Table 1

Systematic evaluation of evidence required by the Tobacco Control Act and evidence provided by PMI vs extant evidence to support or refute MRTP claims

Evidence required by
Tobacco Control Act
PMI’s evidenceExtant evidence as of 1 June 2018
Will IQOS and its marketing increase the likelihood that AYA non-users (including never users and former tobacco products users) will start using the product?PMI did not provide this evidence.
PMI claimed that in a premarket setting, the effect of IQOS on initiation among non-users could not be assessed. Instead, PMI used ‘behavioural intentions’ among adults as a proxy for behaviour.
Large proportions of non-users are using IQOS and other non-cigarette tobacco products. Studies have found evidence of gateway from e-cigarettes to combusted tobacco products.
Intentions are not a suitable proxy for actual behaviour, especially for adolescents.10–13 48 55–57 77 96
Does IQOS expose consumers to the claimed reduced level of harm considering how consumers actually use IQOS, including concurrent use of multiple nicotine or tobacco products?Given that dual and poly use were the prevailing patterns in the PMI studies, PMI did not demonstrate that IQOS, as actually used by consumers, reduced levels of harm.Epidemiological evidence suggests that for other non-cigarette tobacco products, switching completely has not been the most common outcome.48 77
Does IQOS advertising or labelling enable the public to comprehend the information concerning modified risk in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products and cessation aids?PMI’s application did not include information from studies with adolescents younger than 18.
In PMI’s studies, adult never-smokers had higher perceived risks of IQOS use compared with current or former smokers. They perceived risks of IQOS as lower than those of combusted cigarettes, but similar to health risks of e-cigarettes.
Extensive literature on adolescents conducted independently of the industry that PMI could have, but did not, present on current, former and non-users of cigarettes demonstrates the need to consider both perceptions of risks and benefits.15
The actual marketing of IQOS to date in countries other than the USA demonstrates that PMI has not adequately protected against use by non-smokers and suggests that the product’s name, physical appearance, flavours and retail environment will appeal to young people.11 13 14 16–25 68 97
  • AYA, adolescents and young adults; MRTP, modified-risk tobacco product; PMI, Philip Morris International.