{"id":60315,"date":"2024-11-12T04:05:39","date_gmt":"2024-11-12T03:05:39","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-reauthorizes-swedish-matchs-general-snus-as-a-modified-risk-tobacco-product\/"},"modified":"2024-11-12T04:05:39","modified_gmt":"2024-11-12T03:05:39","slug":"fda-reauthorizes-swedish-matchs-general-snus-as-a-modified-risk-tobacco-product","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-reauthorizes-swedish-matchs-general-snus-as-a-modified-risk-tobacco-product\/","title":{"rendered":"FDA Reauthorizes Swedish Match\u2019s General snus as a Modified Risk Tobacco Product"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nPhilip Morris International affiliate, Swedish Match, earned first-ever FDA authorization for a modified risk marketing claim and now is the first to achieve an FDA renewal<\/li>\n<li>\nPMI affiliates have secured 13 of the 16 modified risk tobacco product (MRTP) authorizations that the FDA has granted, demonstrating the company\u2019s commitment to a smoke-free future.<\/li>\n<\/ul>\n<p>STAMFORD, Conn.&#8211;(BUSINESS WIRE)&#8211;The U.S. Food and Drug Administration (FDA) authorized a renewal of a risk modification order submitted by Swedish Match USA, Inc. (Swedish Match), an affiliate of Philip Morris International, Inc. (PMI) (NYSE: PM), for eight <i>General <\/i>snus<i> <\/i>products. As part of the authorization, the agency granted use of the modified risk claim to reach more adults 21+ who smoke or use traditional tobacco products. The agency concluded that renewing the <i>General <\/i>snus risk modification order will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.<\/p>\n<p>\nInitially granted by the FDA in October 2019, the modified risk order permitted Swedish Match to communicate on its website to legal-age consumers that <i>\u201cUsing General snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.\u201d<\/i><\/p>\n<p>\nFor a product to be authorized as a modified risk tobacco product (MRTP), applications must demonstrate that they will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. Swedish Match\u2019s submission included 330 scientific studies, including numerous epidemiological studies from Sweden. Sweden has one of the world\u2019s lowest smoking rates which in part can be attributed to the availability of alternatives such as snus that are better than conventional cigarettes. The FDA noted the importance of the \u201cSwedish experience\u201d in their decision.<\/p>\n<p>\n<i>\u201cSwedish Match is on a mission to end smoking for good,\u201d said Tom Hayes, president of Swedish Match North America. \u201cThe FDA\u2019s decision is an important step in helping cigarette smokers and other traditional tobacco users make the switch to smoke-free products as a better alternative to continued smoking and in helping to protect public health.\u201d<\/i><\/p>\n<p>\n<i>General <\/i>snus is a smoke-free oral tobacco product, traditionally produced in Sweden, that is non-fermented and air-cured. The renewed risk modification order applies to the eight <i>General <\/i>snus<i> <\/i>varieties, which have been available in the U.S. for over a decade and were previously authorized as MRTPs.<\/p>\n<p>\nIn 2022, a PMI affiliate acquired Swedish Match, a leader in oral nicotine delivery. Since 2008, PMI affiliates have invested more than $12.5 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke.<\/p>\n<p>\n<b>Note to Editor<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe MRTP marketing orders were issued following a 2009 law that granted FDA regulatory authority over tobacco products, including through oversight of innovative tobacco products.<\/li>\n<li>\nFDA noted that it will continue to monitor the marketing of the product and its impact on the population.<\/li>\n<li>\nThe FDA first authorized <i>General<\/i> snus products as \u201cappropriate for the protection of the public health\u201d in 2015 through its premarket tobacco product application process.<\/li>\n<li>\nSince then, Swedish Match USA, Inc. has submitted eight annual reports, the last four of which were combined with MRTP annual reporting.<\/li>\n<li>\nThe modified risk products submitted and authorized for renewal include eight <i>General <\/i>snus varieties that have been available in the U.S. for more than a decade and include:<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<i>General <\/i>snus original (pouch)<\/li>\n<li>\n<i>General <\/i>snus original (loose)<\/li>\n<li>\n<i>General <\/i>snus white (pouch)<\/li>\n<li>\n<i>General <\/i>snus mint (pouch)<\/li>\n<li>\n<i>General <\/i>snus wintergreen (pouch)<\/li>\n<li>\n<i>General <\/i>snus mini mint (pouch)<\/li>\n<li>\n<i>General <\/i>snus classic blend (pouch)<\/li>\n<li>\n<i>General <\/i>snus Nordic mint (pouch)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>\n<b>Philip Morris International in the U.S.: Delivering a Smoke-Free Future<br \/>\n<br \/><\/b>PMI\u2019s U.S. affiliates are working to deliver a smoke-free future. Since 2008, PMI affiliates have invested $12.5 billion globally to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke with the goal of transitioning them to better alternatives. In 2022, a PMI affiliate acquired Swedish Match \u2013 a leader in oral nicotine delivery \u2013 creating a global smoke-free champion led by the <i>IQOS<\/i> and <i>ZYN<\/i> brands. The U.S. Food and Drug Administration has authorized versions of <i>IQOS<\/i> electronically heated tobacco devices and Swedish Match\u2019s <i>General <\/i>snus as modified risk tobacco products. Renewal applications for these IQOS products are pending before the FDA. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pmi.com%2Fus%2F&amp;esheet=54150927&amp;newsitemid=20241111062598&amp;lan=en-US&amp;anchor=www.pmi.com%2Fus%2F&amp;index=1&amp;md5=4028c2319c56e30106b18230c2fe5b3f\" rel=\"nofollow noopener\" shape=\"rect\">www.pmi.com\/us\/<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pmiscience.com%2F&amp;esheet=54150927&amp;newsitemid=20241111062598&amp;lan=en-US&amp;anchor=www.pmiscience.com&amp;index=2&amp;md5=88aa8f5199bf875b7143918622f337d9\" rel=\"nofollow noopener\" shape=\"rect\">www.pmiscience.com<\/a>.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nPhilip Morris International<br \/>\n<br \/>U.S. Communications<br \/>\n<br \/>Matt Sheaff<br \/>\n<br \/>+1 (203) 524-9146<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;&#58;&#x6d;&#97;&#x74;&#116;&#x68;e&#x77;&#46;&#x73;h&#x65;a&#x66;f&#x40;p&#109;&#x69;&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#x61;&#116;t&#x68;&#x65;&#119;&#46;s&#x68;&#x65;&#97;&#102;f&#x40;&#x73;&#109;pm&#x69;&#x2e;&#99;o&#x6d;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Philip Morris International affiliate, Swedish Match, earned first-ever FDA authorization for a modified risk marketing claim and now is the first to achieve an FDA renewal PMI affiliates have secured 13 of the 16 modified risk tobacco product (MRTP) authorizations that the FDA has granted, demonstrating the company\u2019s commitment to a smoke-free future. STAMFORD, Conn.&#8211;(BUSINESS &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/fda-reauthorizes-swedish-matchs-general-snus-as-a-modified-risk-tobacco-product\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-60315","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Reauthorizes Swedish Match\u2019s General snus as a Modified Risk Tobacco Product - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/fda-reauthorizes-swedish-matchs-general-snus-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 Reauthorizes Swedish Match\u2019s General snus as a Modified Risk Tobacco Product - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Philip Morris International affiliate, Swedish Match, earned first-ever FDA authorization for a modified risk marketing claim and now is the first to achieve an FDA renewal PMI affiliates have secured 13 of the 16 modified risk tobacco product (MRTP) authorizations that the FDA has granted, demonstrating the company\u2019s commitment to a smoke-free future. 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