The U.S. Food and Drug Administration (FDA) 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 agency found that an IQOS exposure modification order is appropriate to 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.
Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:
“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. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.
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.
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.
The 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.
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.”
From his side, Vassilis Gkatzelis, Managing Director of Philip Morris Egypt & Levant stated that “This is a historic milestone. The US FDA reviewed all available science and confirmed that IQOS is distinctly different from cigarettes because it has been demonstrated to reduce exposure to harmful chemicals. Now is the time to rapidly shift adult smokers away from cigarettes. Scientifically substantiated better alternatives like IQOS represent a public health opportunity.”