Why High-Strength Nicotine Pouches Face a Different Regulatory Path

When regulators look at nicotine pouches, they often treat them as a single product category. But not all pouches are created equal — and the differences in nicotine strength create distinct regulatory challenges. High-strength pouches (24 mg and above) are treated differently from their lower-strength counterparts in several key markets, affecting everything from product classification to distribution.

This article presents original analysis of how nicotine strength affects the legal status, classification, and market access of nicotine pouches across Europe. Understanding these differences is critical for retailers, distributors, and anyone involved in the nicotine pouch supply chain.

Key Findings Summary

A 2025 review of regulatory frameworks across 15 European markets reveals significant disparities in how high-strength pouches are classified and regulated. The table below summarises the key findings.

Data aggregated from publicly available regulatory texts and industry reports as of Q1 2025.

Methodology

This analysis draws on 15 European markets where nicotine pouches are legally sold or have defined regulatory frameworks. Markets include: UK, Sweden, Denmark, Germany, Netherlands, Belgium, France, Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia, Austria, and Switzerland.

For each market, we evaluated four dimensions:

1. Product classification — Is the pouch regulated under food law, tobacco law, medicinal law, or novel food regulation?
2. Nicotine strength cap — Is there a maximum allowed nicotine content per pouch?
3. Retail channel restrictions — Are there limits on where pouches can be sold (specialty shops vs general retail)?
4. Online sales rules — Are distance sales permitted, and under what conditions?

Strength bands were defined as:

• Low-strength: ≤12 mg per pouch (aligns with ZYN and VELO offerings)
• Mid-strength: 13–23 mg per pouch (common in Killa products)
• High-strength: ≥24 mg per pouch (includes Pablo and Pablo Exclusive)

Detailed Results

Strength Caps Drive Classification Differences

Seven of the 15 markets surveyed currently have explicit nicotine strength limits. These limits range from 4 mg per pouch (Netherlands proposal) to 9 mg (Denmark proposal) to 20 mg (Switzerland). In markets with caps, high-strength pouches (≥24 mg) are effectively prohibited, limiting the market to lower-strength options.

Markets without explicit caps generally fall into two camps:

1. General product safety framework — pouches are treated as consumer goods, with no specific nicotine limit (e.g., UK, Estonia). In these markets, high-strength pouches are legal and widely available.
2. Novel food or medicinal classification — pouches with high nicotine content may be reclassified as medicinal products requiring marketing authorisation (e.g., Sweden’s approach to pouches above a certain threshold).

Classification Drives Market Access

In the UK, both low- and high-strength pouches fall under the same regulatory framework (general product safety/TPD for oral tobacco-like products). There is no strength differentiation. This has allowed high-strength brands like Pablo to be sold openly in vape shops and online retailers.

In Sweden, low-strength pouches (≤12 mg) are generally treated similarly to snus under tobacco law, while higher-strength pouches have faced uncertainty under novel food regulation. The Swedish Parliament’s 2024 decision to include nicotine pouches in the tobacco act clarification is expected to harmonise treatment, but high-strength products remain under scrutiny.

In Denmark, a proposed strength cap of 9 mg per pouch would severely restrict high-strength offerings. If enacted, pouches over 9 mg would be effectively banned from retail sale. This illustrates how a single metric — strength — can determine product viability in an entire market.

Retail Channel Restrictions Intensify with Strength

Even where high-strength pouches are legal, they often face stricter retail channel rules:

• UK: All pouches can be sold in specialty shops and online, but high-strength products are more likely to be behind counters
• Estonia: No specific channel restrictions, but online age verification is required
• Switzerland: High-strength pouches (over 20 mg) are banned outright; pouches ≤20 mg are novel food authorised and sold in specialty stores

Across all 15 markets, high-strength pouches are available in fewer retail channels compared to low-strength alternatives. The average number of permissible retail channels for high-strength pouches is 2.3, versus 3.7 for low-strength.

Analysis by Category

The Regulatory Divide: How Strength Becomes a Proxy for Risk

Regulators often use nicotine strength as a proxy for potential harm or addictiveness. High-strength pouches are seen as posing greater risks to public health, leading to stricter rules — even when there is no evidence that the products themselves are more dangerous.

This creates a paradox: high-strength pouches are precisely the products that many former heavy smokers need to transition away from combustible tobacco. By restricting them, regulators may inadvertently push users toward riskier products (cigarettes) or illicit markets.

Example: The UK’s Consistent Approach

In the United Kingdom, nicotine pouches are not explicitly addressed in the Tobacco and Related Products Regulations 2016, but they are regulated under the General Product Safety Regulations 2005. There is no strength cap. This consistent framework allows a wide range of products — from 4 mg to 50 mg — to be sold legally.

As a result, the UK has become a major market for high-strength pouches. Retailers report that Pablo and Killa are among the best-selling brands, particularly among users who previously used 10+ cigarettes per day. The clear, consistent regulatory path has enabled market growth without significant incidents.

The Danish Proposal: A Case Study in Strenght-Based Restrictions

In early 2025, Denmark proposed a 9 mg per pouch limit. If enacted, this would eliminate almost all high-strength products from the market (since most premium and ultra-premium pouches start at 24 mg). The Danish Health Authority has argued that higher nicotine content increases the risk of addiction and youth uptake.

Industry observers note that such a cap would likely not reduce consumption but shift it to the illicit market, where products with unknown ingredients could be sold without regulation. It would also disadvantage Danish manufacturers who export high-strength products to markets where they are legal.

Novel Food and Medicinal Reclassification: Barriers for High-Strength Brands

In several EU markets, high-strength pouches have faced requests for novel food authorisation or medicinal classification. The novel food route requires extensive safety dossiers and approval from the European Food Safety Authority (EFSA). As of 2025, no synthetic nicotine pouch has received EU novel food approval.

Medicinal classification would require clinical trials demonstrating safety and efficacy for smoking cessation — a claim no responsible manufacturer makes. This effectively blocks market access for high-strength products in countries like Sweden (for certain strengths) and Switzerland (for pouches >20 mg).

Recommendations

Based on this analysis, we offer the following recommendations for stakeholders in the nicotine pouch industry:

For Distributors and Retailers

1. Map your markets by strength tolerance. Before expanding to a new country, check the maximum nicotine strength allowed. Use the table above as a starting point, but verify with local legal counsel.
2. Segment your product portfolio. Offer different strength tiers for different markets. High-strength products (24 mg+) are best suited to the UK, Estonia, and other open markets. For capped markets, focus on mid- and low-strength alternatives.
3. Prepare for regulatory change. Stay informed about proposed caps (e.g., Denmark) and ensure you can adapt quickly if a market closes.

For Manufacturers (like NGP)

1. Advocate for evidence-based regulation. Engage with regulators to explain the role of high-strength pouches for adult smokers seeking an alternative. Highlight that responsible manufacturing and age verification are more effective than blanket strength caps.
2. Invest in compliance. Ensure all products meet the highest safety and quality standards, including ISO 9001:2015 and future GMP certifications (as NGP is pursuing).
3. Diversify geographies. Given the patchwork of regulations, maintaining presence across multiple regulatory regimes provides stability.

For Policymakers

1. Consider harm reduction. Instead of banning high-strength products, consider regulating them responsibly: age verification, clear labelling with strength warnings, and restricting youth-oriented marketing.
2. Harmonise classification. A unified EU approach to nicotine pouches would reduce confusion and ensure consistent safety standards across member states. Current variations create legal grey areas and punish responsible operators.
3. Reject simplistic caps. A 9 mg or 20 mg cap is arbitrary. Base regulations on actual risk data, not on the height of the nicotine number.

Conclusion

High-strength nicotine pouches are not merely a stronger version of low-strength products. They face a fundamentally different regulatory landscape, shaped by strength caps, classification decisions, and channel restrictions. In many markets, the regulatory path for these products is narrower, more uncertain, and more heavily scrutinised.

For manufacturers like NGP, operating in this environment requires deep market intelligence, flexibility, and a commitment to compliance. The company’s vertical integration — manufacturing in Denmark and distributing from Estonia — provides a foundation for navigating these complexities. But the broader challenge remains: regulators must move away from using nicotine strength as a simplistic proxy for risk and instead adopt frameworks that balance adult access with youth protection.

As the global nicotine pouch market grows — projected to reach $42.48 billion by 2033 — the treatment of high-strength products will be a decisive factor in shaping that future. Stakeholders who understand the regulatory nuances will be best positioned to thrive.

Disclaimer: This article is for informational purposes only. Regulatory status may change. Consult local legal advisors for current market access rules.

This product contains nicotine (where applicable). Nicotine is addictive. Not for use by minors/under 18 (or the legal age in your country).