The US Food and Drug Administration (FDA) has authorised the marketing of IQOS, Philip Morris International’s electrically heated tobacco system, as a modified risk tobacco product (MRTP). IQOS is the first next-generation inhalable tobacco product to receive such authorisation as a modified risk tobacco product.

This decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking. It also follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.

The FDA authorised the marketing of IQOS with the following information and evidence: 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 IQOS is expected to benefit the health of the population as a whole, considering both users of tobacco products and persons who do not currently use tobacco products.

The FDA’s decision further builds on the emerging independent international scientific consensus that IQOS is a better choice than continuing to smoke, and follows the FDA’s April 2019 decision authorising the commercialisation of IQOS in the US. This decision also provides an example of how governments and public health organisations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote the public health.

IQOS is already available in 44 countries, including 19 EU countries, and in just two years 7.3 million adult smokers have chosen to switch from combustible cigarettes to this product.

At present, and despite the high number of smokers in Malta, IQOS is still prohibited under an old general ban on smokeless tobacco products. Malta is the only EU member state that still maintains this kind of ban.