This submission is provided on behalf of the Global Institute for Novel Nicotine (GINN), which advocates for proportionate, science-based regulation that recognises tobacco harm reduction (THR) as a legitimate public health strategy
Our focus is on the necessary regulation of nicotine products, specifically nicotine pouches, which are currently available on the UK market but operate within a regulatory vacuum (a ‘grey market’). The Tobacco and Vapes Bill presents a critical opportunity to introduce robust and sustainable product standards and market controls for this category.
GINN is the leading industry association for novel nicotine products. It advocates harm reduction and science-based proportionate regulation on behalf of its members. GINN is not linked or funded by the combustible tobacco industry.
1. INTRODUCTION
Nicotine pouches, when produced according to recognised manufacturing and toxicology standards, present a very low health-risk profile. Unlike combustible and inhaled nicotine products, pouches do not involve heating, burning or aerosolisation. As a result, they do not produce tar, carbon monoxide, volatile carbonyls, particulates, or heavy metals. This alone removes nearly all toxicant exposure associated with smoking and a significant portion of the risks associated with vaping.
The most common side effects reported with nicotine-pouch use are mild oral irritation, gum sensitivity and dryness. These are temporary, dose-related and easily managed by adjusting usage patterns. Crucially, there is no evidence linking regulated nicotine pouch use to periodontal disease, systemic toxicity, respiratory harm or carcinogenic risk.
Safety requirements embedded within existing technical standards ensure that all flavourings are food-grade or pharmacopeia-grade, and substances with known carcinogenic or sensitising properties (e.g., pulegone, safrole, coumarin) are prohibited. Toxicological assessments must be conducted on complete formulations, ensuring that pH regulators, humectants and flavourings meet safety thresholds and do not introduce harmful exposures.
International real-world data reinforces the low-risk assessment. Sweden’s and Norway’s decades-long reliance on oral nicotine, with widespread substitution of cigarettes, has coincided with some of the lowest rates of lung cancer, COPD and cardiovascular disease in Europe. These countries provide a unique evidence base showing that long-term oral nicotine use produces dramatically fewer health harms than smoking.
The primary risk arises from high-strength products that exceed safe nicotine levels (often above 50-100 mg per pouch). Such products increase risks of nausea, dizziness and accidental overuse without any improvement in cessation efficacy. A regulated limit of 20 mg per pouch avoids this risk and ensures products remain appropriate for adult smokers and former smokers.
Importantly, flavourings in nicotine pouches pose far less concern than in inhaled products because they are not heated. Their role is primarily behavioural – supporting adult adherence.
In summary, regulated nicotine pouches present a safety profile comparable to medicinal oral NRT and substantially safer than smoking. Harm arises primarily from non-compliant imports, not from compliant regulated products.
II. Regulating Flavour Presentation, More Effective Than Regulating Flavour Itself
For nicotine pouches, the most effectivestrategy to deal with flavours is to regulate the way flavour is presented, not the flavour itself. Evidence from Sweden and Norway, where oral nicotine products are widely used and smoking prevalence is among the lowest in the world, shows that adult access to flavoured oral nicotine has been central to successful smoking cessation. Flavours serve a cessation-supportive function by helping adults maintain adherence and mask nicotine’s natural bitterness with mint, fruit, and spice profiles to aid compliance. Evidence shows flavours improve product acceptability among adult smokers without introducing additional toxicological risk when ingredients meet existing safety benchmarks.
Flavours help adult smokers replace cigarettes and avoid relapse, mirroring the role flavoured NRT gums play in improving adherence. Removing or excessively restricting flavours would undermine these harm-reduction benefits without achieving a measurable benefit to public health. This is supported in the international evidence.
The safest and most proportionate approach is to regulate flavour presentation, packaging, and marketing, rather than banning entire flavour categories. The Arcus Compliance Primary Authority Assured Advice, for instance, offers a strong, existing model for this. It requires adult-oriented packaging, restricted colour palettes, clear nicotine-strength labelling, unambiguous “18+” age symbols, and a prohibition on confectionery-like designs and product names or branding that might appeal to children. These standards significantly reduce youth interest without limiting the adult-cessation benefit of flavours.
PAS 8877 reinforces this approach by requiring full toxicological assessment of flavouring ingredients, ensuring that only food-grade or pharmacopeia-grade substances are used. This ensures flavours remain safe for oral use and problematic compounds are excluded. The technical standard also ensures that flavourings cannot introduce harmful contaminants, a core component of responsible flavour regulation.
To further strengthen flavour oversight, nicotine pouches should be subject to mandatory MHRA pre-market notification, mirroring the TPD model already used for vapes. Pre-market notification would require manufacturers to submit full ingredient and toxicology data, packaging designs, and labelling for review before a product is sold. This ensures that only compliant flavours and compliant packaging reach the UK market, while providing a national registry of approved products.
Additional safeguards include officially adopting the currently recommended 20mg nicotine caар-which prevents the pairing of strong flavours with extreme nicotine strengths and requiring ISO-compliant child-resistant containers, including child-resistant used-pouch bins, to eliminate accidental exposure.
The evidence clearly shows that flavour bans are neither necessary nor proportionate for a non-inhaled, low-risk product like nicotine pouches. A more effective strategy is to preserve flavours for adult smokers while eliminating youth appeal through strict packaging rules, adult-only branding, toxicology-based flavour screening, child-resistant containers, and MHRA notification. This approach protects young people while maintaining the cessation benefits that have driven the dramatic reductions in smoking seen in Sweden and Norway.
III. No Combustion, Lower Heavy Metal Presence In High-Quality Nicotine Pouches
Nicotine pouches are an essential cessation tool for adults seeking a non-inhaled, low-risk alternative to smoking. Extensive evidence from Sweden and Norway show demonstrates major reductions in tobacco-related disease. These population-level outcomes provide compelling real-world evidence that nicotine pouches play a meaningful role in helping smokers quit and in preventing relapse among former smokers.
Nicotine pouches typically contain pharmaceutical-grade nicotine, purified plant fibres, food-grade flavourings, pH regulators, and moisture-control ingredients. Established technical standards require strict ingredient purity, toxicological assessment of all components, exclusion of harmful or carcinogenic flavouring substances, and compliance with food-contact materials criteria. These requirements ensure consistency, minimise potential irritants, and prevent the types of contaminants historically associated with tobacco products.
A critical safety advantage of nicotine pouches is that they are not heated, eliminating combustion and aerosol-related toxicants. Without heating elements, there is no generation of tar, carbonyls, volatile gases, heavy metals, or particulate matter. This removes the exposure pathways responsible for the overwhelming majority of smoking-related harm. Presence of heavy metals in high-quality nicotine pouches occurs at very low levels and exposure to them is negligible. When manufactured to recognised technical and toxicological standards, nicotine pouches offer one of the cleanest safety profiles of any nicotine product. Combined with adult-appropriate flavour regulation and packaging controls, they represent a viable, effective, and substantially safer alternative to smoking.
IV. Regulated Nicotine Levels To Support Cessation and Reduce Potential For Adverse Effects. Nicotine Absorption From High-Quality Pouches
Nicotine pouches deliver nicotine through buccal absorption, resulting in slow, steady rises in plasma nicotine levels comparable to medicinal NRT gum. This absorption pattern differs fundamentally from smoking, which produces rapid spikes in nicotine concentration that create strong addiction reinforcement. The slower, controlled profile of nicotine pouches reduces dependence potential while still effectively alleviating cravings, making them highly suitable for both smoking cessation and relapse prevention.
Nicotine absorption research demonstrates that strengths between 9-20 mg per pouch provide effective craving relief for dependent smokers, with most smokers achieving stable craving control using 9-15 mg per pouch and heavy smokers benefiting from strengths up to 20 mg. Consistent evidence shows no improvement in craving suppression or cessation outcomes at strengths above 20 mg. Excessive strengths increase adverse effects such as nausea or dizziness, particularly for inexperienced users of nicotine pouches. This evidence supports a regulated strength cap of 20 mg, which strikes the right balance between therapeutic effectiveness and consumer safety. In real-world practice, smokers transitioningto nicotine pouches report rapid stabilisation of cravings and significant reduction in cigarette consumption as demonstrated in Sweden and Norway.
Because nicotine pouches are not inhaled, their pharmacokinetic profile is predictable and avoids the risks associated with combustion or aerosolisation. There are no temperature-related degradation products, no variances caused by puff topography, and no device-related discrepancies in dose delivery. This consistency is particularly valuable for former smokers who require reliable nicotine delivery to prevent relapse.
Overall, the evidence shows that nicotine pouches deliver therapeutic nicotine in a controlled, low-risk manner. A 20 mg maximum nicotine level ensures adequate delivery for dependent smokers while preventing excessive dosing and misuse. Their pharmacological simplicity and lack of inhalation make them one of the most suitable long-term harm-reduction options available.
From a regulatory perspective, maintaining a clear ceiling at 20mg also helps distinguish compliant, adult-oriented products from illicit high-strength with no potential to benefit public health. A fixed maximum simplifies enforcement, toxicology assessment and MHRA notification, and prevents the emergence of extreme-strength products that could undermine confidence in the category or pose risks to inexperienced users. It also anchors the category firmly within a harm-reduction framework rather than allowing it to drift into recreational high-strength use.
V. Responsible Businesses Benefit From Predictability Brought By Proportionate Regulation
Clear, proportionate regulation benefits responsible manufacturers by creating predictable operating conditions, supporting investment and preventing illicit competition. When regulatory frameworks align with established technical standards-covering ingredient purity, toxicology requirements, pH limits, and stability criteria-businesses can plan production, sourcing and compliance with confidence. This approach is already used successfully in Sweden and Norway, where regulated oral nicotine markets coexist with extremely low smoking rates and stable, compliant supply chains.
A vital regulatory tool missing in the UK is a mandatory MHRA notification system. Vaping products already follow this structure: manufacturers must submit toxicology data, ingredient lists, packaging details and emissions information before entering the UK market. The same process should apply to nicotine pouches. Notification would ensure all products are reviewed before sale, enable rapid enforcement against non-compliant imports, and protect responsible manufacturers from unfair competition.
Packaging rules anchored in the Arcus Compliance Primary Authority Assured Advice would further increase regulatory clarity. This model provides a standardised approach to warnings, age-restriction symbols, information hierarchy, and adult-oriented presentation. It gives businesses a clear, stable foundation for product development and avoids repeated redesigns caused by unclear requirements.
Overly restrictive measures-such as flavour bans, impractically low nicotine caps or excessive packaging constraints-can destabilise legal supply chains and push consumers toward illicit markets. Evidence from global nicotine policy consistently shows that when regulated reduced-risk products become unattractive or difficult to access, consumers turn to illegal high-strength alternatives.
Therefore, a balanced UK framework should include: technical standards for purity and toxicology, mandatory MHRA notification, a 20mg nicotine cap, ISO-level child-resistant packaging, adult-oriented labelling, and strong age-verification requirements. This model supports responsible businesses, protects consumers and reinforces UK harm-reduction goals.
VI. Summary On Product Regulation Including Oral Health Considerations For Nicotine Pouches
For nicotine pouches, the key evidence base on flavours, ingredients and “emissions” points towards a very low-risk profile when products are manufactured and presented in line with recognised standards, but with some specific considerations for oral health and youth protection.
Flavours in nicotine pouches primarily serve a behavioural function. Adult smokers and ex-smokers report that palatable flavours are crucial for long-term adherence and relapse prevention, in the same way flavoured NRT gums increase compliance. Where products follow technical and toxicological standards, flavourings are food-grade or pharmacopeia-grade and screened to exclude substances with known carcinogenic, mutagenic or sensitising properties. There is no heating or combustion, so there is no thermal breakdown of flavourings and no inhalation exposure; this substantially reduces risk compared with inhaled products.
The “emissions” from nicotine pouches are limited to saliva containing dissolved nicotine and flavour constituents, which is swallowed. Studies show very low levels of tobacco-specific nitrosamines and other contaminants when high-purity pharmaceutical nicotine and clean plant fibres are used. In practice, exposure profiles resemble those of licensed oral NRT rather than smoked tobacco.
On oral health, the main observed effects are transient local irritation, gingival redness or minor recession at the placement site, particularly with high-frequency use. These effects appear to be dose- and time-dependent and generally reversible. There is currently no convincing evidence that regulated nicotine pouches cause the level of periodontal damage, tooth loss or oral cancer associated with smoking. However, ongoing surveillance and transparent labelling advising rotation of placement and regular dental check-ups are prudent.
To manage residual risk, two structural measures are essential. First, a maximum strength of 20mg nicotine per pouch should be maintained. Evidence shows this is sufficient for heavy smokers to quit and for ex-smokers to avoid relapse, while higher strengths add side effects without improving cessation outcomes. Second, all nicotine pouches should be supplied in genuinely child-resistant containers, including any built-in “used-pouch” bin, given the residual nicotine left after use. Together, a 20mg cap, strict ingredient and flavour controls, Arcus-aligned labelling and mandatory child-resistant packaging provide a coherent, evidence-based framework for maximising the harm-reduction benefits of nicotine pouches while minimising oral and accidental-exposure risks. GINN has a curated collection of independent scientific reports and surveillance data concerning nicotine pouches, which can be found on our website or made available to regulators, that supports the measures herein proposed.
VII. Licensing
GINN strongly supports the objectives to protect public health and prevent crime. A comprehensive national licensing scheme would benefit strengthened enforcement, drive up industry standards, and ensure that only law-abiding retailers can sell these products. A licensing system supports enforcement of age-restrictions and quality standards, particularly concerning the reported sales of nicotine pouches that do not adhere to agreed quality and safety standards. Licensing would serve as a mechanism for accountability and consumer protection.
Key factors for granting a premises licence should ensure the applicant is a responsible adult-focused retailer:
1. Exclusion of Youth-Focused Retail: Businesses that primarily stock and sell products which are disproportionately youth appealing (e.g., confectionery and toys) should be automatically blocked from obtaining a licence.
2. Compliance History: The business should be prevented from obtaining a licence if it has received repeated official warnings, fines, or enforcement action for selling age-gated products (such as alcohol or cigarettes) to minors within the past two years.
3. Supervision: A licence should only be granted if the business nominates a Designated Premises Supervisor (DPS) who holds a personal licence.
4. Nature of Business: The primary function of the business must be retail; service providers (e.g., takeaways, taxi drivers, hairdressers) should not be eligible.
Licensing conditions imposed on a premises licence should include:
Traceability: Licence holders must keep records of all transactions with distributors and manufacturers for at least six years to ensure traceability through the supply chain.
Environmental Responsibility: Retailers should be required to offer in-store collection points where consumers can drop off used devices for recycling.
Online retailers must be required to have a licence, and requirements should broadly mirror those for physical retailers.
Administration: Online retailers should register with the local authority area in which their head office is located. They must nominate a Designated Site Supervisor (DSS).
Compliance Monitoring: Compliance monitoring for online sales should be enhanced. Online retailers must demonstrate robust age verification processes at the point of purchase and delivery. They should be subjected to a higher number of annual test purchasing exercises than brick-and-mortar stores, reflecting their broader reach.
Marketing Scrutiny: Monitoring must ensure the website is not designed in a way that disproportionately appeals to minors, and that vape products are listed in a dedicated, separate section.
Importantly, the design of any licensing scheme, applicable fees, conditions for granting, compliance surveillance, sanctioning, renewals, etc. must bear in mind the principles of rule of law, such as proportionality, and appropriate market regulation that protects responsible businesses of all sizes.
VIII. A Product Registration Scheme Is Necessary
Nicotine pouches are currently not subject to any notification requirements. However, the nicotine pouch market is experiencing rapid expansion, projected to see 15% year-on-year growth. This growth reflects strong consumer interest in lower-risk nicotine alternatives. There appears to be emerging evidence of increased use of nicotine products, such as nicotine pouches, among younger men in Great Britain. In markets with controlled frameworks, such as the Kingdom of Saudi Arabia (KSA), nicotine pouches drove approximately 55% of adult smokers to partially or fully switch in less than two years. GINN supports a product registration model that enables harm reduction efficacy and benefits from effective strategies in existing systems. For comparison, these is the view on registration rules applicable in other jurisdictions:
| Registration Model | Advantages | Disadvantages / Risks |
|---|---|---|
| Specific Non-Pharmaceutical Regulation (e.g., Czech Republic, Greece) | – Pragmatic and evidence-based approach with clear standards and nicotine caps (12mg/20mg).- Strong youth-protection measures.- Channels innovation toward public-health goals. | – Full impact on smoking-cessation outcomes not yet fully assessed due to recent implementation. |
| Premarket Review (PMTA, USA) | – Stringent, science-based regulatory pathway.- FDA recognises nicotine pouches as APPH (appropriate for the protection of public health).- FDA introduced a streamlined, fast-track PMTA review process. | – Requires significant industry resources.- System depends on strict enforcement against unauthorised products. |
| Pharmaceutical Licensing (e.g., India) | – Creates a highly controlled marketplace.- Strict dosage limits enhance regulatory oversight. | – Low dosage limits (e.g., 4mg in India) often insufficient for heavy smokers to quit.- Stifles innovation.- Reduces uptake as smokers may not identify as patients. |
In the UK, registration requirements should mandate evidence that supports the product’s intended use and adherence to industry best practice:
Comparative Risk Data: Data demonstrating the relative risk difference between the registered nicotine pouch product and combustible cigarettes should be required. Suppressing accurate comparative risk information weakens efforts to encourage smokers to switch.
Code of Practice Compliance: Manufacturers should be required to provide an attested declaration that the product complies with an established industry Code of Conduct. GINN supports such a Code (e.g., through the Nicotine Standards Authority NSA) to ensure product safety, transparency, and that manufacturers protect young people at every touchpoint.
Testing should be mandated at the point of registration, meaning it must be conducted before a product is supplied to the UK market. This requirement for pre-market checks is essential to prevent suppliers from providing false information and to ensure non-compliant products are caught before sale.
Building on the current TRPR framework for nicotine vapes, a “responsible person” can be nominated. However, this role is currently limited to acting as a contact point, and no enforcement action can be taken against them. GINN recommends that the new registration scheme must make the nominated responsible person liable for the information provided and subject to penalties if the information is found to be false. This is necessary to enforce accountability and counter issues with suppliers providing fraudulent information.
Fees should be set to reflect the product risk profile, the cost of administering the registration and testing schemes. Given that nicotine pouches are a significantly lower-risk product compared to combustible tobacco (where testing fees start at £1,000 for cigarettes), the fees charged for nicotine pouches should be substantially lower and proportionate to their risk profile.
While implementing clear standards and market controls will impose increased costs associated with registration fees and enhanced testing requirements on businesses that were previously operating in the unregulated “grey market”, this is a necessary cost to ensure consumer safety and product integrity. Good communication, training, accessible fees or payment plans, simplified renewal process for compliant retailers could ease the burden on businesses.
- A well-designed licensing and registration system protects responsible manufacturers by excluding “rogue players” and short-lived brands. Strong enforcement against non-compliant products is vital to reward compliant businesses.
- GINN, via the proposed Nicotine Standards Authority (NSA), supports industry-led mechanisms to enforce high standards. NSA signatories agree to uphold public trust, promote harm reduction, and support decisions of an Independent Complaints Panel. This approach seeks to professionalise the marketplace and provide predictable oversight, which benefits legitimate trade.
Effective enforcement requires a globally aligned regulatory framework and clear penalties.
1. Define Standards and Caps: Enforcement capacity will improve only once a comprehensive framework is established, clearly defining product standards, manufacturing standards, responsible marketing, and, critically, nicotine caps.
2. Decisive Action and Penalties: Regulatory approval must be matched with decisive action against non-compliant products to deter abuse. Penalties must be substantial enough to outweigh any profit from illegal trade. The proposed licensing framework includes escalating penalties, with fines of up to £10,000 for serious or repeated offences, alongside the loss of the right to sell products.
3. Accountability: Enforcement must hold the responsible person liable for false information submitted during product registration.
4. Ring-fenced Funding: Enforcement functions should be supported by a self-sustaining national enforcement fund, financed through revenues from the proposed licensing scheme. This funding should be ring-fenced specifically for test purchasing, compliance inspections, and action against illicit imports.
Sources
The following sources from The Royal College of Physicians, Public Health England, the Royal College of General Practitioners, Cochrane reviews, studies from dentist associations from Sweden, longitudinal studies from Sweden and Norway, the Global State of Tobacco Harm Reduction 2024 and others are provided for reference as generally informing GINN’s views.
Nicotine without smoke: Tobacco harm reduction https://www.rcp.ac.uk/media/xcfal4ed/nicotine-without-smoke_0.pdf
E-cigarettes and non-combustible inhaled tobacco products https://www.rcp.org.uk/representing-you/policy-areas/e-cigarettes
Potential Impact of Oral Nicotine Pouches on Public Health https://academic.oup.com/ntr/article/27/4/598/7693924
Evaluation of high-nicotine oral products shows potential to … https://www.nature.com/articles/s41598-025-21812-x
Self-reported oral health outcomes after switching to a … https://pmc.ncbi.nlm.nih.gov/articles/PMC12138386/
Oral and periodontal implications of tobacco and nicotine … https://onlinelibrary.wiley.com/doi/10.1111/prd.12395
Systematic review of longitudinal studies on the … https://pmc.ncbi.nlm.nih.gov/articles/PMC11302646/
What are the benefits and risks of oral nicotine pouches … https://www.cochrane.org/evidence/CD016220_what-are-benefits-and-risks-oral-nicotine-pouches-when-used-help-people-stop-smoking-vaping-nicotine
UNITED KINGDOM https://gsthr.org/documents/309/GSTHR2024_S_7.pdf
The New Nicotine Pouch Category: A Tobacco Harm … https://pmc.ncbi.nlm.nih.gov/articles/PMC8887571/
Nicotine vaping in England: 2022 evidence update summary https://www.gov.uk/government/publications/nicotine-vaping-in-england-2022-evidence-update/nicotine-vaping-in-england-2022-evidence-update-summary
Addiction Call for Papers Oral Nicotine Pouches https://onlinelibrary.wiley.com/page/journal/13600443/call-for-papers/si-2025-001109
A systematic review of possible serious adverse health effects … https://pmc.ncbi.nlm.nih.gov/articles/PMC5634244/
E-cigarettes and harm reduction: An evidence review https://www.rcp.ac.uk/media/5takdlc6/e-cigarettes-and-harm-reduction-evidence-review_0.pdf
Nicotine vaping in England: an evidence update including … https://assets.publishing.service.gov.uk/media/633496fc4bf1580662b81e2a/Nicotine-vaping-in-England-2022-report.pdf
E-cigarettes and harm reduction: An evidence review https://www.rcp.ac.uk/policy-and-commentary/policy-documents/e-cigarettes-and-harm-reduction-an-evidence-review/
Smoking: processes and related dental factors in … https://www.sciencedirect.com/science/article/pii/S0002563923021547
Nicotine Vaping: an evidence update including … https://www.gov.uk/government/publications/nicotine-vaping-in-england-evidence-update-march-202
Oral Health Consequences of Smokeless Tobacco Use https://www.cureus.com/articles/409816-oral-health-consequences-of-smokeless-tobacco-use-a-narrative-review
