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Heated tobacco product regulation under US law and the FCTC
  1. Lauren Kass Lempert1,
  2. Stanton A Glantz1,2
  1. 1 Center for Tobacco Control Research and Education, University of California San Francisco, San Francisco, California, USA
  2. 2 Division of Cardiology, Department of Medicine, University of California San Francisco, San Francisco, California, USA
  1. Correspondence to Lauren Kass Lempert, Center for Tobacco Control Research and Education, University of California San Francisco, San Francisco, CA 94143, USA; Lauren.Lempert{at}


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.

  • public policy
  • non-cigarette tobacco products
  • packaging and labelling
  • advertising and promotion

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  • Contributors Both authors conceptualised the study, contributed to the writing and revision, and approved the final version of the manuscript. LKL analysed the data.

  • Funding This work was supported by the US National Cancer Institute and Food and Drug Administration Center for Tobacco Products (P50 CA180890). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the FDA. The funding agencies played no role in design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.