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美国FDA批准IQOS作为改良风险烟草产品进行销售

July 07, 2020 02:47 PM Eastern Daylight Time

2020年7月7日 美国东部夏令时

 

The U.S. Food and Drug Administration (FDA) today authorized the marketing of IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP). In doing so, the agency found that an IQOS exposure modification order is appropriate to promote the public health.

美国食品和药品监督管理局(FDA)今天授权许可菲利普莫里斯国际公司(PMI)的电子加热烟草系统IQOS作为改良风险烟草产品进行销售(MRTP)。在对产品暴露风险改良性的评估中,FDA发现IQOS符合保护公共健康的原则。

- Today’s decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking

- 今天的决定表明,IQOS从根本上有别于其他烟草产品,对于那些会继续吸烟的成年烟民来说,IQOS是一个更好的选择

IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process

- IQOS是目前第一个且唯一一个通过FDA改良风险烟草产品认证过程,获得批准以MRTP进行销售的电子尼古丁产品

- The FDA authorized the marketing of IQOS with the following information:

- FDA对于IQOS的销售许可包含以下信息:

- The IQOS System heats tobacco but does not burn it

- IQOS系统对烟草进行加热但不燃烧烟草

- This significantly reduces the production of harmful and potentially harmful chemicals

- 这显著降低了有害和潜在有害化学物质的产生

- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces your body’s exposure to harmful or potentially harmful chemicals.

- 科学研究结果表明从传统卷烟彻底转用IQOS可以降低人体暴露于有害或潜在有害化学物质的风险。

- The agency concluded that the available scientific evidence demonstrates that IQOS is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products

- FDA的结论是,现有的科学证据表明,考虑到烟草制品的使用者和目前不使用烟草制品的人,IQOS被认为有益于公共群体的健康

- The FDA’s decision further builds on the emerging independent international scientific consensus that IQOS is a better choice than continuing to smoke, and follows the FDA’s April 2019 decision authorizing the commercialization of IQOS in the U.S.

- 20194FDA批准在美销售IQOS以来,FDA的这一决定进一步建设着一个新的全球独立科研共识:相比于继续吸烟,IQOS是更好的选择。

- The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote the public health

-政府及公共卫生组织应如何对无烟气替代产品进行监管,以将其区别于传统卷烟、促进公共健康,FDA的决定提供了一个重要的范例

This decision follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.

201612月,菲莫国际向FDA提交了大量科学研究证据申请改良风险烟草产品认证,基于对这些科研结果的审查,FDA做出了批准决定。

Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:

对于FDA的声明,菲莫国际总裁谭崇博做出如下评论:

“The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.

FDA的决定是公共健康历史性的里程碑。成千上万美国成年男性和女性烟民会戒烟—但仍有许多人不会戒烟。今天的决定使得我们可以告诉这些不会戒烟的成年人,彻底转用IQOS是比继续吸烟更好的选择。FDA认定科学研究结果证实了从吸烟彻底转用IQOS降低了暴露在有害或潜在有害化学物质中的风险。”

IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.

FDA的决定证实了IQOS从根本上区别于传统可燃卷烟,应该对这样的产品进行有区别的监管。现在—相比于以往任何时候—我们更迫切地需要对如何实现无烟气未来开展从根本上有别以往的合作性的对话。政府和公共卫生组织应当如何监管无烟气替代产品,使其区别于传统卷烟,以促进公共健康,FDA的决定提供了一个重要的范例。

We are excited that this important decision will help guide the choices of adult smokers in the U.S. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS. We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.

我们很高兴这一重要决定将帮助指引美国成年烟民做出选择。对健康来说,最好的选择是永远不要开始吸烟或者彻底戒烟。而对于那些不戒烟的人,他们能做的最好的事情就是转用经过科学证实的无烟气产品。据PMI估算,截止2020331日,全球约有1060万成年烟民停止吸烟转用IQOS。我们相信FDA的决定能够帮助美国成年人继续远离传统卷烟。我们和获得授权许可方奥驰亚集团一起,将继续致力于防止非目标群体对产品的使用,并全力支持FDA对保护青少年的关注。

Today’s decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible.

在我们寻求尽快用无烟气替代产品取代传统卷烟的道路上,我们一直致力于把科学放在最重要的位置上,这样的做法使我们最终得以收获今天的FDA批准。

We look forward to working with the FDA to provide any additional information they may require in order to market IQOS with reduced risk claims.

对于将IQOS作为风险降低产品进行销售,我们期待着与FDA继续合作,提供他们可能需要的任何额外信息。

Harnessing innovations like IQOS to dramatically speed-up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences.”

利用像IQOS这样的创新来大幅加速吸烟量的下降是本世纪的机遇。在防范非目标群体使用的同时,以科学为基础的全面监管有助于迅速将原本会继续吸烟的成年吸烟者转向更好的选择。

Note to Editor

编者须知

The MRTP marketing orders were issued pursuant to a 2009 law that empowers FDA to regulate tobacco products, including through oversight of innovative tobacco products.

MRTP销售指令是根据2009年的一项法律发布的,该法律授权FDA监管烟草产品,包括监管创新型烟草产品。

PMI submitted MRTP applications for the IQOS device and three HeatStick variants: Marlboro HeatSticksMarlboro Smooth Menthol HeatSticks, and Marlboro Fresh Menthol HeatSticks.

菲莫申请MRTP的产品包括IQOS设备及三种规格的加热烟支:Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks; 以及 Marlboro Fresh Menthol HeatSticks

On April 30, 2019, the FDA authorized IQOS for sale in the U.S. through issuance of premarket tobacco authorization marketing orders that deemed the marketing of the product appropriate for the protection of public health.

2019430日,FDA批准IQOS烟草产品预上市申请,授权IQOS在美国销售,认为该产品适合保护公共健康的原则。

On March 30, 2020, PMI submitted a supplemental premarket tobacco product application for the IQOS 3 tobacco heating device with the FDA.

2020330日,PMIFDA提交了IQOS 3烟草加热装置的烟草产品预上市补充申请。

Philip Morris International: Delivering a Smoke-Free Future

Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the United States. In addition, PMI ships a version of its IQOS Platform 1 device and its consumables authorized by the U.S. Food and Drug Administration to Altria Group, Inc. for sale in the U.S. under license. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free IQOS product portfolio includes heat-not-burn and nicotine-containing vapor products. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to PMI's heat-not-burn product, available for sale in 53 markets in key cities or nationwide under the IQOS brand.

菲利普莫里斯国际:创造无烟气未来

菲利普莫里斯国际(PMI)正在引领烟草行业的转型,创造无烟气未来,并最终用无烟气产品取代传统卷烟,造福那些原本会继续吸烟的成年人、社会、公司及其股东。PMI是一家领先的国际烟草公司,在美国以外的市场从事传统卷烟、无烟气产品和相关电子设备及配件以及其他含尼古丁产品的制造和销售。此外,PMI授权奥驰亚集团(Altria GroupInc.)在美销售经美国FDA许可销售的平台1产品IQOS设备及加热烟支。PMI正在建立一个新的无烟气产品类别的未来,这类产品虽然不是无风险的,但比继续吸烟要好得多。以多学科产品开发能力、最先进的设施和科学研究证明为基础,PMI旨在确保其无烟气产品符合成年消费者的喜好和严格的监管要求。PMI的无烟气产品IQOS品牌组合包括加热不燃烧及含尼古丁蒸汽产品。据PMI估算,截至2020331日,全球约有1060万成年烟民已经停止吸烟并用PMI的加热不燃烧产品,IQOS在全球53个市场的重点城市或全国范围内进行销售。


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