[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-juicefly-llc-682421-04302024":3,"fda-latest-sync-dates":30},{"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":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":28,"updated_at":29},1494,"juicefly-llc-682421-04302024","Warning Letter","JuiceFly LLC",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2024-05-01","2024-04-30","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjuicefly-llc-682421-04302024","RW2402148","682421","Tobacco","VIA UPS and Electronic Mail","Melo Melih Pamuk","\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\">RW2402148\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>\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\">Melo Melih Pamuk\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\">Ahmet Pamuk\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>JuiceFly LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">10725 Jefferson Boulevard\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Culver City\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">90230\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:support@juicefly.com\"> support@juicefly.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>April 30, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Melo Melih Pamuk and Ahmet Pamuk:\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\u002Fjuicefly.com and determined that electronic nicotine delivery system (ENDS) product listed there is 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)), this product is a tobacco product because it is 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 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 Product Without Required Marketing Authorization are Adulterated and Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA has determined that you offer for sale or distribution to customers in the United States an ENDS product that lacks a marketing authorization order: Funky Republic Ti7000, Peach Pie.\u003C\u002Fp>\n\n\u003Cp>The tobacco 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 (21 U.S.C. § 387e(j)).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\n\n\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>\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 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 adequately 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>\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 and take any necessary actions to bring these 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 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 http:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\n\n\u003Cp>Please note your reference number, RW2402148, 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 CTPCompliance@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Jill Atencio\u003Cbr>\nActing Director\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>Joyce Yi\u003Cbr>\n101 North Brand Boulevard, 11th floor\u003Cbr>\nGlendale, CA 91203\u003C\u002Fp>\n\n\u003Cp>Sandra Menjivar\u003Cbr>\n101 North Brand Boulevard, 11th floor\u003Cbr>\nGlendale, CA 91203\u003C\u002Fp>\n\n\u003Cp>Redacted for Privacy\u003Cbr>\nac8ea99b6612473b8efcdlae2557d651.protect@witheldforprivacy.com\u003C\u002Fp>\n\n\u003Cp>Namecheap Inc.\u003Cbr>\nabuse@namecheap.com\u003C\u002Fp>\n\n\u003Cp>Shopify Inc.\u003Cbr>\nabouse@shopify.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\nReference #:\n\nRW2402148\n\nProduct:\n\nTobacco\n\nRecipient:\n\nRecipient Name\n\nMelo Melih Pamuk\n\nRecipient Title\n\nAhmet Pamuk\n\nJuiceFly LLC\n\n10725 Jefferson Boulevard\n\nCulver City, CA 90230\n\nUnited States\n\nsupport@juicefly.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nApril 30, 2024\n\nWARNING LETTER\n\nDear Melo Melih Pamuk and Ahmet Pamuk:\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fjuicefly.com and determined that electronic nicotine delivery system (ENDS) product listed there is 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)), this product is a tobacco product because it is 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 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 Product Without Required Marketing Authorization are Adulterated and Misbranded\n\nFDA has determined that you offer for sale or distribution to customers in the United States an ENDS product that lacks a marketing authorization order: Funky Republic Ti7000, Peach Pie.\n\nThe tobacco 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 (21 U.S.C. § 387e(j)).\n\nConclusion and Requested Actions\n\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.\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 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 adequately 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.\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 and take any necessary actions to bring these 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 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 http:\u002F\u002Fwww.fda.gov.\n\nPlease note your reference number, RW2402148, 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 CTPCompliance@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nJill Atencio\n\nActing Director\n\nOffice of Compliance and Enforcement\n\nCenter for Tobacco Products\n\nVIA UPS and Electronic Mail\n\ncc:\n\nJoyce Yi\n\n101 North Brand Boulevard, 11th floor\n\nGlendale, CA 91203\n\nSandra Menjivar\n\n101 North Brand Boulevard, 11th floor\n\nGlendale, CA 91203\n\nRedacted for Privacy\n\nac8ea99b6612473b8efcdlae2557d651.protect@witheldforprivacy.com\n\nNamecheap Inc.\n\nabuse@namecheap.com\n\nShopify Inc.\n\nabouse@shopify.com","2026-08-20T00:08:03.182+00:00",[24,25,26,9,10,27,27,27],"\u003Ctime datetime=\"2024-05-01T13:00:00Z\">05\u002F01\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-04-30T04:00:00Z\">04\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjuicefly-llc-682421-04302024\">JuiceFly LLC\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.185295+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]