FDA Warned Amazon, Walmart Over Unapproved Herpes Drugs
The agency identified unapproved treatments for sexually transmitted infections being sold online.
Updated on Oct. 14, 2026 in Sexual Health
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The FDA issued warning letters to Amazon and Walmart on October 1, 2026, after discovering unapproved herpes products for sale on their platforms. The agency is demanding that the retailers propose corrective actions within 15 business days to address the violations.
Why it matters
The agency cautions that relying on unapproved treatments can delay necessary professional medical care. Because there are no over-the-counter products approved to treat or cure sexually transmitted infections, delayed care poses serious health risks, including potential sepsis or infertility.
In an official enforcement action, the FDA identified nine unapproved products on Amazon and three on Walmart during investigative purchases conducted in July 2026. The agency has stated that no over-the-counter drug is currently approved to treat, cure, or prevent sexually transmitted infections.
The players
Food and Drug Administration
The federal public health agency responsible for regulating drugs, medical devices, and the safety of the U.S. food supply.
Amazon
A global e-commerce corporation that stores and ships third-party and retail products through its fulfillment programs.
Walmart
A multinational retail corporation that operates an online marketplace and manages its own product distribution and fulfillment.
The details
The FDA identified these products after agency staff purchased them from the retailers' websites in July 2026. These items were marketed with claims to soothe sores, fight viruses, and manage outbreaks. Because these products are categorized as unapproved drugs, they cannot legally be shipped across state lines, prompting the FDA to demand that Amazon and Walmart detail their plans for compliance.
Timeline
572,000 new genital herpes infections occurred in the U.S. during 2018.
FDA staff purchased the products from online retailers in July 2026.
The FDA issued official warning letters to both companies on October 1, 2026.
Retailers must report their corrective actions within 15 business days of October 1, 2026.
Health Landscape
This enforcement action highlights the ongoing regulatory challenge of preventing the sale of unapproved health products via major online marketplaces. It underscores the FDA's mandate under the Federal Food, Drug, and Cosmetic Act to protect consumers from products that lack proven efficacy.
If you are managing a sexually transmitted infection, avoid purchasing unapproved treatments online, as these products have not been vetted for safety or efficacy. Always speak with your doctor to determine a safe and proven treatment plan that aligns with clinical standards.
The takeaway
No over-the-counter product is authorized to treat or cure genital herpes, and relying on such products may jeopardize your health. If you are experiencing symptoms, prioritize a conversation with your healthcare provider to discuss evidence-based treatment options.
Further reading
For more on navigating effective care, visit our Sexual Health section.
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