[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-alohma-llc-dba-kure-cbd-vape-682314-08062024":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":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":8,"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},1325,"alohma-llc-dba-kure-cbd-vape-682314-08062024","Warning Letter","Alohma LLC d\u002Fb\u002Fa Kure CBD & Vape",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2024-08-07","2024-08-06","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Falohma-llc-dba-kure-cbd-vape-682314-08062024","ER2401041","682314","Tobacco","VIA UPS and Electronic Mail","\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 UPS and Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">ER2401041\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Tobacco                          \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>\u003C\u002Fdd>\n                    \n            \u003Cdd>Alohma LLC d\u002Fb\u002Fa Kure CBD & Vape\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">7520 West 119th Street\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Overland Park\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">KS\u003C\u002Fspan> \u003Cspan class=\"postal-code\">66213\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \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 Tobacco Products\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>August 6, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>To Whom It May Concern:\u003C\u002Fp>\n\n\u003Cp>The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and determined that Alohma LLC\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> d\u002Fb\u002Fa Kure CBD & Vape manufactures, sells and\u002For distributes e-liquid products to customers in the United States.\u003C\u002Fp>\n\n\u003Cp>Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1, and are required to be in compliance with the requirements in the FD&C Act.\u003C\u002Fp>\n\n\u003Cp>Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA’s jurisdiction to products “containing nicotine from any source,” not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of “tobacco product” under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) to include products containing nicotine from any source. Tobacco products, including e-liquid products, containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https:\u002F\u002Fwww.fda.gov\u002Ftobacco-products\u002Fctp-newsroom\u002Frequirements-products-made-non-tobacco-nicotine-take-effect-april-14.\u003C\u002Fp>\n\n\u003Cp>Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA has determined that you manufacture and offer for sale or distribution to customers in the United States the following e-liquid products that lack a marketing authorization order: Sweet Moro.\u003C\u002Fp>\n\n\u003Cp>The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion.\u003C\u002Fp>\n\n\u003Cp>For a list of products that received marketing granted orders, please visit our website: https:\u002F\u002Fwww.fda.gov\u002Ftobacco-products\u002Fmarket-and-distribute-tobacco-product\u002Ftobacco-products-marketing-orders#PMTAView%20all%20marketing%20granted.\u003C\u002Fp>\n\n\u003Cp>It is your responsibility to ensure that all tobacco products you sell and\u002For distribute in the United States and all related labeling and\u002For advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq. or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, or 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and\u002For injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and\u002For misbranded may be detained or refused admission.\u003C\u002Fp>\n\n\u003Cp>The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.\u003C\u002Fp>\n\n\u003Cp>Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale, and\u002For distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA’s homepage at http:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\n\n\u003Cp>Please note your reference number, ER2401041, in your response and direct your response to the following address:\u003C\u002Fp>\n\n\u003Cp>DEM-WL Response, Office of Compliance and Enforcement\u003Cbr>\nFDA Center for Tobacco Products\u003Cbr>\nc\u002Fo Document Control Center\u003Cbr>\nBuilding 71, Room G335\u003Cbr>\n10903 New Hampshire Avenue\u003Cbr>\nSilver Spring, MD 20993-0002\u003C\u002Fp>\n\n\u003Cp>If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>John E. Verbeten\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance and Enforcement\u003Cbr>\nCenter for Tobacco Products\u003C\u002Fp>\n\n\u003Cp>CC:\u003C\u002Fp>\n\n\u003Cp>Alohma Iowa 3\u003Cbr>\n285 Broadway\u003Cbr>\nCouncil Bluffs, IA 51503\u003C\u002Fp>\n\n\u003Cp>Alohma Iowa 1\u003Cbr>\n4501 Southern Hills Drive\u003Cbr>\nSioux City, IA 51106\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 2\u003Cbr>\n9719 M Street\u003Cbr>\nOmaha, NE 68127\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 1\u003Cbr>\n725 North 120th Street\u003Cbr>\nOmaha, NE 68154\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 4\u003Cbr>\n3430 South 144th Street\u003Cbr>\nOmaha, NE 68144\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 9\u003Cbr>\n2390 North Diers Ave\u003Cbr>\nGrand Island, NE 68803\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 3\u003Cbr>\n4652 Dodge Road\u003Cbr>\nOmaha, NE 68132\u003Cbr>\n\u003Cbr>\nAlohma Nebraska 8\u003Cbr>\n33 West 6th Street\u003Cbr>\nFremont, NE 68025\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 6\u003Cbr>\n11527 South 36th Street\u003Cbr>\nBellevue, NE 68123\u003C\u002Fp>\n\n\u003Cp>Alohma Iowa 2\u003Cbr>\n3221 Gordon Drive\u003Cbr>\nSioux City, IA 51105\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 10\u003Cbr>\n4230 South 33rd, Suite 104\u003Cbr>\nLincoln, NE 68508\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 11\u003Cbr>\n1401 North 56th Street, Suite 102\u003Cbr>\nLincoln, NE 68504\u003C\u002Fp>\n\n\u003Cp>Alohma Illinois 1\u003Cbr>\n1301 Thelma Keller Ave, Suite K\u003Cbr>\nEffingham, IL 62401\u003C\u002Fp>\n\n\u003Cp>Alohma Kansas 2\u003Cbr>\n7939 Frontage Road\u003Cbr>\nOverland Park, KS 66204\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 12\u003Cbr>\n201 Capital Beach Blvd\u003Cbr>\nLincoln, NE 68528\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 5\u003Cbr>\n6112 Military Avenue\u003Cbr>\nOmaha, NE 68104\u003C\u002Fp>\n\n\u003Cp>Alohma Kansas 3\u003Cbr>\n1570 Southwest Wanamaker Road\u003Cbr>\nTopeka, KS 66604\u003C\u002Fp>\n\n\u003Cp>Alohma Nebraska 7\u003Cbr>\n8515 Park Drive ,\u003Cbr>\nOmaha, NE 68127\u003C\u002Fp>\n\n\u003Cp>__________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> This establishment is registered with FDA as owned and operated by Alohma, LLC, which owns and operates 18 additional establishments registered with FDA under the Alohma name in the United States. These entities are listed below, and CTP will send each of them a copy of this Warning Letter. This may not be an exhaustive list of entities owned and operated by Alohma, LLC. It is your responsibility to ensure that all tobacco products you manufacture, sell, and\u002For distribute in the United States, both online and in physical establishments, comply with applicable provisions of the FD&C Act and FDA’s implementing regulations.\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 UPS and Electronic Mail\n\nReference #:\n\nER2401041\n\nProduct:\n\nTobacco\n\nRecipient:\n\nAlohma LLC d\u002Fb\u002Fa Kure CBD & Vape\n\n7520 West 119th Street\n\nOverland Park, KS 66213\n\nUnited States\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nAugust 6, 2024\n\nWARNING LETTER\n\nTo Whom It May Concern:\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our inspection records and determined that Alohma LLC1 d\u002Fb\u002Fa Kure CBD & Vape manufactures, sells and\u002For distributes e-liquid products to customers in the United States.\n\nUnder section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1, and are required to be in compliance with the requirements in the FD&C Act.\n\nPlease be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA’s jurisdiction to products “containing nicotine from any source,” not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of “tobacco product” under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) to include products containing nicotine from any source. Tobacco products, including e-liquid products, containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https:\u002F\u002Fwww.fda.gov\u002Ftobacco-products\u002Fctp-newsroom\u002Frequirements-products-made-non-tobacco-nicotine-take-effect-april-14.\n\nGenerally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).\n\nNew Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded\n\nFDA has determined that you manufacture and offer for sale or distribution to customers in the United States the following e-liquid products that lack a marketing authorization order: Sweet Moro.\n\nThe tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act.\n\nConclusion and Requested Actions\n\nFDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion.\n\nFor a list of products that received marketing granted orders, please visit our website: https:\u002F\u002Fwww.fda.gov\u002Ftobacco-products\u002Fmarket-and-distribute-tobacco-product\u002Ftobacco-products-marketing-orders#PMTAView%20all%20marketing%20granted.\n\nIt is your responsibility to ensure that all tobacco products you sell and\u002For distribute in the United States and all related labeling and\u002For advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq. or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, or 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and\u002For injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and\u002For misbranded may be detained or refused admission.\n\nThe violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.\n\nPlease submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale, and\u002For distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA’s homepage at http:\u002F\u002Fwww.fda.gov.\n\nPlease note your reference number, ER2401041, in your response and direct your response to the following address:\n\nDEM-WL Response, Office of Compliance and Enforcement\n\nFDA Center for Tobacco Products\n\nc\u002Fo Document Control Center\n\nBuilding 71, Room G335\n\n10903 New Hampshire Avenue\n\nSilver Spring, MD 20993-0002\n\nIf you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nJohn E. Verbeten\n\nDirector\n\nOffice of Compliance and Enforcement\n\nCenter for Tobacco Products\n\nCC:\n\nAlohma Iowa 3\n\n285 Broadway\n\nCouncil Bluffs, IA 51503\n\nAlohma Iowa 1\n\n4501 Southern Hills Drive\n\nSioux City, IA 51106\n\nAlohma Nebraska 2\n\n9719 M Street\n\nOmaha, NE 68127\n\nAlohma Nebraska 1\n\n725 North 120th Street\n\nOmaha, NE 68154\n\nAlohma Nebraska 4\n\n3430 South 144th Street\n\nOmaha, NE 68144\n\nAlohma Nebraska 9\n\n2390 North Diers Ave\n\nGrand Island, NE 68803\n\nAlohma Nebraska 3\n\n4652 Dodge Road\n\nOmaha, NE 68132\n\nAlohma Nebraska 8\n\n33 West 6th Street\n\nFremont, NE 68025\n\nAlohma Nebraska 6\n\n11527 South 36th Street\n\nBellevue, NE 68123\n\nAlohma Iowa 2\n\n3221 Gordon Drive\n\nSioux City, IA 51105\n\nAlohma Nebraska 10\n\n4230 South 33rd, Suite 104\n\nLincoln, NE 68508\n\nAlohma Nebraska 11\n\n1401 North 56th Street, Suite 102\n\nLincoln, NE 68504\n\nAlohma Illinois 1\n\n1301 Thelma Keller Ave, Suite K\n\nEffingham, IL 62401\n\nAlohma Kansas 2\n\n7939 Frontage Road\n\nOverland Park, KS 66204\n\nAlohma Nebraska 12\n\n201 Capital Beach Blvd\n\nLincoln, NE 68528\n\nAlohma Nebraska 5\n\n6112 Military Avenue\n\nOmaha, NE 68104\n\nAlohma Kansas 3\n\n1570 Southwest Wanamaker Road\n\nTopeka, KS 66604\n\nAlohma Nebraska 7\n\n8515 Park Drive ,\n\nOmaha, NE 68127\n\n__________________\n\n1 This establishment is registered with FDA as owned and operated by Alohma, LLC, which owns and operates 18 additional establishments registered with FDA under the Alohma name in the United States. These entities are listed below, and CTP will send each of them a copy of this Warning Letter. This may not be an exhaustive list of entities owned and operated by Alohma, LLC. It is your responsibility to ensure that all tobacco products you manufacture, sell, and\u002For distribute in the United States, both online and in physical establishments, comply with applicable provisions of the FD&C Act and FDA’s implementing regulations.","2026-08-19T23:54:18.876+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-08-07T13:00:00Z\">08\u002F07\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-08-06T04:00:00Z\">08\u002F06\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Falohma-llc-dba-kure-cbd-vape-682314-08062024\">Alohma LLC d\u002Fb\u002Fa Kure CBD & Vape\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"]