FDA Warned Amazon and Walmart Over Herpes Products

The FDA issued warning letters regarding the sale of unapproved products marketed for the treatment of herpes.

Updated on Oct. 14, 2026 in Sexual Health

Bold flat-color editorial illustration of medical vials and lab containers, representing federal regulatory oversight of healthcare products.
The FDA issued warning letters to Amazon and Walmart for the online sale of unapproved products marketed as treatments for genital herpes. AI Illustration. Upload story photo >

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The FDA has sent warning letters to Amazon and Walmart for selling unapproved products that claim to treat or cure genital herpes. Federal regulators found these items were sold and distributed through the retailers' own fulfillment programs.

Why it matters

The FDA warns that using these unapproved products can cause patients to delay necessary professional medical care. Such delays in treatment for sexually transmitted infections increase the risk of serious health complications, including infertility, sepsis, and death.

The FDA identified nine unapproved products sold on Amazon and three sold on Walmart. There are currently no over-the-counter products approved by the agency to treat, cure, or prevent sexually transmitted infections.

The players

Food and Drug Administration

The agency is the federal body responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs.

Amazon

This multinational technology company operates one of the largest online retail marketplaces in the world.

Walmart

This retail corporation operates a chain of hypermarkets, discount department stores, and grocery stores across the United States.

The details

Agency staff purchased the items in July 2026 and confirmed they were processed through the retailers' fulfillment programs. The FDA states that the products were marketed with claims to fight viruses, soothe sores, and manage outbreaks.

Timeline

  1. 572,000 new genital herpes infections occurred in the U.S. in 2018.

  2. FDA staff purchased the products from the websites in July 2026.

  3. The FDA issued official warning letters to the companies on October 1, 2026.

  4. Companies have a deadline of 15 business days from October 1, 2026, to respond.

Health Landscape

The FDA's action reflects its ongoing enforcement mandate under the Federal Food, Drug, and Cosmetic Act regarding the distribution of unapproved medical products. This intervention aims to protect public safety as the agency attempts to limit the online availability of unverified health treatments.

Consumers should be aware that no over-the-counter products are FDA-approved to treat, cure, or prevent sexually transmitted infections like herpes. Relying on these items instead of seeking professional medical care can lead to dangerous health outcomes.

The takeaway

Patients should consult a licensed healthcare provider for any diagnosis or treatment related to sexually transmitted infections. Avoid purchasing medical products from online retailers that make unsubstantiated claims about curing or preventing infections.

What happens next

The retailers have 15 business days from October 1, 2026, to submit a plan for corrective actions to the FDA.

Further reading

For more information on the risks associated with unproven treatments, visit the Sexual Health section.

Source note: This article includes information reported by Healthday.

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