FDA Issues Warning to Amazon Over Unapproved Herpes Treatments

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved treatments for herpes.

In July, FDA investigators purchased several herpes‑related products listed on Amazon’s website and identified multiple regulatory violations, including that the items qualify as unapproved new drugs.

The agency warned that reliance on such products poses a serious public‑health risk because users may delay appropriate medical care, increasing the likelihood of severe complications such as infertility, sepsis, and death.

Moreover, a false sense of being adequately treated could cause individuals to unknowingly transmit the infection to partners.

The unapproved items include 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.

Although several of these products are marketed as homeopathic, the FDA notes they remain drugs and are not exempt from approval requirements. Additionally, many contain lemongrass, which is not listed as an active ingredient in the Homeopathic Pharmacopeia of the United States (HPUS), meaning the products do not meet the agency’s definition of a legitimate homeopathic drug.

The FDA has not approved any over‑the‑counter treatments for sexually transmitted infections.

“The public should not be subject to these quack medicines,” Jeffrey Klausner, M.D., M.P.H., founder and president of the non‑profit Herpes Cure Advocacy, told MedPage Today.

Dr. Klausner noted that consumers often assume that products sold by major retailers are legitimate. As more individuals lose health‑insurance coverage, they are increasingly turning to online marketplaces like Amazon for their health‑care needs.

He warned that “there are a lot of unscrupulous vendors out there that put up products that don’t work.” This problem is common with infectious‑disease and sexually transmitted‑infection products. Herpes is one of the most common lifelong infections, affecting millions of Americans who seek treatment. When unapproved products are on the market, patients waste money and may unknowingly spread the virus because they believe they are no longer contagious.

This is not the first FDA warning letter Amazon has received in recent years. In 2024, the agency warned the retailer about overly concentrated chemical‑peel products that were unsafe for home use without medical supervision. In 2023, another warning addressed energy‑enhancing supplements that contained undeclared erectile‑dysfunction drugs after FDA testing.

Scott Furness, Ph.D., of the Consumer Healthcare Products Association, told MedPage Today, “FDA oversight and compliance with applicable regulatory requirements are essential to ensuring that nonprescription medicines are safe, effective, high‑quality, and appropriately labeled.” He added that the association “supports strong enforcement of these standards to protect consumers and maintain confidence in the products they rely on to manage their health.”

The warning letter, issued by the FDA’s Center for Drug Evaluation and Research on Oct. 1, is addressed to Amazon CEO Andy Jassy. Amazon is required to provide a written response within 15 business days describing the corrective and preventive actions it has taken.

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