Amazon is getting heat from federal regulators over a set of eyebrow-raising health products in its virtual aisles. The Food and Drug Administration has issued a warning letter to the e-commerce giant after finding that the site was offering unapproved topical creams marketed to treat penile conditions. FDA investigators bought three such products on Amazon in May and concluded that the way they were labeled crossed into disease-treatment claims that require formal FDA approval. The letter, addressed to Amazon’s CEO, gives the company a short window to spell out how it plans to keep similar items from popping up again.
In a warning letter dated June 17, 2026, the U.S. Food and Drug Administration said it purchased "Vajraang Phimosis Mini Combo," "Penile Heal Cream" and "Beilloso Balanitis Relief Cream" from Amazon and determined that their labeling established them as "unapproved new drugs." The agency gave Amazon fifteen (15) business days to respond in writing. As reported by The Dallas Morning News, the FDA also pointed to Amazon’s Fulfillment by Amazon service as the route those products took into interstate commerce.
How the FDA Classified the Products
According to the agency, short, punchy label claims such as "FOR PHIMOSIS" and "Balanitis Relief Cream" show that the creams were intended to diagnose, treat or prevent disease. That intent lands them squarely in the "new drug" category, which requires premarket approval before a product can be legally sold in the United States. "These products are unapproved new drugs," the letter states, and selling them without an approved application violates sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA also emphasized that having third-party products shipped through Amazon’s Fulfillment by Amazon network does not insulate the company from responsibility under federal law.
A Pattern of Enforcement
Regulatory watchers see this June action as part of a broader FDA effort to rein in unapproved or misbranded health products sold on major online marketplaces. In recent years, the agency has fired off warning letters over everything from injectable fat-dissolving ampoules to mole-removal ointments, signaling that the do-it-yourself medical aisle on the internet is very much on its radar. Industry outlets say platforms are facing growing pressure to sharpen both listing and fulfillment controls. Fierce Pharma has chronicled prior letters the FDA sent to Amazon and other sellers caught up in these crackdowns.
What Amazon Could Face Next
The warning letter does not just scold; it hints at what could come if Amazon’s response falls short. The FDA wrote that "Failure to adequately address violations may result in regulatory or legal action," wording that leaves the door open to seizure or injunction as potential next steps. For now, Amazon has a narrow deadline to detail the corrective actions it will take and to explain how it plans to stop third-party sellers from using its fulfillment network to move potentially unsafe, unapproved drugs into customers’ carts. Industry compliance teams will be watching closely to see whether Amazon changes how it screens product listings or manages Fulfillment by Amazon inventory in the wake of this notice.
Consumer Note
For shoppers who have already bought these creams or anything similar, the FDA’s message is straightforward: be cautious. The agency says the safety and effectiveness of these products have not been reviewed. Anyone who experiences health issues after using such items should talk with a medical provider and consider reporting problems through the FDA’s safety channels.
