Panel rejects plan for tobacco device
SILVER SPRING, MD.
Government advisers dealt a blow Thursday to Philip Morris International’s hopes to sell its heat-not-burn device in the U.S. as a less-harmful alternative to cigarettes.
The penlike device heats Marlboro-branded sticks of tobacco but stops short of burning them. It is already sold in more than 30 countries and Philip Morris aims to make it the first “reduced risk” tobacco product ever sanctioned by the U.S.
The votes Thursday by the panel of Food and Drug Administration advisers on the marketing of the iQOS device are nonbinding. The FDA will make a separate decision on whether to allow the product on the market, and – if so – how it could be marketed to consumers.
FDA clearance would mark a major milestone in efforts by both the industry and government officials to provide alternative tobacco products to U.S. smokers.
The nine-member panel voted on several statements that Philip Morris wants to use to market iQOS. According to the company, the heat-not-burn approach reduces exposure to tar and other deadly byproducts of cigarettes.
But panelists expressed doubts that company studies, primarily from animals and laboratory experiments, could predict lower rates of diseases and death in humans. They voted unanimously, with one abstention, that the studies did not show that the device reduces deadly diseases tied to smoking.