PMI Will Launch U.S. IQOS Production to Bypass Import Ban

Tobacco giant Philip Morris International (PMI) will begin U.S. production of heated tobacco product IQOS in the United States, putting the product back on convenience store shelves by next year. IQOS is sold in the U.S. under license by PMI’s American partner Altria.

Last September, the federal International Trade Commission (ITC) upheld an earlier ruling and ordered imported IQOS products off the U.S. market. Domestic sales of IQOS ended Nov. 29, 2021. According to Bloomberg, domestically made IQOS products will begin selling some time in the first half of 2023.

The ITC decision was the result of a patent dispute between PMI and British American Tobacco (BAT), the parent company of American company Reynolds American (RAI). The ITC ordered PMI and Altria to stop importing IQOS for sale in the U.S., but did not prevent PMI from producing the product here.

IQOS was authorized for U.S. sale by the FDA in 2019 through the agency’s Premarket Tobacco Application (PMTA) pathway, and granted Modified Risk (MRTP) status in 2020. PMI could have altered the design of the product to skirt the ITC import ban, but the company would have been forced to submit the updated device for PMTA and MRTP authorization all over again—a lengthy process.

Unlike e-liquid-based vaping products, heated tobacco products (HTPs) like IQOS heat actual tobacco (in small cigarette-like refills called HeatSticks) to temperatures high enough to vaporize the nicotine and some of the flavor compounds, but not to the point of combustion.

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