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US FDA Decisions: a New Milestone for IQOS

IQOS is the first and only tobacco heating system that has completed the US FDA Modified Risk Tobacco Product application process,


A key milestone: the FDA concludes that switching completely to IQOS reduces your body’s exposure to harmful and potentially harmful chemicals* On July 7, 2020, the US Food and Drug Administration (FDA), a government agency responsible for protecting public health, made a historic decision concerning IQOS. It authorized IQOS and three HeatSticks variants, to be marketed in the US as a modified risk tobacco product (MRTP), with a reduced exposure claim.

IQOS is the first and only tobacco heating system that has completed the US FDA Modified Risk Tobacco Product application process, concluding that switching completely to IQOS reduces your body’s exposure to harmful and potentially harmful chemicals*, and communicating this is appropriate for the promotion of public health.

The FDA’s decisions came after several years of scientific reviews of the evidence provided by Philip Morris International. After having reviewed the totality of scientific evidence available for IQOS, the US FDA concluded that: -IQOS heats tobacco but does not burn it. -The absence of combustion significantly reduces the production of harmful and potentially harmful chemicals. -Scientific evidence have shown that switching completely from conventional cigarettes to IQOS significantly reduces your body’s exposure to harmful and potentially harmful chemicals**.

The FDA’s decisions shows that IQOS is a fundamentally different product compared to cigarettes and a better choice for adults who would otherwise continue smoking. Unlike cigarettes, which burn tobacco, IQOS heats it instead. This significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke.

For the past 10 years, we built a team of over 400 scientists and invested billions with one goal: creating an alternative to cigarettes for those adult smokers who want a better choice than continued smoking. So we are proud to celebrate this milestone, on our journey together we aim to prove ourselves step by step and continue delivering on our promises.

Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

* Source: PMI 3-month reduced exposure studies ran in Japan and the US in near real world condition. These studies measured exposure to 15 harmful chemicals, and compared to the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.

**Source: Based on FDA’s marketing order for the IQOS system dated July 7, 2020.


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