FDA: IQOS is a modified risk product

The U.S. Food and Drugs Agency (FDA) reached the decision to allow IQOS, Philip Morris’ heat-not-burn product, be classified in the Modified Risk Tobacco Products (MRTP) category, as well as concluded that informing consumers that exposure to harmful chemicals when using this device is in accordance with the promotion of public health.

The U.S. Food and Drugs Agency (FDA) reached the decision to allow IQOS, Philip Morris’ heat-not-burn product, be classified in the Modified Risk Tobacco Products (MRTP) category, as well as concluded that informing consumers that exposure to harmful chemicals when using this device is in accordance with the promotion of public health.

„The FDA’s decision represents a historical milestone in the area of public health. It significantly adds on to the growing scientific consensus that IQOS is a better alternative to continued smoking,” said Aleksandar Jakovljević, Philip Morris Southeast Europe GM, adding that IQOS is essentially different from traditional cigarettes, and that, therefore, it has to have a fundamentally different regulatory framework. “Collaboration of governments and public health organisations, such as demonstrated in the USA, would accelerate the switch of adult smokers to the products which are a better choice for their health. It is still the only option that carries no risk of never starting or completely quitting all nicotine products, but for those who do not quit, the best thing they can do is to completely switch to scientifically based, smoke-free products. As of March 31, 2020, 10.6 million smokers worldwide completely quit smoking and switched to IQOS, „ added Jakovljević, concluding that the innovation such as this one may dramatically accelerate the reduction of the number of smokers, which is an opportunity of the century that must not be missed.

The decision to allow the MRTP application to Philip Morris, ranking the IQOS system as a modified risk tobacco product, followed an extensive review of comprehensive scientific documentation submitted by the company in December 2016. The FDA previously allowed the IQOS commercialisation in the US market.

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