Introduction
Global tobacco control has achieved remarkable progress over the past two decades through implementation of the WHO Framework Convention on Tobacco Control (WHO FCTC). Measures such as smoke-free legislation, advertising bans, taxation, graphic health warnings, and cessation support have contributed substantially to reducing cigarette smoking worldwide.
However, the nicotine market has undergone profound transformation. Electronic cigarettes, heated tobacco products, nicotine pouches, synthetic nicotine, nicotine analogues, and other novel nicotine delivery systems increasingly dominate commercial strategies of the tobacco and nicotine industry.
Although these products differ technologically, they share a common pharmacological characteristic: they deliver nicotine, the substance responsible for addiction.
The Republic of Palau has now initiated what may become one of the most consequential discussions in international drug policy since adoption of the 1971 Convention on Psychotropic Substances by requesting that nicotine undergo a formal scientific review by the WHO Expert Committee on Drug Dependence (ECDD).
This initiative seeks to determine whether nicotine should be included within the international scheduling system governing psychoactive substances.
Why Is Nicotine Not Internationally Scheduled?
International drug control currently regulates psychoactive substances with significant dependence potential and public health risks through three principal UN drug conventions.
Surprisingly, nicotine has never been assessed under this framework despite decades of scientific evidence demonstrating that it fulfills many of the same pharmacological characteristics that justify control of other addictive substances.
This historical anomaly largely reflects the fact that tobacco products evolved outside international narcotics regulation, eventually becoming governed through a dedicated public health treaty, the WHO FCTC, rather than through drug control conventions.
While the FCTC successfully regulates tobacco products, it does not regulate nicotine itself.
As nicotine becomes increasingly separated from tobacco leaves through synthetic production and novel delivery technologies, this regulatory distinction has become progressively more problematic.
The Regulatory Gap
The current regulatory framework is product-based rather than substance-based.
Traditional tobacco products fall under the WHO FCTC.
However, synthetic nicotine, nicotine pouches, emerging nicotine analogues, and future pharmaceutical or recreational nicotine products may exploit regulatory gaps because the active addictive molecule remains outside international scheduling.
Palau’s proposal recognizes that regulating nicotine itself rather than only tobacco products could provide a scientifically coherent and future-proof regulatory framework capable of adapting to technological innovation.
Rather than constantly developing regulations for each new nicotine product, governments would possess an internationally recognized legal framework applicable to nicotine regardless of the delivery system.
Does Nicotine Meet WHO Scheduling Criteria?
The WHO Expert Committee evaluates substances according to four principal criteria:
- dependence potential;
- likelihood of abuse;
- threat to public health;
- therapeutic usefulness.
The evidence supporting nicotine is compelling.
Dependence potential
Since the landmark 1988 U.S. Surgeon General’s Report, nicotine has been recognized as a powerfully addictive drug producing neurobiological dependence comparable to heroin and cocaine in many respects.
Subsequent neuroscience has greatly strengthened this evidence.
Modern electronic cigarettes employing nicotine salt formulations can deliver nicotine concentrations similar to, or exceeding those obtained from conventional cigarettes, while nicotine pouches may deliver even larger doses.
Abuse liability
The commercial evolution of nicotine products has deliberately enhanced abuse potential.
Nicotine salts reduce throat irritation while increasing absorption efficiency, facilitating repeated use and stronger dependence.
Clinical studies demonstrate that higher nicotine concentrations increase craving, reinforce reward pathways, and make cessation more difficult.
Adolescent studies consistently show early loss of autonomy over nicotine use among youth who vape regularly.
Public health threat
Nicotine is the addictive substance underlying the global tobacco epidemic responsible for more than seven million deaths each year.
Beyond maintaining cigarette addiction, nicotine increasingly drives initiation among adolescents through attractive electronic products with flavors, promoted through seductive marketing.
More than 100 million individuals worldwide now use electronic nicotine delivery systems, with adolescent prevalence frequently exceeding adult prevalence several-fold.
Although nicotine alone causes fewer diseases than combustible tobacco smoke, it remains a neuroactive substance affecting cardiovascular function, brain development, fetal development, and produces addiction.
Therapeutic usefulness
Importantly, scheduling nicotine would not necessarily compromise smoking cessation therapies.
Nicotine replacement therapies (NRT) patches, gum, lozenges, inhalers, and related medicinal products, have well-established therapeutic value.
The 1971 Convention explicitly allows exemptions for medicinal preparations with recognized clinical use and low abuse potential, meaning that WHO-recommended NRTs could remain fully available under an appropriate exemption mechanism.
ATHP/NextGenU Position on Therapeutic Nicotine
ATHP /NextGenU strongly support preserving the internationally accepted medical use of nicotine as part of evidence-based treatment for tobacco dependence. Nicotine Replacement Therapy (NRT), including patches, gum, lozenges, inhalers, and other approved medicinal formulations, is recognized by the World Health Organization as an essential component of comprehensive tobacco cessation treatment and is included in the WHO Model List of Essential Medicines. Any future international regulatory framework for nicotine should therefore explicitly protect the manufacture, availability, accessibility, affordability, and appropriate clinical use of these medicinal products.
Likewise, ATHP and NextGenU support legitimate scientific research into the potential therapeutic applications of nicotine or nicotinic receptor pharmacology for other health conditions, provided such research is conducted independently, according to internationally accepted scientific and ethical standards, and remains free from commercial influence by the tobacco and nicotine industries.
At the same time, ATHP and NextGenU emphasize that these legitimate medical and scientific uses must not be confused with the commercial promotion of nicotine products under the narrative of “tobacco harm reduction.” The latter has increasingly been employed by the tobacco and nicotine industries as a marketing strategy to sustain nicotine addiction, recruit new users, particularly youth and undermine implementation of the WHO Framework Convention on Tobacco Control. Public health policy should clearly distinguish evidence-based medicinal nicotine, used under clinical indications, from commercial nicotine products promoted as consumer goods. Protecting access to approved therapeutic nicotine while preventing the exploitation of medical narratives for commercial purposes is fully consistent with the objectives of both the WHO FCTC and any future international framework governing nicotine.
What Exactly Has Palau Requested?
On 10 June 2026, the Republic of Palau submitted a formal notification under Article 2 of the 1971 Convention requesting that WHO conduct a critical scientific review of nicotine.
Importantly, Palau has not requested immediate scheduling.
Rather, it has requested initiation of the scientific evaluation process established under international law.
The review will be conducted independently by the WHO Expert Committee on Drug Dependence (ECDD).
If the WHO concludes that nicotine meets the criteria for inclusion on the list, it will make a recommendation to the United Nations Commission on Narcotic Drugs, composed of 53 member states that rotate periodically. This body will vote on the matter. A two-thirds majority is required to subject any substance, in this case nicotine, to international drug control.
Relationship with the WHO Framework Convention on Tobacco Control
Some observers have questioned whether nicotine scheduling could duplicate or undermine the WHO FCTC.
In reality, the two systems address different regulatory objectives.
The WHO FCTC regulates tobacco products and tobacco industry practices through public health measures.
International drug control regulates psychoactive substances according to pharmacological risk.
These frameworks could therefore function as complementary rather than competing systems.
The FCTC would continue governing tobacco product regulation, taxation, packaging, smoke-free policies, and advertising restrictions.
Meanwhile, UN scheduling could establish international oversight over nicotine manufacture, cross-border trade, monitoring, and licensing irrespective of product type.
Potential Public Health Benefits
If eventually adopted, nicotine scheduling could generate several important benefits.
First, it would close regulatory loopholes exploited through synthetic nicotine and future nicotine analogs.
Second, it would provide a common international framework applicable across jurisdictions.
Third, it could strengthen international cooperation against illicit nicotine manufacturing and unregulated cross-border trade.
Fourth, it could reinforce global efforts to protect children and adolescents from nicotine addiction by recognizing nicotine itself, not merely combustible tobacco, as the central driver of dependence.
Finally, it aligns conceptually with the emerging Tobacco Endgame movement, which seeks progressive elimination of commercial nicotine addiction .
Challenges and Controversies
The proposal will inevitably generate debate.
Critics may argue that international drug scheduling risks stigmatizing nicotine replacement therapies or creating barriers for smoking cessation.
Those advocating for tobacco harm reduction, which involves maintaining the use of electronic nicotine products, will surely express concern and, like the tobacco and nicotine industries, are likely to oppose this inclusion, as it would subject the manufacture and distribution of nicotine to greater international oversight.
However, the scheduling process itself is evidence-based, transparent, and gradual. It begins with independent scientific review rather than political decision-making.
Anyway, It should be made explicit that any scheduling mechanism should include appropriate exemptions for approved medicinal nicotine products and should not hinder clinical access to WHO-recommended cessation medications or legitimate biomedical research. Rather, its primary objective should be to prevent the continued commercialization of addictive nicotine products through misleading claims of harm reduction that primarily serve commercial rather than public health interests.
Implications for Global Tobacco Control
The nicotine marketplace has changed more rapidly than the regulatory systems designed to govern it.
Today, multinational corporations increasingly market nicotine independently of tobacco, expanding commercial opportunities through products that may evade traditional tobacco legislation.
Palau’s initiative recognizes that addiction, not combustion alone, has become the central public health challenge.
Whether nicotine is ultimately scheduled or not, the review itself will stimulate a necessary international discussion regarding how global governance should evolve in response to emerging nicotine technologies.
Conclusion
Palau’s notification represents a landmark moment in international public health policy. Rather than seeking immediate prohibition, it calls for an independent scientific assessment of whether nicotine satisfies internationally accepted criteria for control under the 1971 Convention on Psychotropic Substances.
Given nicotine’s well-established addictive properties, expanding range of delivery systems, increasing youth uptake, and central role in sustaining the global tobacco epidemic, such a review appears both timely and scientifically justified.
The initiative also highlights an important evolution in global tobacco control thinking: from regulating products toward regulating the addictive substance itself.
Whatever the final outcome of the WHO review and subsequent deliberations by the Commission on Narcotic Drugs, the process initiated by Palau is likely to influence future international nicotine policy for decades to come.
Further information regarding the notification issued by Palau can be accessed at the following link: https://nicotinereview.org/notification
Dr. Eduardo Bianco, Director ATHP
Author
References
- WHO Framework Convention on Tobacco Control. Geneva: World Health Organization.
- WHO Expert Committee on Drug Dependence (ECDD). Procedures for substance review.
- United Nations. Convention on Psychotropic Substances, 1971.
- U.S. Department of Health and Human Services. The Health Consequences of Smoking: Nicotine Addiction.Surgeon General’s Report, 1988.
- World Health Organization. WHO Clinical Treatment Guideline for Tobacco Cessation in Adults. Geneva; 2024.
- World Health Organization. WHO Report on the Global Tobacco Epidemic 2025.
- National Academies of Sciences, Engineering, and Medicine. Public Health Consequences of E-Cigarettes.Washington DC; 2018.
- Benowitz NL. Nicotine addiction. N Engl J Med.
- Balfour DJK. The neurobiology of nicotine dependence.
- The case for reviewing nicotine. Supporting paper accompanying the Republic of Palau’s notification under Article 2 of the 1971 Convention on Psychotropic Substances.