PMI Promotion of IQOS Using FDA MRTP Order

 PMI Promotion of IQOS Using FDA MRTP Order

In December 2016, Philip Morris International (PMI) applied to the U.S. Food and Drug Administration (FDA) to have IQOS, its heated tobacco product (HTP), classified as a Modified Risk Tobacco Product (MRTP) in the US.12 The US Tobacco Products Advisory Committee (TPSAC) recommended against approving PMI’s application to market IQOS as a reduced risk product.To get more news about iqos, you can visit hitaste.net official website.

The FDA denied PMI a ‘risk modification’ order, for which PMI originally applied. A ‘risk modification’ order requires a burden of proof that products “(1) Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (2) Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products”. PMI “did not demonstrate” that IQOS met these standards. The exposure modification standard that PMI was awarded “establishes a lower standard” than that of risk modification.7

PMI’s press release and a statement from CEO André Calantzopoulos hailed the ruling as a “historic public health milestone”. PMI focussed on the granted exposure modification order while limiting reference to the denied risk modification order.5

In July 2020, the Tobacco Control Research Group (TCRG) at the University of Bath produced a STOP briefing, summarising the evidence from academic research on IQOS, and highlighting the potential for the misrepresentation of the partial approval applying to the marketing of IQOS, which only applies in the US.8 In September 2020, TCRG researchers additionally published a peer-reviewed paper in BMJ highlighting how the decision increases confusion around the safety of HTPs.9