{"id":38341,"date":"2021-12-24T05:17:31","date_gmt":"2021-12-24T05:17:31","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=84555"},"modified":"2021-12-24T05:17:31","modified_gmt":"2021-12-24T05:17:31","slug":"fda-authorizes-marketing-of-22nd-century-groups-vln-as-a-modified-risk-tobacco-product","status":"publish","type":"post","link":"https:\/\/timessouthafrica.com\/fda-authorizes-marketing-of-22nd-century-groups-vln-as-a-modified-risk-tobacco-product\/","title":{"rendered":"FDA Authorizes Marketing of 22nd Century Group\u2019s VLN\u00ae as a Modified Risk Tobacco Product"},"content":{"rendered":"<div>\n<div>\n<div>\n<div>\n<h5 style=\"text-align: right;\">VLN\u00ae Cigarettes<\/h5>\n<\/div>\n<div>\n<div style=\"width: 248px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/NewsRoom\/AttachmentNg\/f2454099-23c6-4b74-a46b-28fbb97124d5\/en&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw1IknTBSs1H-HkQstxgQJNU\"  rel=\"noreferrer\"><img fetchpriority=\"high\" decoding=\"async\" class=\"\" src=\"https:\/\/ci6.googleusercontent.com\/proxy\/9u0jqfeow5Co4dFyplOYfJg9x17SFh52WeObxWUOvsILkSVGP9tZJeHzlJFJ1GEQBIosYZ76i0eF5c1NrDW_pxgGobb-3Bv5ymaz7LeE1LX2ZZF_1M3jUegozwEDowFd2rb-p1eCwRopXOo2LNGNRkKRFzo=s0-d-e1-ft#https:\/\/ml.globenewswire.com\/media\/f2454099-23c6-4b74-a46b-28fbb97124d5\/medium\/vln-cigarettes.png\" alt=\"\" width=\"238\" height=\"238\" \/><\/a><\/p>\n<p class=\"wp-caption-text\">VLN\u00ae King &amp; VLN\u00ae Menthol King<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<ul type=\"disc\">\n<li><em>VLN\u00ae Is World\u2019s First and Only Combustible Cigarette to Receive FDA MRTP Designation<br \/>\n<\/em><\/li>\n<li><em>FDA Adds Evidence-Based, Headline Claim \u201cHelps You Smoke Less\u201d to Company\u2019s Requested Claims <\/em><\/li>\n<\/ul>\n<ul type=\"disc\">\n<li><em>VLN\u00ae 95% Reduced Nicotine Content Cigarettes to Launch in the U.S. Within 90 Days<\/em><\/li>\n<li><em>VLN\u00ae to Launch Outside the U.S. in First Quarter 2022<\/em><\/li>\n<\/ul>\n<p>BUFFALO, N.Y., Dec. 23, 2021 (GLOBE NEWSWIRE) &#8212; 22nd Century Group, Inc. (Nasdaq: <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Dx1ggA81N9Zm_cdbHOGYctcmpqVpHdN5QERhoDAKTEZxLpKbtRlf1HH1w_pEgdQFqi5Mb0ovS7ug4Y6lwMCegSrhawQHZz49g3IRMxOYir-RKjtn4WAkqIib8XH-RRfwV&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw2dMwbUxSmbhqD8eCC3G3eV\"  rel=\"nofollow noreferrer\">XXII<\/a>), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, announced today that the U.S. Food and Drug Administration (FDA) has <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DRdQalHi-v0uNJuxMXsrlNz1wTQCs2IJAuYFAs9lGjxdTxEwSrR7uGhx7PdzE2HGGhxmvVdUkcLSqJe1UakVkfWTtqhmQ4So1aIkQaOh2Ru_9mv_B2WZuH9Z1tdb64ffRa1a11X2OMpl8GUf1JIyTe8J3CAQZbVAkKS_CJJ9NE321kpweDB1I0HQ5jQJhD67psBtTEt-byDFBhofpmkdF0_8BozAgVuYA69V6BCBg3hB3DOF_UQdHCaMcxeVHuMT8&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw27SJcyvDfPDIuYx-L8cP1F\"  rel=\"nofollow noreferrer\">authorized the<\/a><a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DAN_-6zNPRqgrKg8VGKrXHCAR5o6Z4kLBbHa3VIRfvIXnCUdgvp9UzBml0IKrjIvYRZDJddNWv3X-MI60w0dHcg9YhMKURS9sQF6Q-h6PU8hULDxqD7X0DXRimHnq89qiEhysHya_hNDK8QcExNrtgDAT0JCKfkTKe_keneRoH837FeabypqLEJdlMOtq45I9hnkpFcl75p0yGeBoMU6YGfwWm9J8jEm4XP3X2n8HS1CGi_gicppQLBVW3MDWQsdu&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw09qq1IHvZ86FOFmbqExuoX\"  rel=\"nofollow noreferrer\"> marketing<\/a> of the Company\u2019s VLN\u00ae King and VLN\u00ae Menthol King reduced nicotine content cigarettes as modified risk tobacco products (MRTPs). In doing so, the Agency found that VLN\u00ae \u2013 which smokes, tastes, and smells like a conventional cigarette but contains 95% less nicotine than conventional, highly addictive cigarettes \u2013 \u201chelp reduce exposure to, and consumption of, nicotine for smokers who use them.\u201d<\/p>\n<p>\u201cToday\u2019s decision to authorize VLN\u00ae\u2019s MRTP application places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry. With 60% of adult smokers in our U.S. market research telling us they are likely to try VLN\u00ae, this is a complete game-changer for 22nd Century, the tobacco industry, public health, and adult smokers looking to change their relationship with nicotine \u2013 the addictive chemical found in all tobacco products. This is the first, and most likely will be the only, combustible cigarette to ever carry the FDA\u2019s MRTP designation. The FDA\u2019s decision to require the additional headline claim \u2018Helps You Smoke Less\u2019 alongside our requested headline claim of &#8216;95% Less Nicotine&#8217; gives adult smokers a crystal-clear reason to replace their conventional and highly addictive cigarettes with VLN\u00ae,\u201d said James A. Mish, chief executive officer at 22nd Century Group.<\/p>\n<p>\u201cOur mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,\u201d <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DknjCJ1c9jFtYoOzZhTdOk7F_d05rJlh9p6E-h4xALLTHPeptPwEVpVXfOLGiMqWGCX_enPlnQVBVPXHTpd703eS_m3tyWAzpcTDlXro_4TlKCNvJFF9Rl9ZoMaAjYzwK0NPrtbXt1BNyHqmB4lRduTDhRRmFeqMZBq8PBawov_ycHHE_Q54aYa-niLmooQsOMVPf5nxLyifHTSNwfwCcTtyRh96FUJNRXXFhdErC6ijPL8e9lljso4nyTg1wJfat&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw39Z-2Zs4HYt_dXRzpdOxZf\"  rel=\"nofollow noreferrer\">said<\/a> Mitch Zeller, J.D., director of the FDA\u2019s Center for Tobacco Products. \u201cHaving options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.\u201d<\/p>\n<p>\u201cHaving secured this FDA marketing order, we are fully prepared to launch VLN\u00ae with select retail and marketing partners in our pilot markets in the U.S. within the next 90 days and in the first of several global markets by the end of the first quarter of 2022. We are also in discussions with additional retail trade, marketing, and strategic partners to scale VLN\u00ae sales in the U.S. and internationally, including through potential licensing of our technology to facilitate the broader industry transition to RNC products. We will provide additional details on strategic partners and the rollout of VLN\u00ae in the coming months,\u201d said Mish.<\/p>\n<p>The FDA authorized the marketing of VLN\u00ae with the following MRTP claims:<\/p>\n<ul type=\"disc\">\n<li>\u201cHelps you smoke less.\u201d<\/li>\n<li>\u201c95% less nicotine.\u201d<\/li>\n<li>\u201cHelps reduce your nicotine consumption.\u201d<\/li>\n<li>\u201c&#8230;Greatly reduces your nicotine consumption.\u201d<\/li>\n<\/ul>\n<p>The FDA\u2019s decision to authorize the Company\u2019s MRTP claims and to require the additional claim of \u201cHelps You Smoke Less\u201d on every VLN\u00ae pack and in every VLN\u00ae advertisement where any of the other authorized claims are also used was based on an extensive body of science consisting of dozens of independent scientific and clinical studies using 22nd Century\u2019s reduced nicotine content (RNC) tobacco cigarettes. These studies, which were funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, as well as studies funded by 22nd Century, show that smokers who use RNC cigarettes \u2013 even those with no intention of quitting at the beginning of the studies \u2013 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 symptoms or compensatory smoking.<\/p>\n<p>In its <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DN8xtcsz03XNcsMyh7LNOZgVTa0JYJ4pUmw0lcK1dUgiagiaC_qxIwOmFZ3xEPev2UBnYZT01_k-j6NOw2AQzwF5Ri6nboy00B3j_OqGYwa1ep4mU_PwR3v2t1vPjzEW2hhTa5bGiKpYbHNclp17kcnqfD64FCOikEXlVdYXyOlK1OL3bkNvCsWzwOMEzuUAikzbN-eKc0LVwIby1JmHWejFpy8cEQZ3YTpx9ZeKN_--wrLcymUn5ECItCELjl-ug&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw3ZHNeEgFhfA37M5WDwbsag\"  rel=\"nofollow noreferrer\">announcement<\/a> of its decision today, FDA explained, \u201cThe data also showed it is reasonably likely that using these products reduces nicotine dependence, which is anticipated to lead to long-term reductions in exposure to the smoking-related toxicants associated with morbidity and mortality by reducing smoking. Published studies have shown that significantly reducing the number of cigarettes smoked per day is associated with lower risk of lung cancer and death, with greater reductions in cigarettes per day resulting in less risk. Additionally, as required for authorization, the FDA found that the applications supported consumer understanding of the claims that VLN\u00ae cigarettes contain much lower levels of nicotine than other cigarettes.\u201d<\/p>\n<p>VLN\u00ae is also the first and only combustible cigarette to come to market that complies with the FDA\u2019s proposed nicotine cap for conventional cigarettes in its <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3D9S5mXO_vsWVxAVtSnHN46bhi28FGpZceT5udKo78fjhnmb38GI-GO9i0spODsa-ciygH0NUVDps8Eg8PbO3KdlpaB9l2hGHTRKtumZkrW-n_4vaFm1QNeS1iTA-_CKANMPGZ-lqIKX_a5FtLLON4u48RA20Vssg30-8ozgTbx25ErSpbOF_XJp72FTdPyjQBMv8xqhz3IWXWo_jPM9dIJEE-0Xeqyb0Ah27CWMYlKrAkpoLt9tMMczccRIT3a-VS&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw27ECipjL28caYe52AJKsfn\"  rel=\"nofollow noreferrer\">Comprehensive Plan for Tobacco and Nicotine Regulation<\/a> as well as New Zealand\u2019s recently <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DDR7iF87dLGJy7xgsvGC7Qbd15ee5NlE6V65oGu7XXPBn7ZLlwG1TfUjYkRn8hMiljWQwn7EyFGT5weQtJDe5LMtYfIVvB3lapPiJ7l6NpVo64CyIBW6WUTEQSPngJpTRlsNXrs4mBGefwYIeZX7Ul42Ma6ZvDSZwBOY2kFB3EXtwzo64LgVrHQNAO1pvv8uCgrXjXrNBmLS4xHJ4fStuhA%3D%3D&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw1U5eOy71gJzBonmWu3ABHE\"  rel=\"nofollow noreferrer\">proposed<\/a> reduced nicotine content mandate.<\/p>\n<p>\u201cWe believe today\u2019s announcement by the FDA is a clear indication that the FDA is moving forward with its Plan to address the incredible harms caused by smoking. This plan includes the authorization of less toxic tobacco products such as e-cigarettes and other non-combustible products along with a nicotine cap of 0.5 mg of nicotine per gram of tobacco in combustible tobacco products. This level of nicotine content, which the FDA has described as being \u2019minimally or non-addictive,\u2019 has already been achieved by 22nd Century in its VLN\u00ae products,\u201d said Mish.<\/p>\n<p>The FDA reiterated in its <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DN8xtcsz03XNcsMyh7LNOZhxrwjKWQ6Tmsih3-VmQhfI_nFsL81fRuQAj_m7F8q7j5GMvxRWZlMv4cF_gBzjJDzVde2bueAW_yFQ7WwJwnDuQs76f12YcmBnEuWIxEWpNjxuXd3t33aIB4dLRw14iXV-1lgBgZW46uVysDwsOYZkr7oiEjGnO59siH678WsSaO_2LSZz31blOOnGOi9O-4S1lFnjhvtiJM7vy5bv4GvnlL5nLU324Akw1X411g1Wb&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw2tOs4OhzN5rCqwSV6XpSID\"  rel=\"nofollow noreferrer\">announcement<\/a> today that it is \u201ccommitted to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022\u201d and that both VLN\u00ae King and VLN\u00ae Menthol King cigarettes \u201ccould help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day.\u201d<\/p>\n<p>\u201cAs the FDA also looks to ban menthol in highly addictive cigarettes, we fully expect the FDA will allow our VLN\u00ae Menthol cigarettes, which offer little appeal for youth and former smokers because of their reduced nicotine content, to be allowed by the FDA to remain on the market to provide an off-ramp for adult smokers of menthol cigarettes,\u201d added Mish.<\/p>\n<p>The FDA\u2019s decision further builds on <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DI95d9IRpfWF4J8l86T9VCmJBDN-JiW_6q1v8NB3d-heqh_TKcmXz3dApdmo_8mhL75_9YM8l81YwCHGfeKYyOfYAuSHF9NDjV9V6EwvWd8lhazj7fl3EM1rpD_pJOUvC0w8EU9MJLRHGSQ3luDJMZA_59XJ6JMEFZsGx31RHJyWLSPWoX0ie8I5TrXmiBHjbleFYVxIAlkAN07CH25LbWQwrxZz2k9SkzsELSOebZxY%3D&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw31NqDX4LKPmCYCGMnAdZYY\"  rel=\"nofollow noreferrer\">research<\/a> projecting that an industry product standard to lower nicotine content in cigarettes to minimally or non-addictive levels would significantly change the trajectory of cigarette addiction, which is the leading cause of preventable disease and death in the U.S. Approximately five million adult smokers would quit within just one year of implementation, more than 33 million people would avoid becoming regular smokers, and more than eight million premature deaths from tobacco could be avoided. With almost half a million Americans dying from smoking and more than $300 billion spent per year on smoking-related diseases, there is a clear and urgent need for substantial change in the tobacco industry.<\/p>\n<p>22nd Century is ready to supply the market with RNC tobacco and finished products such as VLN\u00ae to enable both 22nd Century and other manufacturers to comply with the proposed nicotine caps in the U.S., New Zealand and other countries as they embrace this innovative and highly effective approach to tobacco harm reduction first proposed by the <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DHVyoS5D3pIKr5FN0jwifPkWPLUIJMSB3WYuelTC0dSyl4aSMGvvC7QLbRgEoJKzuk-56JUrZsc85cM7ecBB-Lw17lmENZImfczbUkfHZ6hs%3D&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw1rAIEA4F6a_1MH9kaCox4E\"  rel=\"nofollow noreferrer\">WHO in 2015<\/a>. 22nd Century\u2019s plant-based technology and products are superior to costly extraction and similar de-nicotinization technologies because those technologies typically use chemicals that strip out not just nicotine but also flavor and aroma compounds, resulting in a product that has been found unacceptable to smokers because it delivers no smoking satisfaction. In contrast, 22nd Century\u2019s reduced nicotine tobacco naturally grows with very low levels of nicotine resulting in products that smoke, taste and smell like conventional cigarettes but contain 95% less nicotine than conventional, highly addictive cigarettes. This is critical to creating an acceptable solution and \u201coff-ramp\u201d for current smokers looking to change their relationship with nicotine.<\/p>\n<p>22nd Century remains committed to licensing its technology and products to every manufacturer to enable industry wide compliance with the proposed nicotine caps.<\/p>\n<p><strong>About 22nd Century Group,\u00a0Inc.<\/strong><br \/>\n22nd Century Group, Inc. (Nasdaq:\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Dx1ggA81N9Zm_cdbHOGYctSS8XrfbUvdgBmG90DJoJ_OvSkPvhnpInnWGaFFk_ihGDLYqJ12zk37GQs245DpRxsXTZKM7XsgkB02z4kDXXnWWkLmAmNvFxkysQ7WRRHjs&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw3cNjTo9YXaW3aeEpKoljoU\"  rel=\"nofollow noreferrer\">XXII<\/a>) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DYfByHci_W_spkjnnMp7JeQbAfiKqFB4jHHLvEANu6R2X4ZGF25uCo-dMhjQvTgJknHov58zpybP5IzGbW-SsUxOAJi52regJPoi2uir3yJkTnzWKGtDdH_i0DhcOHcXOz3k0xSN3Hifc2Eswhv6mvBMlCG0XrSc_3X3VGQYe_VrVQrIJToa1i8pLCYfnXYRymqI9Z9zKoJFzwOoJc8Y92-lwDzLN61NaoFpDTmnm2NiBTRDgux39V9oCzGP-gafNMjIVZZG65CkQyGh5afloVAcx5TlFFsTr9Ff7oLiqOfYDbViHa7qEQO9Zyl88FzLwqMDNcp6F7LB_qTEXWSrogFXxnvVSbFK56H9ORq_hnZbLW-OKlehMn52ruPgN3T3XvalrlYXbmC2EcvGTt4rN5ue7bWSwSeUdjJ99HJGa-bQ%3D&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw2nDalzLy5ZIPioeADXw6j7\"  rel=\"nofollow noreferrer\">FDA\u2019s Comprehensive Plan<\/a>\u00a0to address the widespread death and disease caused by smoking. In tobacco, hemp\/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.<\/p>\n<p align=\"justify\">Learn more at\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DXsE4u-YJeps17Efl_60CGU5gJiktBo6CjHlrprN5Jzc3XArNoPmfJytHqLP7W5lzzf7fR15uPVfLoImpTRH4t8sXs2SM-n3Z2-PPuqY-N7I%3D&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw0lUqVfoCnTl5dWJ3Pt6YSo\"  rel=\"nofollow noreferrer\">xxiicentury.com<\/a>, on Twitter\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Da1pp3GZaqOz3ImmbsbQdyyf_PcIX2K2bgJccfQaOVTxWWa-ia7Xbl7BPGeQuocpgG6tDe7kDSlQMLs8lZAoCC-Ja7ozamYeVdfwHdtzkEmc%3D&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw3PJ4qErqWp4VXUhHPlcKQ3\"  rel=\"nofollow noreferrer\">@_xxiicentury<\/a>, and on\u00a0<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3Db4Q2Zc2YWB9zdXbvo0WHtWlC81_QzAAOctXZMmR7mp40Le9c-c_Cc2fOBPzsDvqXIGGug0mZ8q47JJRqmGNdjDTRtAK_jq1CY6o_FqCxaKPrfI1ufYVcc6XopQVt7yBg&amp;source=gmail-html&amp;ust=1640409395644000&amp;usg=AOvVaw28ZW4oZk7dEDZzRThIjatM\"  rel=\"nofollow noreferrer\">LinkedIn<\/a>.<\/p>\n<p align=\"justify\">Learn more about VLN\u00ae at <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DXVG8nLrp1Vn1csLSL3yotHlFCGuGDz-C5N9XQPWHH6k1b4PlWrsRyZPy4gfkhctGbqQile6hmQ_0YFl2hBJtHg%3D%3D&amp;source=gmail-html&amp;ust=1640409395645000&amp;usg=AOvVaw0txzi5xUusB3QlPE8UJ35k\"  rel=\"nofollow noreferrer\">tryvln.com<\/a>.<\/p>\n<p align=\"justify\"><strong>Cautionary Note Regarding Forward-Looking Statements<\/strong><br \/>\nExcept 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\"><strong>Investor Relations &amp; Media Contact:<\/strong><br \/>\nMei Kuo<br \/>\nDirector, Communications &amp; Investor Relations<br \/>\n22nd Century Group, Inc.<br \/>\n(716) 300-1221<br \/>\n<a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DcFPBxSZXns3EQMPIMM2mIsNEh_EALQtKrIjydBOw4zBlgJ3FuXMddS7gNcXTTSSyznhyfaaJOmTp7HCvIvrdK4pI-mMvMDcZGnlj27KA5dE%3D&amp;source=gmail-html&amp;ust=1640409395645000&amp;usg=AOvVaw2Pl2TE-jVU5BaBzkGD9LhK\"  rel=\"nofollow noreferrer\">mkuo@xxiicentury.com<\/a><\/p>\n<p>A photo accompanying this announcement is available at <a href=\"https:\/\/www.google.com\/url?q=https:\/\/www.globenewswire.com\/Tracker?data%3DJza7oeQG_ABsCqzSPtnYPfz2hkMHXPR8wX2QnboGBTsYLxlU14BAONwTkXgvU8dlkIWRcVL74GyRSnw1BAT-YLmWk1c3bzdhfMvoYtiJnMJwN6Qn_fvZxSzjXQwHv1d5Y7fKav0hNHpnzQGOyAOGE80uE1dZrRUwAb5zNIPfK4-LQ-LfiahN4jwtRbUq67naBw5rstSs6iSj7pzVR7FiALiamdiqdhdrqONDA71fRqkDmCal4cNZjRlBJ99ZHHxoll8-5KeA3IPSR1gospLVWA%3D%3D&amp;source=gmail-html&amp;ust=1640409395645000&amp;usg=AOvVaw0A-2KFGSZVWHaO9S3Jz60z\"  rel=\"nofollow noreferrer\">https:\/\/www.globenewswire.com\/<wbr \/>NewsRoom\/AttachmentNg\/<wbr \/>f2454099-23c6-4b74-a46b-<wbr \/>28fbb97124d5<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>VLN\u00ae Cigarettes VLN\u00ae Is World\u2019s First and Only Combustible Cigarette to Receive FDA MRTP Designation FDA Adds Evidence-Based, Headline Claim \u201cHelps You Smoke Less\u201d to Company\u2019s Requested Claims VLN\u00ae 95% Reduced Nicotine Content Cigarettes to Launch in the U.S. Within 90 Days VLN\u00ae to Launch Outside the U.S. in First Quarter 2022 BUFFALO, N.Y., Dec. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[10,19,12],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Authorizes Marketing of 22nd Century Group\u2019s VLN\u00ae as a Modified Risk Tobacco Product - Times South Africa<\/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:\/\/timessouthafrica.com\/fda-authorizes-marketing-of-22nd-century-groups-vln-as-a-modified-risk-tobacco-product\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Authorizes Marketing of 22nd Century Group\u2019s VLN\u00ae as a Modified Risk Tobacco Product - Times South Africa\" \/>\n<meta property=\"og:description\" content=\"VLN\u00ae Cigarettes VLN\u00ae Is World\u2019s First and Only Combustible Cigarette to Receive FDA MRTP Designation FDA Adds Evidence-Based, Headline Claim \u201cHelps You Smoke Less\u201d to Company\u2019s Requested Claims VLN\u00ae 95% Reduced Nicotine Content Cigarettes to Launch in the U.S. Within 90 Days VLN\u00ae to Launch Outside the U.S. in First Quarter 2022 BUFFALO, N.Y., Dec. 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