FDA Advisory Panel Deals Blow to Phillip Morris International’s iQOS Device

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FDA Advisory Panel Deals Blow to Phillip Morris International’s iQOS Device

Phillips Morris International, Inc. was dealt a slight blow on Thursday when a group of U.S. health advisers offered the opinion that the big tobacco company should not be allowed to claim that its iQOS tobacco product is less harmful than traditional cigarettes. The U.S. Food and Drug Administration (FDA) could still grant Phillip Morris International’s heat-not-burn device its modified risk classification, regardless of the recommendation, though it may now seek more data before doing so.

The advisory panel took aim at the lack of support to the claims that iQOS truly reduced harm compared to cigarettes. Research did show users of iQOS would be exposed to a lower level of harmful chemicals but the correlation between these chemicals and being truly reduced harm were not yet proven by the research. In order or iQOS to be truly modified risk, it would need to prove both.

News of the advisory comments caused shares of Phillip Morris International, Inc. to fall 2.8 percent and close at $107.49. Earlier in the day, shares had fallen as much as 6.8 percent.

Not all the comments made by the advisory group were negative, offering a chance the device could still earn its modified risk classification, a move Phillips Morris International, Inc. has been working toward with the decline of traditional cigarette sales and the FDA’s recent policy shift toward nicotine addiction and seeking safer alternatives to smoking and traditional tobacco products. A final decision from the FDA is expected this year, though no exact timeframe is available.

If approved, Phillip Morris International, Inc.’s partner Altria Group, Inc. would be able to sell and market iQOS within the U.S. with modified-risk claims.

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