FDA Authorizes IQOS as a Modified Risk Tobacco Product

8. July 2020by ficba

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.

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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