The U.S. Food and Drug Administration (FDA) has authorized Philips Morris International’s heated tobacco system IQOS as a modified risk tobacco product (MRTP) for sale. IQOS is the first next-generation inhalable tobacco product to receive such authorization as a modified risk tobacco product.
This decision shows that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue to smoke. Prior to this, the extensive scientific evidence package PMI submitted to the FDA in December 2016 was also reviewed to support its MRTP application.
The US Food and Drug Administration authorizes the sale of IQOS, providing the following information and evidence: The IQOS system heats tobacco, but does not burn tobacco; this greatly reduces the production of harmful and potentially harmful chemicals. Scientific research shows that a complete shift from traditional cigarettes to the IQOS system can reduce the chance of human exposure to harmful or potentially harmful chemicals.
The agency concluded that the available scientific evidence shows that considering the users of tobacco products and those who do not currently use tobacco products, IQOS is expected to benefit the health of the entire population.
The FDA’s decision is further based on the emerging independent international scientific consensus that IQOS is a better choice than continuing to smoke, and it was made after the FDA’s decision to approve the commercialization of IQOS in the United States in April 2019. The decision also provides an example of how the government and public health organizations regulate smoke-free alternatives to distinguish them from cigarettes in order to protect and promote public health.
IQOS has been launched in 44 countries (including 19 EU countries). In just two years, 7.3 million adult smokers have chosen to switch from combustible cigarettes to this product.
Currently, despite the large number of smokers in Malta, IQOS is still banned under an old ban on smokeless tobacco products. Malta is the only EU member state that still maintains this ban.
