[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-cigsway-631906-04262022":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},2656,"cigsway-631906-04262022","Warning Letter","Cigsway",null,"Center for Tobacco Products","Family Smoking Prevention and Tobacco Control Act\u002FAdulterated\u002FMisbranded","2022-05-24","2022-04-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcigsway-631906-04262022","RW2201767","631906","Tobacco","VIA 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 Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">RW2201767\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>Cigsway\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            \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:merabibegiashvilli@hotmail.com\"> merabibegiashvilli@hotmail.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:info@cigsway.com\"> info@cigsway.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>The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fcigsway.com and determined that the cigarette products listed there are offered for sale or distribution to customers in the United States.  Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.  Certain tobacco products, including cigarettes products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).\u003C\u002Fp>\n\n\u003Cp>FDA has determined that several cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.  Additionally, FDA has determined that several cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Modified Risk Tobacco Product Violations\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>FDA has determined that your cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. \u003C\u002Fp>\n\n\u003Cp>Our review of https:\u002F\u002Fcigsway.com revealed that you sell or distribute cigarette products while explicitly or implicitly representing that: (1) the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; (2) the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance; or (3) the products or their smoke do not contain or are free of a substance.  Additionally, the labeling or advertising of these cigarette products uses the descriptors “mild” and “light.”  The website https:\u002F\u002Fcigsway.com includes the following claims regarding your cigarette products, such as Camel Compact Filters, Pall Mall King Nano Blue, and Parliament Reserve:\u003Cbr>\n• “mild and light”\u003Cbr>\n• “mild”\u003Cbr>\n• “low tar” \u003Cbr>\n• “low nicotine”\u003C\u002Fp>\n\n\u003Cp>Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A modified risk tobacco product application under section 911(d) of the FD&C Act (21 U.S.C. § 387k(d)) is required to provide scientific evidence and other information to support issuance of an order under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).  \u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Flavored Cigarette Violations\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Additionally, our review of https:\u002F\u002Fcigsway.com revealed that you offer for sale or distribute the following cigarette product: Dunhill Fine Cut Blue (clove).\u003C\u002Fp>\n\n\u003Cp>This product is purported to contain an artificial or natural flavor that is a characterizing flavor of the product.  Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:\u003C\u002Fp>\n\n\u003Cp>[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.\u003C\u002Fp>\n\n\u003Cp>Cigarettes that are distributed or offered for sale in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).  Thus, your flavored cigarette product is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).\u003C\u002Fp>\n\n\u003Cp>If, however, this cigarette product does not contain a characterizing flavor, it is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as its labeling or advertising is false or misleading because it makes the representation that the product contains clove as a characterizing flavor of the tobacco product.\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 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., 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 or 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 address any violation that is referenced above, as well as violations that are the same as or similar to that 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 http:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\n\n\u003Cp>Please note your reference number, RW2201767, 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 Bryan Hills at (301) 796-9367 or via email at CTPCompliance@fda.hhs.gov.    \u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\nSincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nAnn Simoneau, J.D.\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance and Enforcement \u003Cbr>\nCenter for Tobacco Products\u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\n\u003Cstrong>VIA Electronic Mail\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>cc:\u003C\u002Fp>\n\n\u003Cp>GoDaddy.com, LLC\u003Cbr>\nabuse@godaddy.com \u003C\u002Fp>\n\n\u003Cp>Cloudflare, inc.\u003Cbr>\nabuse@cloudflare.com\u003Cbr>\n \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 Electronic Mail\n\nReference #:\n\nRW2201767\n\nProduct:\n\nTobacco\n\nRecipient:\n\nCigsway\n\nUnited States\n\nmerabibegiashvilli@hotmail.com\n\ninfo@cigsway.com\n\nIssuing Office:\n\nCenter for Tobacco Products\n\nUnited States\n\nThe Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https:\u002F\u002Fcigsway.com and determined that the cigarette products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).\n\nFDA has determined that several cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that several cigarette products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor.\n\nModified Risk Tobacco Product Violations\n\nFDA has determined that your cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.\n\nOur review of https:\u002F\u002Fcigsway.com revealed that you sell or distribute cigarette products while explicitly or implicitly representing that: (1) the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; (2) the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance; or (3) the products or their smoke do not contain or are free of a substance. Additionally, the labeling or advertising of these cigarette products uses the descriptors “mild” and “light.” The website https:\u002F\u002Fcigsway.com includes the following claims regarding your cigarette products, such as Camel Compact Filters, Pall Mall King Nano Blue, and Parliament Reserve:\n\n• “mild and light”\n\n• “mild”\n\n• “low tar”\n\n• “low nicotine”\n\nUnder section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A modified risk tobacco product application under section 911(d) of the FD&C Act (21 U.S.C. § 387k(d)) is required to provide scientific evidence and other information to support issuance of an order under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).\n\nFlavored Cigarette Violations\n\nAdditionally, our review of https:\u002F\u002Fcigsway.com revealed that you offer for sale or distribute the following cigarette product: Dunhill Fine Cut Blue (clove).\n\nThis product is purported to contain an artificial or natural flavor that is a characterizing flavor of the product. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:\n\n[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice . . . that is a characterizing flavor of the tobacco product or tobacco smoke.\n\nCigarettes that are distributed or offered for sale in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette product is adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).\n\nIf, however, this cigarette product does not contain a characterizing flavor, it is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as its labeling or advertising is false or misleading because it makes the representation that the product contains clove as a characterizing flavor of the tobacco product.\n\nConclusion and Requested Actions\n\nIt is your responsibility to ensure that all of 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., 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 or misbranded may be detained or refused admission.\n\nThe violations discussed in this letter do 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 that 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, RW2201767, 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 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 Electronic Mail\n\ncc:\n\nGoDaddy.com, LLC\n\nabuse@godaddy.com\n\nCloudflare, inc.\n\nabuse@cloudflare.com","2026-08-20T01:52:46.272+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2022-05-24T13:20:00Z\">05\u002F24\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-04-26T04:00:00Z\">04\u002F26\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcigsway-631906-04262022\">Cigsway\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+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"]