FWD Care, Inc. dba FWD
FDA issued a warning letter to FWD Care, Inc. dba FWD on September 9, 2025, after reviewing the company's website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro). The agency determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb) because compounded drugs are not FDA-approved and cannot lawfully be represented as the same as approved products. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (3)
Same active ingredient in Mounjaro and Zepbound
Same active ingredient as Ozempic and Wegovy
Manage weight affordably with compounded GLP-1, the same active ingredients as Wegovy, Ozempic, Zepbound & Mounjaro
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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