Premium Health Management Inc. dba Premium Health
FDA issued a warning letter to Premium Health Management Inc. dba Premium Health (Santa Ana, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The FDA found that the website falsely implied Premium Health was the compounder of the products and that the products had received FDA approval or evaluation for safety and effectiveness. The products were deemed misbranded under FDCA sections 502(a) and 502(bb), with their interstate commerce constituting a prohibited act under section 301(a). The company was given 15 working days to respond with corrective steps, and was warned that failure to comply may result in seizure or injunction.
Flagged claims (3)
generic compounded medication
Tirzepatide (active ingredient used in Mounjaro®)
Semaglutide (the active ingredient used in Ozempic® and Wegovy®)
Required actions (3)
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.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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