Nicotine Science and Policy

A reset of the FDA’s PMTA process is overdue if regulation is meant to guide the market rather than paralyse it. The current pathway has left many smoke-free products trapped in uncertainty while cigarettes remain legally available and illicit alternatives gain space. A better system should be rigorous, transparent and fast enough to distinguish responsible products from those that do not meet standards. Harm reduction depends on regulation that can make timely decisions, not one that delays safer options out of reach.

The new GSTHR briefing paper focuses on a shift that is already happening: people moving from cigarettes to safer nicotine products. These transitions are not theoretical policy models; they can be seen across countries where vapes, pouches, snus and heated tobacco products are changing patterns of nicotine use. That matters because the public health gain comes from reducing exposure to combustion, even when nicotine use continues. Regulation should understand these pathways before it disrupts them.

Australia’s nicotine policy is drifting further from the reality consumers are living in. Cigarettes remain legal, illicit tobacco is expanding, and many vapers are navigating workarounds, informal supply or rules that do not match how people actually quit smoking. That gap matters because policy cannot reduce harm effectively while pretending demand has disappeared or that restriction equals control. A better approach would start from real behaviour: keep people inside legal channels, make safer alternatives accessible, and measure success by fewer people smoking.

Europe’s nicotine debate is becoming a house divided. Some countries are moving towards risk-proportionate regulation, while others are pushing bans, higher taxes and restrictions that may leave cigarettes in a stronger position. That split matters because smokers across Europe are not facing the same chances to move away from combustion. A coherent EU strategy should protect young people, recognise product differences and make the lower-risk route easier to take than the deadly one.