[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-nykdpouchescom-705189-04102025":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},936,"nykdpouchescom-705189-04102025","Warning Letter","nykdpouches.com",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2025-04-29","2025-04-10","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnykdpouchescom-705189-04102025","RW2502270","705189","Tobacco","VIA USPS 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 USPS and Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">RW2502270\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>nykdpouches.com\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2834 Hamner Ave #315\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Norco\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">92860\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:hello@nykdpouches.com\"> hello@nykdpouches.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:nykd@thepuffbrands.com\"> nykd@thepuffbrands.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 10, 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\u002Fnykdpouches.com and determined that nicotine pouch 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 nicotine pouch 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 nicotine pouch 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-nicotinetake-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 nicotine pouch products that lack a marketing authorization order, including: NYKD – Berry Lemon Ice Nicotine Pouches, NYKD – Strawberry Watermelon Ice Nicotine Pouches, and NYKD –Tropical Ice Nicotine Pouches.\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>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: www.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 ecommerce, 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>\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 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 http:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\u003Cp>Please note your reference number, RW2502270, 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 UPS, USPS, and Electronic Mail\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>cc:\u003C\u002Fp>\u003Cp>The Puff Brands d\u002Fb\u002Fa NYKD\u003Cbr>1809 W Frankford Rd #160\u003Cbr>Carrollton, TX 75007\u003C\u002Fp>\u003Cp>TIW Holdings, LLC\u003Cbr>Attn: Walker Wilkerson\u003Cbr>c\u002Fo Paracorp Incorporated\u003Cbr>318 N Carson St. #208\u003Cbr>Carson City, NV 89701\u003C\u002Fp>\u003Cp>Puff Labs LLC\u003Cbr>Attn: Walker Wilkerson\u003Cbr>17100 Norwalk Blvd Ste 110, PMB 103\u003Cbr>Cerritos, CA 90703\u003C\u002Fp>\u003Cp>Nioo Technology Co., Limited\u003Cbr>hwang@nioolabs.com\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 USPS and Electronic Mail\n\nReference #:\n\nRW2502270\n\nProduct:\n\nTobacco\n\nRecipient:\n\nnykdpouches.com\n\n2834 Hamner Ave #315\n\nNorco, CA 92860\n\nUnited States\n\nhello@nykdpouches.com\n\nnykd@thepuffbrands.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nApril 10, 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\u002Fnykdpouches.com and determined that nicotine pouch 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 nicotine pouch 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 nicotine pouch 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-nicotinetake-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 nicotine pouch products that lack a marketing authorization order, including: NYKD – Berry Lemon Ice Nicotine Pouches, NYKD – Strawberry Watermelon Ice Nicotine Pouches, and NYKD –Tropical Ice Nicotine Pouches.\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)).\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: www.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 ecommerce, 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.\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 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 http:\u002F\u002Fwww.fda.gov.\nPlease note your reference number, RW2502270, 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 UPS, USPS, and Electronic Mail\ncc:\nThe Puff Brands d\u002Fb\u002Fa NYKD\n1809 W Frankford Rd #160\nCarrollton, TX 75007\nTIW Holdings, LLC\nAttn: Walker Wilkerson\nc\u002Fo Paracorp Incorporated\n318 N Carson St. #208\nCarson City, NV 89701\nPuff Labs LLC\nAttn: Walker Wilkerson\n17100 Norwalk Blvd Ste 110, PMB 103\nCerritos, CA 90703\nNioo Technology Co., Limited\nhwang@nioolabs.com\nGoDaddy.com, LLC\nabuse@godaddy.com\nShopify, Inc.\nabuse@shopify.com","2026-08-19T16:50:44.301+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-04-29T04:00:00Z\">04\u002F29\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-04-10T04:00:00Z\">04\u002F10\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnykdpouchescom-705189-04102025\">nykdpouches.com\u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+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"]