Philip Morris’s Claims Over Health Benefits Of Heated Tobacco Device Rejected By U.S. FDA

The aim of Philip Morris International to begin the sale of fits heat-not-burn device in the United States and be identified to be a device that will be a less less-harmful alternative to cigarettes was dashed by the U.S. government.

Marlboro-branded sticks of tobacco are heated by the pen-like device but the tobacco is not burned. The company wants the device to be identified as the first “reduced risk” tobacco product to be ever sanctioned by the U.S. even though the company already markets the product in over 30 countries globally.

The voting result that nulled the identification of the device as a less harmful smoke than cigarettes in the U.S. by the U.S. Food and Drug Administration advisers and preventing the marketing of the iQOS device in the country as such is nonbinding. A separate decision would be made by the FDA on whether or not to allow marketing of the product and the manner in which it would be allowed to be marketed if allowed too do so.

If the iQOS is cleared by the FDA it would be identified as a major milestone in the path of the U.S. government as well as the tobacco industry to offer an alternative to tobacco products. Even while smoking related ailments still persists to be the country’s leading preventable source of illness and death, the number of adult smokers has seen a fall and reach a historic low of 15 per cent among adults.

Philip Morris had claimed that there is lesser exposure to tar and some of the other deadly byproducts of cigarettes by the approach of heat-not-burn. Number of statements of the company about the manner of its plans to market iQOS formed the basis of the vote of the nine-member panel.

However, doubts about the studies conducted by the company to come to its conclusion about the lesser impact of the device – mainly derived from tests on animals and experiments in the laboratory, were expressed by the panelists. The conclusion that the device could lower instances of deadly diseases tied to smoking was based on the experiments.

“I voted no because, based on the evidence presented to us, it was premature to make such a claim,” said Deborah Ossip, of the University of Rochester’s public health department.

The complete switching to the iQOS from cigarettes causes reduction in exposure of the user to harmful chemicals was one statement of the company that was supported by the panel. But that claim is insufficient to establish health benefits according to the panel and hence was not conclusive.

In the U.S., smoking reportedly results in deaths of 1 in 5 Americans annually and there is a raging debate over the possibility of allowing alternative products such as electronic cigarettes to reduce the impact of smoking. It is amidst such an environment that both the tobacco industry and the public health community had been looking forward towards this week’s meeting and FDA’s ultimate ruling.

(Adapted from http://www.statnews.com)

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Categories: Economy & Finance, Strategy, Uncategorized

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