Since 2012 and the publication of the MRTP guidance by the U.S. FDA encouraging the use of computational modelling, many robust dynamic models have been developed that are projecting net health benefits in the whole population after introduction of modified-risk tobacco products.

The purpose of this additional exploratory analysis is to evaluate what could be the computational impact when varying the size of the market in illegal counterfeit cigarettes, given the potential for these products to increase risk of harm versus legal cigarettes.

We developed and ran an average population modelling having the capability to differentiate relative risks between the legal and illegal counterfeit markets in combustible cigarettes, as well as the effect of MRTP availability.

National Survey on Drug Use and Health (NSDUH) smoking prevalence and U.S. census bureau demographics data were combined into the model from 2010 and computed until 2030. Status quo scenario (i.e. without any MRTP) as well as introduction of MRTP scenario from 2020 were tested and compared.

While the wide range of scenarios is still showing a beneficial health impact in the long run after introduction of MRTPs, the analysis is showing that there are cut-off points in prevalence and harmful potential of the illegal trade counterfeit cigarettes beyond which no further benefits are observed (e.g. counterfeit cigarettes prevalence of 20 % being 20 % more harmful on average).

In conclusion, high prevalence of harmful illegal counterfeit cigarettes may have the potential to limit or even lower all foreseen benefits achieved through the introduction of MRTPs.