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 The sleekly packaged little tube would not look out of place in an
Apple store. It is designed to heat tobacco but not burn it. Most of
the harmful chemicals in tobacco are released when tobacco is
burned.
The advisers to the Food and Drug Administration will discuss the
product on Wednesday and Thursday and recommend whether it should be
cleared. The FDA is not obliged to follow the recommendations of its
outside advisers but typically does.
If cleared, iQOS would become the first product to carry a
modified-risk claim and could help advance the FDA's proposed new
approach to reducing the dangers of smoking.
For decades, U.S. health agencies have worked to help Americans quit
cigarettes to avoid the risks of lung cancer and other disease.
National smoking rates have declined to near historic lows of around
15 percent.
But in July, newly appointed FDA Commissioner Scott Gottlieb
proposed reducing nicotine levels in cigarettes to "non-addictive"
levels while increasing development of lower-risk alternatives. The
policy assumes that some percentage of the population will be unable
or unwilling to give up nicotine.
To make the new strategy succeed, the agency needs a stable of
vetted, reduced-risk alternatives to cigarettes on the market.
Philip Morris is one of the few companies that can finance such a
long and expensive development process. It has spent close to $3
billion on reduced-risk products.
"If this application fails, it will be clear that this is an
expensive, wasteful, regulatory dead end," said Clive Bates, a
tobacco expert who runs the consulting firm Counterfactual and
advocates for alternative nicotine products.
Bates and others argue that if Philip Morris cannot win FDA
clearance for a modified-risk product, no one will be able to.
Other companies have submitted modified-risk products for FDA
review. 22nd Century Group Inc <XXII.A>, which genetically engineers
tobacco plants to have lower nicotine levels, seeks clearance for
its "Brand A" very low nicotine cigarettes. R.J. Reynolds Tobacco
Co, owned by British American Tobacco Plc <BATS.L>, is seeking
clearance for six snus products - a moist smokeless tobacco pouch
placed under the lip - under the Camel brand.
(For a graphic on market share of smokeless tobacco and vapor
products, see: (http://tmsnrt.rs/2DQ7cIH)
THE CLAIM
IQOS is used by nearly 4 million people in 30 markets outside the
United States. It consists of a small pen-like holder containing a
heated tobacco stick, and a charger. It looks similar to an
e-cigarette, but uses real tobacco rather than nicotine-laced
liquid.
Philip Morris says that iQOS contains up to 95 percent fewer harmful
or potentially harmful chemicals than the cigarette smoke produced
from burning tobacco. If approved, the product would be marketed by
U.S. partner Altria Group Inc <MO.N>.
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The hurdles for success are high.
To sell a new tobacco product, a company must demonstrate that it
significantly reduces the risk of disease and does not encourage
more smoking or delay quitting.
To date, the FDA has determined that only eight products meet that
standard, all of them snus smokeless tobacco pouches made by Swedish
Match AB <SWMA.ST>. The agency has granted no company the right to
specifically claim that their product is less risky than cigarettes.
Tobacco control activists say companies like Philip Morris cannot be
trusted to make reduced-risk claims. They point to the industry's
previous promotion of "light" and "low-tar" cigarettes as safer
alternatives despite evidence showing they were not.
Others argue that things have changed. Since 2009, the tobacco
industry has had to answer to the FDA under federal law. New
technology, including e-cigarettes and heat-not-burn products, may
help smokers quit or shift those who cannot quit onto a less harmful
substitute, they say.
"Many of my friends in the tobacco control movement are still
fighting the tobacco wars of the 1980s," said Scott Ballin, an
independent health policy consultant and long-time anti-tobacco
activist. "We are beyond that now."
The FDA's Gottlieb favors an approach to treating addiction that
makes available less harmful versions of addictive substances,
including nicotine and opioids. These products, he argues, can help
minimize damage to those unable to quit.
Mitch Zeller, head of the FDA's tobacco division, refers frequently
to a "continuum of risk" for nicotine products, with nicotine gums
and lozenges on one end and cigarettes on the other. The FDA would
like to shift smokers unable to quit nicotine from high-risk to
low-risk products.
"What we have developed is an offering on the continuum of risk,"
said Ruth Dempsey, Philip Morris' director of scientific engagement.
"We believe it is better than cigarettes."
(Reporting by Toni Clarke; Editing by Michele Gershberg and Matthew
Lewis)
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