The U.S. Food and Drug Administration (FDA) yesterday authorized the marketing of IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP).
In doing so, the US FDA found that an IQOS exposure modification order is appropriate to promote the public health.
The decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking.
IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process.
“The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t.
Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke, “André Calantzopoulos, PMI’s Chief Executive Officer, said.
“IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized.
Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future.
The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health,” Calantzopoulos added.
The FDA authorized the marketing of IQOS with the following information:
– The IQOS System heats tobacco but does not burn it
– This significantly reduces the production of harmful and potentially harmful chemicals
– Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces your body’s exposure to harmful or potentially harmful chemicals.
The agency concluded that the available scientific evidence demonstrates that IQOS is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products