Body Good Studio
FDA issued a warning letter to Body Good Studio (Miami, FL) in September 2025 after reviewing their website and finding a false or misleading claim about compounded semaglutide products implying equivalence to FDA-approved drugs Ozempic and Wegovy. The claim violates FDCA sections 502(a) and 502(bb), rendering the products misbranded, and their interstate commerce distribution violates section 301(a). FDA demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (1)
Compound semaglutide is made of the same active ingredients as Ozempic and Wegovy, which are GLP-1 receptor agonist [sic]….
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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