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# Amazon Distributing Misbranded, Unapproved Drugs: FDA
- URL: https://www.fdaweb.com/amazon-distributing-misbranded-unapproved-drugs-fda/
- Published: 2022-11-01T12:00:00.000Z
- Updated: 2026-09-14T18:04:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153091

An FDA 10/28 Warning Letter says Amazon.com, Seattle, WA, is distributing three products that violate the Federal Food, Drug, and Cosmetic Act. The [letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-631751-10282022?ref=fdaweb.com) says the firm is responsible for introducing the unapproved drugs into interstate commerce through the Fulfillment by Amazon service.

The letter gives examples of the claims observed on the products’ labeling that establish the intended use of the products as drugs. It also says the products are not recognized as safe and effective for their referenced uses.

Amazon was told to respond with an explanation of specific steps it has taken to address the violations and prevent their recurrence, with related documentation and a schedule for completing the corrections.