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WARNING LETTER
•Kin Meds•December 31, 2025

Kin Meds – FDA Warning Letter, Dec 31, 2025

Record Details

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Kin Meds on February 20, 2026, following a December 2025 review of its website. The agency identified significant violations related to the company"s offering of compounded semaglutide and tirzepatide drug products. Main issues included false and misleading claims that suggested Kin Meds was the actual compounder of these drugs, which was inaccurate. Additionally, the website featured claims implying that these compounded products shared the "Same Active Ingredient as common brands" and were comparable to FDA-approved medications regarding safety and effectiveness, despite compounded drugs not undergoing FDA approval processes. These practices led to the products being deemed misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), and their introduction into interstate commerce constituted a prohibited act under section 301(a) of the FDCA. Kin Meds must provide a written response within fifteen working days, outlining corrective actions. This includes identifying product producers, submitting labeling samples, and modifying or removing all false or misleading website claims. Failure to comply may result in further legal action.

Company
Kin Meds
Inspection date
December 31, 2025
Product type
drugs
Office
Center for Drug Evaluation and Research
Person
  • Matthew J. Lash (Acting Director)
View Company Profile

ID · d85f96ff-931d-4aa9-9141-075d8c28fa69

Violation Codes10
FD&C Act 502(a)FD&C Act 502(b)21 U.S.C. 352(a)21 U.S.C. 352(bb)FD&C Act 301(a)21.U.S.C. 331(a)FD&C Act 301(c)21 U.S.C. 331(c)FD&C Act 503AFD&C Act 503B

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