The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Amazon.com Inc., alleging the online retail giant distributed unapproved drug products through its Fulfillment by Amazon (FBA) service.
The enforcement action, dated June 17, identifies three products—Vajraang Phimosis Mini Combo, Penile Heal Cream, and Beilloso Balanitis Relief Cream—that were allegedly promoted with claims to treat medical conditions despite lacking approved new drug applications.
According to the FDA’s Center for Drug Evaluation and Research (CDER), agency investigators purchased the products directly from Amazon in May 2026 and determined they met the legal definition of “new drugs” because they were marketed to treat conditions such as phimosis and balanitis. The FDA says the products are not generally recognised as safe and effective for those intended uses and therefore cannot be legally sold in the United States without prior approval.
The warning also highlights wider concerns about the role of online marketplaces in the distribution of health products. It raises questions over the extent to which e-commerce platforms should be held accountable for third-party products they store, ship and fulfil, and whether existing safeguards are sufficient to prevent consumers from accessing unapproved medicines.
Amazon has been given 15 business days to outline the corrective measures it intends to take or provide evidence challenging the FDA’s findings.
