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Philip Morris International (PMI) has recently submitted modified risk tobacco product (MRTP) applications to the Food and Drug Administration (FDA) for market approval of its iQOS heated tobacco products.
iQOS is a tobacco harm reduction tool similar to other electronic nicotine delivery devices (ENDS), containing a rechargeable lithium-ion battery in which the user inserts a tobacco heatstick charged by a gold platinum and ceramic heatblade. The heatblade heats the tobacco heatstick creating a vapor containing nicotine and tobacco products. After a set number of puffs the user discards and replaces the tobacco heatstick.
iQOS is another example of a tobacco harm reduction product by means of eliminating harmful constituents that are exposed to cigarette users by the smoke, or combustion of tobacco. Studies increasingly suggest it is the chemicals found in this combustion of tobacco that cause the greatest harm, and companies like PMI have introduced innovative products that can deliver the satisfaction of tobacco consumption without the negative health effects, but are facing regulatory hurdles by created by FDA.
In 2016, FDA applied other tobacco products such as ENDS and cigars to the same regulations as combustible cigarettes. These deeming regulations require tobacco products introduced after 2007 to comply with lengthy application processes, including MRTPs and pre market tobacco applications (PMTA). These applications are expected to cost millions to comply.
PMI has recently submitted their applications and FDA allows public comments until December 12, 2017. Like The Heartland Institute, many free market organizations support FDA’s approval of PMI’s iQOS.
Robert McClure III, President and CEO of the James Madison Institute writes, “the traditional tobacco market is on the verge of finally experiencing the type of innovation that has improved the lives of millions elsewhere and through other industries…the only thing that potentially stands in the way is the FDA.”
Scott W. Drenkard, Director of State Projects at the Tax Foundation urges FDA to approve stating that “evidence is sufficient in my view to give consumers the opportunity to use and benefit from heat-not-burn technology. I will note also my desire to see this MRTPA process streamlined so that it can be better utilized for future technologies that might help smokers move away from traditional cigarettes and toward reduced harm products.”
Carrie Wade, PhD, MPH and Edward Anslem, MD of RStreet, state that “approving IQOS is the first step in a race to innovation whose ultimate outcome could be drastic improvements in the health of smokers,” and “in light of the FDA’s recent proposal to begin a dialogue that will eventually lead to cigarettes with reduced nicotine content (to levels that are considered “nonaddictive”), it is necessary that the FDA approve products that can serve as acceptable alternatives to current smokers.”
Jeff Stier, Director of the Risk Analysis Division at the National Center for Public Policy Research notes “the choice is between smoking and using a lower-risk product. Our world requires the agency to compare the risks of the use of this product against that of combustible cigarettes.” Stier goes on to state “the only question is whether the products are combustible and as such, are less dangerous than cigarettes. The scientific basis to answer that question affirmatively already exists. The only uncertainty is how much less harmful the product is when compared to their combustible cousins.”
The public comment period is open until December 12, 2017. Those who wish to publish comments can do at the Regulations.gov website. More information at iQOS can be found at PMI’s website. For more information on tobacco harm reduction, including ENDS, please visit The Heartland Institute’s Consumer Freedom Lounge.