Amazon.com, Inc.

On October 1, 2026, FDA's Center for Drug Evaluation and Research issued Warning Letter Reference No. 736006 to Amazon.com, Inc., addressed to CEO Andy Jassy, concerning nine drug products purchased through www.amazon.com and fulfilled via Amazon's Fulfillment by Amazon (FBA) service in July 2026. The products at issue are: "FemiClear," "HClear for him," "HerpCare Ointment," "HerpCare Spray," "Herstat GST," "Genital Herpes Ointment," "RoyceDerm Herpes Relief Cream," "Terragen HG Formula," and "Genital Herpes Intimate Wash." FDA purchased each product directly through Amazon's website and documented violations based on review of product labeling. FDA determined that each product is a "drug" under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 321(g)(1), because labeling claims establish intended use for the diagnosis, cure, mitigation, treatment, or prevention of disease. Cited label claims include, among others: "Genital Herpes Symptoms," "Fast-acting ointment for recurring outbreak symptoms," "FIGHTS OUTBREAKS," "REDUCES RECURRENCE," "Antiviral Action . . . reduce viral activity," "relief of swelling and pain associated with genital sores," and "Genital Sore Treatment." None of the nine products holds an approved new drug application under section 505 of the FD&C Act, 21 U.S.C. § 355, and none is generally recognized as safe and effective (GRASE) for the claimed uses. FDA charged that introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. §§ 331(d) and 355(a). The letter specifically notes that Amazon distributed each product directly to individual U.S. consumers on behalf of third-party sellers through the FBA program, under which Amazon picks, packs, ships, and handles customer service and returns. With respect to "Herstat GST," FDA further stated that the product's indications for genital sores exceed the permissible indications under OTC Monograph M017 (External Analgesic Drug Products for OTC Human Use), foreclosing any pathway to lawful marketing under section 505G of the FD&C Act without an approved application. Several products are labeled as homeopathic. FDA stated that homeopathic drug products are subject to the same statutory requirements as other drugs and that no exemption from approval, adulteration, or misbranding requirements exists under the FD&C Act for such products. FDA further noted that "FemiClear," "HClear for him," "HerpCare Ointment," "HerpCare Spray," and "Genital Herpes Ointment" do not meet FDA's own definition of a homeopathic drug product because they contain lemongrass, which is not listed as an active ingredient in the Homeopathic Pharmacopeia of the United States. The letter stated that even if these products qualified as homeopathic, they would fall within the category FDA has identified as posing higher risks to public health and subject to prioritized enforcement under FDA's December 2022 homeopathic drug guidance. FDA warned that failure to adequately address violations may result in seizure and injunction without further notice, and required a written response within 15 business days.