July 07, 2020 02:47 PM Eastern Daylight Time
2020年7月7日 美國東部夏令時
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.
美國食品和藥品監督管理局（FDA）今天授權許可菲利普莫里斯國際公司（PMI）的電子加熱煙草系統IQOS作為改良風險煙草產品進行銷售（MRTP）。在對產品暴露風險改良性的評估中，FDA發現IQOS符合保護公共健康的原則。
- Today’s decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking
- 今天的決定表明，IQOS從根本上有別于其他煙草產品，對于那些會繼續吸煙的成年煙民來說，IQOS是一個更好的選擇
- IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process
- IQOS是目前第一個且唯一一個通過FDA改良風險煙草產品認證過程，獲得批準以MRTP進行銷售的電子尼古丁產品
- The FDA authorized the marketing of IQOS with the following information:
- FDA對于IQOS的銷售許可包含以下信息：
- The IQOS System heats tobacco but does not burn it
- IQOS系統對煙草進行加熱但不燃燒煙草
- This significantly reduces the production of harmful and potentially harmful chemicals
- 這顯著降低了有害和潛在有害化學物質的產生
- 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.
- 科學研究結果表明從傳統卷煙徹底轉用IQOS可以降低人體暴露于有害或潛在有害化學物質的風險。
- 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的結論是，現有的科學證據表明，考慮到煙草制品的使用者和目前不使用煙草制品的人，IQOS被認為有益于公共群體的健康
- 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.
- 繼2019年4月FDA批準在美銷售IQOS以來，FDA的這一決定進一步建設著一個新的全球獨立科研共識：相比于繼續吸煙，IQOS是更好的選擇。
- 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
-政府及公共衛生組織應如何對無煙氣替代產品進行監管，以將其區別于傳統卷煙、促進公共健康，FDA的決定提供了一個重要的范例
This decision follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.
2016年12月，菲莫國際向FDA提交了大量科學研究證據申請改良風險煙草產品認證，基于對這些科研結果的審查，FDA做出了批準決定。
Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:
對于FDA的聲明，菲莫國際總裁譚崇博做出如下評論：
“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的決定是公共健康歷史性的里程碑。成千上萬美國成年男性和女性煙民會—但仍有許多人不會。今天的決定使得我們可以告訴這些不會的成年人，徹底轉用IQOS是比繼續吸煙更好的選擇。FDA認定科學研究結果證實了從吸煙徹底轉用IQOS降低了暴露在有害或潛在有害化學物質中的風險。”
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的決定證實了IQOS從根本上區別于傳統可燃卷煙，應該對這樣的產品進行有區別的監管?，F在—相比于以往任何時候—我們更迫切地需要對如何實現無煙氣未來開展從根本上有別以往的合作性的對話。政府和公共衛生組織應當如何監管無煙氣替代產品，使其區別于傳統卷煙，以促進公共健康，FDA的決定提供了一個重要的范例。
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.
我們很高興這一重要決定將幫助指引美國成年煙民做出選擇。對健康來說，最好的選擇是永遠不要開始吸煙或者徹底。而對于那些人，他們能做的最好的事情就是轉用經過科學證實的無煙氣產品。據PMI估算，截止2020年3月31日，全球約有1060萬成年煙民停止吸煙轉用IQOS。我們相信FDA的決定能夠幫助美國成年人繼續遠離傳統卷煙。我們和獲得授權許可方奧馳亞集團一起，將繼續致力于防止非目標群體對產品的使用，并全力支持FDA對保護青少年的關注。
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.
在我們尋求盡快用無煙氣替代產品取代傳統卷煙的道路上，我們一直致力于把科學放在最重要的位置上，這樣的做法使我們最終得以收獲今天的FDA批準。
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.
對于將IQOS作為風險降低產品進行銷售，我們期待著與FDA繼續合作，提供他們可能需要的任何額外信息。
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這樣的創新來大幅加速吸煙量的下降是本世紀的機遇。在防范非目標群體使用的同時，以科學為基礎的全面監管有助于迅速將原本會繼續吸煙的成年吸煙者轉向更好的選擇。
Note to Editor
編者須知
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銷售指令是根據2009年的一項法律發布的，該法律授權FDA監管煙草產品，包括監管創新型煙草產品。
PMI submitted MRTP applications for the IQOS device and three HeatStick variants: Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks, and Marlboro Fresh Menthol HeatSticks.
菲莫申請MRTP的產品包括IQOS設備及三種規格的加熱煙支：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.
2019年4月30日，FDA批準IQOS煙草產品預上市申請，授權IQOS在美國銷售，認為該產品適合保護公共健康的原則。
On March 30, 2020, PMI submitted a supplemental premarket tobacco product application for the IQOS 3 tobacco heating device with the FDA.
2020年3月30日，PMI向FDA提交了IQOS 3煙草加熱裝置的煙草產品預上市補充申請。
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.
菲利普莫里斯國際：創造無煙氣未來
菲利普莫里斯國際（PMI）正在引領煙草行業的轉型，創造無煙氣未來，并最終用無煙氣產品取代傳統卷煙，造福那些原本會繼續吸煙的成年人、社會、公司及其股東。PMI是一家領先的國際煙草公司，在美國以外的市場從事傳統卷煙、無煙氣產品和相關電子設備及配件以及其他含尼古丁產品的制造和銷售。此外，PMI授權奧馳亞集團（Altria Group，Inc.）在美銷售經美國FDA許可銷售的平臺1產品IQOS設備及加熱煙支。PMI正在建立一個新的無煙氣產品類別的未來，這類產品雖然不是無風險的，但比繼續吸煙要好得多。以多學科產品開發能力、最先進的設施和科學研究證明為基礎，PMI旨在確保其無煙氣產品符合成年消費者的喜好和嚴格的監管要求。PMI的無煙氣產品IQOS品牌組合包括加熱不燃燒及含尼古丁蒸汽產品。據PMI估算，截至2020年3月31日，全球約有1060萬成年煙民已經停止吸煙并用PMI的加熱不燃燒產品，IQOS在全球53個市場的重點城市或全國范圍內進行銷售。
