Healthy Living Clinic
FDA issued a warning letter to Healthy Living Clinic (Edgewater, CO) in September 2025 after reviewing its website and finding a false or misleading claim implying that its compounded semaglutide products are equivalent to FDA-approved brand-name drugs (Wegovy, Ozempic, Rybelsus). The claim violates FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (1)
It is also available under brand names like Wegovy, Ozempic, and Rybelsus.
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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