The case for reviewing nicotine

Nicotine is one of the most widely used psychoactive substances in the world. It is neurotoxic, strongly addictive, and the molecule driving more than seven million tobacco-related deaths a year. It has never been brought under international drug control.

The regulatory gap

International drug control exists to regulate psychoactive substances with significant dependence potential and threat to public health, through a process called scheduling. The scientific case for nicotine meeting those criteria is strong. Yet it has never been brought into that framework.

Tobacco regulation, under the WHO Framework Convention on Tobacco Control (FCTC), governs tobacco products — cigarettes, heated tobacco, smokeless tobacco. It has been a landmark achievement and saved millions of lives. But it regulates tobacco products, not the addictive molecule. As the industry shifts to diverse nicotine products, such as nicotine pouches, synthetic nicotine, and novel delivery systems, manufacturers can move beyond the reach of existing product-based regulation while the addictive substance remains the same. Scheduling nicotine would address that gap at source — targeting the molecule wherever it appears, in whatever form.

The WHO Expert Committee on Drug Dependence evaluates substances against four criteria: dependence potential, abuse risk, threat to public health, and therapeutic usefulness. The scientific case for reviewing nicotine appears to meet all four.

The four criteria

WHO ECDD Criterion 1 / 4

Dependence potential

The 1988 US Surgeon General's Report concluded that nicotine is a powerfully addicting drug, and that the pharmacological processes driving tobacco addiction are comparable to those behind addiction to heroin and cocaine. That evidence base has strengthened considerably since 1988. Today's e-cigarettes deliver nicotine as fast as a cigarette, and both e-cigarettes and oral nicotine pouches can deliver higher doses than a cigarette — well above the doses delivered by WHO-recommended nicotine replacement therapies (NRTs) such as patches, gums, and lozenges.

The evidence

The scientific evidence underlying these claims is set out in full in a critical review prepared in accordance with the WHO Expert Committee on Drug Dependence requirements and submitted as part of Palau's notification. The full scientific dossier is available for download.

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