The Future of Nicotine Regulation: Six Predictions for the Next Decade

The nicotine regulatory landscape is in motion—faster than at any point since the 2009 Tobacco Control Act. The forces driving change are multiple: the accumulating evidence on harm reduction, the transformation of the industry, the pressure from consumer advocates, the fiscal crisis of cigarette-dependent government revenue, and the geopolitical shifts that are reshaping global trade. **Based on current trajectories, here are six predictions for nicotine regulation in the next decade—predictions grounded in the evidence, the politics, and the institutional dynamics that have shaped the nicotine landscape for the past half-century.**

**1. Risk-proportionate regulation will become the global norm.** The countries that have adopted risk-proportionate frameworks—the UK, New Zealand, Sweden—have the best outcomes. The countries that have resisted—the US, Australia, much of the EU—are under increasing pressure from the evidence and from their own smoking populations. Within a decade, the precautionary, abstinence-oriented framework that currently dominates global tobacco control will be in retreat, and risk-proportionate regulation will be the standard. **2. The PMTA process will be reformed—or replaced.** The current system is unsustainable: a million-product backlog, a decision rate below 1%, and a regulatory paralysis that is costing lives. Congressional reform—likely a tiered review system with streamlined pathways and provisional authorizations—will come, driven by the recognition that the status quo is failing. **3. Nicotine will be regulated more like cannabis.** The licensing, labeling, age-verification, and consumer-education models developed for legal cannabis will be adopted for nicotine—a shift toward treating nicotine consumers as capable of informed decision-making, rather than as addicts to be managed.

**4. Consumer participation will become institutionalized.** The exclusion of nicotine users from the policy process is increasingly indefensible—and increasingly contested. Within a decade, the major regulatory agencies will have established mechanisms for consumer representation, and the 'nothing about us without us' principle will have been extended to nicotine policy. **5. The cigarette endgame will accelerate—in high-income countries.** Smoking prevalence in wealthy countries will fall below 5% by 2040, driven by the combined effects of taxation, regulation, reduced-risk alternatives, and generational decline. The cigarette will become a niche product in the Global North—even as it persists, at high levels, in the Global South. **6. The nicotine industry will complete its transformation—or be replaced.** The companies that successfully transition to reduced-risk portfolios will thrive. The companies that don't—that remain cigarette-dependent—will be acquired, restructured, or eliminated by the market. The nicotine industry of 2035 will look more like the pharmaceutical industry or the consumer technology industry than the cigarette industry of the 20th century.

**💬 Which of these predictions do you think is most likely—and which is most unlikely?** What would you add to the list? And what do you think the nicotine regulatory landscape will look like in 2035?