The HCG Institute
FDA issued a warning letter to The HCG Institute (Medford, NJ) 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). The claims falsely implied that compounded semaglutide is equivalent to FDA-approved products, constituting misbranding. FDA demanded the company cease using the offending language and 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 to reduce appetite, lower food cravings, improve food intake regulation and glycemic control.
Compounded Generic Semaglutide is a revolutionary FDA-inspected medication for rapid weight loss that is given once weekly.
'Generic' or compounded semaglutide, like what we sell here at the HCG Institute, are the same medication, as well.
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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