> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Amazon Warning Letter Raises Questions: Attorneys
- URL: https://www.fdaweb.com/amazon-warning-letter-raises-questions-attorneys/
- Published: 2022-08-24T12:00:00.000Z
- Updated: 2026-09-14T17:57:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152578

Attorneys **Joanna Hawana** and **Benjamin Zegarelli** (Mintz) say a recent FDA Warning Letter to Amazon.com “signals that the agency may be adding new tools to its arsenal in the perpetual fight to protect U.S. consumers from adulterated, misbranded, and potentially unsafe products. It also highlights the fact that the Federal Food, Drug, and Cosmetic Act broadly prohibits any actions that put unapproved products into the stream of commerce, reminding online fulfillment services and retailers alike that they have independent responsibilities to ensure that FDA-regulated products they offer comply with all applicable federal laws.”

The Amazon letter involves the agency’s purchase of unapproved mole and skin tag remover drug products from the online platform that were then shipped by the company’s Fulfillment by Amazon service.

The attorneys say that the key element was delivery from Amazon Fulfillment, meaning that Amazon warehoused the products for the sellers and then packed and shipped them, making it the entity responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of the products.

The post raises the question of what kinds of controls and systems FDA will consider sufficient for a fulfillment service such as Amazon’s and says there will undoubtedly be major negotiations and discussions between the company and the agency to resolve the Warning Letter.