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STAMFORD, Conn.--(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.
康涅狄格州斯坦福德(商业新闻短讯)--美国食品和药物管理局(FDA)授权续签由瑞典Match USA,Inc.(瑞典Match)提交的风险修改令,瑞典Match USA,Inc.(瑞典Match)是菲利普莫里斯国际公司(PMI)(纽约证券交易所:PM)的附属公司,用于八种通用鼻烟产品。作为授权的一部分,该机构批准使用修改后的风险索赔,以惠及更多21岁以上吸烟或使用传统烟草制品的成年人。
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..
该机构的结论是,延长一般鼻烟风险修改令将大大减少烟草相关疾病对个体烟草使用者的危害和风险,并有利于整个人群的健康。。
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.”.
最初由FDA于2019年10月批准,修改后的风险指令允许瑞典Match在其网站上向法定年龄的消费者传达“使用普通鼻烟代替香烟可以降低口腔癌,心脏病,肺癌,中风,肺气肿和慢性支气管炎的风险。”。
For 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.
对于被授权为改良风险烟草产品(MRTP)的产品,应用程序必须证明它们将显着降低对个体烟草使用者的危害和烟草相关疾病的风险,并有利于整个人群的健康。瑞典Match提交的资料包括330项科学研究,其中包括瑞典的许多流行病学研究。
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..
瑞典是世界上吸烟率最低的国家之一,这在一定程度上可以归因于替代品的可用性,例如比传统香烟更好的鼻烟。FDA在他们的决定中指出了“瑞典经验”的重要性。。
“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.”.
瑞典Match北美总裁汤姆·海斯(TomHayes)表示:“瑞典Match的使命是永远戒烟。”。“美国食品和药物管理局的决定是帮助吸烟者和其他传统烟草使用者转向无烟产品的重要一步,作为继续吸烟的更好替代品,并有助于保护公众健康。”。
General 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.
通用鼻烟是一种无烟口腔烟草产品,传统上在瑞典生产,不发酵,空气固化。新的风险修改令适用于八种通用鼻烟品种,这些品种在美国已有十多年的历史,以前被授权为MRTPs。
In 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.
2022年,PMI的一家附属公司收购了口服尼古丁递送领域的领导者瑞典Match。自2008年以来,PMI附属公司已投资125多亿美元,为那些原本会继续吸烟的成年人开发、科学证实和商业化创新无烟产品。
Note to Editor
编辑注意事项
The MRTP marketing orders were issued following a 2009 law that granted FDA regulatory authority over tobacco products, including through oversight of innovative tobacco products.
MRTP营销订单是根据2009年的一项法律发布的,该法律授予FDA对烟草产品的监管权限,包括通过监督创新烟草产品。
FDA noted that it will continue to monitor the marketing of the product and its impact on the population.
FDA指出,它将继续监测该产品的营销及其对人群的影响。
The FDA first authorized General snus products as “appropriate for the protection of the public health” in 2015 through its premarket tobacco product application process.
2015年,FDA通过其上市前烟草产品应用程序,首次授权通用鼻烟产品“适合保护公众健康”。
Since then, Swedish Match USA, Inc. has submitted eight annual reports, the last four of which were combined with MRTP annual reporting.
此后,瑞典Match USA,Inc.提交了八份年度报告,其中最后四份与MRTP年度报告合并。
The 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:
提交并授权更新的改良风险产品包括八种通用鼻烟品种,这些品种在美国已有十多年的历史,其中包括:
General snus original (pouch)
普通鼻烟原装(袋装)
General snus original (loose)
普通鼻烟原味(松)
General snus white (pouch)
通用鼻烟白(袋)
General snus mint (pouch)
普通鼻烟薄荷(袋装)
General snus wintergreen (pouch)
冬青普通鼻烟(袋装)
General snus mini mint (pouch)
通用鼻烟迷你薄荷(袋)
General snus classic blend (pouch)
通用鼻烟经典配方(袋装)
General snus Nordic mint (pouch)
通用鼻烟北欧薄荷(袋)
Philip Morris International in the U.S.: Delivering a Smoke-Free Future
菲利普·莫里斯国际在美国:打造无烟未来
PMI’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.
PMI的美国分支机构正在努力实现无烟未来。自2008年以来,PMI附属公司在全球投资125亿美元,为成年人开发、科学证实和商业化创新无烟产品,否则他们将继续吸烟,目的是将其转变为更好的替代品。
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.
2022年,PMI的一家附属公司收购了口服尼古丁输送领域的领导者瑞典Match,创造了一个由IQOS和ZYN品牌领导的全球无烟冠军。美国食品和药物管理局已授权IQOS电子加热烟草设备和瑞典Match的通用鼻烟作为改良风险烟草产品。
Renewal applications for these IQOS products are pending before the FDA. For more information, please visit www.pmi.com/us/ and www.pmiscience.com..
这些IQOS产品的续期申请正在FDA面前等待。有关更多信息,请访问www.pmi.com/us/和www.pmiscience.com。。