Sunday, 18 February, 2018

Philip Morris seen landing IQOS risk claim despite setback

The Philip Morris International Inc. iQOS electronic cigarette including packs of Marlboro HeatStick 'Deeming rule' set to harm small businesses and discourage positive health outcomes
Steve Townsend | 27 January, 2018, 18:39

A panel of advisers to the U.S. Food and Drug Administration has been examining an application from tobacco giant Phillip Morris to market such a device, called iQOS, in the United States.

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.

However, the panel did vote 8-1 in favor of the firm's claim IQOS reduces the body's exposure to harmful or potentially harmful chemicals.

The FDA is now considering Philip Morris International and partner company Altria Group's application to sell its "heatstick" product in the United States.

Philip Morris is aiming to bring the product to market this year, and has said it hopes to convert every adult smoker into IQOS users.

Outside the USA, iQOS is already available in more than two-dozen countries.

The IQOS is a type of "heat-not-burn" tobacco product.

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The committee is charged with reviewing and evaluating tobacco products and will make a recommendation to FDA on whether to approve the company's application to market the product as "lower-risk".

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 advisory panel's recommendation is nonbinding.

"We know from experience that the tobacco industry and their allies will not wait for all the facts to begin making health claims", he added. Its most notable rejection came in 2015, when it turned down Swedish Match AB's application to be allowed to advertise snus, little pouches of moist tobacco that are placed beneath the user's upper lip, as less harmful than smoking.

United Kingdom regulators have embraced e-cigarettes more fervently than any other national authority and are reviewing whether to lift a prohibition on e-cigarette manufacturers claiming their products are safer than cigarettes. "So selling IQOS in the U.S. isn't going to solve the problem".

Because the tobacco is heated instead of burned, the company claims it cuts the harmful cancer-causing chemicals found in a combustible cigarette by 90 to 95 percent. It will decide separately whether to authorise the modified-risk claims. Instead, the panel showed that getting smoking alternatives like IQOS marketed in the U.S. with packaging that suggests they're safer than cigarettes, won't be easy - especially when they are coming from companies that helped create America's tobacco problem in the first place.

If cleared in the US, iQOS would be marketed by Altria, the largest USA cigarette maker.

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