The FDA has flagged patient safety risks tied to nine products sold through Amazon that the agency said are unapproved new drugs marketed to treat sexually transmitted infections or their symptoms.
The agency identified the violations after reviewing labeling for products it purchased from Amazon in July 2026, according to an Oct. 1 warning letter. The FDA said the products were introduced or delivered for introduction into interstate commerce by Amazon through its Fulfillment by Amazon service.
The FDA said no OTC drug product has been approved for the treatment, cure, mitigation or prevention of any STI. The agency said effective treatment requires diagnosis and supervision by a licensed healthcare professional.
Patients who rely on the unapproved products may forgo timely medical care, increasing their risk of complications including infertility, sepsis and death, the FDA warned. The agency also said patients who believe they have been adequately treated could unknowingly transmit infections to their partners.
Amazon was directed to respond within 15 business days of receiving the letter with steps taken to correct the violations and prevent their recurrence.
