Updated: 14 March 2022
On 7 July 2020, the U.S. Food and Drug Administration (FDA) authorized the marketing of the IQOS tobacco heating system as a modified risk tobacco product (MRTP) with reduced exposure information. IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA's MRTP process. In doing so, the agency found that the issuance of the modified risk tobacco product orders with reduced exposure information would be "appropriate to promote the public health and is expected to benefit the health of the population as a whole.”
In particular, the agency determined the company demonstrated that because the IQOS system heats tobacco and does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke.
The FDA’s action allows Philip Morris International (PMI) to market IQOS system to consumers in the U.S. with the following information:
AVAILABLE EVIDENCE TO DATE:
- The IQOS system heats tobacco but does not burn it.
- This significantly reduces the production of harmful and potentially harmful chemicals.
- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
Further, FDA also concluded that the totality of evidence presented suggests that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely to be established in subsequent studies. The order letters as well as the decision summaries are available on the FDA’s website, and these orders apply to IQOS 2.4 as of July 2020 and IQOS 3 as of March 2022.
This decision follows the agency’s April 2019 authorization of the marketing of the IQOS tobacco heating system as “appropriate for the protection of public health” pursuant to the Premarket Tobacco Product Application (PMTA) pathway. MRTP applications to the FDA were submitted by PMI on 5 December 2016, and were prepared in accordance with the FDA’s Draft Guidance of 2012.
FDA’s press release quotes Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, as saying: “Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable. Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch. The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth. It is important to note that these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product.”
The marketing order requires PMI to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.