According to an article published by The Motley Fool, Philip Morris International reported it had submitted a premarket tobacco product application (PMTA) on March 31 for its electronically heated tobacco product Iqos to the FDA’s Center for Tobacco Products.
According to the Philip Morris International website, Iqos, which resembles an electronic cigarette, “heats the tobacco just enough to release a flavorful nicotine-containing vapor but without burning the tobacco.” This is a “smoke-free” alternative to traditional cigarettes that heats tobacco below 350oF, “without combustion, fire, ash, or smoke,” PMI says.
The Motley Fool article explains that, by submitting Iqos for premarket approval, PMI and Altria Group are looking to commercialize the product within the US market. However, the article points out that PMI is also looking to get the product designated as a modified risk tobacco product, which would mean it wouldn’t be regulated the same as traditional tobacco cigarettes:
“It’s important to put the PMTA process into the proper context with the other actions that Philip Morris has taken with iQOS. Late last year, Philip Morris filed a modified risk tobacco product application or MRTPA with the FDA, seeking to have iQOS recognized as qualifying for favorable treatment. Philip Morris still wants to have iQOS treated as a modified risk tobacco product, but the company emphasized that if the regulatory agency issues a favorable decision on the PMTA marketing order, it and Altria would be allowed to market iQOS in the US even without a final decision on the modified risk side of the question.”
PMI has stated that the Iqos device’s heating process significantly reduces the levels of harmful chemicals and has announced research to support that claim, published in Nicotine & Tobacco Research.