FDA WARNING_LETTER - Lumimeds - August 31, 2025

The FDA issued a Warning Letter to Lumimeds on September 9, 2025, following a review of their website in August 2025. The FDA identified that Lumimeds was marketing compounded drug products, specifically semaglutide and tirzepatide, with misleading claims. These claims suggested that their compounded products were equivalent to FDA-approved drugs, which they are not. This constitutes a violation under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded and unlawfully introduced into interstate commerce, violating section 301(a) of the FDCA.

The FDA highlighted specific misleading statements on Lumimeds" website, such as claims that their compounded products contain the same active ingredients as FDA-approved medications. The FDA emphasized that compounded drugs are not FDA-approved, and such claims could mislead consumers regarding the safety and efficacy of these products.

Lumimeds is required to take immediate corrective actions, including ceasing the use of misleading language. The company must respond within 15 working days, detailing the steps taken to address the violations and prevent recurrence. Failure to comply may result in legal actions, including product seizure and injunctions. Lumimeds must ensure compliance with all federal laws and FDA regulations and provide a written response to the Office of Compounding Quality and Compliance. If Lumimeds believes their products are not in violation, they must provide supporting information for FDA consideration.