2020/09/16

US FDA decision on IQOS

Important decision: the FDA concludes that switching completely to IQOS reduces your body’s exposure to harmful or potentially harmful chemicals*


On July 7, 2020, the US Food and Drug Administration (FDA), a government agency responsible for protecting public health, made an important decision concerning IQOS. It authorized IQOS, along with different tobacco stick variants, to be marketed in the US as a modified risk tobacco product (MRTP), with a reduced exposure claim.

IQOS is the 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 or potentially harmful chemicals.*

The FDA’s decisions came after several years of reviews of the scientific evidence available on IQOS.

Having reviewed the scientific evidence for IQOS, the US Food & Drug Administration (FDA) has concluded** that:

  • IQOS heats tobacco but does not burn it.
  • The absence of combustion significantly reduces the production of harmful or potentially harmful chemicals.
  • Scientific studies have shown that switching completely from cigarettes to IQOS significantly reduces your body’s exposure to harmful and potentially harmful chemicals.

  • The FDA’s decisions show that IQOS is a fundamentally different product compared to cigarettes. IQOS is 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 or potentially harmful chemicals compared to cigarette smoke.

    For the past 10 years, we built a team of more than 400 scientists and R&D experts and have significantly invested towards one goal: creating an alternative to cigarettes for those adult smokers who want a better choice than continued smoking.

    So we are proud to our journey, together we aim to prove ourselves step by step and continue delivering on our promises.

    Important information: IQOS is not risk-free and provides nicotine, which is addictive.

    * Source: PMI 3-month reduced exposure studies conducted in Japan and the US in near real world conditions. 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: FDA’s marketing order for the IQOS system dated July 7, 2020.

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