FDA Authorizes Marketing of IQOS as a Modified Risk Tobacco Product
July 07 2020 - 2:47PM
Business Wire
Regulatory News:
The U.S. Food and Drug Administration (FDA) today 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.
- Today’s 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 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
- Scientific studies have shown that
switching completely from conventional cigarettes to the IQOS
system reduces your 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.
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.
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.
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.”
Note to Editor
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 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.
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, as well
as smoke-free products and associated electronic devices and
accessories, and other nicotine-containing products in markets
outside the United States. In addition, PMI ships a version of its
IQOS Platform 1 device and its consumables authorized by the U.S.
Food and Drug Administration to Altria Group, Inc. for sale in the
U.S. under license. 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, 2020, PMI estimates that approximately 10.6 million
adult smokers around the world have already stopped smoking and
switched to PMI's heat-not-burn product, available for sale in 53
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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Corey Henry Philip Morris International Media Office T. +1 (202)
679 7296 E. corey.henry@pmi.com
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