It seems that although FDA giveth, the ITC taketh away.
IQOS is a tobacco heating system in which “heatsticks” (reconstituted tobacco blended with glycerin) are electrically heated to release nicotine-containing aerosol, but the tobacco is not combusted. Because IQOS was classified as a cigarette by FDA, it was required to have FDA marketing authorization before it could be marketed. Accordingly, the IQOS premarket tobacco applications (PMTAs) were submitted to the FDA Center for Tobacco Products (CTP) on May 15, 2017. On April 30, 2019 CTP issued PMTA marketing orders for IQOS to Phillip Morris S.A., Marketing Order from Matthew R. Holman, Ph.D., Office of Science Director, Center for Tobacco Products, U.S. Food and Drug Admin., to Philip Morris Products S.A. (Apr. 30, 2019), which became the second company of only three companies to date ever to receive such an order. Accordingly, the CTP’s 122-page “Decision Summary” for IQOS, U.S. Food and Drug Admin., Premarket Tobacco Product Marketing Order Decision Summary for IQOS System Holder and Charger, PM0000479 (Apr. 30, 2019), became something of a guidepost for companies seeking a PMTA marketing order, particularly for those products such as e-cigarettes and the other deemed tobacco products that were required to submit a PMTA by the September 9, 2020 deadline (the uncertain fate of these PMTAs will be discussed in a later post).
However, in a patent case filed by R.J. Reynolds, the U.S. International Trade Commission ruled on September 30, 2021 that Philip Morris International and Altria must stop the sale and import of the IQOS tobacco product. Certain Tobacco Heating Articles and Components Thereof; Commission’s Final Determination Finding a Violation of Section 337, 86 Fed. Reg. 54,998 (USITC Oct. 5, 2021) (notice). The trade agency found that IQOS infringed two of Reynolds’ patents. The import and sales ban will take effect in two months after an administrative review that requires President Joe Biden’s signature. While an appeal or settlement is always a possibility, it appears that for now consumers will not be able to obtain IQOS in the United States.