Nicotine control and the case against international scheduling

Abstract

Palau’s attempt to bring nicotine within the 1971 Convention on Psychotropic Substances would move a widely consumed substance toward an international regime designed to restrict supply to medical and scientific purposes. Evidence of dependence does not establish that this intervention would improve health. This paper separates the scientific evidence from the legal consequences, examines WHO’s earlier decisions, and assesses medicalization, adult autonomy, and institutional incentives. A comparison with caffeine tests whether dependence and biological activity are being used consistently as grounds for prohibition. The central objection is that proponents have not demonstrated the suitability or net benefit of scheduling, particularly if tobacco products remain outside controls imposed on their competitors. Organizations promoting the process should disclose the legal outcomes they seek and the funding supporting the work.

Introduction

Imagine a man who tells a psychiatrist that he is George Washington. Asking whether he should have crossed the Delaware farther upstream would concede the very premise that needs challenging. Once the conversation turns to boats, weather, and troop movements, the question of whether the man is Washington has quietly disappeared.

Something similar happens when an international institution begins deliberating whether nicotine belongs under a drug-control treaty. The machinery starts moving. Experts assemble, questionnaires circulate, organizations sign letters, and the public is invited to take the proceedings seriously. The existence of the process begins to lend credibility to the proposition that triggered it. What should have been challenged at the threshold becomes the accepted starting point for an elaborate debate.

The premise at issue is not that nicotine acts on the brain or can cause dependence. Both are established. It is that these properties justify bringing ordinary adult consumption within an international framework that generally reserves lawful supply for medical and scientific purposes. That is an extraordinary proposition. Imagine making the same leap from caffeine withdrawal to medical permission for coffee. Evidence that a substance has effects is not a scientific warrant for such a restriction.

The nicotine initiative deserves to be rejected at that threshold. Instead, its sponsors have secured institutional attention and the support of a large coalition. Whatever their individual reasons, their campaign creates work for governments, scientists, businesses, and consumers who must now explain why this exercise should not proceed toward restrictions. The burden of argument has been shifted from those proposing coercion to those wishing to preserve adult choice.

Unfortunately, the possibility of legal consequences means that ridicule is not an adequate response. We find ourselves discussing where to launch the boats. This paper therefore works through the science, the law, the policy consequences, the funding, and the precedent. Doing so does not concede that scheduling is a reasonable starting point. It records the case against a proposal whose promoters have not established why the world needs it.

Public-health resources and expert time have alternative uses. Requiring a lengthy rebuttal of an unjustified intervention carries a cost even if the intervention is ultimately defeated. The analysis that follows should be read with that in mind: its necessity arises from the reach of the machinery being invoked, not from the strength of the case for invoking it.

On June 10, 2026, the Republic of Palau notified the UN Secretary-General that it wanted nicotine critically reviewed under the Convention on Psychotropic Substances. The request opens a route to international scheduling. The published campaign timetable anticipates WHO consideration in October 2027 and targets a Commission on Narcotic Drugs vote in March 2028. These remain prospective milestones (Palau’s notification; Palau’s proposal and timetable).

The immediate act is a request for review, not a completed prohibition. That procedural distinction should not obscure the purpose of choosing this machinery. ASH US explicitly describes incorporating nicotine into the UN narcotics system as a tobacco-endgame approach, and says that it and its partners are providing scientific and legal support (ASH’s account of the initiative). An investigation into nicotine could be commissioned without invoking a treaty designed to impose controls. The selection of that treaty is itself a policy choice.

The scientific issue concerns the effects of nicotine; the legal issue concerns what a scheduling decision obliges governments to do. The policy issue is whether the resulting restrictions would improve outcomes compared with feasible alternatives. Funding and precedent illuminate how the choice of intervention is shaped. These questions must be examined separately before their answers can support a coherent recommendation.

Clive Bates has recognized exactly this difficulty. His July analysis called the initiative “The worst idea in the history of tobacco control,” yet examined its legal machinery in detail. He subsequently submitted a referenced evidence briefing to the WHO committee’s Secretariat, reproducing his November 9 email in a post explaining the submission. He regards the proposal as profoundly misguided, but its capacity to acquire institutional authority warrants a substantive response (Clive Bates’s July analysis; Clive Bates’s evidence submission).

That is the approach adopted here. We should take the consequences seriously without conceding the premise. Washington does not become Washington because we have been obliged to inspect the boats. Nor does nicotine become an appropriate candidate for international scheduling because organizations have persuaded a government to initiate the process.

Science

The chemical is not the disease burden

Nicotine is pharmacologically active and can sustain dependence. None of this licenses the transfer of cigarette mortality to the nicotine molecule. FDA explicitly distinguishes nicotine’s addictive role from the mixture of chemicals responsible for the grave disease burden of tobacco use (FDA’s explanation of nicotine and smoke toxicants). The distinction is essential when considering products that avoid combustion.

The appropriate scientific task is to identify risks attributable to nicotine, at relevant doses and routes, and compare the consequences of competing policies. Human clinical outcomes must be separated from transient physiological changes, laboratory mechanisms, and animal findings. A mechanism may establish biological plausibility without establishing the magnitude of a clinical risk. Observational studies also need to account for previous smoking, dual use, and the possibility that illness prompted a change in product.

Cancer illustrates the need for care. An analysis of the Lung Health Study did not find nicotine-replacement use to be a significant predictor of lung cancer after adjustment, whereas smoking during the study was a significant predictor. It was not a definitive experiment proving every nicotine exposure harmless, and cannot establish the safety of every newer product. It does challenge a casual inference from nicotine exposure to smoking-like cancer risk (the Lung Health Study cancer analysis).

Palau’s dossier discusses cardiovascular and developmental toxicity and acknowledges therapeutic nicotine use. Those topics warrant scrutiny. Yet acknowledging a hazard does not settle whether its magnitude warrants international scheduling. The dossier’s emphasis on dependence and nicotine delivery must be assessed against both observed disease outcomes and the consequences of restricting access (Palau’s scientific dossier).

The case against scheduling therefore does not require a claim that nicotine has no risks. It requires advocates to show why a treaty restriction would be a better response to those risks than product standards, informed adult choice, and measures directed at children. On the public evidence examined here, they have not established that proposition.

The missing comparison is continued smoking

A smoker considering alternatives is not choosing between nicotine and a lifetime without nicotine exposure. Continued smoking is one of the realistic outcomes. A policy analysis that treats every new nicotine product solely as an additional source of exposure can miss its role in replacing a much more hazardous one.

In a randomized trial conducted through UK stop-smoking services, one-year abstinence was 18.0% among participants assigned e-cigarettes and 9.9% among those assigned nicotine-replacement therapy; both groups received behavioral support (Hajek and colleagues’ randomized trial). A Swiss trial subsequently found validated continuous smoking abstinence at six months of 28.9% in an intervention offering e-cigarettes alongside counseling, versus 16.3% in the control group. The interventions included different material support, so that comparison should not be reduced to a pure pharmacological effect (Auer and colleagues’ randomized trial).

Cochrane concludes that nicotine e-cigarettes improve smoking cessation compared with nicotine-replacement therapy, with high-certainty evidence, while further safety evidence is needed (the Cochrane e-cigarette review). These studies do not establish the effect of every commercial market. They establish a benefit that any serious assessment of restricting access must include.

FDA has also authorized reduced-risk claims for 20 specified ZYN products when used instead of cigarettes. That is a product-specific regulatory conclusion, not a blanket finding about pouches or an authorization as cessation medicines. It nevertheless demonstrates the possibility of recognizing differences in disease risk within a consumer-product framework (FDA’s ZYN modified-risk decisions).

The comparison should include new initiation, sustained dual use, complete switching, relapse, and cessation of all nicotine. The relevant endpoint is avoidable illness and death. Counting every continuing nicotine user as a policy failure can conceal an improvement in health when smoking has ended. Conversely, a decline in legal sales does not establish success if users move to illicit products or cigarettes.

Dependence is not a complete risk assessment

Nicotine’s capacity to sustain repeated use is not in dispute. The scientific dispute concerns the inference drawn from that property. Dependence, intoxication, poisoning, chronic disease, and harm to others are distinct outcomes. A person can be dependent without exhibiting the impairment associated with a sedative or hallucinogen. A concentrated substance can be dangerous to ingest in a large dose without ordinary use producing the same risk. International control requires a judgment about the significance and management of these properties, rather than a checklist of whether any exists.

Delivery speed and dose are relevant, but their implications can run in more than one direction. A product that delivers sufficient nicotine may be more attractive to a smoker seeking a substitute. Whether that translates into displacement of cigarettes, continued dual use, or new initiation is an empirical question. Describing efficient delivery solely as increased abuse liability risks assuming that all continuation of nicotine is the outcome to avoid.

A sound evidence review should report absolute as well as relative risks, distinguish clinical endpoints from surrogate measures, and describe the populations studied. A result in young never-smokers should not be applied without qualification to older smokers considering a switch. Equally, benefits among smokers do not justify encouraging children to begin using nicotine. Different populations can warrant different policies without putting the molecule under international drug control.

Cardiovascular effects must be distinguished from cardiovascular events

A claim about nicotine and heart disease should distinguish a physiological response from a clinical event. The relevant evidence includes randomized trials rather than mechanisms alone. In a 1996 trial, 584 outpatients with established cardiovascular disease received nicotine patches or placebo for 10 weeks and were monitored for 14 weeks. Primary cardiovascular endpoints occurred in 5.4% and 7.9%, respectively; the difference was not statistically significant. The predominantly male sample and limited follow-up restrict generalization (the randomized cardiac-patient trial).

The EAGLES cardiovascular-safety study included 8,058 smokers assigned to nicotine patch, varenicline, bupropion, or placebo. Serious cardiovascular events were uncommon and did not differ significantly by treatment. Participants with acute or unstable cardiovascular disease were excluded. Pfizer and GlaxoSmithKline funded the study and participated in its conduct and analysis; those relationships should be considered alongside its randomized design (the EAGLES cardiovascular-safety trial).

These findings do not show that prolonged high-dose nicotine exposure is harmless, or establish the safety of inhaled nicotine or pouches. They do require a review alleging serious nicotine-mediated cardiovascular harm to explain the relationship between mechanisms, actual exposures, and observed outcomes. A conclusion cannot be established by selectively treating mechanistic findings as decisive and clinical results as irrelevant.

Cochrane’s NRT review found more reported chest pain or palpitations with NRT than control, while those symptoms were rare and serious adverse events extremely rare. That evidence supports a differentiated assessment rather than either a declaration of complete harmlessness or the assumption that all cardiovascular effects carry the same clinical significance (the Cochrane NRT review).

Nicotine exposure and toxicant exposure can move differently

A UK cross-sectional study of 181 participants compared smokers, exclusive long-term e-cigarette or NRT users, and dual users. Exclusive alternative-product users had substantially lower measured carcinogen and toxicant exposures, despite broadly similar nicotine exposure. The same pattern was not seen in dual users who continued smoking. The self-selected, cross-sectional sample cannot establish lifetime disease risks; Cancer Research UK was the primary funder (Shahab and colleagues’ biomarker study).

The finding is valuable because it separates two quantities that molecule-based advocacy can conflate. Maintaining nicotine intake does not necessarily maintain the accompanying toxicant exposure. Conversely, adding a new product while continuing cigarettes does not necessarily produce the same benefit as complete switching. A sound assessment must distinguish those trajectories rather than treating nicotine exposure as a sufficient proxy for disease burden.

The strongest argument for scheduling still needs an intervention test

The strongest version of the proponents’ case is that nicotine dependence can become entrenched before adulthood; novel products can expand initiation; dependence can sustain repeated exposure; and governments with limited regulatory capacity may struggle to respond. A common international framework could appear attractive to those governments. Palau’s dossier and the supporting submission advance elements of this argument (Palau’s scientific dossier; the coalition’s submission and signatory list).

Those concerns should be tested on their strongest evidence. They still leave several necessary steps uncompleted. Does scheduling improve compliance more effectively than enforceable national standards? Does it reduce initiation enough to offset restrictions on smokers’ alternatives? Would the proposed exceptions preserve access in practice? Can the international framework distinguish products with substantially different risks?

A proposal does not earn exemption from these questions because dependence is well documented. The efficacy of a restriction is a claim about how people and institutions respond to it. Pharmacology cannot answer that claim alone. The error is to present evidence of a problem as if it were evidence that the selected legal instrument will solve it.

Table 1 Evidence and the additional showing required for scheduling

Imagine that the same evidentiary sequence concerned caffeine: a dossier establishes withdrawal, biological effects, and risks in some circumstances, and then presents those findings as a case for international control. The missing step would be immediately apparent. We would still need evidence that the proposed restrictions improve outcomes. Nicotine’s association with smoking must not allow that step to be skipped.

Law

What the treaty controls

The 1971 Convention creates obligations for its parties, implemented through national legal systems. WHO supplies scientific advice; the Commission on Narcotic Drugs makes scheduling decisions; INCB monitors implementation. WHO cannot itself close shops around the world. However, international scheduling can oblige governments to constrain lawful supply. The four treaty schedules are distinct from domestic drug classifications with similar names (the 1971 Convention; WHO’s account of the review process).

Schedule I includes LSD and MDMA; Schedule II includes amphetamine and methylphenidate; Schedule IV includes alprazolam and diazepam. These examples show a system spanning hallucinogens, stimulants, and medicines with recognized uses. They do not establish that all scheduled substances have equivalent risks. Alprazolam was added to Schedule IV in 1984 (the 1971 Convention; the alprazolam scheduling decision).

For substances in Schedules II–IV, Article 5 generally limits use to medical and scientific purposes, subject to specified exceptions. Articles 8 and 9 address licensing and prescriptions. Article 3 permits conditional preparation exemptions. Medical availability and ordinary consumer availability are therefore different legal outcomes (the 1971 Convention).

This matters because the campaign emphasizes monitoring, licensing, and supply-chain oversight. Those may sound like extensions of familiar consumer regulation. An adult who currently buys nicotine for personal use faces a more fundamental change if lawful access requires a therapeutic justification. Describing the lighter schedules as moderate does not explain how such a market would survive. Proponents should publish the precise legal outcome they seek for each product category.

Decision making and national implementation

A scheduling vote under the 1971 Convention requires at least 36 affirmative votes among the Commission’s 53 members. WHO’s medical and scientific findings are determinative in their field, but the Commission may consider economic, social, legal, and administrative factors and can choose a different scheduling outcome. Decisions ordinarily take effect 180 days after communication; parties may seek Economic and Social Council review within the applicable 180-day period (UNODC’s scheduling guide, pp. 5–7).

This creates several points of responsibility. Scientists must establish what the evidence shows. Governments voting on the proposal must consider consequences beyond pharmacology. National legislatures and regulators must decide how obligations operate domestically. No organization should imply that a scientific recommendation eliminates those political judgments. Conversely, national discretion should not be used to suggest that scheduling is legally inconsequential.

Different controls produce different practical burdens

Schedule I provides the most restrictive medical and scientific exceptions. The other schedules retain the general medical-and-scientific limitation but vary in trade and record requirements. For example, the treaty requires individual import and export authorizations for Schedules I and II, while its treatment of lower schedules differs. Later resolutions encourage additional controls beyond the treaty minimum. Those two sources of obligation must not be conflated (the 1971 Convention; UNODC’s scheduling guide, pp. 17–20).

For businesses, a shift into controlled-drug supply could require changes to authorization, distribution, record systems, and customer eligibility. Whether an existing retail business could comply would depend on the schedule and domestic legislation. This is not merely an extra warning on a package. If ordinary nonmedical sales cease to be lawful, administrative compliance does not by itself restore them.

For consumers, a lawful therapeutic route may restrict product choice and purpose of use. Buying a product to manage dependence could be treated differently from buying the same product because an adult prefers it. Cross-border purchases, online supply, and personal carriage would need separate examination. The treaty contains specific provisions for travelers; these should not be mistaken for permission to maintain an ordinary commercial market (the 1971 Convention, Article 4).

Exemptions are conditional rather than automatic

Article 3 concerns preparations presenting no or negligible abuse risk and from which an abusable quantity cannot readily be recovered. It allows exemptions from some controls, with continuing obligations and international notification. It excludes Schedule I preparations from that route. Article 9 also contains a narrow provision concerning exceptional small medical supplies without prescription in Schedules III and IV (the 1971 Convention, Articles 3 and 9).

The existence of an exemption mechanism therefore does not answer which nicotine products would qualify or whether access would be commercially workable. Advocates should specify the proposed preparation, the legal test it meets, who would make the finding, and which obligations would remain. A promise that medicines will be protected leaves the position of adult consumer products unanswered.

Criminal law and the wider treaty system

Article 22 creates penal obligations for intentional conduct contrary to implementing laws, subject to constitutional limitations; serious offenses attract adequate punishment, with treatment alternatives also contemplated. The 1988 trafficking Convention separately addresses illicit manufacture and supply of substances controlled under the earlier conventions. Its provisions on possession or purchase for personal consumption are qualified by constitutional principles and basic concepts of national legal systems (the 1971 Convention, Article 22; the 1988 trafficking Convention, Article 3).

It would be inaccurate to say that WHO scheduling automatically sends every nicotine user to prison. It would be equally misleading to present the resulting regime as ordinary consumer protection with no criminal-law ramifications. The question is which conduct becomes unlawful and how domestic authorities enforce that law. A policy paper must distinguish users from suppliers and treaty requirements from discretionary national penalties.

Reservations and review do not erase obligations

Article 2(7) allows a reasoned notice of exceptional inability to apply all provisions, but retains schedule-dependent minimum duties. It is not an unrestricted opt-out. Article 2(8) provides a review route. The availability of these mechanisms is a reason for governments to understand their options, not a reason to disregard the consequences of the original vote (the 1971 Convention).

There is no general WHO police power behind these provisions. Their reach comes through the commitments of treaty parties and implementation by national authorities. Institutional pressure, international reporting, and restrictions at export can also matter to a country whose domestic approach is less restrictive. The practical legal analysis must therefore examine the entire supply chain rather than treating domestic retail law in isolation.

Could the treaty protect cigarettes from competition

The legal reach is unresolved and potentially perverse. INCB has explained that the 1971 Convention controls certain active chemicals without controlling the plants containing them, and has identified plant preparations outside international control (INCB’s report on botanical materials, paragraph 284). Clive Bates applies that distinction to tobacco, arguing that extracted or synthetic nicotine could be scheduled while tobacco products remain outside the controls (Clive Bates’s July analysis).

That application needs specialist legal examination. It should not be reported as an authoritative ruling on cigarettes. Palau’s public presentation describes molecule-based oversight across product formats; the interpretation and the campaign’s language therefore need to be reconciled (Palau’s proposal and timetable).

If ordinary tobacco sales continue while nicotine alternatives require medical authorization, the policy would create an advantage for the product responsible for the greatest established harm. The relevant question is painfully straightforward: why should an adult need professional permission to obtain nicotine without burning tobacco when the same adult can buy a cigarette?

If tobacco products are included, advocates face a different obligation: explain how restrictions on an immense established consumer market would operate, and evaluate illicit supply and enforcement. The scale of the market is a reason to take implementation seriously. Neither legal interpretation permits those consequences to disappear behind a general appeal to protect children.

A specialist opinion must test the definitions of substance and preparation against the INCB’s interpretation of botanical materials, the precise wording of any scheduling decision, and domestic implementation. Describing the Convention as controlling only molecules is an oversimplification: its definition also refers to scheduled natural material. The present plant distinction is important, but it cannot replace analysis of what is actually listed and how a manufactured tobacco product is classified (the 1971 Convention, Article 1; INCB’s report on botanical materials).

Table 2 Product questions that a scheduling proposal must answer

This is an analytical map of unresolved questions, not a statement that a final scheduling decision has already assigned these products a particular legal status.

At this point, the Washington analogy returns. Debating exemptions, licenses, and penalties is necessary because the machinery has consequences. It does not establish that invoking the machinery was justified. A technically workable scheme can still be an absurd policy. The capacity to administer a restriction cannot substitute for a reason to impose it.

Policy

Medical permission is not a quality standard

Medicalization joins several propositions that should be examined separately. A product can meet strict purity and manufacturing specifications without requiring a prescription. A medicine can be carefully manufactured and still have serious adverse effects. A prescription establishes a condition of access; it is not a chemical property or a universal guarantee of superior health outcomes.

Medicinal authorization can provide valuable evidence and oversight. Its benefits should be identified specifically. Governments can also require consumer products to meet standards for ingredients, dose consistency, labeling, and packaging. The choice is not between medical control and an unregulated market. Proponents should identify what professional gatekeeping adds beyond the standards that can already be imposed.

A medical route can require the consumer to adopt the role of a patient seeking treatment. An adult who values nicotine, or wants to replace cigarettes without committing to abstinence, may not fit that purpose. Such a person’s choices cannot be evaluated solely by asking whether a cessation medicine remains theoretically available.

Appointments, fees, practitioner attitudes, limited formulations, and repeated authorization could deter access. These are plausible burdens to measure, not estimates of effects already demonstrated for this proposal. Their distribution also matters: people with limited money, time, or medical access may face greater obstacles. A route preserved in legislation can be inaccessible in practice.

Dependence can constrain choice, but it does not establish that all adults using nicotine lack decision-making capacity. Nor does it demonstrate that compulsory medical supervision will help them. A public-health case for gatekeeping must account for users’ preferences and behavior, including the possibility that some will continue smoking rather than accept the authorized alternative. Adult autonomy also has value beyond its contribution to a clinical outcome.

Youth protection does not answer the adult question

There are legitimate disputes about age limits, marketing, flavors, packaging, and enforcement. Preventing initiation among children is a defensible objective. Invoking it does not settle whether adults should lose access to a product, and it does not establish that an international drug-control treaty is the necessary instrument.

A credible analysis would specify the youth harm being targeted, explain why existing or strengthened product rules cannot address it, and compare the expected benefit with restrictions imposed on adults. It would distinguish experimentation from frequent use and interpret trends in the context of smoking. This is a demand for usable evidence, not a reason to dismiss concerns about children.

Protection of children becomes a rhetorical shield when it is used to avoid discussing the fate of adult consumers. The organizations supporting this initiative should state whether they accept regulated adult nicotine use as a legitimate outcome. If their answer is no, that position should be argued openly as a restriction on adults rather than presented solely as child protection.

Evaluate the policy against feasible alternatives

The comparator should be an achievable regulatory framework. Product standards, age verification, proportionate marketing restrictions, risk communication, and enforcement against unsafe goods can be combined while preserving adult access. Their effectiveness needs evidence too. But a flaw in current regulation does not establish that international scheduling is the necessary replacement.

The policy assessment should trace the response of different groups: smokers seeking to switch, adults already using alternatives, people using nicotine medicines, and never-users. Lower legal sales could represent reduced initiation, successful abstinence, or displacement into illicit channels. These outcomes have different health implications. Monitoring only authorized sales would risk celebrating a change in market status rather than an improvement in health.

Adults also have interests that cannot be reduced to a treatment protocol. Some value nicotine use, some accept dependence in exchange for perceived benefits, and some will choose an alternative product without seeking a clinician’s approval. These preferences can be criticized or informed through better evidence. They do not disappear because an institution defines nicotine abstinence as its preferred endpoint.

Consider the same access rules applied to caffeine. An adult could obtain an approved preparation for a recognized therapeutic purpose, but ordinary enjoyment would lack that justification. Explaining how carefully the pharmacy dispenses it would not answer why the adult needs medical permission in the first place. The nicotine proposal raises that question even where exceptions preserve selected medicines.

Funding and institutional incentives

The documented advocacy network

The October submission’s annex lists 103 organizations, including ASH US, NCD Alliance, Vital Strategies, Corporate Accountability, the American Thoracic Society, American College of Chest Physicians, ENSP, SEATCA, the Union, and the University of Bath’s Tobacco Control Research Group. The letter formally supports a review without prejudging the result (the coalition’s submission and signatory list). That qualification does not remove responsibility for promoting this particular process.

ASH describes the initiative as part of an endgame agenda and acknowledges its scientific and legal assistance. Its role is active advocacy, not simply observing an independent inquiry (ASH’s account of the initiative). The participation of medical and legal organizations makes it reasonable to expect serious attention to the consequences of scheduling. Their professional authority increases the obligation to explain those consequences to the public.

We cannot infer that every signatory has identical motives or a common private understanding. We can ask what each institution approved, what legal analysis it considered, and whether it supports continued consumer access. If an organization did not examine those questions before endorsing the initiative, that would be a failure of diligence. If it did examine them, it should publish its answers.

The ethical objection is to promoting coercive restrictions while leaving foreseeable burdens unexplained. If safer alternatives become less accessible, adults who smoke bear the consequences. Organizations claiming to speak for their health should assess that risk explicitly. A coalition’s size cannot substitute for causal evidence, nor can an institutional endorsement establish proportionality.

The dossier identifies Coral Gartner as the dependence chapter’s author, Carolyn Dresler as author of its nicotine-and-cancer section, Charis Girvalaki as author of the remaining chapters, and Thomas Münzel as a contributing coauthor. Listing these roles establishes responsibility for the submitted material; it does not show that each contributor endorses every possible legal outcome (Palau’s scientific dossier, p. 2).

What the financial record establishes

ASH’s audited financial statements for 2023 and 2022 disclose conditional grants and substantial donor concentration. Three donors accounted for 39% of total revenue and support in 2023 and 53% in 2022. The notes identify conditions involving specified costs or outputs. These are historical organizational facts, not evidence of a grant for the 2026 Palau initiative (ASH audited accounts, notes 9–10).

Vital Strategies, a signatory, identifies its role administering a grants program for the Bloomberg Initiative to Reduce Tobacco Use. The grants program also identifies the Union among its implementing partners. This documents an overlapping funding and advocacy network. It does not establish that Bloomberg financed the nicotine notification, instructed its authors, or determined any signatory’s position (Vital Strategies’ program description; the tobacco-control grants program).

ASH’s annual-report statement explicitly solicits support for treaty advocacy and enforceable policy. Its own account is evidence of a deliberate effort to change law. That is sufficient to reject a description of the campaign as wholly detached scientific curiosity without inventing a hidden sponsor (ASH’s annual-report statement).

How funding can shape an agenda

Donor influence need not take the form of an instruction to adopt a particular conclusion. Funding can select topics, reward preferred outputs, finance common communications, and sustain organizations with aligned goals. These are mechanisms to investigate. Their operation in this initiative must be established through grants, contracts, governance records, or attributable statements rather than inferred from agreement alone.

The distinction between identifying an incentive and proving an intervention matters. Concentrated funding can create dependence without proving misconduct. Multiple institutional endorsements can reflect coordination without proving that the underlying evidence is false. Neither point excuses opacity. Organizations demanding independence from commercial interests should disclose the financial and institutional interests surrounding their own advocacy.

The useful disclosure would identify who paid for the dossier, legal advice, website, convening, and submission work; whether contributors were compensated; and what deliverables any restricted grants required. Unpaid staff time and donated services should be included. A public statement that there is no industry conflict does not answer these questions.

Those requirements should apply equally to CGHA and any supporter of this analysis. Funding disclosure does not establish scientific validity on either side. It lets readers evaluate institutional incentives while judging claims against evidence. No campaign-specific donor direction has been demonstrated in the records examined here.

Financial conflicts should be assessed in the evidence we use

The EAGLES findings cited here were commercially funded by pharmaceutical manufacturers. The biomarker study cited above was primarily funded by Cancer Research UK. Those facts neither establish validity nor invalidate results. They illustrate why a rule that rejects inconvenient evidence solely because of its source is inadequate. Study design, measurement, analysis, transparency, and replication remain necessary tests (the EAGLES cardiovascular-safety trial; Shahab and colleagues’ biomarker study).

The same discipline should govern our scrutiny of the scheduling campaign. We should identify donor relationships and their terms, then examine whether they shaped the work. We should not claim to have demonstrated donor direction merely because a signatory participates in a funded network. Equally, organizations should not present financial independence from the nicotine industry as independence from every institutional incentive.

Precedent

The historical decision that must be answered

WHO has considered these questions before. At its 1996 meeting, the expert committee reviewed nicotine and declined to recommend critical review, focusing on existing therapeutic preparations and their effects. It recommended examining tobacco separately. At the 1998 meeting, reported in 1999, the committee recognized tobacco’s dependence and severe harms but judged international drug controls unsuitable. It favored the developing tobacco-control convention and did not recommend critical review of tobacco (WHO’s 1998 tobacco assessment, section 3.2).

The earlier reasoning was institutional as well as pharmacological. A framework limiting supply to medical and scientific purposes was poorly suited to a widely used nonmedical product. The subsequent Framework Convention on Tobacco Control was adopted in 2003 and entered into force in 2005 (WHO’s 1998 tobacco assessment; WHO’s tobacco fact sheet).

That history does not prohibit reconsideration. It establishes what reconsideration must address. Evidence about a new delivery device cannot by itself resolve the earlier objection to using drug prohibition as the regulatory instrument. Anyone proposing a different conclusion should explain which previous premises were wrong, which facts have changed, and why the proposed controls now fit the problem.

Palau’s dossier argues that modern products can produce faster delivery and greater reinforcement than the therapeutic preparations examined in the 1990s. That is relevant to dependence. It does not establish that access to nicotine without combustion should be made more difficult, nor that the drug-control framework would improve population health (Palau’s scientific dossier).

Australia shows what medicalization actually means

Australia provides a contemporary example of restricting vaping to a therapeutic supply channel. Since July 2024, retail supply has been confined to pharmacies for smoking cessation or management of nicotine dependence. From October 2024, qualifying adults have been able to obtain therapeutic vapes containing no more than 20 mg/mL nicotine from participating pharmacies without a prescription, subject to conditions and state or territory law. Other circumstances can require a prescription (Australia’s pharmacist guidance; Australia’s therapeutic-vaping rules).

It would therefore be inaccurate to describe the whole Australian model as prescription-only. It remains medicalized because the authorized purpose and distribution channel are therapeutic. The example demonstrates that removing a prescription requirement does not necessarily restore a consumer market. It does not, by itself, demonstrate the health effects of Palau’s proposal or establish that Australia’s approach is a treaty obligation.

Medicalization is consequently a policy with several dimensions: who may sell, who may buy, which products are permitted, what purpose is authorized, and whether professional approval is required. Treating those dimensions as a single marker of quality obscures the choice being imposed on adults.

Existing controlled medicines do not settle the nicotine case

The successful medical use of a scheduled medicine shows that treatment can continue under control. It does not establish the desirability of restricting an existing consumer product to treatment. A patient’s access to alprazolam and an adult’s decision to replace cigarettes are different policy settings. The question is whether the restrictions produce benefits proportionate to the burdens in the setting under consideration.

Approved nicotine medicines already separate quality from prescriptions

FDA lists nicotine patches, gum, and lozenges as over-the-counter medicines, while nicotine nasal spray and inhalers are prescription products. Medicinal status is therefore already compatible with adult access without an individual prescription. The classification, formulation, indication, and access rule are separate decisions (FDA’s nicotine-medicine access guidance).

WHO’s essential-medicines record provides another relevant precedent. Nicotine gum and patches were first included in 2009; additional formulations were added in 2023. The record recognizes cessation benefits, acceptable adverse effects, and the value of product choice and affordable access (WHO’s essential-medicines record).

This is not a reason to require all nicotine products to become medicines. It is a reason to reject the conflation of good manufacturing with mandatory clinical permission. If proponents intend to preserve over-the-counter NRT while restricting other adult products, they should identify the evidence that justifies the difference and the legal route by which existing access will be protected.

Caffeine as a test of consistency

A familiar psychoactive consumer substance

Imagine an international campaign to put caffeine into a system allowing ordinary access chiefly for medical or scientific purposes. Its dossier could truthfully describe central nervous system effects, repeated use, withdrawal, disturbed sleep, and dangerous intoxication at sufficiently high doses. A double-blind cessation study documented headache and other withdrawal effects among habitual users (the double-blind caffeine-withdrawal study). None of those observations would, on its own, justify requiring adults to obtain professional permission for their morning coffee.

This analogy does not claim that nicotine and caffeine have identical pharmacology, dependence liability, or health risks. They do not need to be identical for the comparison to expose a weakness in the reasoning. If dependence, widespread use, and some harmful effects are said to be sufficient for international control, the principle reaches familiar products whose regulation is normally based on dose, formulation, and context.

Regulating a hazardous form without medicalizing the molecule

EFSA’s assessment found that habitual intake up to 400 mg daily did not raise safety concerns for healthy nonpregnant adults, with different considerations for pregnancy and other groups. This is a population-specific assessment, not a guarantee that every person can tolerate that quantity (EFSA’s caffeine safety assessment). FDA separately warns against pure and highly concentrated caffeine sold in bulk and has acted against certain products presenting unreasonable risks (FDA’s concentrated-caffeine guidance; FDA’s concentrated-caffeine warning).

The distinction demonstrates a regulatory option: restrict an unusually hazardous formulation while preserving ordinary consumer access to others. The existence of concentrated caffeine poisoning does not establish that all caffeine belongs behind a pharmacy counter. Equally, evidence about a particularly high-dose nicotine product must not be used to avoid assessing lower-dose products or less hazardous delivery systems separately.

A risk assessment that begins with the molecule can still distinguish route, dose, and users. A policy that ends with the molecule may erase those distinctions if it applies a common access rule. That is the concern with scheduling nicotine across products whose patterns of exposure and disease consequences differ substantially.

The botanical paradox

Now imagine restricting extracted caffeine in tablets or some drinks while leaving coffee beans and brewed coffee outside the relevant international controls. This is a thought experiment about regulatory consistency, not a legal prediction about caffeine. It resembles the unresolved concern that nicotine extracted from tobacco could attract restrictions that do not apply to tobacco itself.

In the nicotine case the stakes are sharper because burning tobacco is central to the established disease burden. If a legal distinction favors tobacco over products that avoid combustion, purity can become a regulatory disadvantage. The scientific case for such an outcome would need to explain why the cleaner source should face more restrictive adult access.

Someone advocating medical permission for coffee would be expected to demonstrate more than its psychoactivity or its capacity to cause withdrawal. The same discipline should apply here. Familiarity does not prove safety, but unfamiliarity or institutional disapproval does not prove that coercion is beneficial. Caffeine exposes the inadequacy of using dependence as a substitute for a complete public-health case.

Questions the sponsoring organizations should answer publicly

The coalition should state which schedule it regards as appropriate and what ordinary adult uses it expects to remain lawful. It should explain its intended treatment of cigarettes and tobacco-containing products, identify the exemptions it anticipates, and publish the legal advice underlying those expectations.

It should also specify its health objectives in terms that can be evaluated. If initiation, dependence, smoking prevalence, and disease burden are separate endpoints, their relative importance and possible conflicts should be explicit. An intervention that reduces one measure while worsening another requires a judgment that advocates should defend rather than conceal.

Finally, the coalition should disclose who commissioned and financed its supporting work and how institutional endorsements were authorized. Those are reasonable questions for organizations seeking restrictions with consequences for millions of adults. A signature is an act of institutional advocacy. The larger and more authoritative the signatory, the less credible an explanation that the consequences were somebody else’s responsibility.

Bates’s response supplies the practical lesson. An idea can be unreasonable and still require careful opposition when it has a government sponsor, organized advocates, and access to international legal machinery. His submission demonstrates the distinction between taking an argument’s consequences seriously and accepting its premises. The task is to prevent institutional procedure from lending an unjustified proposal the authority of established science (Clive Bates’s evidence submission).

Conclusion

WHO’s guidance requires consideration of whether international controls are suitable to solve or alleviate the public-health problem. The 1971 criteria concern dependence or similarity to controlled substances together with a problem warranting international control. Merely showing that nicotine acts on the brain cannot do the work of that final requirement (WHO’s scheduling guidance, paragraphs 53–57).

A defensible decision would identify the harm attributable to nicotine and its distribution across products; establish the legal reach of each proposed schedule; and evaluate the likely response of consumers. It would examine effects on switching, cessation, and illicit supply, alongside prevention of initiation. It would compare scheduling with feasible national regulation and explain why medical gatekeeping is necessary. These are substantive requirements for choosing an intervention, not administrative obstacles to action.

The public materials examined here do not establish that chain of justification. Scientific evidence about dependence and toxicity can support warnings and targeted regulation without supporting international scheduling. The absence of proof that a substance is harmless cannot serve as proof that prohibition or compulsory medicalization is beneficial.

The review should therefore be required to assess the case for leaving nicotine unscheduled, preserving regulated adult access, and improving product standards. If proponents cannot demonstrate that the proposed controls would improve health, WHO should recommend against scheduling. A treaty capable of restricting lawful supply should not become a vehicle for imposing an abstinence preference under the authority of science.

The organizations promoting this initiative should answer for the policy they are helping advance. Adults should not have to become patients to escape smoke. Any proposal that could make cigarettes the easier option must carry an exceptionally demanding burden of proof. That burden has not been met.

We began with Washington and the Delaware because the absurdity of a premise can disappear beneath a detailed discussion of its implementation. The analysis here should restore that first question. Before deciding where the boats should launch, we should ask why anyone has accepted that we are planning Washington’s crossing. Before deciding how to medicalize nicotine, we should require a convincing justification for doing so at all.

The comparison with caffeine makes the institutional choice harder to disguise. The issue is whether adult consumption should be made conditional on a medical purpose, and whether doing so will improve health. Advocates should defend that choice directly. Neither the size of their coalition nor the moral force of protecting children supplies the missing scientific and legal justification.

References

ASH (2024) Action on Smoking and Health financial statements for the years ended December 31, 2023 and 2022. Notes 9 and 10, printed p. 18.

ASH (2026a) Tobacco endgame policy innovation and a critical review of nicotine under the UN narcotics system.

ASH (2026b) Written statement to the 49th ECDD information meeting, October 16, and organizational signatory annex.

ASH (2026d) 2025 ASH annual report. Organizational statement accompanying the report.

Auer, R. et al. (2024) Electronic nicotine-delivery systems for smoking cessation. New England Journal of Medicine, 390, pp. 601–610.

Australian Government Department of Health, Disability and Ageing (n.d.) About vaping and e-cigarettes.

Bates, C. (2026a) The worst idea in the history of tobacco control. The Counterfactual, July 6.

Bates, C. (2026b) Evidence sent to the WHO review of nicotine. The Counterfactual, November 11. Reproduces the November 9 submission email.

Benowitz, N.L., Pipe, A., West, R., Hays, J.T., Tonstad, S., McRae, T., Lawrence, D., St Aubin, L. and Anthenelli, R.M. (2018) Cardiovascular safety of varenicline, bupropion, and nicotine patch in smokers: a randomized clinical trial. JAMA Internal Medicine, 178(5), pp. 622–631. doi:10.1001/jamainternmed.2018.0397.

Commission on Narcotic Drugs (1984) Inclusion of alprazolam in Schedule IV. Decision 5(S-VIII), February 7.

EFSA Panel on Dietetic Products, Nutrition and Allergies (2015) Scientific opinion on the safety of caffeine. EFSA Journal, 13(5), article 4102, 120 pp. doi:10.2903/j.efsa.2015.4102.

FDA (2018) Highly concentrated caffeine in dietary supplements: guidance for industry. April.

FDA (2026) Swedish Match USA modified-risk tobacco product applications for ZYN products. Orders issued June 30.

FDA (n.d.-a) Chemicals in tobacco products and your health.

FDA (n.d.-b) FDA warns consumers about pure and highly concentrated caffeine.

FDA (n.d.-c) Smoking: medicines to help you quit. FDA Office of Women’s Health.

Hajek, P. et al. (2019) A randomized trial of e-cigarettes versus nicotine-replacement therapy. New England Journal of Medicine, 380, pp. 629–637.

Hartmann-Boyce, J., Chepkin, S.C., Ye, W., Bullen, C. and Lancaster, T. (2018) Nicotine replacement therapy versus control for smoking cessation. Cochrane Database of Systematic Reviews, Issue 5, CD000146. doi:10.1002/14651858.CD000146.pub5.

INCB (2011) Report of the International Narcotics Control Board for 2010. Paragraph 284.

Joseph, A.M., Norman, S.M., Ferry, L.H., Prochazka, A.V., Westman, E.C., Steele, B.G., Sherman, S.E., Cleveland, M., Antonuccio, D.O., Hartman, N. and McGovern, P.G. (1996) The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. New England Journal of Medicine, 335(24), pp. 1792–1798. doi:10.1056/NEJM199612123352402.

Lindson, N. et al. (2026) Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews, Issue 8, CD010216.

Murray, R.P., Connett, J.E. and Zapawa, L.M. (2009) Does nicotine replacement therapy cause cancer? Evidence from the Lung Health Study. Nicotine and Tobacco Research, 11(9), pp. 1076–1082.

Republic of Palau (2026a) Formal notification on the international review of nicotine, June 10.

Republic of Palau (2026b) What is being proposed and expected timetable.

Republic of Palau (2026c) Supporting scientific dossier on nicotine, June, especially pp. 2, 5–6 and 40–41.

Shahab, L., Goniewicz, M.L., Blount, B.C., Brown, J., McNeill, A., Alwis, K.U., Feng, J., Wang, L. and West, R. (2017) Nicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users: a cross-sectional study. Annals of Internal Medicine, 166(6), pp. 390–400. doi:10.7326/M16-1107.

Silverman, K., Evans, S.M., Strain, E.C. and Griffiths, R.R. (1992) Withdrawal syndrome after the double-blind cessation of caffeine consumption. New England Journal of Medicine, 327(16), pp. 1109–1114. doi:10.1056/NEJM199210153271601.

Therapeutic Goods Administration (TGA) (n.d.) Vapes: information for pharmacists. Australian Government.

Tobacco Control Grants Program (n.d.) Bloomberg Initiative to Reduce Tobacco Use: implementing partners and grants program.

United Nations (1971) Convention on Psychotropic Substances, especially Articles 2, 3, 5, 8 and 9, and annexed schedules.

United Nations (1988) United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. Vienna, December 20. Article 3. Reproduced by the Office of the High Representative.

UNODC (2020) Scheduling procedures under the international drug control conventions. Vienna: United Nations. Especially pp. 5–7 and 17–20. Publication V.19-11955.

Vital Strategies (n.d.) Tobacco control: Bloomberg Initiative grants administration.

WHO (1999) WHO Expert Committee on Drug Dependence thirty-first report. Technical Report Series 887, section 3.2. Meeting held June 1998.

WHO (2010) Guidance on the WHO review of psychoactive substances for international control, paragraphs 53–57.

WHO (2023) Nicotine replacement therapy: essential medicine recommendation and status history. Electronic Essential Medicines List, recommendation 1097.

WHO (2025) Expert Committee on Drug Dependence questions and answers.

WHO (2026) Tobacco and nicotine. Fact sheet, June 26.