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The U.S. Food and Drug Administration has authorized the marketing of IQOS, Philip Morris International’s (PMI) electrically-heated tobacco system, as a modified risk tobacco product (MRTP). 

In doing so, the US FDA found that an IQOS exposure modification order is appropriate to promote the public health. 

The decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking. 

IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process. 

“The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke, “André Calantzopoulos, PMI’s Chief Executive Officer, said.

“IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health,” Calantzopoulos said.

The FDA authorized the marketing of IQOS with the following information: 

  • The IQOS System heats tobacco but does not burn it;
  • This significantly reduces the production of harmful and potentially harmful chemicals; and
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces the body’s exposure to harmful or potentially harmful chemicals;

The agency concluded that the available scientific evidence demonstrates that IQOS is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products 

The FDA’s decision further builds on the emerging independent international scientific consensus that IQOS is a better choice than continuing to smoke, and follows the FDA’s April 2019 decision authorizing the commercialization of IQOS in the U.S. 

The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote the public health 

This decision follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications. 

The PMI CEO said: “We are excited that this important decision will help guide the choices of adult smokers in the U.S. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS. We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”

“Today’s decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible.  We look forward to working with the FDA to provide any additional information they may require in order to market IQOS with reduced risk claims," he said.

"Harnessing innovations like IQOS to dramatically speed-up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences,” the PMI executive said.

The MRTP marketing orders were issued pursuant to a 2009 law that empowers FDA to regulate tobacco products, including through oversight of innovative tobacco products. 

PMI submitted MRTP applications for the IQOS device and three HeatStick variants: Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks, and Marlboro Fresh Menthol HeatSticks.

On April 30, 2019, the FDA authorized IQOS for sale in the U.S. through the issuance of premarket tobacco authorization marketing orders that deemed the marketing of the product appropriate for the protection of public health. 

On March 30, 2020, PMI submitted a supplemental premarket tobacco product application for the IQOS 3 tobacco heating device with the FDA. 


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