Amazon.com, Inc. – FDA Warning Letter, Oct 1, 2026

On October 1, 2026, the FDA issued a warning letter to Amazon.com, Inc. and its CEO, Andy Jassy, regarding the sale of unapproved drug products on its website. Following a review in July 2026, the FDA identified several products, including FemiClear, HClear for him, HerpCare, Herstat GST, and Terragen HG Formula, which were marketed as treatments or symptom relief for genital herpes and other sexually transmitted infections (STIs). The agency determined these products are unapproved new drugs introduced into interstate commerce via the Fulfillment by Amazon service.

The FDA emphasized that these products pose a significant public health risk. Because no over-the-counter drugs are approved to treat STIs, consumers using these products may delay essential medical diagnosis and treatment, potentially leading to severe complications such as infertility or sepsis, and increasing the risk of spreading infections. These activities violate sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act, as the products are not generally recognized as safe and effective for their labeled uses.

Amazon is required to respond in writing within 15 business days, detailing the specific steps taken to correct these violations and the measures implemented to prevent their recurrence. The company must provide documentation supporting its corrective actions. Failure to address these concerns may result in legal or regulatory action, including product seizures or injunctions.