FDA WARNING_LETTER - Amazon.com, Inc. - March 03, 2025

The FDA issued a Warning Letter to Amazon on March 3, 2025, concerning the distribution of unapproved new injectable lipolytic drug products via www.amazon.com and its Fulfillment by Amazon service. The FDA purchased "LemonBottle Ampoule Solution," "L-Carnitine Body Serum Ampoule," and "Matrigen PPC Ampoule," which are considered drugs under section 201(g)(1) of the FD&C Act due to their intended use for fat reduction and body contouring.

These products are deemed "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their stated uses. Introducing or delivering these products into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the FD&C Act. The letter emphasizes the public health risks associated with unapproved injectable products, which bypass the body's natural defenses.

Amazon is responsible for investigating and correcting these violations and preventing recurrence. The company must submit a written response within fifteen working days, detailing steps taken to address the violations, prevent future occurrences, and ensure no further distribution of unapproved injectable lipolytic drug products. Failure to comply may result in legal action, including seizure and injunction.