FDA Approves Selling New Tobacco Device -- WSJ
May 01 2019 - 3:02AM
Dow Jones News
By Jennifer Maloney
This article is being republished as part of our daily
reproduction of WSJ.com articles that also appeared in the U.S.
print edition of The Wall Street Journal (May 1, 2019).
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.
Philip Morris International Inc. has spent years and billions of
dollars 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. Altria sells Marlboro cigarettes in the U.S.; Philip
Morris sells them everywhere else. The companies split in 2008.
Since IQOS doesn't burn tobacco, the device doesn't produce
smoke when users inhale. It heats tobacco sticks that come in
regular and menthol flavors. 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.
Newport maker British American Tobacco PLC is waiting on FDA
authorization for a similar product, called Glo, although that
company hasn't sought U.S. approval to market it as safer than
cigarettes.
"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.
IQOS marketing will be restricted under the same rules that
apply to cigarettes, the agency said. Cigarettes can't be
advertised on TV, billboards or other media where they are likely
to be seen by children.
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 under the Marlboro brand in about 500 convenience stores
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
May 01, 2019 02:47 ET (06:47 GMT)
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