Medica Weight Loss
FDA issued a warning letter to Medica Weight Loss (Aventura, FL) following a March 2026 review of its website, finding that the company made false or misleading claims about compounded semaglutide and tirzepatide products in violation of FD&C Act sections 502(a) and 502(bb). Specific violations included falsely implying FDA approval of compounded drugs, misrepresenting the compounder's identity on product labels, and describing the sourcing pharmacy as 'FDA-approved' — a designation FDA does not grant to compounding facilities. The misbranding violations constitute prohibited acts under section 301(a) of the FD&C Act, and FDA warned that failure to correct them may result in seizure or injunction.
Flagged claims (3)
Tirzepatide is FDA-approved….
Clinical studies and FDA approval support [semaglutide's] safety and effectiveness….
FDA-approved pharmacy
Required actions (4)
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.
Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
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