June 8, 2026 FDA Warning Letter: FITISH Cited for False & Misleading Claims/Misbranded (Telehealth)

FDA Warning Letter — Violations FDA cited at FITISH

WARNING LETTER FITISH MARCS-CMS 728280 — June 08, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: FITISH 2316 Gravel Drive Fort Worth , TX 76118 United States info@fitish.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 8, 2026 WARNING LETTER Reference number: MARCS-CMS 728280 To FITISH: This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. FDA Review Violations were identified and documented during a review of FITISH’s website, https://fitish.com, FDA Establishment Identifier (FEI) 3044018836, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular. More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “FITISH” on the pictured label, suggesting FITISH is the compounder of those drugs when in fact it is not. 2 2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website: “Semaglutide is the active ingredient in ozempic” [sic] “Tirzepatide is the active ingredient in Mounjaro® and Zepbound®” Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a vio