Analysis of FDA's IQOS marketing authorisation and its policy impacts
Analysis of FDA's IQOS marketing authorisation and its policy impacts
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DOI：
10.1136/tobaccocontrol-2019-055585
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发表时间：
2021-07-01
期刊：
影响因子：
5.2
通讯作者：
Glantz, Stanton
中科院分区：
文献类型：
--
作者：
Lempert, Lauren Kass;Glantz, Stanton
背景 菲利普莫里斯产品公司 (PMPSA) 向美国食品和药物管理局 (FDA) 提交了一份上市前烟草申请 (PMTA)，寻求允许其在美国销售 IQOS 的命令。美国法律要求，如果申请人未能证明其产品“适合保护公众健康”，FDA 将拒绝上市许可。 FDA 于 2019 年 4 月发布了 IQOS 的营销令，菲利普莫里斯公司利用该令在美国境外推广 IQOS。方法 我们分析了 FDA 的技术项目牵头审查和 IQOS 的营销命令、PMTA 的相关法律和指南以及关于 IQOS 健康影响的独立研究。结果 FDA 发现，PMPSA 提交的证据并未证明长期疾病风险降低，并且 IQOS 气雾剂释放出具有致癌和基因毒性潜力的毒素，其中一些毒素的水平比传统卷烟更高。 PMPSA 没有适当考虑双重用途对健康的影响、产品对年轻人的吸引力或数据显示消费者没有准确认识 IQOS 的成瘾风险。尽管 FDA 自己的科学家建议和独立研究表明 IQOS 给使用者带来了严重的风险，包括细胞毒性、基因毒性、肝毒性、心血管和肺部风险，但 FDA 的结论是 IQOS“适合保护公众健康”。结论 FDA 允许 IQOS 在美国上市的决定忽视了有效的科学证据，并误用了法律规定的公共卫生标准。这一决定可能会产生重要的健康影响，影响 IQOS 在美国以外的营销，并削弱公众对 FDA 未来 PMTA 决定的信心。
Background Philip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorisation if applicants fail to demonstrate that their product is 'appropriate for the protection of the public health'. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA. Methods We analysed FDA's Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS. Results FDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential, some at higher levels than conventional cigarettes. PMPSA did not appropriately consider the health impacts of dual use, the product's attractiveness to youth or data showing that consumers do not accurately perceive the addiction risks of IQOS. Despite FDA's own scientists' recommendations and independent research showing that IQOS presents serious risks to users including cytotoxic, genotoxic, hepatotoxic, cardiovascular and pulmonary risks, FDA concluded that IQOS is 'appropriate for the protection of the public health'. Conclusion FDA's decision allowing IQOS to be marketed in the USA disregarded valid scientific evidence and misapplied the public health standard mandated by law. This decision may have important health impacts, influence marketing IQOS outside the USA and erode public confidence in FDA's future PMTA decisions.