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FDA advisory panel weighs alternative cigarette's health claims

Throughout most of its history, Philip Morris International (NYSE: PM) has relied exclusively on traditional cigarettes and tobacco products for its revenue and profits.

Philip Morris International should not be allowed to claim its iQOS electronic tobacco product reduces the risk of smoking-related diseases compared with cigarettes, U.S. health advisers said on Thursday, dealing a blow to the company as it seeks to strengthen its portfolio of alternative nicotine devices. Finally they supported the claim that iQOS significantly reduces exposure to harmful chemicals, by 8-1. The mixed review suggests Philip Morris will be able to market its device to US smokers, but on limited terms.

Philip Morris International (PM) shares fell after losing two key FDA committee votes on its smoke-free device, but recovered somewhat on a third ruling.

The new technology, called IQOS, consists of a tube that gently heats up sticks of tobacco instead of burning them. For one thing, the FDA isn't bound by the recommendations of its advisory panel, and if the full regulatory body considers the Philip Morris application, it can come to a completely different decision.

The FDA's outside tobacco advisory committee voted to reject a request from Philip Morris to market its iQOS device as a less-risky alternative to cigarettes.

The panel said Philip Morris had not proven that iQOS reduced harm compared with cigarettes.

The FDA is expected to decide whether Philip Morris International can sell iQOS within the next few months.

Philip Morris says that the lack of fire, smoke or ash eliminates an average of 90 percent to 95 percent of the harmful chemicals in cigarettes.

Under a 2009 law, the FDA gained authority to regulate a number of aspects of the tobacco industry.

In addition, it's "unclear whether or not enough smokers would actually switch to these products" to have a public health benefit, Shadel said.

The FDA review said some non-smokers, including young people, would likely experiment with iQOS.

In Japan, Philip Morris has already seen the potential of offering iQOS as an alternative to its traditional cigarette lines.

To meet FDA requirements, a company must show that the product will improve the health of individual users and the overall population.

Heat-not-burn products are different from electronic cigarettes (e-cigarettes), because the latter heat up and vaporize a liquid, which usually contains nicotine, Shadel said, while the former heats actual tobacco. The majority of panel members felt the chances of smokers switching completely to IQOS was low.

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