Forty-Five Years After Acyclovir, the FDA's Herpes Headline Is a Warning Letter to Amazon

Herpes simplex has a trick that no drug since 1981 has managed to beat. After the first infection the virus withdraws into nerve cells, where, as the World Health Organization puts it, it alternates between inactive and active phases for the rest of its host’s life. Acyclovir, which Burroughs Wellcome scientists including Gertrude Elion developed in the 1970s and which was approved for medical use in 1981, works by jamming the virus while it is busy copying itself. Its successors, valacyclovir and famciclovir, work the same way. They shorten outbreaks and make them less frequent, but none of them can reach the dormant copies sitting in the nerves. That is why the WHO still calls herpes treatable but not curable, and why, forty-five years into the acyclovir era, the NIH acknowledges there is no cure and no licensed preventive vaccine.

That is the backdrop to the letter the FDA sent Amazon CEO Andy Jassy on October 1, 2026. Agency staff had bought products on amazon.com in July and concluded that a lineup of herpes ointments, sprays and washes were unapproved new drugs. The list included FemiClear, HClear for him, HerpCare Ointment and HerpCare Spray, Herstat GST, RoyceDerm Herpes Relief Cream, Terragen HG Formula, a Genital Herpes Ointment and a Genital Herpes Intimate Wash. Most of the labels promise comfort, such as “FAST-ACTING GENITAL HERPES SYMPTOM RELIEF” or “relief of swelling and pain associated with genital sores.” A few go further: RoyceDerm says it “FIGHTS OUTBREAKS” and “REDUCES RECURRENCE,” and the intimate wash advertises “Antiviral Action” that will “reduce viral activity.” Several were sold as homeopathic, which does not exempt them from federal regulation.

On the narrow question, the agency is right. The FDA “has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI,” the FDA warning letter to Amazon.com, Inc. notes. A wash that claims antiviral action is making a drug claim without having done a drug’s homework, and no homeopathic ointment will follow the virus into nerve tissue where prescription antivirals can’t. The people pushing hardest for a cure agree. “The public should not be subject to these quack medicines,” Jeffrey Klausner, founder and president of the nonprofit Herpes Cure Advocacy, told MedPage Today.

The rest of the letter is less convincing. People who rely on unapproved STI products “may forgo timely, appropriate medical care,” the FDA warns, “increasing their risk of severe complications such as infertility, sepsis, and death.” That warning is written for sexually transmitted infections as a class. Here it is applied to symptom-relief creams for a viral infection that the agency’s own approved drugs can’t clear either. A patient who chooses a homeopathic ointment over a doctor gives up a prescription that shortens outbreaks, and that loss deserves a warning. The patient is not giving up a cure, because no cure exists.

The prescription drugs do earn their place, and the strongest evidence for them is two decades old. In a New England Journal of Medicine trial of nearly 1,500 couples published in 2004, partners of people taking daily valacyclovir were half as likely to catch HSV-2: 14 became infected, compared with 27 in the placebo group, over eight months. Halving transmission is a useful public-health tool. Twenty-two years later it is still about the best the system can offer, because suppression remains the only option.

Washington’s attention to curing herpes has been far thinner than the letter’s alarm suggests. When HHS drew up its 2021 to 2025 STI National Strategic Plan, it built the plan around chlamydia, gonorrhea, syphilis and HPV, the nationally notifiable infections that have federally funded control programs. Herpes is not notifiable and has no national surveillance system, so it was left out. Congress had to direct HHS in fiscal year 2022 to update the plan to cover HSV prevention and treatment, and the department responded with an addendum. The NIH published its Strategic Plan for Herpes Simplex Virus Research in 2023, covering 2023 to 2028; its third priority calls for identifying routes toward eliminating HSV or achieving a functional cure. The scale of the problem is not new. The WHO estimates that about 520 million people aged 15 to 49 carry HSV-2, the strain behind most genital herpes, and that roughly 376 million more have genital HSV-1 infections.

Without a cure, some patients have gambled on alternatives, and the clearest example went badly. In 2013 William Halford, a Southern Illinois University microbiologist who was not a physician, injected at least eight herpes patients with a live, weakened strain of his own making at a Holiday Inn Express and a Crowne Plaza near his lab. According to KFF Health News, he did so without obtaining the written informed consent federal law requires. From April to August 2016 he ran a trial on St. Kitts and Nevis in which 20 Americans and Britons received his experimental vaccine with no institutional review board involved. The FDA did not monitor it and said it lacks jurisdiction over offshore trials that never seek its approval. A company owned by Peter Thiel put millions of dollars into the research after the trial ended. After the reporting, SIU’s review board found “serious noncompliance with regulatory requirements and institutional policies and procedures.” Halford had already died of cancer in June 2017. “We may never know if this vaccine worked, didn’t work or, even worse, harmed anyone,” said Jonathan Zenilman, an STD expert at Johns Hopkins Bayview Medical Center.

The volunteers who flew to the Caribbean were people who had been told for decades to manage the virus and get on with life, and they decided a gamble was better. The Amazon creams sell to the same frustration at the bottom of the price range. Shutting down that end of the market is easy, and the FDA did it quickly: the letter went out less than three months after the July purchases.

The harder deadline is further off. The 2021 to 2025 STI plan’s term has run out, and HHS has said future versions will include HSV from the start instead of adding it by addendum, so the next plan will show whether herpes counts as a priority without Congress having to demand it. The NIH plan ends in 2028. By then, NIAID will either be funding a candidate that can reach the virus inside the nerves, or the government’s record on herpes this decade will consist mostly of warning letters.

Sources

1. FDA warning letter to Amazon.com, Inc.
2. PhillyVoice: FDA warns Amazon over unapproved genital herpes treatments
3. MedPage Today: What We Heard This Week
4. HHS: STI National Strategic Plan, HSV Addendum
5. NIH Strategic Plan for Herpes Simplex Virus Research
6. WHO: Herpes simplex virus fact sheet
7. Fred Hutchinson Cancer Center: 2004 valacyclovir transmission trial
8. KFF Health News: A desperate quest for a herpes cure launched a rogue trial
9. KFF Health News: Years before heading offshore, herpes researcher experimented on people in U.S.
10. Wikipedia: Aciclovir