FDA WARNING_LETTER - Lumimeds - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Lumimeds on September 9, 2025, following a review of the company’s website in August 2025. Based in Las Vegas, Nevada, Lumimeds was found to be marketing compounded drug products, specifically semaglutide and tirzepatide, using false or misleading information. The primary issue cited by the FDA is that the company’s promotional materials suggested these compounded medications were the same as FDA-approved brand-name drugs or were themselves FDA-approved. In reality, compounded drugs do not undergo the FDA approval process, and claims of equivalence to approved medications are deceptive to consumers. These actions violate the Federal Food, Drug, and Cosmetic Act, which classifies such products as misbranded drugs. Under this regulatory framework, selling or distributing misbranded products across state lines is prohibited. The FDA has directed Lumimeds to immediately correct the violations by removing misleading language from its website and investigating the root causes of these issues to prevent them from happening again. Lumimeds is required to submit a written response to the FDA within 15 working days detailing the specific corrective steps taken. The agency warned that failure to address these concerns promptly could result in legal action, including product seizures or a court-ordered halt to operations.