As governments consider how to regulate nicotine pouches, one model is becoming increasingly important: treating oral nicotine products not as general consumer goods, but as medicines, natural health products, poisons, or pharmaceutical-style nicotine replacement therapies.
This approach is most clearly visible in Canada, where Zonnic has become the leading example of a nicotine pouch authorised through a therapeutic pathway. It is also reflected, in different ways, in Australia, France, and Brazil, where regulators have placed or proposed to place nicotine pouches within medical, drug, poison, or pharmaceutical-style frameworks.
These examples raise an important policy question for nicotine governance: does medicalising nicotine pouches improve consumer protection, or does it risk limiting adult access to potentially lower-risk alternatives while combustible tobacco remains widely available?
Canada: Zonnic and the Natural Health Product Route
Canada provides one of the most instructive case studies.
Zonnic is a nicotine pouch product marketed by Imperial Tobacco Canada and authorised by Health Canada as a Natural Health Product nicotine replacement therapy. It is a 4 mg nicotine pouch intended to relieve cravings and withdrawal symptoms in adults who wish to quit or temporarily refrain from smoking.
This created a distinctive regulatory situation. A product resembling modern consumer nicotine pouches was brought to market through a therapeutic pathway, rather than through a general tobacco or novel nicotine product category. Canada does not currently provide a broad federal consumer framework for nicotine pouches comparable to some European markets. As a result, nicotine pouches outside the Natural Health Product or drug pathway are not legally authorised for general retail sale.
Zonnic’s initial launch created significant political and public health scrutiny. The product was authorised as an NRT, but its flavour range, branding style, and initial retail availability raised concerns among health organisations and policymakers about youth appeal and insufficient controls.
Following this backlash, Canadian authorities tightened the framework. Zonnic is now restricted to pharmacy sales, kept behind the counter, and subject to stronger youth protection and marketing controls. Non-mint and non-menthol flavours were also removed or restricted, bringing the product closer to a traditional supervised NRT model.
Canada therefore illustrates both the opportunity and the tension of the pharmaceutical route. On one hand, it provides a legal pathway for a nicotine pouch product to reach adults as a smoking cessation or temporary abstinence aid. On the other, it demonstrates how quickly a product with consumer-style characteristics can generate regulatory concern when introduced through a medicinal framework.
Australia: Pharmaceutical in Principle, Prohibition in Practice
Australia represents a stricter model.
Nicotine pouches are not available as general consumer products. Nicotine, outside traditional NRT products and regulated therapeutic pathways, is generally controlled through poison or prescription frameworks. Nicotine pouches may only be legally possessed or used in limited circumstances, such as with a prescription for smoking or vaping cessation.
However, there are currently no nicotine pouch products registered on the Australian Register of Therapeutic Goods. This means that while the theoretical pathway is medical, the practical outcome is that no approved pouch category exists for ordinary adult access.
Australia therefore represents a “pharmaceutical in principle, prohibition in practice” model. The framework treats nicotine pouches as potential medicines, but the absence of registered products means that legal access is effectively unavailable through normal retail channels.
This model prioritises precaution and regulatory control, but it also raises questions about whether adult smokers are left with fewer legal alternatives while combustible tobacco remains accessible.
France: Drug Classification and Limited Consumer Access
France also reflects a drug-based approach.
Nicotine pouches have been treated as products subject to medicinal or drug regulation rather than as a distinct consumer nicotine category. In practice, this means that products would need to satisfy medicinal authorisation standards before being lawfully marketed.
This creates a high regulatory threshold and prevents the development of a broad consumer-facing pouch category comparable to markets where nicotine pouches are regulated as consumer goods or tobacco-related products.
France’s approach aligns with a broader precautionary model increasingly visible in parts of Europe. The policy emphasis is on preventing youth uptake and controlling nicotine exposure, but it leaves limited space for nicotine pouches to function as adult-access smoke-free alternatives outside a medical framework.
Brazil: ANVISA and the Emerging Pharmaceutical-Style Model
Brazil is one of the most important emerging cases.
ANVISA has proposed a framework for oral nicotine products centred around a 4 mg nicotine ceiling and therapeutic-style controls. While Brazil does not yet have a live regulated nicotine pouch market, the proposed model suggests a pharmaceutical-style pathway rather than a broad consumer nicotine category.
This is significant because Brazil often influences regulatory debates across Latin America. If ANVISA adopts a pharmaceutical-style model, it may become a reference point for other countries in the region considering how to regulate nicotine pouches.
The Brazilian approach appears designed around precaution, standardisation, and controlled exposure. However, it also raises familiar questions. A 4 mg ceiling may align with traditional NRT assumptions, but it may not necessarily provide sufficient nicotine delivery for all adult smokers seeking to substitute away from combustible tobacco.
The Brazilian case therefore deserves close attention. It is not yet an established market model, but it may become an influential regulatory template.
The Strengths of the Pharmaceutical Model
The pharmaceutical classification model offers clear advantages from a regulatory perspective.
It gives authorities strong control over product claims, labelling, distribution, nicotine levels, and consumer messaging. It can help prevent recreational positioning and reduce youth-oriented marketing. It may also provide a clearer route for products that make cessation or withdrawal-relief claims.
For policymakers concerned about youth uptake, product appeal, and uncontrolled market expansion, the pharmaceutical model offers a familiar and structured framework.
It also places responsibility on manufacturers to justify product claims and comply with defined health-product standards.
The Limits of Medicalising Nicotine Pouches
At the same time, the pharmaceutical model has important limitations.
Nicotine pouches are not always used in the same way as traditional NRT products. In a harm reduction context, the policy objective may not always be short-term nicotine abstinence. It may be long-term substitution away from combustible tobacco.
This distinction matters.
If nicotine pouches are regulated only as medicines, access may become limited to pharmacies, prescriptions, or highly restricted channels. Nicotine strength may also be capped at levels designed for traditional NRT rather than for real-world smoking substitution.
This may reduce youth exposure, but it may also reduce the appeal and availability of products for adult smokers who are seeking alternatives to cigarettes.
The risk is that medicalisation may make nicotine pouches safer on paper but less effective in practice as substitutes for smoking.
A Key Governance Question
The central question is not whether nicotine pouches should be regulated. They should be.
The question is whether they should be regulated only as medicines, or whether some jurisdictions should develop dedicated frameworks that combine adult access, strict youth protections, product standards, marketing controls, and post-market surveillance.
Canada, Australia, France, and Brazil show different versions of the pharmaceutical model. Canada has allowed one legal product but has moved it closer to supervised pharmacy distribution. Australia treats the category as therapeutic in theory but effectively unavailable in practice. France places pouches within drug-style controls. Brazil is considering a pharmaceutical-style framework that may influence wider Latin American policy.
Together, these cases show that medical classification can provide regulatory control, but it can also narrow the role nicotine pouches may play in broader harm reduction strategies.
Looking Ahead
As nicotine pouch regulation develops globally, policymakers will need to decide whether the pharmaceutical model is sufficient, or whether more tailored nicotine frameworks are needed.
A proportionate approach would recognise three realities at once: nicotine is addictive and requires strong youth safeguards; combustible tobacco remains the primary driver of smoking-related disease; and non-combustible nicotine products may require regulatory models that reflect their distinct risk, use, and policy profile.
The experience of Canada, Australia, France, and Brazil suggests that the pharmaceutical pathway may be useful in some contexts, but it is not a complete answer to modern nicotine governance.
For regulators, the challenge is to protect young people while ensuring that adult smokers are not left with only the most harmful legal option: combustible tobacco.
