[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-vaping-studio-inc-677327-03062024":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":11,"response_letter_date":8,"closeout_date":8,"case_status":12,"letter_url":13,"reference_number":14,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"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},1571,"vaping-studio-inc-677327-03062024","Warning Letter","Vaping Studio Inc",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2024-03-06","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fvaping-studio-inc-677327-03062024","ER2401027","677327","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\">ER2401027\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>Vaping Studio Inc\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">3027 Coon Rapids Boulevard\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Coon Rapids\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">MN\u003C\u002Fspan> \u003Cspan class=\"postal-code\">55433\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  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\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\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>March 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) has reviewed our inspection records, and determined that Vaping Studio Inc sells and\u002For distributes Electronic Nicotine Delivery Systems (ENDS) products for commercial distribution 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 ENDS 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 ENDS 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 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 sell and\u002For distribute to customers in the United States ENDS products without a marketing authorization order, including Wave Strawberry Mango 8000 Puffs.\u003C\u002Fp>\n\n\u003Cp>The ENDS product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, it is 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 this product was not provided as required by section 905(j) of the FD&C Act. The receipt in interstate commerce of any tobacco product that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise is a prohibited act under section 301(c) of the FD&C Act (21 U.S.C. § 331(c)). FDA also notes that the introduction or delivery for introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)), and, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA has determined that your firm markets a new tobacco product lacking premarket authorization in the United States. 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 of your tobacco products, including those you sell and\u002For distribute, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately 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 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, as well as violations that are the same as or similar to the ones 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 actions to address any violations and bring your 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 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, ER2401027, 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>Ele Ibarra-Pratt\u003Cbr>\nActing Director\u003Cbr>\nOffice of Compliance and Enforcement\u003Cbr>\nCenter for Tobacco Products\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>VIA UPS\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>cc:\u003Cbr>\nVaping Studio Inc Faribault\u003Cbr>\n1930 2nd Avenue Northwest\u003Cbr>\nFaribault, MN 55021\u003C\u002Fp>\n\n\u003Cp>Vaping Studio Inc\u003Cbr>\n907 1st Street North\u003Cbr>\nHopkins, MN 55343\u003C\u002Fp>\n\n\u003Cp>Vermillion River, LLC\u003Cbr>\n8343 210th Street West\u003Cbr>\nLakeville, MN 55044\u003C\u002Fp>\n\n\u003Cp>Vermillion River, LLC\u003Cbr>\n1612 7th Northwest Street\u003Cbr>\nFaribault, MN 59021\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\nER2401027\n\nProduct:\n\nTobacco\n\nRecipient:\n\nVaping Studio Inc\n\n3027 Coon Rapids Boulevard\n\nCoon Rapids, MN 55433\n\nUnited States\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nMarch 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) has reviewed our inspection records, and determined that Vaping Studio Inc sells and\u002For distributes Electronic Nicotine Delivery Systems (ENDS) products for commercial distribution 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 ENDS 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 ENDS 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 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 sell and\u002For distribute to customers in the United States ENDS products without a marketing authorization order, including Wave Strawberry Mango 8000 Puffs.\n\nThe ENDS product listed above is a new tobacco product because it was not commercially marketed in the United States as of February 15, 2007. This product does not have an FDA marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt from the marketing authorization requirement. Therefore, this product is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, it is 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 this product was not provided as required by section 905(j) of the FD&C Act. The receipt in interstate commerce of any tobacco product that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise is a prohibited act under section 301(c) of the FD&C Act (21 U.S.C. § 331(c)). FDA also notes that the introduction or delivery for introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)), and, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).\n\nConclusion and Requested Actions\n\nFDA has determined that your firm markets a new tobacco product lacking premarket authorization in the United States. 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 of your tobacco products, including those you sell and\u002For distribute, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately 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 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, as well as violations that are the same as or similar to the ones 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 actions to address any violations and bring your 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 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, ER2401027, 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\nEle Ibarra-Pratt\n\nActing Director\n\nOffice of Compliance and Enforcement\n\nCenter for Tobacco Products\n\nVIA UPS\n\ncc:\n\nVaping Studio Inc Faribault\n\n1930 2nd Avenue Northwest\n\nFaribault, MN 55021\n\nVaping Studio Inc\n\n907 1st Street North\n\nHopkins, MN 55343\n\nVermillion River, LLC\n\n8343 210th Street West\n\nLakeville, MN 55044\n\nVermillion River, LLC\n\n1612 7th Northwest Street\n\nFaribault, MN 59021","2026-08-20T00:15:03.484+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2024-03-06T20:00:00Z\">03\u002F06\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-03-06T05:00:00Z\">03\u002F06\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fvaping-studio-inc-677327-03062024\">Vaping Studio Inc\u003C\u002Fa>","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+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"]