WARNING LETTER
Walmart, Inc.
MARCS-CMS 683095 —
July 25, 2024
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
July 25, 2024
RE: 683095
Dear Mr. McMillon:
This letter concerns your firm’s distribution of a chemical peel drug product that violates the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). The United States Food and Drug Administration (FDA) reviewed “Skin Beauty Solutions lactic acid skin peel 90%,” a chemical peel drug product purchased on your website, www.walmart.com. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce 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).
FDA purchased “Skin Beauty Solutions lactic acid skin peel 90%” 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.
1
The Agency is concerned about potent chemical peel products that are available to be purchased and used by consumers. Such products pose a public health risk because they can cause skin injuries such as burns on the area of application, wounds, pain, swelling, and scarring. FDA has received adverse event reports of injuries involving use of such products, some of which required emergency room care, specialty care from a dermatologist, and/or surgical intervention.
Unapproved New Drug
“Skin Beauty Solutions lactic acid skin peel 90%” 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 “Skin Beauty Solutions lactic acid skin peel 90%” that establish the intended use of this product as a drug include, but may not be limited to, the following:
From the product label:
“lactic acid skin peel”
“Clears Acne & Scars”
“Removes Dead Skin Cells”
“Skin Beauty Solutions lactic acid skin peel 90%” is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, 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 pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for “Skin Beauty Solutions lactic acid skin peel 90%.” Accordingly, the introduction or delivery of this product 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 or deliver for introduction into interstate commerce of, unapproved chemical peel drug products, 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/
Tina Smith, M.S
Captain, U.S Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
________________________
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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 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).
Content current as of:
07/30/2024
Regulated Product(s)
Drugs