Amazon.com, Inc

Warning LetterOpen

Andrew Jassy CEO Amazon.com, Inc 410 Terry Ave. N Seattle , WA 98109-5210 United States Regulatory-inquiries@amazon.comIssued Aug 18, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateAug 18, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Amazon.com, Inc
Location: Andrew Jassy CEO Amazon.com, Inc 410 Terry Ave. N Seattle , WA 98109-5210 United States Regulatory-inquiries@amazon.com
FEI Number: N/A
Country: United States
Issue Date: August 18, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Amazon.com distributed four unapproved drug products intended to treat molluscum contagiosum (Naturasil Molluscum Treatment Kit, Conzerol 2 Step Treatment, ZymaDerm for Molluscum, and HealthyDerm Molluscum Contagiosum Treatment) through its Fulfillment by Amazon service, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were unapproved new drugs with no legally marketed over-the-counter alternatives for treating molluscum contagiosum, a viral skin infection that requires professional medical evaluation to rule out serious conditions such as skin cancer or fungal infections. Amazon was responsible for introducing or delivering these drugs into interstate commerce without FDA approval, making the company liable for the distribution of these products.

Amazon.com, Inc FDA Warning Letter, August 18, 2023