[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-meddle-vapes-637980-08172022":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":8,"marcs_cms_no":14,"product_type":15,"delivery_method":16,"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},2506,"meddle-vapes-637980-08172022","Warning Letter","Meddle Vapes",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2022-08-17","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmeddle-vapes-637980-08172022","637980","Tobacco","VIA UPS and Electronic Mail","Sushamt Bhattari","\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\">Sushamt Bhattari\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Meddle Vapes\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">8251 North Belt Line Road Suite 150\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Irving\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">TX\u003C\u002Fspan> \u003Cspan class=\"postal-code\">75063\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:Cadabills@gmail.com\"> Cadabills@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>August 17, 2022\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Bhattari:\u003C\u002Fp>\n\n\u003Cp>The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Meddle Vapes manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products 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-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. Therefore, these products 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, electronic nicotine delivery systems (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>\u003Cstrong>Tobacco Products Manufactured in an Unregistered Establishment Are Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>During inspection, FDA observed that you did not register your manufacturing establishment, located at 8251 North Belt Line Road, Suite 150, Irving, TX 75063, as required by section 905(c) of the FD&C Act (21 U.S.C. § 387e(c)). Specifically, section 905(c) states that “[e]very person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person's name, place of business, and such establishment.”\u003C\u002Fp>\n\n\u003Cp>Because your establishment was not registered in accordance with section 905(c) of the FD&C Act, your tobacco products that were manufactured, prepared, propagated, compounded, or processed at that establishment are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). In addition, the failure to register your establishment in accordance with section 905 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>Tobacco Products Not Listed with FDA Are Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA has determined that your tobacco products are not included in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)). Section 905(i)(3)(A) of the FD&C Act (21 U.S.C. § 387e(i)(3)(A)) requires that each person who registers with FDA under section 905 biannually report to FDA a list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the FDA under section 905(i).\u003C\u002Fp>\n\n\u003Cp>Because your tobacco products are not included in a product listing in accordance with 905(i) of the FD&C Act (21 U.S.C. § 387e(i)), these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). Additionally, the failure to provide any information required by section 905(i) of the FD&C Act 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>It is your responsibility to ensure that all of your tobacco products 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 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 that your 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 \u003Ca href=\"http:\u002F\u002Fwww.fda.gov.\">http:\u002F\u002Fwww.fda.gov.\u003C\u002Fa>\u003C\u002Fp>\n\n\u003Cp>Please note your reference number, ER2200605, in your response and direct your response 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 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\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\nSushamt Bhattari\n\nRecipient Title\n\nOwner\n\nMeddle Vapes\n\n8251 North Belt Line Road Suite 150\n\nIrving, TX 75063\n\nUnited States\n\nCadabills@gmail.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nAugust 17, 2022\n\nWARNING LETTER\n\nDear Mr. Bhattari:\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Meddle Vapes manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products 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-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. Therefore, these products 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, electronic nicotine delivery systems (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\nTobacco Products Manufactured in an Unregistered Establishment Are Misbranded\n\nDuring inspection, FDA observed that you did not register your manufacturing establishment, located at 8251 North Belt Line Road, Suite 150, Irving, TX 75063, as required by section 905(c) of the FD&C Act (21 U.S.C. § 387e(c)). Specifically, section 905(c) states that “[e]very person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person's name, place of business, and such establishment.”\n\nBecause your establishment was not registered in accordance with section 905(c) of the FD&C Act, your tobacco products that were manufactured, prepared, propagated, compounded, or processed at that establishment are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). In addition, the failure to register your establishment in accordance with section 905 is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).\n\nTobacco Products Not Listed with FDA Are Misbranded\n\nFDA has determined that your tobacco products are not included in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)). Section 905(i)(3)(A) of the FD&C Act (21 U.S.C. § 387e(i)(3)(A)) requires that each person who registers with FDA under section 905 biannually report to FDA a list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the FDA under section 905(i).\n\nBecause your tobacco products are not included in a product listing in accordance with 905(i) of the FD&C Act (21 U.S.C. § 387e(i)), these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). Additionally, the failure to provide any information required by section 905(i) of the FD&C Act 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\nIt is your responsibility to ensure that all of your tobacco products 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 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 that your 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, ER2200605, in your response and direct your response 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 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","2026-08-20T01:39:35.144+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2022-08-17T19:00:00Z\">08\u002F17\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-08-17T04:00:00Z\">08\u002F17\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmeddle-vapes-637980-08172022\">Meddle Vapes\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"]