Lyfe Rx
FDA issued a warning letter to Lyfe Rx (Bee Cave, TX) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the claims implied the compounded products were equivalent to FDA-approved drugs, which they are not. FDA found the products to be misbranded and introduced into interstate commerce in violation of section 301(a). Lyfe Rx was directed to cease the offending language immediately and provide a written corrective response within 15 working days, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (2)
Clinically Proven Weight Loss – Semaglutide has been shown to….
Clinically Proven Weight Loss – Tirzepatide has been shown to….
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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