纽约-（美国商业资讯）-7月。2020年7月7日- 监管新闻：

这 美国食品药品监督管理局（FDA）今天批准了Philip Morris International（PMI）电加热烟草系统IQOS作为改良风险烟草产品（MRTP）的销售。通过这样做，该机构发现IQOS暴露量修改令适合促进公众健康。

-今天的决定表明，IQOS是一种根本不同的烟草产品，是否则会继续吸烟的成年人的更好选择

- IQOS是通过FDA的MRTP过程中授予销售订单的第一个也是唯一的电子产品的尼古丁

-FDA授权IQOS销售以下信息：

-该IQOS系统加热烟草，但不烧

-这大大减少了有害和潜在有害化学物质的产生

-科学研究表明，从传统香烟完全转换为IQOS系统可以减少人体接触有害或潜在有害化学物质的机会。

-该机构的结论是，考虑到烟草制品使用者和目前不使用烟草制品的人，现有的科学证据表明IQOS有望有益于整个人口的健康

-FDA的决定进一步建立在新兴的独立国际科学共识的基础上，即IQOS是比继续吸烟更好的选择，并遵循FDA的规定。2019年四月决定批准的商业化IQOS在我们

-FDA的决定为政府和公共卫生组织如何规范无烟替代品以区别于卷烟以保护和促进公共卫生提供了重要实例。

该决定是在对PMI在2000年提交给FDA的广泛科学证据包进行审查之后得出的。 2016年12月 支持其MRTP应用程序。

评论FDA的公告， 安德烈·卡兰佐波洛斯（AndréCalantzopoulos）PMI首席执行官表示：

FDA的决定是历史性的公共卫生里程碑。今天吸烟的成千上万的美国男女中有许多人会戒烟，但许多人不会。今天的决定可以告知这些成年人，与继续吸烟相比，完全改用IQOS是更好的选择。FDA确定科学研究表明，从常规香烟完全转换为IQOS可以减少接触有害或潜在有害化学物质的机会。

IQOS是与可燃卷烟根本不同的产品，必须得到FDA认可的不同法规。如今，比以往任何时候都更加迫切需要关于一种合作方式的根本不同的对话，以实现无烟的未来。FDA的决定提供了一个重要的例子，说明政府和公共卫生组织如何规范无烟替代品以使其与卷烟区分开来，从而促进公共卫生。

我们很高兴看到这一重要决定将有助于指导成年人吸烟者的选择。 我们健康的最佳选择是永远不要吸烟或完全戒烟。对于那些不戒烟的人，他们可以做的最好的事情就是改用经过科学证实的无烟产品。作为2020年3月31日据PMI估计，全世界大约有1,060万成年吸烟者已经停止吸烟并改用IQOS。我们认为，这一决定可以帮助进一步加速我们成人远离香烟。我们与我们的被许可人Altria一起致力于防止意外使用，并完全支持FDA对保护青少年的关注。

今天的决定是我们不断致力于将科学置于最前沿的结果，因为我们继续寻求尽快以无烟替代品替代卷烟。

我们希望与FDA合作，提供他们可能需要的任何其他信息，以在降低风险要求的情况下推销IQOS。

利用IQOS之类的创新技术来显着加快吸烟率的下降是本世纪的机遇。全面的，基于科学的法规可以帮助迅速转移成年吸烟者，否则他们将继续吸烟以寻求更好的选择，同时防止意外后果。”

编者注

MRTP营销命令是根据2009年法律发布的，该法律授权FDA监管烟草产品，包括通过监督创新烟草产品。

PMI提交了IQOS设备和三个HeatStick变体的MRTP应用程序：Marlboro HeatSticks，Marlboro Smooth Menthol  HeatSticks和Marlboro Fresh Menthol HeatSticks。

在 2019年4月30日，FDA授权的 IQOS可以在我们 通过发布市场前烟草授权营销命令，认为该产品的营销适合保护公众健康。

在 2020年3月30日，PMI向FDA提交了IQOS 3烟草加热装置的补充上市前烟草产品申请。

菲利普·莫里斯国际：实现无烟的未来

菲利普·莫里斯国际（PMI）正在引领烟草业的转型，以创造无烟的未来，并最终以无烟产品替代卷烟，以造福否则将继续吸烟的成年人，社会，公司及其股东。PMI是一家领先的国际烟草公司，在外部市场上从事卷烟，无烟产品及相关电子设备和配件以及其他含尼古丁产品的生产和销售。美国。此外，PMI还提供了IQOS Platform 1设备及其耗材的版本，该版本已获得美国食品和药品管理局（IP）的授权。美国食品药品监督管理局 出售给奥驰亚集团（Altria Group，Inc.） 我们经许可。PMI正在建立一种新的无烟产品的未来，尽管这种产品并非没有风险，但比继续吸烟是更好的选择。通过产品开发的多学科能力，先进的设施和科学依据，PMI旨在确保其无烟产品满足成人消费者的喜好和严格的监管要求。PMI的无烟IQOS产品组合包括不燃烧和含尼古丁的蒸气产品。作为2020年3月31日据PMI估计，全球大约有1,060万成年吸烟者已经停止吸烟，转而使用了PMI的不燃烧即热产品，该产品以IQOS品牌在主要城市或全国的53个市场上有售。

以下为原文（原文来自菲莫国际官网）：

NEW YORK--(BUSINESS WIRE)--Jul. 7, 2020-- Regulatory News:

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.

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

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

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

- The IQOS System heats tobacco but does not burn it

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

- 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.

- 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

- 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.

- 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

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

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

“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.

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.

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.

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.

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.

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.”

Note to Editor

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.

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

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

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.