FDA told four online sellers their OTC 'herpes cures' are unapproved new drugs

On 1 October 2026, the FDA issued warning letters to four online sellers of over-the-counter sexual-health products after a July 2026 review of their websites and one Amazon storefront found products marketed for treating sexually transmitted infections. The agency's letters state plainly that it has approved no OTC drug to treat, cure or prevent any STI, and that people relying on such products may forgo real care, risking complications the letters list as infertility, sepsis and death — while a false sense of being treated can spread infection to partners.

The largest operation flagged was Terramed's 'HerpCare' line, which its own site called a proprietary line 'fully owned and commercially distributed by Terramed Just Think Comfort, specifically created to support individuals managing genital herpes (HSV-2)': a genital herpes intimate wash, an ointment, a spray and a genital wart remover, each promising relief from sores, itching and tingling. Two of the products were labelled homeopathic; FDA noted that homeopathic drugs fall under the same approval requirements as any other drug.

The other three letters hit the same pattern from different angles. Aidance Scientific's 'Terragen HG Formula' was sold through its site's 'Shop by Condition — Herpes' link straight to an Amazon storefront promising 'FAST RELIEF' for genital sores. Graceful Touch, a two-person South Dakota LLC, sold 'Herpes B Gone', a 'certified organic, plant-based cream' to soothe herpes sores. The Platinum Healthcare of Tennessee sold 'Sycosis' and 'Syphillinum', homeopathic 'oral antigens for desensitizing' the body against problems caused by the 'Gonorrhea miasm' and 'Syphilis miasm'.

Four public FDA warning letters declaring the products unapproved new drugs, with seizure and injunction threatened if the violations continue.

Each seller framed its products as treatment — 'outbreak support', 'soothe herpes sores' — which makes them unapproved new drugs however natural the positioning.

The homeopathic label was used as the compliance strategy; the letters answer that HPUS recognition exempts nothing from approval, adulteration or misbranding rules.

Platform distribution widened the reach: Aidance's product page was reachable through an Amazon storefront, putting an unapproved STI treatment inside a mainstream marketplace.

Small-print disclaimers ('not intended to diagnose, treat, cure or mitigate any disease') sat next to cure-flavoured headlines, and FDA read the overall impression, not the disclaimer.

A disclaimer and a homeopathic label do not turn a treatment claim into a cosmetic one: if the page sells relief from a disease, the FDA reads it as a drug.

Each company had fifteen business days to reply with corrective steps under its letter's reference number, and FDA posts warning letters publicly. The letters warn that failure to correct can bring regulatory or legal action without further notice, including seizure and injunction. No fines were assessed in the letters and no company responses are recorded in them.