{"id":469860,"date":"2021-04-01T10:09:19","date_gmt":"2021-04-01T14:09:19","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=469860"},"modified":"2021-04-01T10:09:19","modified_gmt":"2021-04-01T14:09:19","slug":"multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century\/","title":{"rendered":"Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; Proposed Legislation Would Be Game-Changing for 22nd Century"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li>\n          <em>22nd Century\u2019s Proprietary VLN<sup>\u00ae<\/sup> King and VLN<sup>\u00ae<\/sup> Menthol King Poised to Play a Central Role in Making FDA\u2019s Reduced Nicotine Mandate Feasible<\/em><\/p>\n<\/li>\n<li>\n          <em>MRTP Authorization of VLN<sup>\u00ae<\/sup> King and VLN<sup>\u00ae<\/sup> Menthol King Will Serve as a Major Catalyst for the FDA to Accelerate Rule<\/em><\/p>\n<\/li>\n<li>\n          <em>Containing 95% Less Nicotine than Traditional Cigarettes, VLN<sup>\u00ae<\/sup> is the Only Combustible Tobacco Product that Complies with the FDA\u2019s Proposed Nicotine Cap<\/em><br \/>\n          \n        <\/li>\n<\/ul>\n<p>WILLIAMSVILLE, N.Y., April  01, 2021  (GLOBE NEWSWIRE) &#8212; 22nd Century Group, Inc. (NYSE American: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=QNF44PBpjf96Sgw9UnuXQiI7F710-zbVmZfL5fHCSu00CLdAYH9fviLDPy-UULLtOPFky4PfarV34JAdMsDhRW_NWCEtDwpcrEGVsmjzFII=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">XXII<\/a>), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp\/cannabis research, announced today that it continues to be confident on the renewal of the FDA\u2019s proposed reduced nicotine mandate that would make all cigarettes \u201cminimally or non-addictive.\u201d By way of support, four former U.S. Food and Drug Administration (FDA) commissioners, Robert M. Califf, M.D. MACC; Scott Gottlieb, M.D.; Peggy Hamburg, M.D.; and, Jane Henney, M.D., spoke on a recent <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=iQXm3cv97GgQAAt1LZAQqbHAiKQR7N_sp4yqviu5jHD5nWBI7_b9XX_RFfH7Um2NoiNPB5fAvchpeAVarNL7ZEQDL02ViDYEdJVV5AFwMqY=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">panel<\/a> and were vocal in their endorsement of the mandate to limit the amount of nicotine in cigarettes to levels already achieved by 22nd Century\u2019s reduced nicotine content cigarettes, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=KDNycAYaB_beuvrQ8Z6tlpkD00QTFGGwuZui5_NEItiYIrTSXAZcWa5ZgeITLBiMnb45wyGn2wLU5uwlVEygaDxkdtB3Uxgd4RLemvY_NmQ=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">VLN<sup>\u00ae<\/sup><\/a>.<\/p>\n<p>During the panel discussion, Dr. Gottlieb, who first established the FDA\u2019s <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Rbe4JaTN9OKAckbRu-LMYiTvN9g74gFr_rMOtlbcNVpjAvCWZCURJuvRn0YVvReVxHraW_6pxOejETIZ0lk3mE58HFgHBf6Wdk29jsO7qftNRx7th6kkpLbhI-cAgp_NccVy3_tJkMTHxMcFfz7rKR58-XdhatPauA1cAYOFAxiwGM5-rsOo0tosV52eRXFxmg2-UbcMARY-G35ah0Re9b8m5XHCjgMaE0wOU33OMWWMRzxPtH2X5BBh7JY7OREY\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Comprehensive Plan for Tobacco and Nicotine Regulation<\/a> in 2017, remarked: \u201c[c]ertainly if a Republican administration can begin a process to regulate nicotine in combustible tobacco, I suspect that it\u2019s going to be taken forward by a Democratic administration.\u201d Dr. Hamburg also pointed out that, \u201c[n]ow is the time\u2026to really address a whole range of [tobacco] issues that [the] FDA is now empowered to act on.\u201d<\/p>\n<p>\u201cComing from such a group of experienced and authoritative assembly of public health figures, the comments made during the STAT webcast are a powerful endorsement of the FDA\u2019s plan to implement a reduced nicotine product standard,\u201d said James A. Mish, chief executive officer at 22nd Century. \u201cOver the past year, COVID-19 has brought the criticality of respiratory health to the forefront of public concerns. The FDA has the authority and responsibility to change the trajectory of public health in the U.S., save millions of lives, and protect future generations from addiction by enacting a reduced nicotine mandate. We believe that the Agency will advance their Comprehensive Plan and soon announce its simple, yet powerful reduced nicotine product standard. This will be a grand slam for 22nd Century.\u201d<\/p>\n<p>22nd Century shares the former FDA Commissioners\u2019 enthusiasm. With the recent change in administration at the White House, and Democratic control of both the Senate and the House of Representatives, the Company believes there will be a high focus on improving public health moving forward. The Biden administration is placing public health as a top priority and recently issued a <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=mI0stkwNVZadpNSrkRrrky0-8drWXnIqRgvSPB0j5J8LDafr4yxZizL29ZpcPkwHD1lVhjoKg-Q7P6MCoJwfKM-h28sDKIkXLEhI3WV8E2sZh0jPJIxEDa7ZmMvfg9go9l84bRdqRT76GGhcmAZ_G2uaWiNdujxHU1_9qsN8VjDNhCkA2iFKQ5P0IkD6jbaIQqkCkWLAgn_GJQtHa7K-ejc_ZW3F8hCvoBs06qxcBpw=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">proclamation<\/a> \u201cstrongly committing to improving the prevention and treatment of cancer.\u201d In addition, the appointment of Xavier Becerra as Secretary of the U.S. Department of Health and Human Services (HHS), a long-time proponent of tougher regulation for the tobacco industry, further points to a favorable political climate for the renewal of the reduced nicotine mandate that is projected to <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=BgDd4GEXmZrD61ld4nOYKSw6J29Qhxq9CjVv1yzWRwV4ibtLC94Fg25Pt1ZTIel1pb-RujFTd_DdeWbXqBdqhFxVslpuZvHDH4VundBJ0jYn9xUHZAqBQv3crO4gTu4Mm-tH-dvP9pjfGMeEwed2aQ==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">help<\/a> more than five million people to quit smoking within the first year of implementation and save more than eight million American lives by the end of the century.<\/p>\n<p align=\"justify\">Made from tobacco engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN<sup>\u00ae<\/sup> is the only combustible product that complies with the FDA\u2019s proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts \u2013 all with minimal or no evidence of nicotine withdrawal or compensatory smoking.<\/p>\n<p align=\"justify\">The Company believes that it is in the final stages of the FDA\u2019s application process to obtain a <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=kfWOjPAmJuhZvoLXWmBCZgEPXW1ORfW7begdXlu7W8cEBz96J6b-qfyDAWeFqsBJOR5N4ne1Fr5oPkqjFdFLQS7r8iTroIJUDuDZQsIuym5d7_OiFqAmbpewqWIKjHCLUFfeOPmX82F5U3TLEHFxuFpkuD--UH3tRv8kibXstyd0fJpsj7exfaBfCcF5P-yj54PGLD2aM98OuCIZRvNF5fA2JB7EpuOcjpqyBfNDYO-WewjCZtTo-d8gPiMU9JP3\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Modified Risk Tobacco Product<\/a> (MRTP) designation for VLN<sup>\u00ae<\/sup>. The designation will allow 22nd Century to communicate key features of VLN<sup>\u00ae<\/sup> King and VLN<sup>\u00ae<\/sup> Menthol King, including a headline claim of \u201c95% less nicotine.\u201d Although VLN<sup>\u00ae<\/sup> contains just 0.5 milligrams of nicotine per gram of tobacco, VLN<sup>\u00ae<\/sup> tastes, smells, and smokes like a conventional cigarette. This disruptive product is an innovative alternative to addictive, traditional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN<sup>\u00ae<\/sup> cigarettes within 90 days of receiving authorization from the FDA and believes that a MRTP designation will serve as a catalyst for its VLN<sup>\u00ae<\/sup> brand and tobacco franchise. The Company also remains willing to license its technology to enable every cigarette manufacturer to comply with the FDA\u2019s proposed nicotine cap that will significantly reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.<\/p>\n<p>\n        <strong>About 22nd Century Group,\u00a0Inc.<\/strong><br \/>\n        <br \/>22nd Century Group, Inc. (NYSE American: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=KpjK-PhwryFiD4JAHHnbl2-6GG8A3IyeLFMUV0fVJ3f7s--U-eZ7BUQZUIlVJgFGXfTuZe49FzaQsbITcUA8BA==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">XXII<\/a>) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp\/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century\u2019s primary mission in tobacco is to reduce the harm caused by smoking through the Company\u2019s proprietary reduced nicotine content tobacco cigarettes \u2013 containing 95% less nicotine than conventional cigarettes. The Company\u2019s primary mission in hemp\/cannabis is to develop and commercialize proprietary hemp\/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.<\/p>\n<p align=\"justify\">Learn more at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=pLFY9oVGriZVPxR71oIg_OsLzjeQu3FI1uovR60C3fVSu5Ws-E9TPo_Hp1mMcDhXgaiSgmDAdkkjuJWS9RoBuCzC6jJ-pmu73fwXJIHwzSw=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">xxiicentury.com<\/a>, on Twitter\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AE73jV1n1d2fIHtlhN4LQ5DzBAgAJ_gf0-eF3cw1aTAwAYyj2ip_Zc07x0YsGmMFr_qftcOU5z7sEuI2Co0sKzmjBt91nHUKgD8lTiaYS8Y=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">@_xxiicentury<\/a>, and on\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Uqh6O70vOfvQvWd9HZ6TYafeQZJ0XzHZFu4Q9gwjyUst5lcpWP27afm9jl6GIEhGfcR2Ggk1BZgztQSs5MLvsNx0KGkKFxlHZNBd6NsbNUs4blRSI42yupo8SUaOrL9C\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">LinkedIn<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>Cautionary Note Regarding Forward-Looking Statements<\/strong><br \/>\n        <br \/>Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201cconsider,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cexplore,\u201d \u201cforesee,\u201d \u201cgoal,\u201d \u201cguidance,\u201d \u201cintend,\u201d \u201clikely,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cpreliminary,\u201d \u201cprobable,\u201d \u201cproject,\u201d \u201cpromising,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in \u201cRisk Factors\u201d in the Company\u2019s Annual Report on Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.<\/p>\n<p align=\"justify\">\n        <strong>Investor Relations &amp; Media Contact:<\/strong><br \/>\n        <br \/>Mei Kuo<br \/>Director, Communications &amp; Investor Relations<br \/>22nd Century Group, Inc.<br \/>(716) 300-1221<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=syejdB0Ij65wChNVDvKA_zsR8ZE7WA9KOQ079KLBb200Ugw6RMaCWXGyVJIzDTmqTU6gyDrxEPIyn9RrOBzOg5RBg5RRvomIzUjlhQb7Fws=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">mkuo@xxiicentury.com<\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIwOTgyMCM0MTAwODI4IzIxODg2MDI=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/40201192-e9b9-4e7b-b407-13f8e7cfe425\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>22nd Century\u2019s Proprietary VLN\u00ae King and VLN\u00ae Menthol King Poised to Play a Central Role in Making FDA\u2019s Reduced Nicotine Mandate Feasible MRTP Authorization of VLN\u00ae King and VLN\u00ae Menthol King Will Serve as a Major Catalyst for the FDA to Accelerate Rule Containing 95% Less Nicotine than Traditional Cigarettes, VLN\u00ae is the Only Combustible Tobacco Product that Complies with the FDA\u2019s Proposed Nicotine Cap WILLIAMSVILLE, N.Y., April 01, 2021 (GLOBE NEWSWIRE) &#8212; 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp\/cannabis research, announced today that it continues to be confident on the renewal of the FDA\u2019s proposed reduced nicotine mandate that would &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; Proposed Legislation Would Be Game-Changing for 22nd Century&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-469860","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; Proposed Legislation Would Be Game-Changing for 22nd Century - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; Proposed Legislation Would Be Game-Changing for 22nd Century - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"22nd Century\u2019s Proprietary VLN\u00ae King and VLN\u00ae Menthol King Poised to Play a Central Role in Making FDA\u2019s Reduced Nicotine Mandate Feasible MRTP Authorization of VLN\u00ae King and VLN\u00ae Menthol King Will Serve as a Major Catalyst for the FDA to Accelerate Rule Containing 95% Less Nicotine than Traditional Cigarettes, VLN\u00ae is the Only Combustible Tobacco Product that Complies with the FDA\u2019s Proposed Nicotine Cap WILLIAMSVILLE, N.Y., April 01, 2021 (GLOBE NEWSWIRE) &#8212; 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp\/cannabis research, announced today that it continues to be confident on the renewal of the FDA\u2019s proposed reduced nicotine mandate that would &hellip; Continue reading &quot;Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; Proposed Legislation Would Be Game-Changing for 22nd Century&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-04-01T14:09:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIwOTgyMCM0MTAwODI4IzIxODg2MDI=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/multiple-former-fda-commissioners-voice-support-for-reduced-nicotine-mandate-proposed-legislation-would-be-game-changing-for-22nd-century\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; 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22nd Century Group, Inc. 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