FDA Seeks Public Comments on PMI Application to Market IQOS 3 as Modified Risk Tobacco Product
May 14 2021 - 8:36AM
Business Wire
The U.S. Food and Drug Administration (FDA) today opened a
public comment period on Philip Morris International’s (PMI--NYSE:
PM) application seeking authorization to market the IQOS 3
electrically heated tobacco system as a Modified Risk Tobacco
Product (MRTP).
PMI’s application requests the same reduced exposure
modification orders granted on July 7, 2020, for the IQOS 2.4
system—the first, and only, electronic nicotine product to be
granted marketing orders through the FDA’s MRTP process. To
authorize MRTP consumer communications, the FDA’s Center for
Tobacco Products is required by law to conclude that a product is
appropriate to promote the public health.
The IQOS 3 device contains a number of technological
advancements, compared to the IQOS 2.4 device, including longer
battery life and quicker recharge between uses. It was authorized
for sale in the U.S. via the FDA’s pre-market review process on
December 7, 2020, having met the standard that permitting its sale
is appropriate to protect public health.
Commenting on the FDA’s action Jacek Olczak, PMI’s Chief
Executive Officer, said:
“PMI is fully committed to a smoke-free future, one where we
completely replace cigarettes with scientifically substantiated
smoke-free alternatives that are a better choice for adults who
would otherwise continue smoking. Our commitment to a science-based
future is unmatched, having invested more than $8 billion since
2008 on smoke-free products.
This application underscores PMI’s on-going commitment to make
new innovations available to American adult smokers through the FDA
process; the confidence we have in our science; and our belief that
public scrutiny and open engagement with governments is vital to
achieving a smoke-free future.”
Note to Editor
- The FDA’s reduced exposure marketing orders for IQOS 2.4
authorized communication of 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.
- IQOS is available in the U.S. market through an exclusive
license with Altria Group, Inc.
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, associated electronic devices and
accessories, and other nicotine-containing products in markets
outside the U.S. In addition, PMI ships versions of its IQOS
Platform 1 device and consumables to Altria Group, Inc. for sale
under license in the U.S., where these products have received
marketing authorizations from the U.S. Food and Drug Administration
(FDA) under the premarket tobacco product application (PMTA)
pathway; the FDA has also authorized the marketing of a version of
IQOS and its consumables as a modified risk tobacco product (MRTP),
finding that an exposure modification order for these products is
appropriate to promote the public health. 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
product portfolio includes heat-not-burn and nicotine-containing
vapor products. As of March 31, 2021, PMI’s smoke-free products are
available for sale in 66 markets in key cities or nationwide, and
PMI estimates that approximately 14 million adults around the world
have already switched to IQOS and stopped smoking. 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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