FDA Reauthorizes Swedish Match’s General snus as a Modified Risk Tobacco Product

Business Wire11-12

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...

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PMI affiliates have secured 13 of the 16 modified risk tobacco product  authorizations that the FDA has granted, demonstrating the company’s commitment to a smoke-free future.Initially granted by the FDA in October 2019, the modified risk order permitted Swedish Match to communicate on its website to legal-age consumers that \"Using General snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.\". The MRTP marketing orders were issued following a 2009 law that gr","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0240878834.USD":"SCHRODER ISF GLOBAL SMALL COMPANIES \"A\" (USD) INC AV","LU0661504455.SGD":"Blackrock Global Equity Income A5 SGD-H","LU0426417589.USD":"NINETY ONE GSF GLOBAL FRANCHISE \"A\" (USD) INC","LU1228905037.USD":"NINETY ONE GSF GLOBAL QUALITY DIVIDEND GROWTH \"A\" (USD) ACC","LU0994945656.USD":"NINETY ONE GSF GLOBAL FRANCHISE \"A\" (USD) INC 2","LU2404859741.USD":"FUNDSMITH EQUITY FUND \"R\" (USD) INC","LU0949170772.SGD":"Blackrock Global Equity Income A6 SGD-H","LU2404859667.USD":"FUNDSMITH EQUITY FUND \"R\" (USD) ACC","LU1228905540.USD":"NINETY ONE GSF GLOBAL QUALITY DIVIDEND GROWTH \"A\" (USD) INC 2","BK4585":"ETF&股票定投概念","LU0690374961.EUR":"FUNDSMITH EQUITY \"R\" (EUR) INC","LU0314106906.USD":"MANULIFE GF GLOBAL EQUITY \"AA\" (USD) INC","LU0690374615.EUR":"FUNDSMITH EQUITY \"R\" (EUR) ACC","BK4075":"烟草","LU0738911758.USD":"Blackrock Global Equity Income A6 USD","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","BK4566":"资本集团","PM":"菲利普莫里斯","LU0205193047.USD":"SCHRODER ISF US SMALL & MID-CAP EQUITY \"A\" (USD)  ACC","MTCH":"Match Group, Inc.","LU0545562505.USD":"NINETY ONE GSF GLOBAL QUALITY DIVIDEND GROWTH \"A\" (USD) INC","BK4508":"社交媒体","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","LU0240877869.USD":"SCHRODER ISF GLOBAL SMALL COMPANIES \"A\" ACC","BK4077":"互动媒体与服务","LU1121112475.USD":"NINETY ONE GSF GLOBAL FRANCHISE \"A\" (USDHDG) ACC","BK4588":"碎股","LU0426412945.USD":"NINETY ONE GSF GLOBAL FRANCHISE \"A\" (USD) ACC","LU1506573853.SGD":"MANULIFE GF GLOBAL EQUITY \"AA\" (SGD) INC","LU0205194284.USD":"SCHRODER ISF US SMALL & MID-CAP EQUITY \"A\" (USD) INC AV","GB00B4QBRK32.GBP":"FUNDSMITH EQUITY \"R\" (GBP) INC","GB00B4LPDJ14.GBP":"FUNDSMITH EQUITY \"R\" (GBP) ACC","LU1043141396.HKD":"NINETY ONE GSF GLOBAL FRANCHISE \"A\" (HKD) ACC","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","BK4549":"软银资本持仓","GRO":"Brazil Potash Corp.","LU1043141123.HKD":"NINETY ONE GSF GLOBAL FRANCHISE \"A\" (HKD) INC 2"},"translate_title":"FDA重新授权瑞典火柴公司的通用鼻烟为改良风险烟草产品","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MTCH":1,"GRO":1,"PM":0.9},"content_text":"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\nPMI affiliates have secured 13 of the 16 modified risk tobacco product (MRTP) authorizations that the FDA has granted, demonstrating the company’s commitment to a smoke-free future.\n\nSTAMFORD, Conn., November 12, 2024--(BUSINESS WIRE)--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 General snus 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 General 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.\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 \"Using General snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.\"\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’s submission included 330 scientific studies, including numerous epidemiological studies from Sweden. Sweden has one of the world’s 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 \"Swedish experience\" in their decision.\n\"Swedish Match is on a mission to end smoking for good,\" said Tom Hayes, president of Swedish Match North America. \"The FDA’s 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.\"\nGeneral 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 General snus varieties, which have been available in the U.S. for over a decade and were previously authorized as MRTPs.\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.\nNote to Editor\n\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.\nFDA noted that it will continue to monitor the marketing of the product and its impact on the population.\nThe FDA first authorized General snus products as \"appropriate for the protection of the public health\" in 2015 through its premarket tobacco product application process.\nSince then, Swedish Match USA, Inc. has submitted eight annual reports, the last four of which were combined with MRTP annual reporting.\nThe modified risk products submitted and authorized for renewal include eight General snus varieties that have been available in the U.S. for more than a decade and include:\n  \nGeneral snus original (pouch)\nGeneral snus original (loose)\nGeneral snus white (pouch)\nGeneral snus mint (pouch)\nGeneral snus wintergreen (pouch)\nGeneral snus mini mint (pouch)\nGeneral snus classic blend (pouch)\nGeneral snus Nordic mint (pouch)\n\n\nPhilip Morris International in the U.S.: Delivering a Smoke-Free FuturePMI’s 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 – a leader in oral nicotine delivery – creating a global smoke-free champion led by the IQOS and ZYN brands. The U.S. Food and Drug Administration has authorized versions of IQOS electronically heated tobacco devices and Swedish Match’s General snus as modified risk tobacco products. Renewal applications for these IQOS products are pending before the FDA. For more information, please visit www.pmi.com/us/ and www.pmiscience.com.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241111062598/en/\nContacts\nPhilip Morris InternationalU.S. CommunicationsMatt Sheaff+1 (203) 524-9146matthew.sheaff@smpmi.com","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2482794066"}