FDA WARNING_LETTER - Walmart, Inc - August 18, 2023

The FDA issued a Warning Letter to Walmart concerning the distribution of "Naturasil Molluscum Treatment Kit" on www.walmart.com. The FDA purchased the product, which Walmart introduced into interstate commerce via Walmart Fulfillment Services.

The product is deemed an unapproved new drug under sections 505(a) and 201(p) of the FD&C Act because it is intended to treat molluscum contagiosum, a condition not amenable to self-diagnosis or treatment, and for which no legally marketed OTC drugs exist. Claims on the product's labeling, such as "Molluscum Treatment Kit" and "Symptomatic treatment of molluscum contagiosum," establish its intended drug use. The product is not generally recognized as safe and effective for its stated uses and lacks FDA approval.

The FDA expressed public health concerns, especially given the product's marketing for use in children, and the risk of individuals delaying proper diagnosis and treatment of potentially serious conditions. Even if considered homeopathic, the product contains non-homeopathic ingredients promoted with drug claims and would still fall under categories prioritized for enforcement due to potential higher public health risks.

Walmart is required to respond within fifteen working days, detailing steps taken to address violations, prevent recurrence, and ensure no further introduction of unapproved new drugs for molluscum contagiosum. Failure to comply may result in legal action, including seizure and injunction.