Updated: 8 July 2020
On December 5, 2016, PMI submitted Modified Risk Tobacco Product (MRTP) applications to U.S. Food and Drug Administration (FDA)'s Center for Tobacco Products for the IQOS Tobacco Heating System. The applications were prepared in accordance with the Draft Guidance of Industry.
In a publicly available letter on Tuesday 7, 2020, FDA announced it had completed the review of PMI’s MRTP applications.
Tuesday's action pertains to the separate MRTP applications for these products and further authorizes the manufacturer to market these specific products 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.
The FDA determined that issuing exposure modification orders for the IQOS system is "appropriate to promote the public health" and is "expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products."
The IQOS system is the first and only electronic heated tobacco product to be granted modified risk orders through FDA's MRTP application, and the decision to authorize it confirms it as fundamentally different from cigarettes.
The scientific studies and analyses PMI submitted, among other documents, in the MRTP application can be found on FDA's website.
The Agency reports, "FDA will continue to monitor the marketing of your modified risk tobacco products and their impact on the population."
The orders authorized the marketing of the IQOS system, with the reduced exposure information discussed above. Importantly, no tobacco products are safe or "risk-free" and FDA does not "approve" tobacco products.
Previously, on April 30, 2019, FDA had authorized the commercialization of IQOS after reviewing PMI’s premarket tobacco product application (PMTA).
Modified Risk Tobacco Product Applications | Draft Guidance | FDA
U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products