FDA WARNING_LETTER - Walmart, Inc - July 30, 2024

The FDA issued a Warning Letter to Walmart on July 25, 2024, concerning the distribution of "Skin Beauty Solutions lactic acid skin peel 90%." The FDA purchased this product from www.walmart.com, and it was introduced into interstate commerce via Walmart Fulfillment Services.

The product is classified as a drug under section 201(g)(1) of the FD&C Act due to its intended use, as evidenced by claims on its label. The FDA states that this chemical peel product is an unapproved new drug under section 201(p) of the FD&C Act because it is not generally recognized as safe and effective for its intended uses. Consequently, its introduction or delivery into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, as there is no FDA-approved application for it.

The FDA expressed concern about the public health risks posed by potent chemical peel products, citing adverse event reports of injuries requiring medical attention. Walmart is responsible for investigating and correcting these violations and ensuring future compliance. The company must submit a written response within fifteen working days, detailing steps taken to address the violations, prevent recurrence, and ensure no further distribution of unapproved chemical peel drug products. Failure to comply may result in legal action, including seizure and/or injunction.