美国FDA就PMI申请IQOS 3作为改良风险烟草产品上市征求公众意见

  据外媒报道,近日,美国食品药品监督管理局(FDA)对菲利普莫里斯国际公司(PMI)的申请进行了公开征求意见期,该申请寻求授权将IQOS 3加热不燃烧(HNB)烟草制品作为一种改良风险烟草产品(MRTP)销售。

  IQOS 2.4系统曾在2020年7月7日被授予改良风险烟草产品销售,这是第一个也是唯一一个通过FDA的MRTP流程获得许可的新型烟草尼古丁产品。为了授权MRTP消费者沟通,法律要求FDA的烟草产品中心得出结论,认为该产品适合促进公众健康。

美国FDA就PMI申请IQOS 3作为改良风险烟草产品上市征求公众意见

  与IQOS 2.4相比,IQOS 3设备在技术上有许进步,包括更长的电池寿命和更快的充电间隔。2020年12月7日已通过FDA的上市前审查程序批准其在美国销售,满足了允许其销售的标准,以保护公众健康。

  PMI首席执行官Jacek Olczak说:“PMI致力于无烟的未来,我们将用科学证实的无烟替代品取代香烟,这对那些本来会继续吸烟的成年人来说是一个更好的选择。”

  他表示:我们对以科学为基础的未来的承诺是无与伦比的,自2008年以来,我们已经在无烟产品上投资了80多亿美元。

  这申请强调了PMI的持续承诺,即通过FDA流程向美国成年吸烟者提供新的创新技术。我们对科学的信心,我们相信公众监督和政府的公开参与对于实现无烟未来至关重要。

  附上原文:

  FDA Seeks Public Comments on PMI Application to Market IQOS 3 as Modified Risk Tobacco Product

  NEW YORK--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) today opened a public comment period on Philip Morris International’s (PMI--NYSE: PM) application seeking authorization to market the IQOS 3 electrically heated tobacco system as a Modified Risk Tobacco Product (MRTP).

  PMI’s application requests the same reduced exposure modification orders granted on July 7, 2020, for the IQOS 2.4 system—the first, and only, electronic nicotine product to be granted marketing orders through the FDA’s MRTP process. To authorize MRTP consumer communications, the FDA’s Center for Tobacco Products is required by law to conclude that a product is appropriate to promote the public health.

  The IQOS 3 device contains a number of technological advancements, compared to the IQOS 2.4 device, including longer battery life and quicker recharge between uses. It was authorized for sale in the U.S. via the FDA’s pre-market review process on December 7, 2020, having met the standard that permitting its sale is appropriate to protect public health.

  Commenting on the FDA’s action Jacek Olczak, PMI’s Chief Executive Officer, said:

  “PMI is fully committed to a smoke-free future, one where we completely replace cigarettes with scientifically substantiated smoke-free alternatives that are a better choice for adults who would otherwise continue smoking. Our commitment to a science-based future is unmatched, having invested more than $8 billion since 2008 on smoke-free products.

  This application underscores PMI’s on-going commitment to make new innovations available to American adult smokers through the FDA process; the confidence we have in our science; and our belief that public scrutiny and open engagement with governments is vital to achieving a smoke-free future.”

美国FDA就PMI申请IQOS 3作为改良风险烟草产品上市征求公众意见

  菲利普莫里斯国际公司(Philip Morris International, PMI)正在引领一场烟草行业的变革,以创造一个无烟的未来,并最终以无烟产品取代香烟。目前,PMI的无烟产品包括加热不热燃烧烟草制品和含有尼古丁的雾化产品;截至2021年4月PMI无烟产品已在全球66个国家与地区市场上销售,全球超过1760万消费者已经改用IQOS或因使用IQOS后停止吸烟。

  PMI通过产品开发的多学科能力,最先进的设施和科学证实,确保其无烟产品满足成人消费者的偏好和严格的监管要求,旨在为那些原本会继续吸烟的消费者提供更好的选择。

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中国版IQOS—海玛苏的面世,对加热不燃烧在国内推动意味着什么?

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