PMI has submitted a PMTA application to the FDA for IQOS ILUMA heated tobacco products
PMI has submitted a PMTA application to the FDA for IQOS ILUMA heated tobacco products.
According to a Yahoo Finance report on October 20, Philip Morris International (PMI) has submitted a Premarket Tobacco Product Application (PMTA) and a Modified Risk Tobacco Product Application (MRTPA) to the U.S. Food and Drug Administration (FDA) for IQOS ILUMA heated tobacco products.
To sell new tobacco products in the United States, PMI must obtain PMTA authorization. The company is also seeking an order allowing IQOS ILUMA products to be marketed as modified-risk products that can reduce exposure to harmful and potentially harmful chemicals, as earlier versions of IQOS have already been authorized to do.
Here is the key information released by PMI:
Unlike traditional cigarettes, IQOS products heat tobacco rather than burn it;
IQOS ILUMA products are PMI's most innovative heated tobacco products;
Compared with earlier FDA-authorized versions of IQOS, they show similarly significant reductions in the formation of harmful and potentially harmful constituents;
IQOS ILUMA has demonstrated higher full-switching rates and improved consumer satisfaction among adult smokers in markets worldwide;
IQOS ILUMA products use a completely different heating technology from earlier versions of IQOS products and include many technological advances, including improved devices and battery life;
IQOS ILUMA is currently available in 27 international markets;
PMI's applications are supported by comprehensive scientific assessments, including aerosol chemistry, in vitro toxicology, pharmacokinetic studies, consumer perception and behavior studies, as well as the extensive scientific dataset generated for earlier versions of the IQOS system. IQOS ILUMA devices operate on the SMARTCORE induction system, which heats tobacco from the inside through TEREA SMARTCORE tobacco sticks, which are designed for use exclusively with IQOS ILUMA devices;
PMI submitted applications for three ILUMA devices and five tobacco sticks: TEREA BLUE, TEREA GREEN, TEREA SIENNA, TEREA BRONZE, and TEREA AMBER.



