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The FDA sent Amazon a warning letter dated Oct. 1 over nine unapproved herpes-related products sold on its website. The agency says the products could delay appropriate care and create a false impression that users cannot transmit infection; Amazon was asked to describe corrective steps within 15 business days.
The U.S. Food and Drug Administration sent Amazon a warning letter over nine unapproved herpes-related products sold on the retailer’s website, saying the products could pose a public health risk by delaying medical care or giving users a false sense that they cannot transmit infection. The letter, dated Oct. 1, asks Amazon CEO Andy Jassy to provide a written account of corrective and preventive steps within 15 business days.
The FDA said it bought several herpes products listed on Amazon in July and found multiple violations. The agency classified the products as unapproved new drugs. Its warning letter names 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.
Some of the products are marketed as homeopathic. The FDA said that label does not exempt them from drug approval requirements. The agency also noted that many contain lemongrass, which it said is not listed as an active ingredient in the Homeopathic Pharmacopeia of the United States; on that basis, those products do not meet the FDA’s definition of a homeopathic drug product.
The FDA said it has not approved any over-the-counter treatment for a sexually transmitted infection. Its letter warns that people who rely on the products might delay appropriate medical care, potentially increasing the risk of serious complications. It also says a mistaken belief that treatment has made a person noninfectious could lead to transmission to sexual partners. Those are the agency’s stated concerns; the supplied report does not identify specific patient harms linked to the listed products.
Risks of Unapproved Herpes Products
The warning matters because shoppers may interpret a product’s availability on a major retail platform as a sign that it has been reviewed or approved for the medical claims made about it. FDA approval status is distinct from online availability: the agency says these products are unapproved drugs, and it has not approved nonprescription treatments for sexually transmitted infections.
The concern is not limited to whether a product provides relief. According to the FDA, relying on an unapproved treatment could cause someone to put off medical care or mistakenly believe they cannot pass an infection to another person. That could affect both the person using the product and their partners. Jeffrey Klausner, founder and president of Herpes Cure Advocacy, told MedPage Today that consumers may assume products listed by a major retailer are legitimate. His comments are an outside expert’s assessment, not a finding in the FDA letter.
The agency’s action also puts attention on how online marketplaces handle health products and claims. For consumers, the central takeaway is that the products named in the letter have not been approved by the FDA as herpes treatments. The warning does not, by itself, establish that every listed product caused injury or that every product listing remains available.
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FDA Review and Amazon’s Prior Letters
The FDA’s Center for Drug Evaluation and Research sent the letter to Amazon CEO Andy Jassy on Oct. 1. The agency said it purchased several of the products in July, before identifying what it described as violations of federal drug requirements. The source report does not specify the date the FDA completed its review or whether Amazon had already taken any action before the letter was sent.
This is not the first FDA warning letter to Amazon described in the report. In 2024, the agency warned the company about chemical peel products it said were too concentrated for safe home use without medical supervision. In 2023, Amazon received a warning letter about energy-enhancing supplements that FDA testing found contained undeclared erectile dysfunction drugs. Those earlier matters involved different product categories and do not establish what Amazon will do in response to the current letter.
MedPage Today also quoted Scott Furness of the Consumer Healthcare Products Association, who said the group supports enforcement of regulatory standards for nonprescription medicines. The association’s statement reflects its position on oversight and does not speak for Amazon or the FDA’s findings about the products in this case.
“a serious public health concern”
— FDA warning letter
Amazon’s Response and Product Status
The supplied report does not say whether Amazon has responded to the FDA, removed any of the named listings, or suspended sales. It also does not provide Amazon’s position on the agency’s findings. The warning letter requests a response, but the available information does not establish what corrective action, if any, the company has already taken.
The FDA’s letter raises potential risks but does not, in the supplied account, document specific injuries, transmission events or other outcomes tied to the products. The number of products the agency purchased is also not given, and the report does not detail the evidence for each individual product. It is therefore unclear whether the agency’s findings apply in the same way to all nine named items or what further enforcement steps it may take.
The source account says Amazon must respond within 15 business days, but does not state how the agency will assess the response or whether the FDA will publish further findings. The current status of the listings and any future regulatory action remain unconfirmed.
Amazon’s 15-Day FDA Deadline
Amazon has been asked to send the FDA a written response within 15 business days, describing the corrective and preventive steps it has taken. The letter is addressed to CEO Andy Jassy. The supplied report does not state the exact calendar deadline, so it should not be inferred without knowing how the FDA counts the response period.
The next confirmed development would be Amazon’s response or a further update from the agency. The FDA may review the company’s account of its actions, but the report does not specify what follow-up the agency plans or whether additional enforcement is expected. Until more information is available, it remains unclear whether the listed products have been removed or what changes Amazon will make to its marketplace practices.
Key Questions
Which products did the FDA name?
The letter names nine products: 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.
What does the FDA say is wrong with the products?
The agency classified them as unapproved new drugs and said that marketing products as homeopathic does not exempt them from drug approval requirements. It also said many contain lemongrass, which is not listed as an active ingredient in the Homeopathic Pharmacopeia of the United States.
Has the FDA approved over-the-counter herpes treatments?
According to the warning letter as reported by MedPage Today, the FDA has approved no over-the-counter treatments for sexually transmitted infections. The article does not describe specific prescription treatment options.
What must Amazon do now?
The FDA requested a written response within 15 business days, detailing corrective and preventive steps. The supplied report does not say whether Amazon has replied or whether the products are still listed.
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