[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-evapekingscom-718071-10092025":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},440,"evapekingscom-718071-10092025","Warning Letter","evapekings.com",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2025-12-03","2025-10-09","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fevapekingscom-718071-10092025","RW2502349","718071","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\">RW2502349\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>evapekings.com\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">398 E Dania Beach Blvd, #255\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Dania Beach\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">33004\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:sales@evapekings.com\"> sales@evapekings.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:evapekingss@gmail.com\"> evapekingss@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>October 9, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>To Whom It May Concern:\u003C\u002Fp>\u003Cp>The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fevapekings.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.\u003C\u002Fp>\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>\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>\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>\u003Cp>\u003Cstrong>New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>FDA has determined that you offer for sale or distribution to customers in the United States ENDS products that lack a marketing authorization order: Fume WeFume Disposable Vape Device [30K Puffs] – Dragon Fruit and Fume WeFume Disposable Vape Device [30K Puffs] – Lychee Soda.\u003C\u002Fp>\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 (21 U.S.C. § 387e(j)).\u003C\u002Fp>\u003Cp>\u003Cstrong>Additional Considerations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>FDA finds these products particularly concerning because the products’ labeling and\u002For advertising for Fume WeFume Disposable Vape Device [30K Puffs] products (see Exhibit A) may entice youth by imitating a smartphone or other smart technology (see Exhibit B).\u003C\u002Fp>\u003Cdiv alt=\"Smartphone and Vape Device\" title=\"Evapekings\" data-entity-type=\"media\" data-entity-uuid=\"41896e3a-8384-4d5f-a9af-f433277496d2\" data-embed-button=\"media_browser\" data-entity-embed-display=\"media_image\" data-entity-embed-display-settings=\"Array\" class=\"align-center embedded-entity\" data-langcode=\"en\">  \u003Cimg loading=\"lazy\" src=\"https:\u002F\u002Fwww.fda.gov\u002Ffiles\u002F718071-Evapekings.png\" alt=\"Smartphone and Vape Device\" title=\"Evapekings\" class=\"img-responsive\">\n\n\u003C\u002Fdiv>\n\u003Cp>In particular, youth and young adults may be enticed to the products’ design and functionalities imitating smart phones and other smart technology, including:\u003C\u002Fp>\u003Cul>\u003Cli>“The WeFume isn’t just a vaping device – it’s a smart gadget.”\u003C\u002Fli>\u003Cli>“Equipped with Bluetooth connectivity, this device allows you to sync with your smartphone and access 16 apps for making calls, playing music, and using voice assistants like Siri or Google Assistant.”\u003C\u002Fli>\u003Cli>“It’s intuitive touch screen makes it easy to navigate and customize your settings, while the voice control feature brings hands-free convenience to your vaping routine.”\u003C\u002Fli>\u003Cli>“The device also features practical tools like a built-in clock and flashlight, making it as functional as it is stylish.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Further, the products’ design may entice youth because the design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the products are tobacco products. FDA is concerned about the youth appeal and widespread youth use of ENDS products, which are the most common tobacco products used by students reporting current tobacco use. Any efforts to entice youth to use tobacco products are of concern to FDA. Sales of unauthorized products are prohibited, and FDA is concerned that your actions likely encourage unlawful sales, maintain or increase youth use, and contribute to the public health and safety concerns associated with ENDS products.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\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>\u003Cp>For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https:\u002F\u002Fwww.fda.gov\u002Fsearchtobacco.\u003C\u002Fp>\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, 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>\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>\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 https:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\u003Cp>Please note your reference number, RW2502349, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:\u003C\u002Fp>\u003Cp>DPAL-WL Response, Office of Compliance and Enforcement  \u003Cbr>FDA Center for Tobacco Products  \u003Cbr>c\u002Fo Document Control Center  \u003Cbr>Building 71, Room G335  \u003Cbr>10903 New Hampshire Avenue  \u003Cbr>Silver Spring, MD 20993-0002\u003C\u002Fp>\u003Cp>If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>John E. Verbeten\u003Cbr>Director\u003Cbr>Office of Compliance and Enforcement\u003Cbr>Center for Tobacco Products\u003C\u002Fp>\u003Cp>\u003Cstrong>VIA Electronic Mail\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>cc:\u003C\u002Fp>\u003Cp>GoDaddy.com, LLC\u003Cbr>abuse@godaddy.com\u003C\u002Fp>\u003Cp>Shopify, Inc.\u003Cbr>abuse@shopify.com\u003C\u002Fp>\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\nRW2502349\n\nProduct:\n\nTobacco\n\nRecipient:\n\nevapekings.com\n\n398 E Dania Beach Blvd, #255\n\nDania Beach, FL 33004\n\nUnited States\n\nsales@evapekings.com\n\nevapekingss@gmail.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nOctober 9, 2025\nWARNING LETTER\nTo Whom It May Concern:\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fevapekings.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.\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.\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.\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)).\nNew Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded\nFDA has determined that you offer for sale or distribution to customers in the United States ENDS products that lack a marketing authorization order: Fume WeFume Disposable Vape Device [30K Puffs] – Dragon Fruit and Fume WeFume Disposable Vape Device [30K Puffs] – Lychee Soda.\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 (21 U.S.C. § 387e(j)).\nAdditional Considerations\nFDA finds these products particularly concerning because the products’ labeling and\u002For advertising for Fume WeFume Disposable Vape Device [30K Puffs] products (see Exhibit A) may entice youth by imitating a smartphone or other smart technology (see Exhibit B).\n\nIn particular, youth and young adults may be enticed to the products’ design and functionalities imitating smart phones and other smart technology, including:\n“The WeFume isn’t just a vaping device – it’s a smart gadget.”\n“Equipped with Bluetooth connectivity, this device allows you to sync with your smartphone and access 16 apps for making calls, playing music, and using voice assistants like Siri or Google Assistant.”\n“It’s intuitive touch screen makes it easy to navigate and customize your settings, while the voice control feature brings hands-free convenience to your vaping routine.”\n“The device also features practical tools like a built-in clock and flashlight, making it as functional as it is stylish.”\nFurther, the products’ design may entice youth because the design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the products are tobacco products. FDA is concerned about the youth appeal and widespread youth use of ENDS products, which are the most common tobacco products used by students reporting current tobacco use. Any efforts to entice youth to use tobacco products are of concern to FDA. Sales of unauthorized products are prohibited, and FDA is concerned that your actions likely encourage unlawful sales, maintain or increase youth use, and contribute to the public health and safety concerns associated with ENDS products.\nConclusion and Requested Actions\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.\nFor a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https:\u002F\u002Fwww.fda.gov\u002Fsearchtobacco.\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, 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.\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.\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 https:\u002F\u002Fwww.fda.gov.\nPlease note your reference number, RW2502349, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:\nDPAL-WL Response, Office of Compliance and Enforcement\nFDA Center for Tobacco Products\nc\u002Fo Document Control Center\nBuilding 71, Room G335\n10903 New Hampshire Avenue\nSilver Spring, MD 20993-0002\nIf you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.\nSincerely,\n\u002FS\u002F\nJohn E. Verbeten\nDirector\nOffice of Compliance and Enforcement\nCenter for Tobacco Products\nVIA Electronic Mail\ncc:\nGoDaddy.com, LLC\nabuse@godaddy.com\nShopify, Inc.\nabuse@shopify.com","2026-08-19T11:24:33.472+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-12-03T05:00:00Z\">12\u002F03\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-10-09T04:00:00Z\">10\u002F09\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fevapekingscom-718071-10092025\">evapekings.com\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+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"]