Doug McMillon
President and CEO
Walmart, Inc.
702 SW 8th Street
Bentonville , AR 72716-6299
United States
HWSCSAFETY@wal-mart.comFEI 3012497981Issued Jul 25, 2024Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012497981.
Violations2
Issue DateJul 25, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Walmart, Inc.
Location
Doug McMillon
President and CEO
Walmart, Inc.
702 SW 8th Street
Bentonville , AR 72716-6299
United States
HWSCSAFETY@wal-mart.com
FEI Number
3012497981
Country
United States
Issue Date
July 25, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Walmart was found to be distributing "Skin Beauty Solutions lactic acid skin peel 90%" through its website and fulfillment services, an unapproved new drug product that violated sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The chemical peel product, which contains 90% lactic acid, was determined to be a drug based on its labeling claims related to treating or affecting skin structure and function, yet it lacked FDA approval required for marketing. The FDA expressed concern that potent chemical peel products available to consumers pose significant public health risks, noting adverse event reports of serious injuries including chemical burns, wounds, pain, swelling, and scarring that sometimes required emergency care and surgical intervention.