To enter or stay in the US market, tobacco manufacturers must submit a Premarket Tobacco Product Application (PMTA) to the Food and Drug Administration (FDA) for any new tobacco product (or modified product) commercially marketed after February 2007. Manufacturers can also apply for modified risk tobacco product (MRTP) authorisation, which authorises use of marketing claims indicating ‘reduced risk’ (ie, less health risks than cigarettes) or ‘reduced exposure’ (ie, lower exposure to harmful substances than cigarettes). To date, FDA has provided MRTP authorisation to 15 products, including heated tobacco products (HTPs).
HTPs (ie, electronic devices that heat tobacco) have growing market share globally. IQOS, by Philip Morris (PM), is the global HTP leader,4 first released in 2014 and now sold in >60 countries. In April 2019, IQOS received FDA authorisation to enter the US market; FDA then authorised IQOS to use marketing claims indicating ‘reduced exposure’ (but not ‘reduced risk’) in July 2020. During this time, IQOS established its US market, expanding across four states (ie, Georgia, Virginia, North Carolina, South Carolina)7 and growing consumer interest and use. However, PM had to discontinue IQOS sales in the USA in November 2021 due to a patent-infringement lawsuit, but has stated its intent to resume IQOS sales in the USA and to expand its HTP portfolio globally.