FDA WARNING_LETTER - NativeMed LLC dba NativeMed - March 01, 2026

On June 8, 2026, the FDA issued a warning letter to NativeMed LLC, doing business as NativeMed, following a March 2026 review of the company’s website. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act regarding the sale of compounded semaglutide and tirzepatide products. The FDA determined that NativeMed’s promotional materials were false and misleading, resulting in the products being classified as misbranded. Key violations included the use of NativeMed’s logo on labels for tirzepatide, which incorrectly identified the company as the manufacturer. Additionally, the website claimed its compounded semaglutide contained the "same active ingredient" as FDA-approved medications like Ozempic and Wegovy. The FDA clarified that compounded drugs are not FDA-approved, and such claims suggest a level of safety and efficacy evaluation that has not occurred. Under the current regulatory framework, specifically sections 502(a) and 502(bb), these representations are prohibited. NativeMed is required to respond within 15 business days with a comprehensive plan to address these violations. Required actions include identifying the actual producers of the drugs, providing updated labeling samples, and modifying or removing misleading website content. Failure to implement sustained corrective measures may lead to legal consequences, such as product seizures or court-ordered injunctions.