FDA Warning Letter to Nexlife Inc. dba Nexlife (June 8, 2026) — False & Misleading Claims/Misbranded (Telehealth)

FDA Warning Letter — Violations FDA cited at Nexlife Inc. dba Nexlife

WARNING LETTER Nexlife Inc. dba Nexlife MARCS-CMS 730096 — 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: Nexlife Inc. dba Nexlife 260 Newport Center Dr. Newport Beach , CA 92660 United States hello@nexlife.us Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 8, 2026 WARNING LETTER Reference number: MARCS-CMS 730096 To Nexlife: 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 Nexlife’s website, https://nexlife.us, FDA Establishment Identifier (FEI) 3044820290, 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 “Nexlife” on the pictured label, suggesting Nexlife is the compounder of those drugs when in fact it is not. 2 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 violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)]. You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. It is your responsibility to ensure that your operations comply with all requirements o