Vitals RX
FDA issued a warning letter to Vitals RX in September 2025 after reviewing their website and finding that the company marketed compounded semaglutide and tirzepatide products under a page title that referenced the FDA-approved brand name Ozempic, falsely implying equivalence with FDA-approved drugs. The FDA determined this claim misbranded the compounded products under FDCA sections 502(a) and 502(bb), constituting a prohibited act under section 301(a). The company was directed to immediately cease using the misleading language and to provide a written corrective response within 15 working days, with failure to comply risking seizure and injunction.
Flagged claims (1)
Vitals RX - Semaglutide/Tirzepatide/Ozempic Weight Loss Clinic
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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