FDA Warns Amazon Over Herpes Treatments

The FDA hit Amazon with a warning letter for selling unapproved herpes treatments.

In July, the agency purchased several of the herpes products available on Amazon’s website and found numerous violations, including that these products are considered unapproved new drugs, the agency said in the warning letter.

This poses “a serious public health concern,” the agency wrote, since people relying on these products “may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death.”

Moreover, “a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners,” the letter stated.

The unapproved products 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.”

Several of these products are listed as homeopathic, but FDA noted that they are still considered drugs and aren’t exempt from agency drug approval requirements. Plus, many include lemongrass, which is not listed as an active ingredient in Homeopathic Pharmacopeia of the United States (HPUS), and therefore the products do not meet FDA’s definition of a homeopathic drug product.

FDA noted that it hasn’t approved any over-the-counter treatments for any sexually transmitted infection.

“The public should not be subject to these quack medicines,” Jeffrey Klausner, MD, MPH, founder and president of the non-profit Herpes Cure Advocacy, told MedPage Today.

Klausner noted that when people see products at major retailers, they assume they’re legitimate. As more people lose health insurance, patients are motivated to turn to retailers like Amazon for their health needs.

“There’s a lot of unscrupulous vendors out there that put up products that don’t work,” he said, adding that this is a common issue with infectious disease and sexually transmitted infections. Herpes is one of the most common lifelong infections, with millions of Americans seeking treatment. With these unapproved products on the market, patients waste their money and may spread herpes because they think they’re becoming noninfectious, he noted.

This isn’t the first time Amazon has been hit with an FDA warning letter in recent years. In 2024, FDA warned the retailer about potent chemical peel products that the agency said were too concentrated to be used safely at home without medical supervision. In 2023, it received another warning letter about energy-enhancing supplements after FDA testing revealed the products contained undeclared erectile dysfunction drugs.

“FDA oversight and compliance with applicable regulatory requirements are essential to ensuring that nonprescription medicines are safe, effective, high-quality, and appropriately labeled,” Scott Furness, PhD, of the Consumer Healthcare Products Association, told MedPage Today. He said that the organization “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, sent by FDA’s Center for Drug Evaluation and Research on Oct. 1, is addressed to Amazon’s CEO Andy Jassy and requests a written response within 15 business days detailing the corrective and preventive steps Amazon has taken.