(BUSINESS WIRE) -- The U.S. Food and Drug Administration (FDA) today confirmed that IQOS,
Philip Morris International’s electrically heated tobacco system, is
appropriate for the protection of public health and has authorized it
for sale in the United States. FDA’s decision follows its comprehensive assessment of PMI’s premarket tobacco product applications (PMTAs) filed with the Agency in 2017.
Unlike cigarettes, the IQOS
system heats — but does not burn — tobacco. It is the first
electrically heated tobacco product to qualify for sale in the U.S.
pursuant to the 2009 law that empowers FDA to regulate tobacco products,
including through oversight of innovative products.
Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:
“The FDA’s decision to authorize IQOS in
the U.S. is an important step forward for the approximately 40 million
American men and women who smoke. Some will quit. Most won’t, and for
them IQOS offers a smoke-free alternative to continued smoking.
In just two years, 7.3 million people around the world have abandoned
cigarettes and switched completely to IQOS. Today’s decision by
FDA makes this opportunity available to American adult smokers. All of
us at PMI are determined to replace cigarettes with smoke-free
alternatives that combine sophisticated technology and intensive
scientific validation. FDA’s announcement is a historic milestone.”
He
added, “The order sets out clear commercialization guidelines,
including marketing requirements, that maximize the opportunity for
adults to switch from cigarettes, while minimizing unintended use. We
fully support this objective. FDA has set a high standard and we look
forward to working with them to implement the order so that IQOS is reaching the right audience—current adult smokers.
PMI will bring IQOS
to the U.S. market through an exclusive license with Altria Group,
Inc., whose subsidiary Philip Morris USA has the market expertise and
infrastructure to ensure a successful launch. PM USA is ready to deploy
its initial lead market plans for IQOS.
PMI submitted a comprehensive body of scientific evidence in support of the PMTAs and of the parallel applications for IQOS as a “Modified Risk Tobacco Product”, which FDA continues to review.
Note to Editor
PMP SA submitted PMTA applications for IQOS and three HeatStick variants: Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks; and Marlboro Fresh Menthol HeatSticks.
Philip Morris International: Delivering a Smoke-Free Future
Philip
Morris International (PMI) is leading a transformation in the tobacco
industry to create a smoke-free future and ultimately replace cigarettes
with smoke-free products to the benefit of adults who would otherwise
continue to smoke, society, the company and its shareholders. PMI is a
leading international tobacco company engaged in the manufacture and
sale of cigarettes, smoke-free products and associated electronic
devices and accessories, and other nicotine-containing products in
markets outside the U.S. PMI is building a future on a new category of
smoke-free products that, while not risk-free, are a much better choice
than continuing to smoke. Through multidisciplinary capabilities in
product development, state-of-the-art facilities and scientific
substantiation, PMI aims to ensure that its smoke-free products meet
adult consumer preferences and rigorous regulatory requirements. PMI's
smoke-free IQOS product portfolio includes heat-not-burn and
nicotine-containing vapor products. As of March 31, 2019, PMI estimates
that approximately 7.3 million adult smokers around the world have
already stopped smoking and switched to PMI’s heat-not-burn product,
which is currently available for sale in 47 markets in key cities or
nationwide under the IQOS brand. For more information, please visit www.pmi.com and www.pmiscience.com.
Contacts
Corey Henry
Philip Morris International Media Office
T. +1 (202) 679 7296
E. corey.henry@pmi.com
