[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-m-k-cumberland-inc-dba-big-cloud-vape-tobacco-637701-07152022":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},2551,"m-k-cumberland-inc-dba-big-cloud-vape-tobacco-637701-07152022","Warning Letter","M & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2022-07-26","2022-07-15","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fm-k-cumberland-inc-dba-big-cloud-vape-tobacco-637701-07152022","637701","Tobacco","VIA UPS and Electronic Mail","Naser Mesleh","\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      \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>\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\">Naser Mesleh\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>M & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">4950 N Cumberland Ave, #5\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Norridge\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">IL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">60706\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:bigcloudy.vape@gmail.com\"> bigcloudy.vape@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 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>July 15, 2022\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Naser Mesleh:\u003C\u002Fp>\n\n\u003Cp>The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fwww.bigcloudvape.com and determined that the electronic nicotine delivery system (ENDS) and e-liquid products listed there are advertised and offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including ENDS and e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).\u003C\u002Fp>\n\n\u003Cp>FDA has determined that ENDS and e-liquid products that are advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website advertising ENDS and e-liquid products fails to include the required nicotine warning statement.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>ENDS and E-Liquid Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Our review of the website https:\u002F\u002Fwww.bigcloudvape.com revealed that the advertising for several ENDS and e-liquid products that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 CFR 1143.3(b). Examples include: Posh Plus – Creme Brulee and Naked E-Liquid Juice – All Melon. Under 21 C.F.R. § 1143.3(b), advertising for ENDS and e-liquid products containing nicotine made or derived from tobacco must bear the following warning statement:\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">WARNING: This product contains nicotine. Nicotine is an addictive chemical.\u003C\u002Fp>\n\n\u003Cp>It is unlawful for a manufacturer, packager, importer, distributor, or retailer of ENDS and e-liquid products containing nicotine made or derived from tobacco to advertise or cause to be advertised within the United States any such tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2).\u003C\u002Fp>\n\n\u003Cp>Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations promulgated under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website regarding ENDS and e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your ENDS and e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>It is your responsibility to ensure that your tobacco products and all related labeling and\u002For advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments 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., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may result in FDA taking regulatory action. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.\u003C\u002Fp>\n\n\u003Cp>The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and take any necessary actions to bring your 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 corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and\u002For distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at \u003Ca href=\"http:\u002F\u002Fwww.fda.gov.\">http:\u002F\u002Fwww.fda.gov.\u003C\u002Fa>\u003C\u002Fp>\n\n\u003Cp>Please note your reference number, RW2201791, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:\u003C\u002Fp>\n\n\u003Cp>DPAL-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 Bryan Hills at (301) 796-9367 or via email at CTPCompliance@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Ann Simoneau, J.D.\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance and Enforcement\u003Cbr>\nCenter for Tobacco Products\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>VIA UPS and Electronic Mail\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>cc:\u003C\u002Fp>\n\n\u003Cp>Louis E. Najjar\u003Cbr>\n7101 N Cicero Ave, Ste 108\u003Cbr>\nLincolnwood, IL 60712\u003C\u002Fp>\n\n\u003Cp>Wix.co Ltd.\u003Cbr>\ndomain-abuse@wix.com\u003C\u002Fp>\n\n\u003Cp>Google LLC\u003Cbr>\ngoogle-cloud-compliance@google.com\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\nProduct:\n\nTobacco\n\nRecipient:\n\nRecipient Name\n\nNaser Mesleh\n\nM & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco\n\n4950 N Cumberland Ave, #5\n\nNorridge, IL 60706\n\nUnited States\n\nbigcloudy.vape@gmail.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nJuly 15, 2022\n\nWARNING LETTER\n\nDear Naser Mesleh:\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fwww.bigcloudvape.com and determined that the electronic nicotine delivery system (ENDS) and e-liquid products listed there are advertised and offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including ENDS and e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).\n\nFDA has determined that ENDS and e-liquid products that are advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website advertising ENDS and e-liquid products fails to include the required nicotine warning statement.\n\nENDS and E-Liquid Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded\n\nOur review of the website https:\u002F\u002Fwww.bigcloudvape.com revealed that the advertising for several ENDS and e-liquid products that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 CFR 1143.3(b). Examples include: Posh Plus – Creme Brulee and Naked E-Liquid Juice – All Melon. Under 21 C.F.R. § 1143.3(b), advertising for ENDS and e-liquid products containing nicotine made or derived from tobacco must bear the following warning statement:\n\nWARNING: This product contains nicotine. Nicotine is an addictive chemical.\n\nIt is unlawful for a manufacturer, packager, importer, distributor, or retailer of ENDS and e-liquid products containing nicotine made or derived from tobacco to advertise or cause to be advertised within the United States any such tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2).\n\nUnder section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations promulgated under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website regarding ENDS and e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), your ENDS and e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).\n\nConclusion and Requested Actions\n\nIt is your responsibility to ensure that your tobacco products and all related labeling and\u002For advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments 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., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may result in FDA taking regulatory action. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.\n\nThe violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and take any necessary actions to bring your 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 corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and\u002For distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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, RW2201791, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:\n\nDPAL-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 Bryan Hills at (301) 796-9367 or via email at CTPCompliance@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nAnn Simoneau, J.D.\n\nDirector\n\nOffice of Compliance and Enforcement\n\nCenter for Tobacco Products\n\nVIA UPS and Electronic Mail\n\ncc:\n\nLouis E. Najjar\n\n7101 N Cicero Ave, Ste 108\n\nLincolnwood, IL 60712\n\nWix.co Ltd.\n\ndomain-abuse@wix.com\n\nGoogle LLC\n\ngoogle-cloud-compliance@google.com","2026-08-20T01:44:22.85+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2022-07-26T13:20:00Z\">07\u002F26\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-07-15T04:00:00Z\">07\u002F15\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fm-k-cumberland-inc-dba-big-cloud-vape-tobacco-637701-07152022\">M & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+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"]