WHO对美国FDA授权加热烟草产品上市表示关切

世界卫生组织发表声明，对美国食品药品监督管理局（FDA）的决定表示关切。1美国FDA于2020年7月7日授权IQOS加热烟草系统上市。1世卫组织强调，加热烟草制品仍属烟草产品范畴，应当受到《烟草控制框架公约》的全面管制。1

世卫组织指出，降低加热烟草制品中有害化学物质的暴露并不意味着该产品无害或降低了对健康的风险。1相反，部分毒素在加热烟草制品气溶胶中的含量甚至高于传统烟草烟雾，且存在一些传统烟雾中不存在的额外毒素。1世卫组织援引《烟草控制框架公约》第13.4(a)条款，强调禁止所有虚假、误导或欺骗性的烟草产品广告、推广和赞助。1

FDA在授权该产品时明确表示，"即使经过此授权，这些产品也不安全，不是'FDA批准'产品"。1FDA同时拒绝了声称该产品危害低于其他烟草产品或降低健康风险的主张。1美国并非《世卫组织烟草控制框架公约》的缔约方。1

The World Health Organization has issued a statement expressing concern about the US Food and Drug Administration's decision to authorize the IQOS heated tobacco system for market distribution 1. On July 7, 2020, the FDA granted this authorization, prompting WHO to reaffirm that heated tobacco products remain tobacco products subject to comprehensive regulation under the WHO Framework Convention on Tobacco Control 1.

WHO emphasized that reduced exposure to harmful chemicals in heated tobacco products does not mean the products are safe or pose lower health risks 1. The organization highlighted that certain toxins are present in heated tobacco product aerosols at levels exceeding those found in conventional tobacco smoke, and additional toxins not present in traditional smoke have been detected in these products 1. The FDA itself explicitly stated that "even with this marketing grant order, these products are not safe" and clarified they are not "FDA-approved" products, while rejecting claims that the products pose lower risks than other tobacco products or reduce health risk 1.

WHO further stressed that Article 13.4(a) of the WHO Framework Convention on Tobacco Control prohibits all false, misleading, or deceptive advertising, promotion, and sponsorship of tobacco products 1. The organization's statement underscores the distinction between FDA marketing authorization and approval, noting that the United States is not a party to the WHO Framework Convention on Tobacco Control 1.