In recent years, regulation of novel and emerging nicotine and tobacco products has taken on an increased importance in the context of tobacco control. The emergence of products such as heated tobacco products (HTPs) and electronic nicotine delivery systems (ENDS), also known as e-cigarettes, and their market growth has raised questions about how they should be regulated and how that regulation might affect comprehensive tobacco control.

WHO has previously published its position on regulation of these products, but has not addressed legal issues, such as how those regulations are being challenged in different jurisdictions. The new report and the accompanying case summaries close this gap and provide the facts, discussion of legal issues, arguments advanced, and the reasoning of the courts.

The key messages highlighted in the publication are:

ENDS and HTP manufacturers attempt to avoid products being regulated, so as to fall within regulatory or legislative gaps.

Manufacturers can be expected to deploy arguments concerning the relative risk of different product categories, and the need for coherent regulation along a continuum of risk.

Not all courts are receptive to arguments about relative risk, either because regulations are justified by reference to absolute risk or because the concept of relative risk must be judged at the population level and taking into account factors beyond relative toxicity.

Technological advances employed for the manufacture of novel and emerging nicotine and tobacco products will raise questions of whether a product falls within the ambit of the national legislation of the country.

There are relatively few cases addressing misleading marketing of ENDS, or enforcing restrictions on advertising, promotion and sponsorship, but important cases have been decided, including on how social media posts may constitute advertising and on whether advertising of an HTP device also constitutes advertising of a tobacco product.

HTPs and ENDS

HTPs produce aerosols containing nicotine and toxic chemicals when tobacco is heated or when a device containing tobacco is activated. HTPs contain tobacco and are tobacco products and are therefore subject to the provisions of the WHO Framework Convention on Tobacco Control (WHO FCTC).

ENDS are devices that heat a liquid solution to create an aerosol that is inhaled by the user. Where they are not prohibited, WHO has recommended that Member States regulate the products as tobacco products, medicinal products, consumer products, or other categories, as appropriate, to protect health as much as possible.