NEW YORK--(BUSINESS WIRE)--Apr. 30, 2019--
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
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
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.
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Source: Philip Morris International
Philip Morris International Media Office
(202) 679 7296