[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-skin-authority-llc-628385-04132022":3,"fda-latest-sync-dates":28},{"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":8,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},2726,"skin-authority-llc-628385-04132022","Warning Letter","Skin Authority, L.L.C.",null,"Center for Drug Evaluation and Research | CDER","Finished Pharmaceuticals\u002FUnapproved New Drug\u002FMisbranded","2022-04-19","2022-04-13","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fskin-authority-llc-628385-04132022","628385","Drugs","Ted Hilling","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\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\">Ted Hilling\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Skin Authority, L.L.C.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">3186 Lionshead Ave Ste 150\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Carlsbad\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">92010\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:Ted@skinauthority.com\"> Ted@skinauthority.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>Date: April 13, 2022\u003Cbr>\n\u003Cbr>\nDear Mr. Hilling,\u003C\u002Fp>\n\n\u003Cp>This letter concerns your firm’s distribution of a drug product to bleach and\u002For lighten the skin. skinauthority® Hyperpigmentation Treatment drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Unapproved New Drug and Misbranded Drug Violations\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>skinauthority® Hyperpigmentation Treatment is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a skin bleaching product.\u003C\u002Fp>\n\n\u003Cp>Examples of the claims observed on your product label that provide evidence of the intended use (as defined in 21 CFR 201.128) of your product include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp>“Skin Lightener . . . \u003Cstrong>Drug Facts\u003C\u002Fstrong> . . . Hydroquinone (2%) . . . \u003Cstrong>Purposes\u003C\u002Fstrong> . . . Whitening Agent . . . \u003Cstrong>Uses:\u003C\u002Fstrong> . . . fade spots, freckles, and hyperpigmentation . . .” [from Hyperpigmentation Treatment label]\u003C\u002Fp>\n\n\u003Cp>skinauthority® Hyperpigmentation Treatment is a skin bleaching drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this skin bleaching product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), as added on March 27, 2020 with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), because it is subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> Thus, skinauthority® Hyperpigmentation Treatment is deemed to be a new drug under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003C\u002Fp>\n\n\u003Cp>No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for skinauthority® Hyperpigmentation Treatment. Accordingly, this skin bleaching drug product is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a).\u003C\u002Fp>\n\n\u003Cp>Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).\u003C\u002Fp>\n\n\u003Cp>Moreover, skinauthority® Hyperpigmentation Treatment is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355, and does not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. 355h.\u003C\u002Fp>\n\n\u003Cp>The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>The violations cited in this letter are not intended to be an all-inclusive list of violations regarding your product nor is the skin bleaching\u002Fskin lightening drug product named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and\u002For listed in FDA’s electronic drug registration and listing system (eDRLS), or introduced into interstate commerce. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\u003C\u002Fp>\n\n\u003Cp>Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.\u003Cbr>\n\u003Cbr>\nSpecify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address violations within 15 working days, state your reasons for delay and schedule for completion.\u003C\u002Fp>\n\n\u003Cp>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>Please direct your email response to Office of Unapproved Drugs and Labeling Compliance at the following email address to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.\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> On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products, including but not limited to those that contain hydroquinone as an active ingredient, are not generally recognized as safe and effective.\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> Section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), authorized FDA to take action before September 23, 2020, to extend the period during which a drug subject to that section may be marketed without an approved new drug application if the Agency determined that such an extension is in the interest of public health. However, FDA did not make such a determination for skin bleaching products\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            ","Product:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nTed Hilling\n\nSkin Authority, L.L.C.\n\n3186 Lionshead Ave Ste 150\n\nCarlsbad, CA 92010\n\nUnited States\n\nTed@skinauthority.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nDate: April 13, 2022\n\nDear Mr. Hilling,\n\nThis letter concerns your firm’s distribution of a drug product to bleach and\u002For lighten the skin. skinauthority® Hyperpigmentation Treatment drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.\n\nUnapproved New Drug and Misbranded Drug Violations\n\nskinauthority® Hyperpigmentation Treatment is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a skin bleaching product.\n\nExamples of the claims observed on your product label that provide evidence of the intended use (as defined in 21 CFR 201.128) of your product include, but may not be limited to, the following:\n\n“Skin Lightener . . . Drug Facts . . . Hydroquinone (2%) . . . Purposes . . . Whitening Agent . . . Uses: . . . fade spots, freckles, and hyperpigmentation . . .” [from Hyperpigmentation Treatment label]\n\nskinauthority® Hyperpigmentation Treatment is a skin bleaching drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this skin bleaching product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), as added on March 27, 2020 with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), because it is subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.1 Thus, skinauthority® Hyperpigmentation Treatment is deemed to be a new drug under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.2\n\nNo FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for skinauthority® Hyperpigmentation Treatment. Accordingly, this skin bleaching drug product is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a).\n\nIntroduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).\n\nMoreover, skinauthority® Hyperpigmentation Treatment is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355, and does not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. 355h.\n\nThe introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nConclusion\n\nThe violations cited in this letter are not intended to be an all-inclusive list of violations regarding your product nor is the skin bleaching\u002Fskin lightening drug product named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and\u002For listed in FDA’s electronic drug registration and listing system (eDRLS), or introduced into interstate commerce. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\n\nFailure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.\n\nThis letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.\n\nSpecify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address violations within 15 working days, state your reasons for delay and schedule for completion.\n\nIf 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\nPlease direct your email response to Office of Unapproved Drugs and Labeling Compliance at the following email address to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.\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 On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products, including but not limited to those that contain hydroquinone as an active ingredient, are not generally recognized as safe and effective.\n\n2 Section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), authorized FDA to take action before September 23, 2020, to extend the period during which a drug subject to that section may be marketed without an approved new drug application if the Agency determined that such an extension is in the interest of public health. However, FDA did not make such a determination for skin bleaching products","2026-08-20T02:00:08.922+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2022-04-19T13:20:00Z\">04\u002F19\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-04-13T04:00:00Z\">04\u002F13\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fskin-authority-llc-628385-04132022\">Skin Authority, L.L.C.\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"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"]