One of the earliest regulatory announcements expected for 2018 is the FDA’s decision on Philip Morris International’s premarket tobacco application (PMTA) to launch its iQOS heat-not-burn product in the United States. The application was submitted to the FDA in March 2017 and accepted for scientific review in August. By the agency’s own guidelines, a decision should be made within 180 days of that acceptance—putting it in the February 2018 time frame.

In terms of the product itself, Philip Morris and Altria Group Distribution Co. (who have a technology-sharing agreement for Altria to market iQOS in the United States) have provided plenty of information about its global performance. During an investors call in November 2017, Altria said iQOS sales have topped $1 billion in the 30 global markets where it has launched.

During the call, Sarah Knakmuhs, vice president of Philip Morris USA’s Heated Tobacco Products group, detailed plans for marketing iQOS stateside. These plans include starting with a yet-to-be-announced lead market and expansion markets in major metropolitan areas (selected based on the smoking population, regulatory environment and the presence of strong retail partnerships) and an education campaign similar to the company’s “This Changes Everything” global initiative. The iQOS stores seen globally are just one of several retail execution strategies being considered, she said, and Altria’s existing retail partners will also play a big role in the launch.