FDA Sends Walmart Warning Letter for Molluscum Treatment Kit

Walmart was sent a warning letter from the US FDA related to a molluscum treatment kit that it was distributing through its online store. The kit, according to FDA, is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act.

The Aug. 18, 2023 letter sent to Doug McMillon, president and CEO of Walmart, Inc., FDA stated: “molluscum contagiosum is not a condition amenable to self-diagnosis and treatment, and there are no legally marketed over-the-counter (OTC) drug products to treat this condition.”

The product has been removed from the website, based on a search conducted by Happi.com.

Molluscum

Molluscum contagiosum is a viral skin infection characterized by small, raised lesions on the skin. It affects both children and adults; however, it is more common in children. In healthy individuals, the lesions usually disappear spontaneously within 6 to 12 months, although in some cases, it could take years to resolve. In sexually active individuals, the lesions found in the genital region are considered a sexually transmitted disease/infection (STD/STI). In addition, patients with new or existing skin lesions should seek out a healthcare professional to be evaluated. A healthcare professional is needed to rule out the possibility of a more serious condition, such as, skin cancer, fungal infection, and for the genitalia, anogenital warts.

According to FDA, the “Naturasil Molluscum Treatment Kit” product that was sold via the Walmart  “is especially concerning from a public health perspective because it is marketed for use in children. In addition, FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.”

Unapproved New Drug

“Naturasil Molluscum Treatment Kit” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

FDA cited examples of claims observed on the labeling of “Naturasil Molluscum Treatment Kit” that establish the intended use of this product as a drug. These included:
•  On the Drug Facts label under “Uses” – “Symptomatic treatment of molluscum contagiosum.”
• “Now you can eradicate Molluscum Contagiosum at home with our Two-Part Molluscum Treatment Kit.”
• “Naturasil Molluscum Treatment Kit is recommended as a fast, natural solution that eliminates the need for an expensive dermatologist’s visit.”