Mane & Steel, LLC. dba Mane & Steel
FDA issued a warning letter to Mane & Steel, LLC (Sacramento, CA) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide products were false or misleading under FDCA sections 502(a) and 502(bb). Specifically, the company's claims implied their compounded products were equivalent to FDA-approved drugs, which they are not. FDA found the products misbranded and their interstate commerce introduction a prohibited act under section 301(a). The company was directed to cease the offending language immediately and provide a written corrective response within 15 working days, with failure to comply risking seizure and injunction.
Flagged claims (2)
Clinically Proven Weight Loss
Clinically proven GLP-1 therapy to suppress appetite, regulate blood sugar, and accelerate fat loss—trusted by medical professionals worldwide.
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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