[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-skin-beauty-solutions-683006-07252024":3,"fda-latest-sync-dates":29},{"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":27,"updated_at":28},1338,"skin-beauty-solutions-683006-07252024","Warning Letter","Skin Beauty Solutions",null,"Center for Drug Evaluation and Research (CDER)","Finished Pharmaceuticals\u002FUnapproved New Drugs","2024-07-30","2024-07-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fskin-beauty-solutions-683006-07252024","683006","Drugs","Via Email","Cassandra Pryor","\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\">Cassandra Pryor\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Manager\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Skin Beauty Solutions\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">P.O. Box 25527\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Saint Paul\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">MN\u003C\u002Fspan> \u003Cspan class=\"postal-code\">55125-0527\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:info@skinbeautysolutions.com\"> info@skinbeautysolutions.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>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>July 25, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">RE: 683006\u003C\u002Fp>\n\n\u003Cp>Dear Cassandra Pryor:\u003C\u002Fp>\n\n\u003Cp>This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https:\u002F\u002Fwww.skinbeautysolutions.com\u002F in April 2024 and has observed that your website offers numerous chemical peel drug products; including, multiple strengths of lactic acid, glycolic acid, combination glycolic and lactic acid, and salicylic acid products\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>, including “LACTIC Acid Skin Chemical Peel 90%,” “GLYCOLIC ACID Skin Cosmetic Grade Peel 70%,” “Combination Peel GLYCOLIC 35% LACTIC 45%,” and “SALICYLIC ACID Skin Chemical Peel 30%” (hereinafter referred to as your “chemical peels”) for sale in the United States. As described below, your chemical peels are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).\u003C\u002Fp>\n\n\u003Cp>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\u002For surgical intervention.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Based on a review of your website, your firm’s chemical peels 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>Examples of claims observed on your website https:\u002F\u002Fwww.skinbeautysolutions.com\u002F that establish the intended use of these products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp>\u003Cu>LACTIC Acid Skin Chemical Peel 90%\u003C\u002Fu>\u003Cbr>\n• “lactic acid skin peel 90%\u003Cbr>\nClears Acne & Scars\u003Cbr>\nRemoves Dead Skin Cells”\u003C\u002Fp>\n\n\u003Cp>• “Chemical peels work by loosening and gently sloughing off the damaged, unattractive skin cells. . .. Lactic Peels can also work on the deeper layers of skin to accelerate the skin’s natural production of collagen and elastin.”\u003C\u002Fp>\n\n\u003Cp>\u003Cu>GLYCOLIC ACID Skin Cosmetic Grade Peel 70%\u003C\u002Fu>\u003Cbr>\n• “glycolic acid skin peel 70%\u003Cbr>\nClears Acne & Scars\u003Cbr>\nRemoves Dead Skin Cells\u003Cbr>\nPrevents Fine lines & Wrinkles”\u003C\u002Fp>\n\n\u003Cp>\u003Cu>Combination Peel GLYCOLIC 35% LACTIC 45%\u003C\u002Fu>\u003Cbr>\n• “combination peel\u003Cbr>\nGlycolic Acid 35%\u003Cbr>\nLactic Acid 45%\u003Cbr>\nClears Acne & Scars\u003Cbr>\nRemoves Dead Skin Cells\u003Cbr>\nSmoothes [sic] Fine lines & Wrinkles”\u003C\u002Fp>\n\n\u003Cp>\u003Cu>SALICYLIC ACID Skin Chemical Peel 30%\u003C\u002Fu>\u003Cbr>\n• “salicylic acid skin peel 30%\u003Cbr>\nRemoves Blackheads\u003Cbr>\nClears Acne & Scars”\u003C\u002Fp>\n\n\u003Cp>• “SALICYLIC ACID SKIN CHEMICAL PEEL W\u002F BETA HYDROXY (BHA) BY SKIN BEAUTY SOLUTIONS – IDEAL FOR ACNE, BLACKHEADS, DERMATITIS, WHITEHEADS, CLOGGED PORES.”\u003C\u002Fp>\n\n\u003Cp>Your chemical peels are not generally recognized as safe and effective for the 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). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are 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).\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 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.\u003C\u002Fp>\n\n\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nTina Smith, M.S.\u003Cbr>\nCaptain, U.S. Public Health Service\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> We have observed that your website offers Lactic Acid skin peel 35%, 50%, 70%, 90% strengths, Glycolic Acid skin peel buffered and unbuffered 35%, 50%, 70% strengths, combination Glycolic Acid 35% and Lactic Acid 45% strength, and Salicylic Acid skin chemical peels 10%, 20%, and 30% strengths.\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\nCassandra Pryor\n\nRecipient Title\n\nManager\n\nSkin Beauty Solutions\n\nP.O. Box 25527\n\nSaint Paul, MN 55125-0527\n\nUnited States\n\ninfo@skinbeautysolutions.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\n\nJuly 25, 2024\n\nRE: 683006\n\nDear Cassandra Pryor:\n\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https:\u002F\u002Fwww.skinbeautysolutions.com\u002F in April 2024 and has observed that your website offers numerous chemical peel drug products; including, multiple strengths of lactic acid, glycolic acid, combination glycolic and lactic acid, and salicylic acid products1, including “LACTIC Acid Skin Chemical Peel 90%,” “GLYCOLIC ACID Skin Cosmetic Grade Peel 70%,” “Combination Peel GLYCOLIC 35% LACTIC 45%,” and “SALICYLIC ACID Skin Chemical Peel 30%” (hereinafter referred to as your “chemical peels”) for sale in the United States. As described below, your chemical peels are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).\n\nThe 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\u002For surgical intervention.\n\nUnapproved New Drugs\n\nBased on a review of your website, your firm’s chemical peels 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\nExamples of claims observed on your website https:\u002F\u002Fwww.skinbeautysolutions.com\u002F that establish the intended use of these products as drugs include, but may not be limited to, the following:\n\nLACTIC Acid Skin Chemical Peel 90%\n\n• “lactic acid skin peel 90%\n\nClears Acne & Scars\n\nRemoves Dead Skin Cells”\n\n• “Chemical peels work by loosening and gently sloughing off the damaged, unattractive skin cells. . .. Lactic Peels can also work on the deeper layers of skin to accelerate the skin’s natural production of collagen and elastin.”\n\nGLYCOLIC ACID Skin Cosmetic Grade Peel 70%\n\n• “glycolic acid skin peel 70%\n\nClears Acne & Scars\n\nRemoves Dead Skin Cells\n\nPrevents Fine lines & Wrinkles”\n\nCombination Peel GLYCOLIC 35% LACTIC 45%\n\n• “combination peel\n\nGlycolic Acid 35%\n\nLactic Acid 45%\n\nClears Acne & Scars\n\nRemoves Dead Skin Cells\n\nSmoothes [sic] Fine lines & Wrinkles”\n\nSALICYLIC ACID Skin Chemical Peel 30%\n\n• “salicylic acid skin peel 30%\n\nRemoves Blackheads\n\nClears Acne & Scars”\n\n• “SALICYLIC ACID SKIN CHEMICAL PEEL W\u002F BETA HYDROXY (BHA) BY SKIN BEAUTY SOLUTIONS – IDEAL FOR ACNE, BLACKHEADS, DERMATITIS, WHITEHEADS, CLOGGED PORES.”\n\nYour chemical peels are not generally recognized as safe and effective for the 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). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are 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).\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 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.\n\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nTina Smith, M.S.\n\nCaptain, U.S. Public Health Service\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 We have observed that your website offers Lactic Acid skin peel 35%, 50%, 70%, 90% strengths, Glycolic Acid skin peel buffered and unbuffered 35%, 50%, 70% strengths, combination Glycolic Acid 35% and Lactic Acid 45% strength, and Salicylic Acid skin chemical peels 10%, 20%, and 30% strengths.","2026-08-19T23:55:45.859+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-07-30T13:20:00Z\">07\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-07-25T04:00:00Z\">07\u002F25\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fskin-beauty-solutions-683006-07252024\">Skin Beauty Solutions\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"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"]