Strut Health, LLC dba Strut
FDA issued a warning letter to Strut Health, LLC dba Strut (CEO Simal Patel, MD) on February 20, 2026, concerning false or misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that Strut's website falsely implied the company itself was the compounder of these drugs (by displaying 'Strut' on product labels) and that claims such as 'Generic Zepbound, Mounjaro' falsely implied FDA approval or evaluation for safety and effectiveness. 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 (3)
Generic Zepbound, Mounjaro
Semaglutide is the active ingredient in the brand medications.
Tirzepatide is the active ingredient in the brand medications Zepbound® and Mounjaro®.
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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