Heated tobacco product regulation under US law and the FCTC

Abstract

Tobacco companies are marketing new ‘heated tobacco products’ (HTPs) composed of battery-powered holders, chargers and tobacco plugs or sticks. The non-tobacco HTP components have escaped effective regulation under many countries’ tobacco control laws because they are packaged and sold separately from the tobacco-containing components. In the USA, HTPs cannot be marketed unless the Food and Drug Administration determines that allowing their sale would be ‘appropriate for the protection of the public health’. Philip Morris International (PMI) is seeking permission to market its IQOS HTP in the USA with ‘modified risk tobacco product’ (MRTP) claims that it reduces exposure to harmful substances and is less harmful than other tobacco products. However, PMI has not submitted adequate scientific evidence required by US law to demonstrate that the product is significantly less harmful to users than other tobacco products, that its labelling would not mislead consumers, or that its marketing—with or without MRTP claims—would benefit the health of the population as a whole. Parties to the WHO Framework Convention on Tobacco Control (FCTC) must take measures to reduce tobacco use and nicotine addiction, and prevent false or misleading tobacco product labelling, advertising and promotions; the introduction of new HTPs must be assessed according to these goals. All components of HTPs should be regulated at least as stringently as existing tobacco products, including restrictions on labelling, advertising, promotion and sponsorship, sales to minors, price and taxation policies and smokefree measures. There is nothing in US law or the FCTC that prevents authorities from prohibiting HTPs.

New ideas, old problems? Heated tobacco products – a systematic review

“…The heated tobacco smoking technology has become increasingly popular [6,79]. The most popular HTP product -IQOS from PMI -is widely available in 33 countries worldwide, including 21 European countries [93].…”

“…Moreover, most of them IJOMEH 2019;32(5) 67% male), 3 consecutive measurement days after being overnight smoking abstinent; 3 different products: a conventional cigarette, an e-cigarette, IQOS; during each session 1 product was used for 5 min; the exhaled CO measurements and dedicated questionnaires were administered throughout each session -cigarette smoking for 5 min resulted in a significant increase in the exhaled CO, whereas using IQOS resulted in a small but reliable increase (0.3 ppm) -cigarette craving was reduced significantly after the product use, with the decline being stronger for tobacco smoking than for e-cigarettes or IQOS a short-term use of IQOS can be effective to momentarily reduce the acute cigarette craving and withdrawal symptoms -IQOS is more popular with novice users than an e-cigarette Independent studies performed with the aim of assessing the health impact of HTP use are very limited (Table 3). Adriaens et al showed that 5 min of IQOS use resulted in a small but reliable increase (0.3 ppm) in the exhaled CO level [79].…”

“…The authors encouraged public health experts to carefully formulate opinions, bearing in mind the past experience with the industry-backed "safer tobacco products," such as filtered and low-tar cigarettes, which served to undermine and delay the global tobacco control efforts [97]. Lempert and Glantz pointed out legal uncertainties regarding HTPs, especially electronic devices used to heat up tobacco sticks [98]. The authors concluded that in the USA and parties to the WHO Framework Convention on Tobacco Control (FCTC) all components of HTPs should be regulated at least as stringently as tobacco products and should be subject to all tobacco control laws that apply to other tobacco products [98].…”

“…Lempert and Glantz pointed out legal uncertainties regarding HTPs, especially electronic devices used to heat up tobacco sticks [98]. The authors concluded that in the USA and parties to the WHO Framework Convention on Tobacco Control (FCTC) all components of HTPs should be regulated at least as stringently as tobacco products and should be subject to all tobacco control laws that apply to other tobacco products [98].…”

Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims

“…In particular, IQOS and other HTPs should not be permitted to be marketed with labelling or advertising that claims or implies modified exposure because the PMI’s own studies demonstrate that consumers perceive reduced exposure claims as reduced risk claims. Both US law (FSPTCA, 911(g) and 903) 10 and the Framework Convention on Tobacco Control 38 (FCTC) and FCTC’s Guidelines for Implementation 39 prohibit tobacco product labelling that is false or misleading, especially labelling that would mislead consumers to believe that the product is less harmful than other products 40 …”