FDA: Philip Morris iQOS device doesn't cut disease risk
The panel concluded that Philip Morris had not proven that iQOS - a sleek, penlike device that heats tobacco rather than burning it - reduces harm compared with cigarettes.
IQOS is used by nearly 4 million people in 30 markets outside the United States but needs FDA authorization to be marketed in America.
The panel did conclude that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death.
Philip Morris needs to show both in order to claim the product modifies the risk of cigarettes.
Some panelists were concerned that not all the harmful or potentially harmful chemicals in cigarettes were significantly reduced in the iQOS aerosol.
Philip Morris presented data showing an overall exposure reduction of about 95 percent. ■