SemaBio
FDA issued a warning letter to SemaBio on September 9, 2025, after reviewing the company's website (sema.bio) and finding that it marketed compounded semaglutide products using the term 'generic semaglutide,' a claim FDA determined to be false or misleading because compounded drugs are not FDA-approved and the label implies equivalence to an approved product. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the interstate sale of such misbranded products violates section 301(a). FDA demanded immediate corrective action, including cessation of the misleading language, and warned that failure to comply may result in seizure or injunction.
Flagged claims (1)
generic semaglutide
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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