October 08, 2026
Alison Young/USA Today Network via Reuters Connect
The FDA has not approved any over-the-counter treatments for herpes and warned Amazon that treatments it is selling pose a 'serious public health concern.'
The Food and Drug Administration has warned Amazon that certain unapproved herpes treatments it is selling pose a "serious public health concern."
In an Oct. 1 letter to CEO Andy Jassy, the FDA states that it has not approved "any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI." Genital herpes is among the most common sexually transmitted infections, impacting 1 in 6 Americans ages 14 to 49.
"Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death," the letter says. "Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners."
The FDA purchased products on Amazon in July and determined that 10 were "unapproved new drugs" being sold in violation of federal laws. The products the FDA listed 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.
Herpes is caused by the herpes simplex virus, and transmitted through skin-to-skin contact or contact with bodily fluids. It can lead to oral herpes, which may cause cold sores on the mouth or face. Genital herpes can cause bumps and blisters on the genitals, buttocks and anus.
Worldwide, 3.8 billion people under 50 have oral herpes, and 520 million people ages 15-49 have genital herpes, according to the World Health Organization.
Although herpes can be asymptomatic, it can recur in repeated outbreaks and may lead to serious eye infections. It can also impact the spinal cord, brain and other organs.
Some of the products cited in the FDA warning letter were being sold as homeopathic products, which are still subject to federal regulation.
"The public should not be subject to these quack medicines," Dr. Jeffrey Klausner, founder and president of the nonprofit Herpes Cure Advocacy, told MedPage Today.
The FDA told Amazon that it was responsible for investigating what caused the violations and "implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur."
Amazon did not immediately respond to a request for comment.
Herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) each can cause oral and genital herpes, the Cleveland Clinic says. HSV-1 is more commonly associated with oral herpes and HSV-2 with genital herpes.
Symptoms range from blisters on the face, genitals or anywhere on the skin; discolored skin around the fingernail and finger swelling; eye irritation and pain; sensitivity to light; headache; fever and seizures.
Herpes is diagnosed through physical exams, blood tests and sometimes spinal taps.
Once infected, a person has herpes for life. Stress and other factors can cause recurrent outbreaks.
Prescription antiviral medications, taken either short or long term, are used to treat herpes. There are no approved over-the-counter medications.
