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The FDA sent Amazon a warning letter dated Oct. 1 over nine herpes-related products it said were unapproved drugs. The agency asked Amazon CEO Andy Jassy to respond within 15 business days with corrective and preventive steps; the letter says the products could lead customers to delay care or mistakenly believe they cannot transmit infection.
The U.S. Food and Drug Administration sent Amazon a warning letter over the sale of nine herpes-related products that it said are unapproved drugs, citing potential risks to customers who might delay appropriate care. Dated Oct. 1, the letter asks Amazon CEO Andy Jassy to provide a written response within 15 business days describing corrective and preventive steps.
The FDA said it bought several herpes products listed on Amazon in July and found multiple violations. The agency identified the products as unapproved new drugs. The named listings 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.
Some products were labeled as homeopathic, but 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 Pharmacopoeia of the United States. On that basis, those products do not meet the agency’s definition of a homeopathic drug product, according to the letter.
The FDA said it has approved no over-the-counter treatments for sexually transmitted infections. It warned that people relying on unapproved products could forgo timely medical care, with possible severe complications, and might mistakenly believe they have been adequately treated and transmit an infection to partners. These are risks described by the agency; the source report does not establish that any particular customer suffered harm from the products.
Risks of Delayed Herpes Care
The warning addresses both treatment decisions and infection transmission. The FDA’s concern is that product claims or a customer’s interpretation of them could create false confidence, delay appropriate care or lead someone to believe they are no longer infectious. The letter lists potential severe complications, including infertility, sepsis and death, as risks associated with foregoing timely care—not as outcomes shown to have occurred among buyers of these products.
The issue also concerns the credibility customers may assign to products sold through a major online retailer. Jeffrey Klausner, founder and president of the nonprofit Herpes Cure Advocacy, told MedPage Today that shoppers may assume a product is legitimate because it appears at a large retailer. That observation is his assessment, not a finding in the FDA letter. For customers, the central practical distinction is that an online listing does not itself establish FDA approval or prove a product can treat herpes.
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Earlier FDA Letters to Amazon
The Oct. 1 letter follows two other FDA warning letters to Amazon described in the MedPage Today report. In 2024, the agency warned the retailer about chemical peel products it said were too concentrated for safe home use without medical supervision. In 2023, it warned Amazon about energy-enhancing supplements after FDA testing found undeclared erectile dysfunction drugs, according to the report.
The current action concerns product approval and labeling for herpes-related listings. The FDA’s Center for Drug Evaluation and Research sent the letter directly to Amazon CEO Andy Jassy. The requested response gives the company an opportunity to describe its actions; the supplied report does not say whether Amazon has replied or removed the products.
“a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners”
— FDA warning letter
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Amazon’s Response Remains Pending
The available report does not state whether Amazon has responded to the FDA, removed the listings, or changed how it reviews similar products. It also does not provide the full warning letter’s product-by-product findings or explain what specific corrective measures the agency would consider adequate. The FDA’s concerns describe potential risks; the report does not identify confirmed injuries or transmission cases linked to these listings.
The report names nine products but does not detail how many units were sold, how long each listing was available, or whether every named product was among those the FDA purchased in July. Those details remain unclear from the available material.
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Amazon Must Detail Corrective Steps
Amazon has been asked to send the FDA a written response within 15 business days of the letter, outlining corrective and preventive actions. The next reported development is whether the company responds and what steps it says it has taken. The source material does not specify further deadlines or describe any additional FDA enforcement action already planned.
The FDA’s warning and response request do not, on their own, establish that Amazon has complied or that the listings have been taken down. Customers concerned about herpes or another sexually transmitted infection should seek guidance from a qualified health professional rather than rely on an unapproved product’s claims.
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Key Questions
What did the FDA warn Amazon about?
The FDA said Amazon sold nine herpes-related products that the agency considers unapproved drugs. It cited potential risks if customers rely on them instead of seeking appropriate care.
Which products did the agency name?
The warning named 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.
Does a homeopathic label exempt a product from FDA drug requirements?
No. The FDA said products labeled homeopathic are still considered drugs and are not exempt from approval requirements. It also said many of the named products contain lemongrass, which is not listed as an active ingredient in the Homeopathic Pharmacopoeia of the United States.
What must Amazon do next?
The warning letter asks Amazon CEO Andy Jassy to provide a written response within 15 business days describing corrective and preventive steps. The supplied report does not say whether Amazon has responded.
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