WARNING LETTER
Amazon.com, Inc.
MARCS-CMS 679523 —
July 25, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Andy Jassy
Recipient Title
CEO
Amazon.com, Inc.
410 Terry Ave. N
Seattle
,
WA
98109-5210
United States
(b)(4)
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 25, 2024
RE: 679523
Dear Mr. Jassy:
This letter concerns your firm’s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). The United States Food and Drug Administration (FDA) reviewed chemical peel drug products that were purchased on your website, www.amazon.com. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs 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 these products 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 “MÔOYAM TCA 50%” and “Skin Beauty Solutions lactic acid skin peel 90%” through your website, www.amazon.com. These products, which are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.
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 Drugs
“MÔOYAM TCA 50%” and “Skin Beauty Solutions lactic acid skin peel 90%” are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 that establish the intended use of these products as drugs include, but may not be limited to the following:
MÔOYAM TCA 50%
From the product label:
“REDUCE ACNE AND DARK SPOTS”
Skin Beauty Solutions lactic acid skin peel 90%
From the product label:
“Clears Acne & Scars
Removes Dead Skin Cells”
“MÔOYAM TCA 50%” and “Skin Beauty Solutions lactic acid skin peel 90%” are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” 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 are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products 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 Amazon will no longer introduce, or deliver for introduction into interstate commerce unapproved chemical peel drug products, as well as copies of related documentation. If you believe that the products you distribute are 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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Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products discussed below was “fulfilled” by Amazon; your website states, “
Fulfillment by Amazon (FBA) is a program that lets you outsource order fulfillment to Amazon. It’s part of a fully automated set services we call Supply Chain by Amazon. Sign up for FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders
.” (See https://sell.amazon.com/fulfillment-by-amazon).
Content current as of:
07/30/2024
Regulated Product(s)
Drugs