US FDA Authorizes Marketing Of IQOS As A Modified Risk Tobacco Product

The US 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 agency found that an IQOS exposure modification order is appropriate to promote public health.

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.

“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.

The FDA decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking.

“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.