Walmart, Inc

This letter concerns your firm’s distribution of the “Naturasil Molluscum Treatment Kit,” a product intended to treat molluscum contagiosum, sold on your website www.walmart.com. As discussed below, your firm is responsible for introducing or delivering for introduction into interstate commerce of this product, which is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The United States Food and Drug Administration (FDA) purchased “Naturasil Molluscum Treatment Kit”1 through your website, www.walmart.com. The product, which is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), was introduced or delivered for introduction into interstate commerce by Walmart via your Walmart Fulfillment Services.2

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. Molluscum contagiosum is a viral skin infection characterized by small, raised lesions on the skin that are known as Mollusca. Molluscum 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. The “Naturasil Molluscum Treatment Kit” product 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.

“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.

Examples of claims observed on the labeling of “Naturasil Molluscum Treatment Kit”3 that establish the intended use of this product as a drug include, but may not be limited to, the following: • In the name of the product – “Molluscum Treatment Kit” • 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.”

“Naturasil Molluscum Treatment Kit” is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There is no FDA-approved application in effect for “Naturasil Molluscum Treatment Kit.”4 Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. 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. 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, as well as copies of related documentation. If you believe that the product you distribute is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.