Peaks Curative, LLC dba Peaks
FDA issued a warning letter to Peaks Curative, LLC dba Peaks on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide products. The website falsely implied FDA approval of compounded drug products and misidentified 'Peak Now' as the compounder on product labels. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (4)
Safe, affordable, and effective.
The compounded products offered on PeaksCurative.com use FDA approved active pharmaceutical ingredients (API).
Clinically proven to aid in significant weight loss in overweight adults.
This FDA-approved treatment promotes safe, effective weight loss, helping you reduce up to 20% of your body weight and maintain long-term results.
Required actions (3)
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.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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