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A letter from the American Vaping Association has urged the Food and Drug Administration (FDA) to approve Philip Morris International (PMI)’s applications to sell the iQOS heated tobacco system in the US.
The letter, addressed to FDA commissioner Scott Gottlieb, was offered as a comment on PMI’s premarket tobacco product application (PMTA) and its application for modified risk tobacco product (MRTP) status.
Though smokeless, the heat-not-burn (HnB) iQOS HeatSticks are derived from tobacco. This subjects them to the legal framework for tobacco-based product in the US, and places them under the authority of the FDA and relevant tobacco legislation. For this kind of product to enter the US market, it must first obtain premarket authorisation from the FDA.
In order to get a “modified risk” qualification, which would allow PMI to make reduced-risk claims and would ease some of the regulations it would otherwise be subject to, the company had to file a modified risk tobacco product application, or MRTPA, as detailed in a new ECigIntelligence report, “PMTA and MRTP: navigating the path to FDA approval for reduced-risk products”.
An MRTPA for the iQOS system and three types of HeatStick was submitted in May. The company has also filed for a a premarket tobacco application, or PMTA. Both applications are listed on the FDA website as being under scientific review.
‘Unfortunate reality’
It is worth noting that an MRTPA is useless without a PMTA. PMI therefore has two immediate hurdles: first to get a PMTA then an MRTPA. Historically, a hefty majority of PMTA applications have been rejected by the FDA on procedural grounds.
The American Vaping Association (AVA)’s letter depicts this process as burdensome to PMI as well as to adult smokers, since it denies them legal access to iQOS in the US until and unless the product is approved.
“This reflects the unfortunate reality of tobacco regulation in the US today,” the letter says. “It is easier for an existing cigarette company to bring a new combustible cigarette product to the market than it is for the same company to be innovative with an aim towards greatly reducing exposure to toxicants and contaminants.”
The letter accuses the FDA’s process of causing PMI to spend “billions of dollars to prove what has been a basic tenet of tobacco harm reduction” for decades.
Tobacco control activists also come in for a lashing in the AVA’s letter: “The hand wringing of these groups – so far as they just reflect an ideological and moral opposition to PMI possibly being a part of the solution to the smoking epidemic rather than a true critique of the science presented by PMI – should play no role in the FDA’s decision making.” The comment concludes: “It’s time to tell the truth to adult smokers.”
The resolution of PMI’s PMTA could happen some time between the last quarter of 2017 and 2019, though exactly when is not clear, as the ECigIntelligence report explains. PMI had launched iQOS in 25 countries by last month. Should the PMTA be granted, the Altria Group, former parent company of PMI, will be responsible for commercialising and marketing the product in the US.
What This Means: The AVA’s tactic seems unlikely to sway the FDA, especially as it uses provocative language like “It’s time to tell the truth.” However, this letter certainly suggests the association is aware of the large role iQOS could play in the market in the near future.
It is likely to be just one of numerous submissions from those with an interest in either harm reduction or tobacco control. The libertarian Reason Foundation, for example, has also just made its own representation on the MRTP application.
It takes a more detailed scientific tack, citing the research of Konstantinos Farsalinos into iQOS’s emissions and nicotine delivery, but also cannot resist making a political point: “Information about tobacco and nicotine products provided by government that suggest noncombustible products might be as dangerous as cigarettes have contributed to…potentially deadly misunderstandings,” it says. “The general public, tobacco consumers and even health professionals often fail to appreciate the significant differences in relative risks associated with different products.”
The question now is whether the FDA will be convinced of that difference. ECigIntelligence analysts expect the FDA to accept PMI’s PMTA and reject its MRTPA.
– Daniel Mollenkamp ECigIntelligence staff
Photo: Vaping360
