By Timothy S. Donahue

The Global Institute for Novel Nicotine (GINN) has urged the UK government to establish a fair, science-based regulatory framework for nicotine pouches. In its submission to the ongoing “Call for Evidence” on the country’s Tobacco and Vapes Bill, the organization noted that nicotine pouches currently operate in a “regulatory vacuum” in the UK.

The advocacy group points out that it believes the Bill provides a significant opportunity to establish enforceable product standards, market regulations, and consumer protections without weakening harm reduction efforts.

In its filing, GINN argues that regulated nicotine pouches have a safety profile that is “comparable to medicinal oral nicotine replacement therapy (NRT).” It asserts that the primary public health risks stem from illicit, high-strength imports rather than from compliant products. The organization advocates for a regulatory framework that includes toxicology testing, clear nicotine limits, adult-oriented packaging regulations, pre-market notification and licensing, while also allowing flavors that encourage adult switching.

Safer Science

GINN’s submission begins with an assessment of the toxicology of nicotine pouches, noting that when produced according to established technical standards, pouch products pose a very low health risk, especially when compared to traditional cigarettes. Since pouches do not involve combustion, heating, or aerosol, they avoid exposure pathways linked to most smoking-related diseases. The organization highlights tar, carbon monoxide, volatile carbonyls, particulates, and heavy metals as toxicants that the nicotine pouch format eliminates.

According to the filing, the most common side effects from nicotine pouch use are mild and temporary: gum irritation, dry mouth, and sensitivity. GINN argues that evidence shows no link between regulated pouch use and periodontal disease, cancer, respiratory harm, or systemic toxicity. Additionally, the technical standards referenced in the submission require pharmaceutical-grade nicotine, pH regulators, purified plant fibers, and flavorings that meet food-grade or pharmacopeia-grade standards.

GINN’s submission highlights decades of real-world population data from Sweden and Norway, where widespread oral nicotine use coincided with some of Europe’s lowest rates of lung cancer, COPD, and cardiovascular disease. The group states this presents “unique evidence” indicating that long-term oral nicotine replacement causes significantly fewer health dangers than smoking.

The organization’s main safety concern involves high-strength products—often illegal and sometimes exceeding 50–100 mg per pouch, according to the submission. GINN states such products offer no additional cessation benefits but increase the risks of side effects like dizziness or nausea. The submission recommends a maximum of 20 mg per pouch, describing it as safe, effective, and appropriate for highly dependent smokers without encouraging misuse.

GINN also addresses oral health concerns, noting localized irritation and minor gum recession among frequent users but describing these effects as “transient and reversible.” The submission recommends clear labeling, encouraging rotation of application sites, routine dental care, and the use of mandatory child-resistant containers, including for used-pouch storage due to residual nicotine.

Flavor Facts

A significant part of GINN’s submission focuses on flavors and youth protection, arguing that the most effective regulatory approach is to control how flavors are presented rather than banning them. The organization cites evidence from Sweden and Norway showing that flavored oral nicotine products help smokers switch from cigarettes by masking bitterness and improving product switching success.

GINN asserts that “there is no toxicological basis” to ban flavor profiles when all ingredients are evaluated under PAS 8877 or similar technical standards. Since pouches are not heated, there is no thermal breakdown of flavorings or inhalation risk.

Instead of imposed bans, GINN recommends implementing strict regulations on packaging, marketing, and color schemes. The submission highlights the UK’s Arcus Compliance Primary Authority Assured Advice model as an example already adopted by industry. The framework restricts color palettes, requires clear nicotine-strength labels, mandates unambiguous “18+” symbols, and prohibits confectionery-like designs or branding. GINN argues that such measures significantly reduce youth appeal without limiting flavors that support adult cessation.

To improve oversight, the organization recommends mandatory MHRA pre-market notification. Similar to the vape notification process under the Tobacco and Related Products Regulations (TRPR), this would require manufacturers to submit:

• Full ingredient lists
• Toxicology data
• Flavoring assessments
• Packaging designs
• Nicotine strengths

Before any product is sold in the UK, GINN argues that this step alone would eliminate most non-compliant high-strength imports and establish a national registry of authorized products.

Strength Rules

GINN dedicates a significant portion of its evidence to nicotine pharmacokinetics, arguing that pouches deliver nicotine gradually and consistently through buccal absorption—similar to medicinal gum—and are therefore ideal for both smoking cessation and relapse prevention.

Citing multiple studies, GINN states that 9–20 mg per pouch is effective for dependent smokers, with most adults stabilizing cravings between 9–15 mg and heavier smokers benefiting from strengths up to the 20 mg maximum. The submission indicates that higher strengths do not provide any measurable benefit in reducing cravings or improving abstinence rates.

The organization emphasizes the importance of having a clear nicotine ceiling. A set maximum makes toxicology assessments easier, speeds up MHRA notifications, enhances customs screening, and helps differentiate legitimate cessation products from illegal high-strength imports. GINN describes the 20 mg rule as both a public health safety measure and a way to maintain industry stability.

Market Order

In the submission, GINN discusses retail licensing, product registration, and enforcement. The organization argues that predictable, proportionate regulation benefits responsible manufacturers and retailers by preventing illicit competition, improving compliance clarity, and encouraging long-term investment.

GINN advocates for a comprehensive national licensing system that covers both brick-and-mortar and online retailers. It recommends denying licenses for:

• Retailers mainly sell youth-focused products (e.g., candy, toys)
• Businesses with recent age-restriction violations
• Retailers without a designated supervisor on premise
• Non-retail service providers, like takeout places or taxi services

For those granted a license, GINN proposes requirements including six-year transaction traceability, an adult-only website design, enhanced online age verification, more frequent online test purchases, and in-store recycling collection points.

In its submission, GINN strongly supports establishing a mandatory product registration system modeled after existing TRPR vape notifications. The registration would require providing ingredient lists, toxicology data, flavor assessments, packaging files, proof of compliance with an industry Code of Conduct (such as the proposed Nicotine Standards Authority), and third-party testing before a product can be marketed.

To support enforcement, GINN urges the UK to create a dedicated national enforcement fund. The fund should be funded through licensing and registration fees and used exclusively for compliance inspections, purchasing tests, and actions against non-compliant imported products. Penalties, it argues, must be “substantial enough to outweigh illicit profit,” with fines up to £10,000 for serious or repeat violations and the potential loss of retail privileges.