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WARNING LETTER

August 4, 2022

RE: 631521

Dear Mr. Beck:

This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.justifiedlaboratories.com in August 2022 and has determined that you take orders there for “Skincell Advanced Mole Skin Tag Corrector Serum” (hereinafter “Skincell Advanced”) and “Skincell Mole Skin Tag Corrector Serum (hereinafter “Skincell”). The claims on your website establish that “Skincell Advanced” and “Skincell” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.External Link Disclaimer

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.¹ 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 pre-cancerous. FDA has issued a consumer warning noting that products marketed for removing moles and other skin lesions can cause injuries and scarring.²

Unapproved New Drugs

Based on our review of your website, “Skincell Advanced” and “Skincell” are drugs under 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.

An example of statements observed on your website www.justifiedlaboratories.com (specifically, the webpages for both “Skincell Advanced” and “Skincell”) that establishes the intended use of your products as drugs includes, but may not limited to, the following:

• “Do you want clear skin but have annoying skin tags? Do you wish to get rid of moles but can’t afford expensive surgical procedures? Skin tags are common and often appear on adults. However, they may appear in certain areas that can be distracting and/or cause irritation. They are generally harmless, but when you want clear skin, it’s best to get rid of them. Our Proprietary formula is recommended to be used as an aid to fight skin ailments such as skin tags and moles.”

“Skincell Advanced” 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 your products. The introduction or delivery for introduction into interstate commerce of these products 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

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

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

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1 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)).

2 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.