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# FDA Bought Unapproved New Drugs on Amazon
- URL: https://www.fdaweb.com/fda-bought-unapproved-new-drugs-on-amazon/
- Published: 2026-06-23T12:00:00.000Z
- Updated: 2026-09-14T13:41:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161360

FDA says it purchased three unapproved new drugs from the Amazon Web site and directed the company to address the violations promptly and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

A 6/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-728814-06172026?ref=fdaweb.com) says two of the products were indicated for phimosis and one for balanitis. Because the products are not generally recognized as safe and effective, it says, they are legally considered to be unapproved new drugs, and it is a violation of the Federal Food, Drug, and Cosmetic Act to introduce unapproved new drugs into interstate commerce.

“You are responsible for investigating and determining the root cause of any violations and implementing corrective and preventive measures to ensure future and sustained compliance so that these violations and any others do not occur,” the letter says.