensuring compliance with all federal laws and FDA regulations. If the company believes its products are not in violation, it must provide reasoning and evidence. Correspondence should be directed to the Office of Compounding Quality and Compliance, with the subject line indicating a response to the warning letter.