NewApproaches2026

FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.

Capital is reassessing the global tobacco and modern nicotine industry as heated tobacco, vaping and nicotine pouches reshape demand, profitability and regulation. At the 2026 New Approaches Summit in New York, investors and analysts examined whether smoke-free growth can sustain earnings, how regulation shapes startup value, and whether shareholder engagement can be more effective than divestment. The debate points to a broader shift: tobacco transition is increasingly becoming a capital-allocation, governance and valuation question.

Cliff Douglas, a veteran U.S. tobacco-control and public health policy figure, told NAS 2026 that the “continuum of risk” should play a central role in tobacco policy. He called for clearer market pathways, stronger risk communication, differentiated regulation and enforcement, and said possible FDA reforms to PMTA reviews could be a “welcome correction” if they create a more efficient, predictable route for scientifically substantiated lower-risk products. Read 2Firsts’ on-site coverage.

At the 2026 New Approaches Summit in New York, FDA Center for Tobacco Products Director Bret Koplow said the PMTA pathway is “predicated on tobacco harm reduction.” He outlined four CTP priorities: youth prevention, helping adults quit or switch to lower-risk products, improving relative-risk communication, and reducing unauthorized products. Koplow also addressed flavored e-cigarettes, public risk perceptions, industry credibility and efforts to make PMTA reviews more efficient and predictable.