2020年7月27日

世卫组织借此机会提醒世卫组织《烟草控制框架公约》（FCTC）的成员国根据《公约》承担其义务。加热的烟草制品是烟草制品，这意味着WHO FCTC完全适用于这些产品。 （FCTC / COP8（22）号决定）具体来说，第13.4（a）条规定各缔约方禁止“以任何形式的虚假、误导性、欺骗性或可能产生的手段对烟草产品进行任何形式的烟草广告、促销和赞助以及营造其特性、健康影响、危害或排放的错误印象。”

世卫组织重申，减少接触加热的烟草制品中有害化学物质不会使它们无害，也不会降低对人类健康的风险。实际上，加热不燃烧气溶胶中某些毒素的含量高于常规香烟烟雾中的含量，并且加热不燃烧气溶胶中存在一些其他毒素，而常规香烟烟雾中则不存在。接触这些物质对健康的影响是未知的。

2020年7月7日，美国FDA根据《联邦食品，药品和化妆品法案》授权销售加热的烟草产品IQOS烟草加热系统。该法案要求在将新烟草产品投放美国市场之前，要获得上市前的授权。

美国FDA声明指出：“即使采取这种措施，这些产品也不安全，也未经FDA批准”。暴露修改指令还不允许公司做出任何其他修改后的风险声明或任何明示或暗示的陈述，以传达或可能误导消费者，使他们相信该产品已获得FDA认可或批准，或FDA认为该产品符合以下要求：确保消费者可以安全使用。”

美国FDA的授权拒绝了有关使用该产品的危害性低于另一种烟草产品或降低健康风险的说法。 FDA的命令还要求公司监视年轻人对产品的了解和使用，以帮助确保烟草减害产品的营销不会对年轻人的使用产生意想不到的后果。公司还必须向FDA通报防止青少年接触和暴露的努力。

鉴于使用加热不燃烧时接触其他毒素可能会影响健康，因此与传统香烟相比，加热不燃烧减少了对有害化学物质的接触的说法可能会产生误导。

此外，相关命令基于美国的特定因素授予美国内部的临时市场许可，美国不是《世界卫生组织烟草控制框架公约》（WHO FCTC）的缔约国。

所有烟草制品都对健康构成威胁，世界卫生组织敦促充分执行《世界卫生组织烟草控制框架公约》。严格的实施将支持戒烟尝试，并减少非烟草制品使用者（尤其是年轻人）的戒烟行为。世卫组织建议通过干预措施停止所有烟草使用，例如卫生专业人员的简短建议，全国免费戒烟热线，尼古丁替代疗法和通过移动短信传递的戒烟干预措施。

WHO statement on heated tobacco products and the US FDA decision regarding IQOS

27 July 2020

WHO takes this opportunity to remind Member States that are Parties to the WHO Framework Convention of Tobacco Control (FCTC) of their obligations under the Convention. Heated tobacco products are tobacco products, meaning that the WHO FCTC fully applies to these products. (Decision FCTC/COP8(22)) Specifically, Article 13.4(a) obliges Parties, to prohibit "all forms of tobacco advertising, promotion and sponsorship that promote a tobacco product by any means that are false, misleading or deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions."

WHO reiterates that reducing exposure to harmful chemicals in Heated Tobacco Products (HTPs) does not render them harmless, nor does it translate to reduced risk to human health. Indeed, some toxins are present at higher levels in HTP aerosols than in conventional cigarette smoke, and there are some additional toxins present in HTP aerosols that are not present in conventional cigarette smoke. The health implications of exposure to these are unknown.

On 7 July 2020, the US FDA authorized the marketing of a heated tobacco product, the IQOS Tobacco Heating System, under the Federal Food, Drug and Cosmetic Act. This Act requires pre-market authorization of new tobacco products before they can be placed on the US market.

The US FDA statement noted that, “Even with this action, these products are not safe nor “FDA approved“. The exposure modification orders also do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.”

The US FDA authorization rejected claims that the use of the product is less harmful than another tobacco product or reduces risks to health. The FDA orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use. The company must also keep the FDA apprised of efforts to prevent youth access and exposure.

Given that health may be affected by exposure to additional toxins when using HTPs, claims that HTPS reduce exposure to harmful chemicals relative to conventional cigarettes may be misleading.

Moreover, the relevant orders grant a temporary market authorization within the US and are based on factors specific to the US, which is not a Party to the WHO Framework Convention on Tobacco Control (WHO FCTC).

All tobacco products pose risks to health and WHO urges full implementation of the WHO FCTC. Rigorous implementation will support quit attempts and reduce initiation by non-users of tobacco products, especially the young. WHO recommends cessation of all tobacco use with interventions, such as brief advice from health professionals, national toll-free quit lines, nicotine replacement therapies and cessation interventions delivered via mobile text messaging.