US Food and Drug Administration: IQOS is a modified risk product

The authorization to inform consumers about the reduced exposure to harmful substances when using this device is in accordance with public health promotion.

IQOS is the first and only electronic product that generates a nicotine-containing aerosol, which FDA has classified as a "modified risk product", explaining its decision with the following conclusions:

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 significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

"This decision by the FDA is a historic milestone in the area of public health. It significantly upgrades the growing scientific consensus that IQOS is a better choice than continuing to smoke”, said Aleksandar Jakovljevic, Managing Director for Southeast Europe at Philip Morris, adding that IQOS is fundamentally different from traditional cigarettes and therefore must be fundamentally different when it comes to the regulatory framework.

"Cooperation between governments and public health organizations, as demonstrated on this occasion in the United States, will contribute to a faster transition of adult smokers to products that are a better choice for their health. Still the best option that carries no risk is to never start smoking or to completely abandon all nicotine-containing products, but for those who will not stop smoking, the best thing they can do is to switch completely to controlled, scientifically based, smokeless products. As of March 31st this year, 10.6 million smokers worldwide have completely given up smoking and switched to IQOS”, Jakovljevic added, stating that innovations like this could dramatically accelerate the decline of the number of smokers, which is an exceptional opportunity which must not be missed.

This decision of the US Food and Drug Administration to approve the application of Philip Morris, which classifies IQOS as "modified risk tobacco product" was followed by Agency’s comprehensive and rigorous analysis on the extensive scientific dossier submitted by the company in December 2016. This decision followed after FDA’s authorization in April 2019, which allowed IQOS to be commercialized on the US market.

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