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WARNING LETTER

Amazon.com, Inc. MARCS-CMS 629452 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Andy Jassy
Recipient Title
CEO
Amazon.com, Inc.

2021 7th Ave
Seattle, WA 98121-2601
United States

Regulatory-inquiries@amazon.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

August 4, 2022

RE: 629452

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”). As explained below, the United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products intended for mole and skin tag removal. As discussed further below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs under section 505(a) of 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 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

FDA purchased the mole and skin tag remover products, “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” (hereinafter “Deisana”) and “Skincell Mole Skin Tag Corrector Serum” (hereinafter “Skincell”) 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

There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses.2 Moles should be evaluated by a health care practitioner; self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and even cancer progression. Consumers who use such products may forgo, delay, or discontinue medical treatments found safe and effective for diagnosing and treating moles, including those which are potentially cancerous or precancerous. FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring.3

Unapproved New Drugs

Deisana and Skincell 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 labels of Deisana and Skincell that establish the intended use of these products as drugs include, but may not be limited to, the following:

Deisana:

  • “SKIN TAG, WART & MOLE REMOVER”
  • “Take a small amount of the cream on a toothpick. Tap it on the tag . . . If there are redness and swelling, it means that the application is successful. . . . The target area will turn red and the color will become darker. After the scab forms, wait for 7-10 days before the scab falls off naturally. . . . [A]pply the repair lotion with your hand . . . until complete healing, it will take only two weeks to completely heal the tag, and the perfect, beautiful skin will be yours” accompanied by photos of moles disappearing with Deisana treatment.

Skincell:

  • “Mole & Skin Tag Corrector Serum”
  • “[T]his product is recommended to be used as an aide to fight skin ailments such as skin tags as (sic) moles.”

Deisana and Skincell 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). 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 are no FDA-approved applications in effect for these products. Introduction or delivery of these products into interstate commerce without an approved application 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, deliver, or cause the introduction or delivery into interstate commerce of, unapproved new drugs products with mole and skin tag removal claims, 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, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

____________________________

1 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “With Fulfillment by Amazon (FBA), [sellers] store [their] products in Amazon's fulfillment centers, and [Amazon] pick[s], pack[s], ship[s], and provide[s] customer service for these products” (see https://sell.amazon.com/fulfillment-by-amazon.html).

2 Such agency concerns were reflected in the OTC final monograph for wart remover drug products (now a final administrative order under section 505G of the FD&C Act), which specifically warns against the use of OTC topical wart remover products on moles and birthmarks. (See 55 FR 33246, 33255 (Aug. 14, 1990); also see 45 FR 65609, 65611 (Oct. 3, 1980)).

3 FDA Consumer Update “Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring,” available at: https://www.fda.gov/consumers/consumer-updates/products-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring.

 
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