FDA Warns Amazon Over Unapproved STI Treatment Listings

The US Food and Drug Administration has issued Amazon a warning letter concerning nine products sold through its marketplace with claims related to sexually transmitted infections or their symptoms. The FDA letter is dated 1 October 2026 and received renewed public attention on 17 October.

The regulator said it purchased the products through Amazon in July and concluded that they were unapproved new drugs. According to the FDA, all nine were fulfilled by Amazon on behalf of third-party sellers. The agency stated that no over-the-counter drug is FDA-approved to treat, cure, mitigate or prevent an STI.

The letter asks Amazon to address the cited violations and warns that inadequate action could lead to regulatory or legal steps. A warning letter records the agency’s position and gives the recipient an opportunity to respond; it is not a final court judgment. Consumers with possible STI symptoms should seek diagnosis and care from a licensed healthcare professional. Source: US Food and Drug Administration.