WARNING LETTER

Walmart, Inc MARCS-CMS 648620 — August 18, 2023

Delivery Method:: Via Email
Product:: Drugs

Recipient:: Recipient Name

Doug McMillon; Recipient Title

President and CEO; Walmart, Inc; 702 SW 8th Street
Bentonville, AR 72716-6299
United States; HWSCSAFETY@wal-mart.com

Issuing Office:: Center for Drug Evaluation and Research | CDER; United States

WARNING LETTER

August 18, 2023

RE: 648620

Dear Mr. McMillon:

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.

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.

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).

Conclusion

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.

Sincerely,
/S/

Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

________________________

1 The kit is composed of “Naturasil Molluscum Relief Soap” and “Naturasil Molluscum Topical Liquid.”

2 Walmart distributes the product directly to individual U.S. consumers on behalf of third parties. The product was “fulfilled” by Walmart; your website states, “Walmart Fulfillment Services (WFS) allows sellers to store their inventory at Walmart fulfillment centers. When a customer places an order on Walmart.com, we’ll pick, pack, and ship the item(s) to the customer on your behalf. WFS also handles all customer support and returns for these orders.” (See https://sellerhelp.walmart.com/seller/s/guide?language=en_US&article=000009214).

3 This product is marketed as being “child-safe (2 yrs & above).”

4 We recognize that the “Naturasil Molluscum Treatment Kit” labeling describes the product as being “homeopathic.”

First, we note that under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” “Naturasil Molluscum Treatment Kit” includes non-homeopathic ingredients that, although listed as “inactive ingredients,” are considered active ingredients under 21 C.F.R. 201.66(b)(2) because they are promoted with claims to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body. These other active ingredients are not listed in dilutions and at least some are not listed in the HPUS, and thus these products fall outside the scope of products addressed in this guidance. Notwithstanding, even if “Naturasil Molluscum Treatment Kit” was considered a “homeopathic drug product" under this guidance, this product would fall under the guidance’s categories of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.