FDA Cites Roen Health, Inc. dba RoenRx in June 8, 2026 Warning Letter — False & Misleading Claims/Misbranded (Telehealth)

FDA Warning Letter — Violations FDA cited at Roen Health, Inc. dba RoenRx

WARNING LETTER Roen Health, Inc. dba RoenRx MARCS-CMS 728293 — 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: Recipient Name Kyle Robertson Recipient Title Founder & Chief Executive Officer Roen Health, Inc. dba RoenRx 30 Irving Pl New York , NY 10003 United States support@roenrx.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 8, 2026 WARNING LETTER Reference number: MARCS-CMS 728293 To Mr. Robertson: 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 RoenRx’s website, https://roenrx.com, FDA Establishment Identifier (FEI) 3044022969, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide products. 1 As described below, your website’s false or misleading claims concerning compounded semaglutide 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 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 products displayed on your website identify “RoenRx” on the pictured label, suggesting RoenRx is the compounder of those drugs when in fact it is not. 2 2. The following claims concerning compounded semaglutide products appear on your website: “Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….” “RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….” “Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.” 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