[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-jb-exchange-incjustified-laboratories-631521-08042022":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},2520,"jb-exchange-incjustified-laboratories-631521-08042022","Warning Letter","JB Exchange Inc.\u002FJustified Laboratories",null,"Center for Drug Evaluation and Research | CDER","Finished Pharmaceuticals\u002FUnapproved New Drug","2022-08-09","2022-08-04","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjb-exchange-incjustified-laboratories-631521-08042022","631521","Drugs","Via Email","Justin Beck","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Justin Beck\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>JB Exchange Inc.\u002FJustified Laboratories\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2131 N. Collins Suite 433-732\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Arlington\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">76011\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:service@justifiedlaboratories.com\"> service@justifiedlaboratories.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:justinbeck1984@gmail.com\"> justinbeck1984@gmail.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research | CDER\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>August 4, 2022\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>RE: 631521\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Beck:\u003C\u002Fp>\n\n\u003Cp>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 \u003Ca href=\"\u002F\u002Fwww.fda.gov.\">www.fda.gov.\u003C\u002Fa>\u003C\u002Fp>\n\n\u003Cp>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.\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> 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.\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>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\u002For intended to affect the structure or any function of the body.\u003C\u002Fp>\n\n\u003Cp>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:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“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\u002For 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.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>“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).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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\u002For injunction.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research\u002FOffice of Compliance\u002FOffice of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Carolyn E. Becker\u003Cbr>\nDirector\u003Cbr>\nOffice of Unapproved Drugs and Labeling Compliance\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\u003C\u002Fp>\n\n\u003Cp>_____________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> 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)).\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> FDA Consumer Update “Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring,” available at: \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fconsumer-updates\u002Fproducts-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring\">https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fconsumer-updates\u002Fproducts-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nJustin Beck\n\nJB Exchange Inc.\u002FJustified Laboratories\n\n2131 N. Collins Suite 433-732\n\nArlington, TX 76011\n\nUnited States\n\nservice@justifiedlaboratories.com\n\njustinbeck1984@gmail.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nAugust 4, 2022\n\nRE: 631521\n\nDear Mr. Beck:\n\nThis 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.\n\nThere 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\n\nUnapproved New Drugs\n\nBased 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\u002For intended to affect the structure or any function of the body.\n\nAn 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:\n\n“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\u002For 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.”\n\n“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).\n\nConclusion\n\nThis 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.\n\nThis 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\u002For injunction.\n\nPlease 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.\n\nYour response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research\u002FOffice of Compliance\u002FOffice of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nCarolyn E. Becker\n\nDirector\n\nOffice of Unapproved Drugs and Labeling Compliance\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\n_____________________\n\n1 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)).\n\n2 FDA Consumer Update “Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring,” available at: https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fconsumer-updates\u002Fproducts-marketed-removing-moles-and-other-skin-lesions-can-cause-injuries-scarring.","2026-08-20T01:40:57.88+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2022-08-09T13:20:00Z\">08\u002F09\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-08-04T04:00:00Z\">08\u002F04\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjb-exchange-incjustified-laboratories-631521-08042022\">JB Exchange Inc.\u002FJustified Laboratories\u003C\u002Fa>","Finished Pharmaceuticals\u002FUnapproved New Drug\u003Cbr \u002F>\r\n","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]