CRITICALNutrition / SupplementsFDA Warning Letter · August 18, 2023

Walmart, Inc

Atlas ID: 2023-08-fda-walmart-inc-1bxrdg

FDA issued a warning letter to Walmart, Inc. (CEO Doug McMillon) regarding its distribution of the 'Naturasil Molluscum Treatment Kit' through Walmart Fulfillment Services on walmart.com. The product was flagged as an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act because it bears claims to treat molluscum contagiosum, a condition with no legally marketed OTC drug products, and is not FDA-approved. FDA expressed particular public health concern because the product is marketed for use in children and may cause consumers to forgo proper medical diagnosis of potentially serious conditions. Walmart was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure and/or injunction.

Flagged claims (4)

Molluscum Treatment Kit

Cure claim · unapproved-new-drug-product-name

Now you can eradicate Molluscum Contagiosum at home with our Two-Part Molluscum Treatment Kit.

Cure claim · eradication-claim

Symptomatic treatment of molluscum contagiosum.

Cure claim · unapproved-drug-use-claim

Naturasil Molluscum Treatment Kit is recommended as a fast, natural solution that eliminates the need for an expensive dermatologist's visit.

Unsubstantiated efficacy · avoid-professional-care-claim

Required actions (3)

Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations.

Response required · 15 days

Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Walmart will no longer introduce, deliver, or cause the introduction or delivery into interstate commerce of, unapproved new drugs products claiming to treat molluscum contagiosum.

Claim removal

Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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