On July 7, 2020, the US Food and Drug Administration (FDA) authorized IQOS, along with three different HeatSticks variants, to be marketed in the US with a claim of reduced exposure to harmful chemicals. This makes IQOS the first and only tobacco heating system that has completed the Modified Risk Tobacco Product application process in the US with reduced exposure information.
The US FDA decisions came after several years of reviews of all of the scientific evidence available on IQOS. Between the opening and the closure of the scientific review, the FDA asked 86 questions related to the applications, seeking clarifications or additional data.
After reviewing the scientific evidence on IQOS, the US FDA authorized the marketing order of IQOS, concluding that:
The IQOS system heats tobacco but does not burn it.
The absence of combustion significantly reduces the production of harmful or potentially harmful chemicals.
Switching completely to IQOS reduces your body’s exposure to harmful or potentially harmful chemicals*.
Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.
*Source: FDA’s marketing order for the IQOS system dated July 7, 2020.
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