[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-grand-vapors-613962-03262021":3,"fda-latest-sync-dates":31},{"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":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},3439,"grand-vapors-613962-03262021","Warning Letter","Grand Vapors",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2021-03-30","2021-03-26","2023-08-16","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgrand-vapors-613962-03262021","613962","Tobacco","VIA UPS and Electronic Mail","Karisa Jones","\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\">Karisa Jones\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Grand Vapors \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">4601 W Sahara Ave, Ste Q\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Las Vegas\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NV\u003C\u002Fspan> \u003Cspan class=\"postal-code\">89102\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@grandvapors.com\"> info@grandvapors.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>March 26, 2021\u003Cbr>\n \u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Karisa Jones:\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.grandvapors.com and determined that e-liquid products listed there are manufactured and offered for sale or distribution 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 and intended for human consumption. Certain tobacco products, including e-liquids, 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. Therefore, e-liquids are required to be in compliance with the requirements in the FD&C Act.\u003C\u002Fp>\n\n\u003Cp>Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the FD&C Act. These products include, but are not limited to, ENDS (including e-cigarettes and e-liquids), cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at \u003Ca href=\"https:\u002F\u002Ffederalregister.gov\u002Fa\u002F2016-10685\">https:\u002F\u002Ffederalregister.gov\u002Fa\u002F2016-10685\u003C\u002Fa>.\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>Our review of the website https:\u002F\u002Fwww.grandvapors.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order, including Grand Vapors e-liquids: Snozzberry, King Kustard, and Punk Bubblegum.\u003C\u002Fp>\n\n\u003Cp>The e-liquid 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 an FDA marketing authorization order 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. In addition, these products are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products were 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>Your firm is a registered manufacturer with over 2,400 products listed with FDA. 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 initiating 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 or misbranded may be subject to detention and refusal of admission.\u003C\u002Fp>\n\n\u003Cp>The violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly 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 actions to address any violations and bring your products into compliance, 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, RW2101551, 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 Ele Ibarra-Pratt at \u003Cspan class=\"baec5a81-e4d6-4674-97f3-e9220f0136c1\" style=\"white-space: nowrap;\">(301) 796-9235\u003Ca href=\"#\" style=\"margin: 0px; border: currentColor; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; float: none; display: inline; white-space: nowrap; position: static !important;\" title=\"Call: (301) 796-9235\">\u003Cimg src=\"data:image\u002Fpng;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8\u002F9hAAABcklEQVR4XpXTPUvDUBTH4aR2c2hBQXGpTiIORhBcBOvgYKf0Awi+4Ggr1MVPIIrYdnEpShddHIyLi6AVXVxsRRDRwbi4KNgu4lCIv8i\u002Fi6QRDzycy+09555LqOl5nhEUptPoJe1iDHU8oYlrlDw79m4QEbSLPexzsIc8hDRm8YBjLpj4q8EgxQdab+MNd4ghhQ2adIc1+ORAFEnWWfTDRp7GDfImlsIavKALLuqoqMGUCs4wHtagiQ5uc8kDyCOBKlP1k78QNTOZnMXCQRxWsbjl6iuskV41SQG2Gj9rikvcR1WcgKFDBa1LOEUK56hqv8BUFV3SGWkVS9JQ6Dsv4wQ1DKMPORUvkm78BhdQMI1CTa5I0yrcwSFqFD+SZ7DQesIkCG5S\u002FJpkHYERQRmuNsrZ7Grc+Ef8\u002FBcoslkfae8Wc7CUHZ++TuAEBj86pHntjaDKXllPy6PW\u002FgkKFaThwp\u002FK87N8hDcQTTKKFTioSxqB8Q2BNX5JtAljwgAAAABJRU5ErkJggg==\" style=\"margin: 0px; border: currentColor; left: 0px; top: 0px; width: 16px; height: 16px; right: 0px; bottom: 0px; overflow: hidden; vertical-align: middle; float: none; display: inline; white-space: nowrap; position: static !important;\" title=\"Call: (301) 796-9235\">\u003C\u002Fa>\u003C\u002Fspan> 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>Grand Vapors\u003Cbr>\n1228 E Division St\u003Cbr>\nSpringfield, MO 65803-3817\u003C\u002Fp>\n\n\u003Cp>GoDaddy.com LLC\u003Cbr>\nabuse@godaddy.com\u003C\u002Fp>\n\n\u003Cp>Cloudflare, Inc.\u003Cbr>\nabuse@cloudflare.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\nKarisa Jones\n\nGrand Vapors\n\n4601 W Sahara Ave, Ste Q\n\nLas Vegas, NV 89102\n\nUnited States\n\ninfo@grandvapors.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nMarch 26, 2021\n\nWARNING LETTER\n\nDear Karisa Jones:\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fwww.grandvapors.com and determined that e-liquid products listed there are manufactured and offered for sale or distribution 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 and intended for human consumption. Certain tobacco products, including e-liquids, 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. Therefore, e-liquids are required to be in compliance with the requirements in the FD&C Act.\n\nPlease be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the FD&C Act. These products include, but are not limited to, ENDS (including e-cigarettes and e-liquids), cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https:\u002F\u002Ffederalregister.gov\u002Fa\u002F2016-10685.\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\nOur review of the website https:\u002F\u002Fwww.grandvapors.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order, including Grand Vapors e-liquids: Snozzberry, King Kustard, and Punk Bubblegum.\n\nThe e-liquid 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 an FDA marketing authorization order 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. In addition, these products are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products were not provided as required by section 905(j) of the FD&C Act.\n\nConclusion and Requested Actions\n\nYour firm is a registered manufacturer with over 2,400 products listed with FDA. 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 initiating 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 or misbranded may be subject to detention and refusal of admission.\n\nThe violations discussed in this letter do not necessarily constitute an exhaustive list. You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly 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 actions to address any violations and bring your products into compliance, 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, RW2101551, 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 Ele Ibarra-Pratt at (301) 796-9235 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\nGrand Vapors\n\n1228 E Division St\n\nSpringfield, MO 65803-3817\n\nGoDaddy.com LLC\n\nabuse@godaddy.com\n\nCloudflare, Inc.\n\nabuse@cloudflare.com","2026-08-20T03:14:42.027+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2021-03-30T13:20:00Z\">03\u002F30\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-03-26T04:00:00Z\">03\u002F26\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgrand-vapors-613962-03262021\">Grand Vapors \u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgrand-vapors-613962-07302021\">\u003Ctime datetime=\"2023-08-16T04:00:00Z\">08\u002F16\u002F2023\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.386127+00:00","2026-08-20T03:14:44.160074+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"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"]