Analysis of FDA's IQOS marketing authorisation and its policy impacts.

ABSTRACT: Philip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorisation if applicants fail to demonstrate that their product is 'appropriate for the protection of the public health'. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA. We analysed FDA's Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS. FDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic pot

SUBMITTER: Lempert LK 

PROVIDER: S-EPMC7952009 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature