Healthy Male
FDA issued a warning letter to Healthy Male (Tempe, AZ) in September 2025 after reviewing their website and finding that marketing claims for compounded tirzepatide products were false or misleading under FDCA sections 502(a) and 502(bb). The claims implied the compounded products were equivalent to FDA-approved drugs, which they are not, constituting misbranding. FDA directed Healthy Male to immediately cease using the offending language and to provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (3)
Clinically proven medications and compounds for sustainable weight management
Clinically proven to deliver sustainable results….
Clinically shown to support 15-22% average body weight reduction.
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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