Elite Health Center
FDA issued a warning letter to Elite Health Center (Washington Township, NJ) on September 9, 2025, after reviewing the website eliterapidfatloss.com and finding a false or misleading claim about compounded semaglutide implying FDA approval of the compounded product. The claim falsely stated that compounded semaglutide received FDA approval as a diabetes treatment in 2017 and an obesity treatment in 2021, when in fact compounded drugs are never FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and directed Elite Health Center to cease the misleading language and respond within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (1)
Compounded semaglutide was first introduced and patented in 2016, and FDA approved as a type 2 diabetes treatment in 2017. It wasn't until 2021 that compounded semaglutide was approved as a treatment for obesity!
Required actions (2)
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.
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