Walmart, Inc

Warning LetterOpen

Doug McMillon President and CEO Walmart, Inc 702 SW 8th Street Bentonville , AR 72716-6299 United States HWSCSAFETY@wal-mart.comFEI 3012497981Issued Aug 18, 2023Center for Drug Evaluation and Research | CDER

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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: August 18, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Walmart was cited for distributing the "Naturasil Molluscum Treatment Kit" through its website and fulfillment services, an unapproved new drug intended to treat molluscum contagiosum that violated sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to ensure the product had FDA approval before introducing it into interstate commerce, despite molluscum contagiosum being a condition that requires professional medical evaluation to rule out serious conditions like skin cancer and fungal infections, with no legally marketed over-the-counter treatments available. The FDA emphasized the particular concern with this product given that genital molluscum lesions constitute a sexually transmitted infection requiring proper medical assessment.