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Steve Birr Vice Reporter
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Tobacco giants looking to “phase-out” cigarettes are shaking up global markets with heat-not-burn products, which face a slew of regulatory hurdles in the U.S.

Tobacco companies, lead by Philip Morris International (PMI), are introducing products that heat tobacco instead of burning it, producing a more powerful buzz than e-cigarettes while eliminating much of the harms of smoking. The products are already taking over tobacco sales in Japan and a number of European cities with looser regulatory restrictions than the U.S., reports Bloomberg.

The U.S. Food and Drug Administration began reviewing PMI’s product application this year for their heat-not-burn device iQOS, which will determine if the product can be sold in the country. The FDA also started reviewing PMI’s Modified Risk Tobacco Product (MRTP) application May 25, which will determine if the iQOS can be marketed as a safer alternative to smoking. There is no deadline for the review and PMI expects it could take up to a year.

“We welcome FDA and public review of the comprehensive scientific evidence package that we submitted to the agency,” Dr. Moira Gilchrist, PMI Vice President Corporate Affairs of Reduced-Risk Products, said in a statement May 25. “PMI’s application demonstrates our commitment to develop innovative, smoke-free technologies that can ultimately replace combustible cigarettes to the benefit of smokers, public health and society at large.”

Unlike a traditional e-cigarette, which vaporizes nicotine fluid, the iQOS heats tobacco leaves. Tobacco sticks branded HEETS, which resemble small cigarettes, are inserted into the heating device for use.

The iQOS is proving a smash hit in Japan, where it debuted nationwide in April 2016. British American Tobacco launched a similar product in December called glo and Japan Tobacco recently released their device called Ploom Tech, a hybrid vape, however PMI’s iQOS device remains the industry leader.

The device is outperforming the hopes of PMI in Japan, accounting for 7.1 percent of Japan’s overall tobacco sales as of the first quarter of 2017.

Evidence suggests that because the majority of cancer-causing chemicals are inhaled through smoke, e-cigarettes eliminate up to 95 percent of the risk. Recent research evaluating the impact of heat-not-burn devices on overall health are bolstering their image as a harm reduction product that can help move smokers away from traditional cigarettes.

“Heating tobacco at lower temperatures than combustible cigarettes allows nicotine to be delivered in ways that retain much of the ritual and experience of smoking,” Dr. Edward Anselm, a senior fellow of the R Street Institute, told The Daily Caller News Foundation. “Comprehensive scientific programs have demonstrated these products present significantly reduced risk when compared to traditional cigarettes. Collectively, they represent a new set of tools to reduce the harm of combustible tobacco.”

Andre Calantzopoulos, CEO of Philip Morris International, said last year the company’s ultimate goal is to stop selling traditional cigarettes. The company produces roughly 870 billion cigarettes a year.

“I believe there will come a moment in time where I would say we have sufficient adoption of these alternative products…to start envisaging, together with governments, a phase-out period for cigarettes,” Calantzopoulos told BBC Radio 4 Nov. 30. “I hope this time will come soon.”

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