[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-u-mart-international-inc-659734-05252023":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":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"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},2055,"u-mart-international-inc-659734-05252023","Warning Letter","U Mart International, Inc.",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2023-06-13","2023-05-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fu-mart-international-inc-659734-05252023","659734","Tobacco","VIA UPS and Electronic Mail","Mingzhe Pang","\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\">Mingzhe Pang\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>U Mart International, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">4 Brighton Ave\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Allston\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">MA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">02135\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:we.care@umartgo.com\"> we.care@umartgo.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:umartinternational@gmail.com\"> umartinternational@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>May 25, 2023\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mingzhe Pang:\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\u002Fwww.umartgo.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>\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 ENDS, 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, ENDS are required to be in compliance with the requirements in the FD&C Act.\u003C\u002Fp>\n\n\u003Cp>FDA has determined that your RELX Classic Replacement Pod – Dark Sparkle (Cola) ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Tobacco Product Sold to an Individual Under the Age of 21 are Misbranded\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA’s investigation of the website https:\u002F\u002Fwww.umartgo.com revealed that you sold an ENDS product to an individual under the age of 21.1 Specifically, during our investigation of https:\u002F\u002Fwww.umartgo.com, a person younger than 21 years of age purchased RELX Classic Replacement Pod – Dark Sparkle (Cola) ENDS product from your website. No retailer may sell tobacco products to a person younger than 21 years of age under section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Because this tobacco product is sold or distributed to persons younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion and Requested Actions\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>It is your responsibility to ensure that your tobacco products and all related labeling and\u002For advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments 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., and FDA’s implementing regulations, including those 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. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.\u003C\u002Fp>\n\n\u003Cp>Please be aware that the FD&C Act requires “new tobacco products” to have premarket authorization. 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. See Section 910(a) of the FD&C Act. Retailers should discuss with their suppliers the current marketing status of any particular tobacco product’s application or any product’s marketing authorization.\u003C\u002Fp>\n\n\u003Cp>The violation discussed in this letter does not necessarily constitute an exhaustive list. You should address any violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and promptly 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 labeling, advertising, 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, RW2301920, 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 Bryan Hills at (301) 796-9367 or via email at 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\u003Cp>\u003Cstrong>VIA UPS and Electronic Mail\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>cc:\u003C\u002Fp>\n\n\u003Cp>U Mart International Inc\u003Cbr>\nAttn: Mingzhe Pang and Jin Gao\u003Cbr>\n75 Braintree St Apt 215\u003Cbr>\nAllston, Massachusetts 02134-1858\u003C\u002Fp>\n\n\u003Cp>Name.com, Inc.\u003Cbr>\nabuse@name.com\u003C\u002Fp>\n\n\u003Cp>Fastly, Inc.\u003Cbr>\nabuse@fastly.com\u003C\u002Fp>\n\n\u003Cp>___________________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https:\u002F\u002Fwww.fda.gov\u002Ftobacco-products\u002Fctp-newsroom\u002Fnewly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21.\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\nMingzhe Pang\n\nU Mart International, Inc.\n\n4 Brighton Ave\n\nAllston, MA 02135\n\nUnited States\n\nwe.care@umartgo.com\n\numartinternational@gmail.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nMay 25, 2023\n\nWARNING LETTER\n\nDear Mingzhe Pang:\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fwww.umartgo.com and determined that electronic nicotine delivery system (ENDS) products listed there are 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 ENDS, 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, ENDS are required to be in compliance with the requirements in the FD&C Act.\n\nFDA has determined that your RELX Classic Replacement Pod – Dark Sparkle (Cola) ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age.\n\nTobacco Product Sold to an Individual Under the Age of 21 are Misbranded\n\nFDA’s investigation of the website https:\u002F\u002Fwww.umartgo.com revealed that you sold an ENDS product to an individual under the age of 21.1 Specifically, during our investigation of https:\u002F\u002Fwww.umartgo.com, a person younger than 21 years of age purchased RELX Classic Replacement Pod – Dark Sparkle (Cola) ENDS product from your website. No retailer may sell tobacco products to a person younger than 21 years of age under section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)). Because this tobacco product is sold or distributed to persons younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. § 387f(d)(5)), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).\n\nConclusion and Requested Actions\n\nIt is your responsibility to ensure that your tobacco products and all related labeling and\u002For advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments 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., and FDA’s implementing regulations, including those 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. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.\n\nPlease be aware that the FD&C Act requires “new tobacco products” to have premarket authorization. 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. See Section 910(a) of the FD&C Act. Retailers should discuss with their suppliers the current marketing status of any particular tobacco product’s application or any product’s marketing authorization.\n\nThe violation discussed in this letter does not necessarily constitute an exhaustive list. You should address any violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and promptly 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 labeling, advertising, 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, RW2301920, 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 Bryan Hills at (301) 796-9367 or via email at 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\n\nVIA UPS and Electronic Mail\n\ncc:\n\nU Mart International Inc\n\nAttn: Mingzhe Pang and Jin Gao\n\n75 Braintree St Apt 215\n\nAllston, Massachusetts 02134-1858\n\nName.com, Inc.\n\nabuse@name.com\n\nFastly, Inc.\n\nabuse@fastly.com\n\n___________________________\n\n1 Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https:\u002F\u002Fwww.fda.gov\u002Ftobacco-products\u002Fctp-newsroom\u002Fnewly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21.","2026-08-20T01:03:26.387+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2023-06-13T13:20:00Z\">06\u002F13\u002F2023\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-05-25T04:00:00Z\">05\u002F25\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fu-mart-international-inc-659734-05252023\">U Mart International, Inc.\u003C\u002Fa>","","2026-08-18T06:42:29.145918+00:00","2026-08-20T02:24:56.344395+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"]