FDA Clears Philip Morris International Heat-Not-Burn IQOS Device for Sale in U.S.
April 30 2019 - 4:59PM
Dow Jones News
By Jennifer Maloney
The Food and Drug Administration said it would allow two of the
world's biggest cigarette makers to start selling in the U.S. a
hand-held device that heats but doesn't burn tobacco, though the
agency hasn't yet ruled on whether they will be allowed to market
it as safer than cigarettes.ddd
Philip Morris International Inc. has spent billions of dollars
and years developing the product, called IQOS, which is already
sold in dozens of other countries. It has been waiting for FDA
approval for its U.S. partner Altria Group Inc. to market IQOS to
adult smokers.
Since IQOS doesn't burn tobacco, the device doesn't produce
smoke when users inhale. It differs from other smoking alternatives
such as e-cigarettes that produce vapor from nicotine-laced
liquid.
The FDA said it found that the aerosol produced by IQOS contains
fewer toxic chemicals than cigarette smoke. In a separate
application to the FDA, Philip Morris is seeking authorization to
say in marketing materials that switching from cigarettes to IQOS
reduces the risks of tobacco-related disease.
"While the authorization of new tobacco products doesn't mean
they are safe, the review process makes certain that the marketing
of the products is appropriate for the protection of the public
health," Mitch Zeller, director of the FDA's Center for Tobacco
Products, said in a news release.
Philip Morris already sells IQOS in more than 40 countries,
often in sleek boutiques.The product has made big strides in Japan
though demand has cooled recently, prompting the company and rivals
to reduce prices and step up marketing.
"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," said Philip Morris CEO André
Calantzopoulos.
Altria plans to launch the product this summer in Atlanta, where
it will open its first IQOS retail store along with several mobile
retail units. It will also distribute the accompanying tobacco
sticks there in about 500 retail stores under banners including
Circle K, QuikTrip and Speedway. Other markets will follow soon, a
spokesman said.
In Atlanta, the tobacco giant hopes "to learn as much as
possible, as quickly as possible, and intends to make the most of
the company's first-mover advantage in heated tobacco," said Altria
Chief Executive Howard Willard.
IQOS is one of a wave of smoking-alternative products the
tobacco industry is counting on for growth as sales of conventional
cigarettes decline.
Altria also has invested $12.8 billion to buy a stake in Juul
Labs Inc., a controversial startup whose e-cigarettes currently
dominate the U.S. market. Sales of Juul have surged in the past two
years while Philip Morris and Altria awaited the FDA's review.
Write to Jennifer Maloney at jennifer.maloney@wsj.com
(END) Dow Jones Newswires
April 30, 2019 16:44 ET (20:44 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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