Updated: 9 July 2020

On March 31, 2017, PMI submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA)’s Center for Tobacco Products, seeking FDA's authorization to commercialize the IQOS Tobacco Heating System in the United States, a requirement for new tobacco products that are not substantially equivalent to products commercially marketed in the U.S. as of February 15, 2007. On April 30, 2019, FDA authorized the commercialization of the IQOS Tobacco Heating System in the United States, the specifics of which versions can be found on FDA’s website. PMI has also issued a press release on the regulator’s decision.

The agency said, “Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes […] While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or 'FDA approved'.”

The U.S. FDA’s decision on PMI's Modified Risk Tobacco Product (MRTP) applications were submitted for the same products on December 5, 2016. On July 7, 2020, FDA authorized marketing with reduced exposure information of the IQOS Tobacco Heating System as a MRTP.

"Applications for Premarket Review of New Tobacco Products" | Draft Guidance | FDA

Press release authorizing IQOS Tobacco Heating System commercialization | News Release | FDA

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