US FDA decisions: a new milestone for IQOS

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 lower levels of harmful chemicals compared to cigarettes.* Important information: IQOS ILUMA is not risk-free.
The FDA’s decisions came after several years of reviews of the scientific evidence available on IQOS.

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 or potentially harmful chemicals.
• Scientific evidence have shown that switching completely from conventional cigarettes to IQOS significantly reduces your body’s exposure to harmful or 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 lower levels of harmful chemicals compared to cigarettes.*
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 celebrate this milestone on our journey, together we aim to prove ourselves step by step and continue delivering on our promises.

* Reductions in levels of the 9 harmful chemicals the World Health Organization recommends to reduce in cigarette smoke, which do not include nicotine. See Important Information on IQOS.com
Important information: IQOS is not risk-free. It delivers 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.