FDA WARNING_LETTER - Amazon.com, Inc. - July 30, 2024

On July 25, 2024, the FDA issued a Warning Letter to Amazon concerning the distribution of unapproved new drug products. The FDA purchased "MÔOYAM TCA 50%" and "Skin Beauty Solutions lactic acid skin peel 90%" through www.amazon.com, which were distributed via Amazon's Fulfillment by Amazon service.

These products are classified as drugs under section 201(g)(1) of the FD&C Act due to their intended use for affecting body structure or function, as evidenced by claims on their labeling. The FDA states these products are not generally recognized as safe and effective for their intended uses, making them "new drugs" under section 201(p) of the FD&C Act.

Introducing or delivering these unapproved new drugs into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the FD&C Act. The FDA expressed concern about the public health risk posed by potent chemical peel products, citing adverse event reports of skin injuries requiring medical attention.

Amazon is responsible for investigating and preventing recurrence of these violations and ensuring compliance with federal law. The company must submit a written response within fifteen working days, detailing corrective actions taken to prevent the distribution of unapproved chemical peel drug products, including supporting documentation. Failure to address the matter may result in legal action, including seizure or injunction.