BluefitMD
FDA issued a warning letter to BluefitMD (Lakewood Ranch, FL) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified BluefitMD as the compounder of these drugs when it was not, and marketing language implied the compounded products shared FDA-approved status with brand-name drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. FDA determined the products were misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). BluefitMD was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
BluefitMD
Compounded Tirzepatide (the same active ingredient as Mounjaro® & Zepbound®)
Compounded Semaglutide (the same active ingredient as Ozempic® and Wegovy®)
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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