IQOS received FDA authorization back in 2019 along with several other Marlboro HeatSticks products. Phillip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental premarket tobacco product application (PMTA) for modified versions and line extensions of the tobacco-flavored product for which there company had previously received a marketing granted order. When an applicant is looking to secure authorization for a new product that is a modified version of a tobacco product that they already have received a marketing ranted order for, they can do so through the submission of a supplemental PMTA.
After a rigorous scientific evolution of these applications, the FDA determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product. Like those products that were approved before, the FDA has placed strict marketing restrictions on the new products in order to prevent youth access and exposure.
You can read the full press release regarding these authorizations by clicking here.
For all the latest news from the FDA, visit fda.gov.