FDA Tells Amazon Nine Herpes Products It Shipped Are Unapproved Drugs, Sets 15-Business-Day Deadline
The FDA bought the over-the-counter products on amazon.com in July and says Amazon's fulfillment service delivered them to consumers for third parties.
The FDA made public on Tuesday a warning letter it sent to Amazon CEO Andy Jassy on Thursday, Oct. 1, saying nine herpes-treatment products sold on amazon.com are unapproved new drugs under federal law. The agency says Amazon introduced them into interstate commerce through Fulfillment by Amazon.
What the letter says
A warning letter is the FDA's formal notice that it found violations and expects them fixed. It is not a fine, a recall or a sales ban. This one, reference number 736006, was sent five days before the agency posted it.
The FDA said it bought the products through amazon.com in July 2026 and reviewed their labeling. The nine are 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.
Amazon shipped each one directly to U.S. consumers on behalf of third parties, the letter says, through its Fulfillment by Amazon program.
The agency cited label claims as evidence the products are meant as drugs. FemiClear's label says "Fast-acting ointment for recurring outbreak symptoms" and "90% OF USERS REPORTED LESS SEVERE OUTBREAKS." The Genital Herpes Intimate Wash label promises "Antiviral Action."
The FDA also addressed homeopathic labeling. Terragen HG Formula is labeled homeopathic, but the letter says homeopathic drugs face the same legal requirements as other drugs. Five other products carry a homeopathic label but contain lemongrass, which the letter says is not listed as an active ingredient in the official homeopathic reference, so they fall outside the FDA's homeopathic enforcement guidance.
Why the FDA says it matters
The letter says no over-the-counter drug is approved to treat, cure, mitigate or prevent any sexually transmitted infection. It says people relying on such products may skip timely care, raising their risk of "infertility, sepsis, and death." It adds that a false sense of being treated may lead people to pass infections to partners.
For Herstat GST, the FDA said its sore-relief claims go beyond what the external analgesic monograph (the OTC rulebook) permits.
What Amazon has to do
The FDA asked for a written response within 15 business days of receipt, sent to FDAAdvisory@fda.hhs.gov with "736006" in the subject line. It wants the specific steps taken, how recurrence will be prevented and supporting documents.
The letter warns that failure to address the violations may bring "seizure and injunction." The material contains no Amazon reply.
Amazon closed at $251.40 on Monday, before the letter was public, and shares were up about 1% in Tuesday pre-market trading (market data).
Amazon's written reply, due within 15 business days of receipt, is the next document to look for.
Sources
- Warning letter — Amazon.com, Inc. (MARCS-CMS 736006) — U.S. Food and Drug Administration
