IQOS is the first and only electronic nicotine product, among tobacco heating products and e-cigarettes, authorized in the US as a Modified Risk Tobacco Product by the FDA, concluding that IQOS is a fundamentally different product compared to cigarettes.
In 2016, we submitted the authorization file to the FDA.
On 7 July 2020, the FDA announced a historic decision.
WHAT DOES THIS DECISION MEAN?
- IQOS heats the tobacco, but does not burn it.
- The absence of the combustion significantly reduces the production of harmful and potentially harmful chemicals*.
- FDA concluded that switching completely from cigarettes to IQOS significantly reduces the body’s exposure to harmful or potentially harmful chemicals.
MORE TO LEARN
What is the US FDA: The US Food and Drug Administration is considered worldwide as one of the most rigid regulatory authorities, setting high standards in products’ evaluation.
Mission: To protect and promote public health.
Role: To regulate and monitor the safety of a wide range of products for human use which are circulated in the US market. The FDA is responsible for the regulation and authorisation for tobacco products.
*Source: 3-month reduced exposure studies concluded in Japan and the US in near real world conditions. These studies measured exposure to 15 harmful chemicals and compared the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.