The FDA has sent Amazon a warning letter about unapproved herpes treatments sold on its platform. After purchasing several of the products in July, the agency found they are unapproved new drugs and called the situation a serious public health concern. The letter, dated Oct. 1, is addressed to Amazon CEO Andy Jassy.
People relying on these products may forgo timely medical care, the FDA said, raising the risk of severe complications such as infertility, sepsis, and death. A false sense of being adequately treated could also lead individuals to unknowingly transmit herpes to partners. The listed products include FemiClear, Hclear for him, HerpCare Ointment and Spray, Herstat GST, Genital Herpes Ointment, RoyceDerm Herpes Relief Cream, Terragen HG Formula, and Genital Herpes Intimate Wash. Some are labeled homeopathic, but the FDA says they do not meet the definition of a homeopathic drug product, partly because lemongrass is not listed as an active ingredient in the Homeopathic Pharmacopeia of the United States.
Jeffrey Klausner of Herpes Cure Advocacy called the products "quack medicines" and noted that shoppers often assume items sold by major retailers are legitimate. He said people losing health insurance may turn to Amazon for health needs, and unscrupulous vendors put up products that don't work. The FDA has not approved any over-the-counter treatments for any sexually transmitted infection.
This is not Amazon's first FDA warning. In 2024, the agency warned about chemical peel products; in 2023, about energy supplements containing undeclared erectile dysfunction drugs. The warning letter requests a written response within 15 business days. Scott Furness of the Consumer Healthcare Products Association said the group supports strong enforcement of standards to protect consumers.