Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Palo Alto, California, USA.
School of Public Health, Georgia State University, Atlanta, Georgia, USA.
Tob Control. 2018 Nov;27(Suppl 1):s41-s47. doi: 10.1136/tobaccocontrol-2018-054596.
Beginning in the 1960s in the USA and globally since 1998, tobacco companies have beenaggressively promoting heated tobacco products (HTP). In 2016, Philip Morris International (PMI) applied to the US Food and Drug Administration (FDA) seeking authorisation to market their IQOS HTP system and flavoured 'HeatSticks' in the USA as a modified-risk tobacco product (MRTP).
We systematically evaluated the publicly available data PMI submitted to FDA in its MRTP application to determine whether PMI's IQOS product meets the US Tobacco Control Act's standard for MRTP claims. We examined whether PMI provided sufficient data showing tobacco users will not initiate with IQOS, that youth will not misperceive the MRTP-related claims being made concerning IQOS, and how youth perceive health risks associated with IQOS.
PMI's own studies failed to provide evidence that youth, including non-users and former users, will not find IQOS appealing, will not initiate use of IQOS and will not perceive these products as risk-free. Further, PMI did not refer to independent studies conducted among adolescents which could influence their conclusions. Finally, their studies suffered from design and implementation flaws and cannot be relied on to support the proffered claims.
PMI's own data and available evidence from scientific studies conducted independent of the tobacco industry regarding how novel tobacco products are currently being marketed suggest that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.
自 20 世纪 60 年代在美国，以及自 1998 年以来在全球范围内，烟草公司一直在积极推广加热烟草产品（HTP）。2016 年，菲利普莫里斯国际公司（PMI）向美国食品和药物管理局（FDA）申请授权，在美国将其 IQOS HTP 系统和调味“HeatSticks”作为改良风险烟草产品（MRTP）进行营销。
我们系统地评估了菲利普莫里斯国际公司在其向 FDA 提交的 MRTP 申请中提供的公开数据，以确定 IQOS 产品是否符合美国《烟草控制法》对 MRTP 声明的标准。我们检查了菲利普莫里斯国际公司是否提供了充分的数据，证明烟草使用者不会开始使用 IQOS，年轻人不会错误地理解与 IQOS 相关的 MRTP 声明，以及年轻人如何看待与 IQOS 相关的健康风险。
菲利普莫里斯国际公司自己的研究未能提供证据表明，包括非使用者和前使用者在内的年轻人不会发现 IQOS 具有吸引力，不会开始使用 IQOS，也不会认为这些产品是无风险的。此外，菲利普莫里斯国际公司没有提到在青少年中进行的独立研究，这些研究可能会影响他们的结论。最后，他们的研究存在设计和实施缺陷，不能依赖这些研究来支持所提出的声明。
菲利普莫里斯国际公司自己的数据以及来自独立于烟草行业进行的关于新型烟草产品当前营销方式的科学研究的现有证据表明，引入 IQOS 将导致青少年和年轻成年人非使用者开始使用 IQOS，并且还可能增加 IQOS 与其他烟草产品的多用途使用。
