October 5, 2018

Stanton A. Glantz, PhD

Heated tobacco product regulation under US law and the FCTC

As the FCTC Conference of the Parties and individual countires grapple with how to fit heated tobacco products, such as PMI's IQOS, into existing regulatory regiemes, Lauren Lempert and I just published " Heated tobacco product regulation under US law and the FCTC" in Tobacco Control.

The abstract sums up the legal arguments:

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.

The full citation is  Lempert LK, Glantz SA.  Heated tobacco product regulation under US law and the FCTC.  Tobacco Control Published Online First: 05 October 2018. doi: 10.1136/tobaccocontrol-2018-054560.  It is available for free here.

Add new comment

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.