CHICAGO -- The U.S. Food and Drug Administration (FDA) was prominently featured at last week’s Society for Research on Nicotine and Tobacco Conference, sharing the first results from its long-term Population Assessment of Tobacco and Health study, as well as an update on upcoming tobacco regulatory actions.
Vivien Azer, a tobacco analyst for the New York-based Cowen Group, covered the opening night presentation by the FDA’s Center for Tobacco Products director, Mitch Zeller.
“In thinking about the potential for incremental tobacco regulation going forward, director Zeller stressed the importance of due diligence in order to prevent litigation, or at least prevail in court if legal action is taken,” Azer wrote in a research note.
Though he didn’t speak on the long-awaited deeming regulations, Zeller gave an update on 2015 regulatory actions, including substantial equivalence (SE) applications—stating the FDA has resolved 73% of regular SEs, but just 14% of provisional SEs—as well as premarket tobacco applications (PMTA) and modified-risk tobacco product applications (MRTP).
Swedish Match North America was at the center of both the PMTA and MRTP presentations, with the FDA presenting a brief case study on the eight Swedish Match tobacco products that recently garnered the first-ever PMTA approvals. The study outlined the criteria required by the FDA for PMTA approval, including the likely impact on existing tobacco user behavior, the likelihood the new product would attract consumers currently not using nicotine, and the overall population effects.
“In addition to reviewing documents submitted from Swedish Match, the agency conducted its own lab tests to verify results submitted from the company,” Azer said. “(These) showed the products had significantly lower levels of cancer risk compared to products currently on the market: 90% lower compared to MST and 67% lower than chewing tobacco.”
Azer noted, “We have more clarity on the PMTA pathway” but that “uncertainty remains around the specific criteria needed to get clearance for modified-risk statements.”
In fact, Zeller did not offer any new information on Swedish Match’s MRTP application for its snus products (the first MRTP application to be reviewed by the FDA). Instead, a summary of last April’s Tobacco Products Scientific Advisory Committee review of Swedish Match’s MRTP application was presented without further commentary.
According to the FDA’s own guidance, a decision should be issued within 360 days of a modified-risk application. However, Azer said it is now past the 18-month mark since Swedish Match submitted its application in June 2014.
“Given this is the agency’s first MRTP application review, going through the more than 100,000 pages submitted by Swedish Match, as well as public comments, certainly takes time,” she said.
The delay could affect how Philip Morris introduces its heat-not-burn iQos brand to the United States. The manufacturer has previously indicated that iQos could be launched in the U.S. through the PMTA pathway, without a modified-risk claim (as Swedish Match did with its eight new snus products).
“While the FDA guides for 180 days to review a PMTA application and 360 days for a MRTP application, both will likely take a longer than expected (in particular the MRTP application),” Azer said. “We believe it’s increasingly more likely iQos is introduced to the U.S. market without a modified-risk claim.”
Azer predicted a 2018 approval and U.S. launch of iQos, which is currently being tested in multiple markets internationally.
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