FDA WARNING_LETTER - Amazon.com, Inc. - May 01, 2026

On June 17, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Amazon.com, Inc. following a review conducted in May 2026. The agency identified several products—specifically "Vajraang Phimosis Mini Combo," "Penile Heal Cream," and "Beilloso Balanitis Relief Cream"—that were sold on Amazon’s website and distributed through its "Fulfillment by Amazon" service. The core violation involves the sale of unapproved new drugs. According to the regulatory framework established by the Federal Food, Drug, and Cosmetic Act, these products are classified as drugs because their labeling claims they can treat or mitigate medical conditions such as phimosis and balanitis. However, these products have not been reviewed by the FDA for safety or effectiveness, nor do they meet the criteria for generally recognized safe over-the-counter use. Consequently, introducing these unauthorized treatments into the marketplace is a breach of federal law. Amazon is required to take immediate action to address these violations. This includes investigating the root causes of the oversight and implementing comprehensive corrective and preventative measures. The FDA requested a formal written response within 15 business days detailing the specific steps Amazon has taken to ensure sustained compliance and prevent recurrence. Failure to resolve these issues promptly may result in further legal consequences, including product seizures or court injunctions.