FDA Authorizes IQOS as a Modified Risk Tobacco Product

The U.S. Food and Drug Administration (FDA) has decided that IQOS, a product of Philip Morris that heats rather than burns tobacco, can be classified as a "modified risk tobacco product" (MRTP), and that informing consumers about reduced exposure harmful substances when using this device in accordance with the promotion of public health.

The IQOS tobacco heating system is the first and only electronic product to use nicotine, which the FDA has classified as a "modified risk product", explaining its decision with the following conclusions: IQOS system heats tobacco but does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke. Scientific research confirms that switching completely from combusted cigarettes to the IQOS Tobacco Heating System significantly reduces the body’s exposure to 15 specific harmful and potentially harmful substances.

"This FDA decision represents a historic milestone in public health in the prevention of smoking-related diseases. It significantly builds on the growing scientific consensus that IQOS is a better choice than continuing smoking," said Aleksandar Jakovljevic, Philip Morris' CEO for Southeast Europe, adding that the IQOS tobacco heating system is fundamentally different from traditional cigarettes and must therefore have a fundamentally different regulatory framework, which the FDA has recognized in this decision.

"Cooperation between governments and public health organizations, as demonstrated in the United States on this occasion, would accelerate the transition of adult smokers to products that are a better choice for their health. It is still the only option that carries no risk of never starting or quit all nicotine products altogether, but for those who don’t quit, the best they can do is switch completely to controlled, science-based, smokeless products. As of March 31, 2020, 10.6 million smokers worldwide have quit smoking altogether, and switched to IQOS ", added Jakovljevic and concluded that innovations such as IQOS can dramatically accelerate the reduction of the smokers, which is an opportunity of the century that should not be missed.

The decision to grant Philip Morris an MRTP application to classify the IQOS system as a modified-risk tobacco product followed a comprehensive analysis of the extensive scientific documentation the company submitted to the FDA in December 2016. This decision was preceded by FDA approval in April 2019, which enabled the commercialization of IQOS in the US market.


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