FDA WARNING_LETTER - GenLabMeds - August 31, 2025

GenLabMeds received a warning letter from the FDA on September 9, 2025, following a review of their website in August 2025. The FDA identified significant regulatory violations concerning the company"s marketing of compounded drug products, including retatrutide, semaglutide, and tirzepatide. The primary issues include the sale of unapproved new drugs and misbranded drugs, violating sections 505(a), 502(f)(1), 301(a), and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The compounded retatrutide products do not meet the conditions for exemptions under sections 503A and 503B of the FDCA. Specifically, retatrutide is not covered by a United States Pharmacopeia or National Formulary monograph, is not an FDA-approved drug component, and is absent from the 503A and 503B bulks lists. Consequently, these products lack FDA approval and adequate labeling, rendering them misbranded.

Furthermore, the website"s claims about the compounded products are deemed false or misleading, suggesting equivalence to FDA-approved drugs, which they are not. This misrepresentation results in additional violations under sections 502(a) and 502(bb) of the FDCA.

The FDA requires GenLabMeds to cease the introduction of these unapproved and misbranded products into interstate commerce. The company must address these violations promptly to comply with federal regulations and avoid further enforcement actions.