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US regulator adds to confusion around heated tobacco products

BMJ 2020; 370 doi: (Published 16 September 2020) Cite this as: BMJ 2020;370:m3528
  1. Anna B Gilmore, professor1,
  2. Sophie Braznell, PhD student1
  1. 1Tobacco Control Research Group, Department for Health, University of Bath, Bath, UK
  1. Correspondence to: A B Gilmore abcg20{at}

Tobacco manufacturer exploits FDA’s ambiguous ruling

The emergence of new consumer tobacco and nicotine products, notably electronic cigarettes and heated tobacco products,1 has produced controversy and confusion. This is partly because the two products are often conflated, not least by Philip Morris International, the world’s largest tobacco company.2 With global sales of cigarettes inexorably declining, the company’s future now depends on IQOS, its flagship heated tobacco product.23

Yet e-cigarettes and heated tobacco products are quite different. E-cigarettes contain no tobacco but heat nicotine-containing liquids to produce an inhalable aerosol. They can (with behavioural support) help smokers quit4 and, while not safe, are currently considered a less harmful alternative to smoking for those who switch fully.45 By contrast, IQOS (sold through Altria in the US), which heats small cigarette-like tobacco sticks, has not been shown to enable quitting or to be significantly lower risk than smoking.1

Confusion has now been escalated by the US Food and Drug Administration’s recent decision about the status of IQOS under its “modified risk tobacco product” criteria.6 The poorly titled criteria actually comprise two different standards—risk modification and exposure modification. The FDA denied risk modification status for IQOS, clearly stating that Phillip …

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