As nicotine pouches gain popularity worldwide, governments are grappling with how best to regulate them. While some countries have embraced these smoke-free alternatives as part of their harm reduction strategies, others have implemented strict restrictions or outright bans. Understanding the global regulatory landscape is essential for ensuring that nicotine pouches remain accessible to adult consumers while preventing youth use and maintaining product safety.
This article provides an overview of nicotine pouch regulations across different regions, highlighting best practices, policy challenges, and key areas of contention in the evolving regulatory framework.
1. Europe: A Divided Approach
Sweden – A Model for Harm Reduction
Sweden, often cited as a harm reduction success story, has long embraced snus—a tobacco-based oral product that has significantly reduced smoking rates. Nicotine pouches, which contain no tobacco, are widely available and regulated as consumer products rather than tobacco products. Swedish policymakers support risk-proportionate regulation, ensuring that adult smokers have access to lower-risk nicotine alternatives.
United Kingdom – Proportionate Regulations Underway
Nicotine pouches are currently regulated under the UK’s General Product Safety Regulations, but the Tobacco and Vapes Bill aims to introduce age restrictions, marketing controls, and potential nicotine limits. The UK government has acknowledged their harm reduction potential but is working to balance public health goals with youth protection.
Germany and France – Stricter Controls
In Germany, nicotine pouches cannot be legally sold due to the lack of a clear regulatory framework. French authorities have also signaled their intent to closely regulate these products, citing concerns about youth appeal.
Spain – A Push for Restrictions
Spain’s Royal Decree on Nicotine Pouches proposes a 1mg nicotine cap and a flavor ban, which could eliminate 99% of products from the market. Critics argue that such restrictive policies ignore harm reduction benefits and could drive consumers toward illicit products.
2. North America: Regulatory Challenges and Opportunities
United States – PMTA Approval and Enforcement Gaps
In the U.S., nicotine pouches fall under the jurisdiction of the Food and Drug Administration (FDA) and require Premarket Tobacco Product Applications (PMTAs) to remain on the market. Recently, 20 ZYN products received FDA authorization, setting a precedent for legal sales. However, enforcement remains a challenge, with illicit high-nicotine products flooding the market and regulatory oversight struggling to keep up.
Canada – Gradual Integration into Tobacco Control Policies
Canada has started integrating nicotine pouches into its tobacco harm reduction discussions, but regulatory clarity is still evolving. Like the U.S., Canada is expected to implement marketing restrictions and nicotine content limits in the coming years.
3. Asia-Pacific: Mixed Regulatory Approaches
New Zealand – Aligning with Vaping Laws
New Zealand has taken a progressive stance on harm reduction, and is expected to regulate nicotine pouches similarly to vaping products later this year. Age restrictions, marketing controls, and product safety standards ensure responsible distribution.
Australia – Strict Bans and Prescription Models
Domestica sales of nicotine pouches are effectively banned in Australia, mirroring the country’s strict stance on nicotine-containing products. Critics argue that overly restrictive policies push consumers toward illicit markets.
Japan and South Korea – Focus on Heated Tobacco
While Japan and South Korea have welcomed heated tobacco products (HTPs), they have yet to establish clear regulatory pathways for nicotine pouches. The region remains a developing market with future potential for regulatory alignment.
4. Africa and Latin America: Emerging Markets with Evolving Policies
South Africa – Pending Legislation
South Africa’s Tobacco and Electronic Delivery Systems Control Bill could classify nicotine pouches under broader tobacco product regulations, imposing marketing restrictions and sales limitations. However, the lack of specific guidance creates uncertainty for manufacturers and retailers.
Brazil and Mexico – Strict Bans
Both Brazil and Mexico have banned nicotine pouches outright, citing concerns about public health and youth appeal. This has led to thriving illicit markets, raising concerns about unregulated and unsafe products.
Best Practices for Proportionate Regulation
Based on global trends, the most effective regulatory frameworks include:
✅ Risk-Based Categorization: Distinguishing nicotine pouches from combustible tobacco products to ensure proportionate policies.
✅ Youth Protection Measures: Implementing age restrictions, marketing controls, and responsible packaging.
✅ Clear Manufacturing Standards: Ensuring product safety through quality controls, nicotine content limits, and transparent labeling.
✅ Science-Based Decision Making: Aligning regulations with harm reduction principles rather than blanket bans.
GINN’s Role in Advocacy and Regulation
At the Global Institute for Novel Nicotine (GINN), we advocate for evidence-based, proportionate regulations that ensure nicotine pouches remain accessible for adult smokers while preventing misuse. Our work includes:
🔹 Engaging with policymakers in the UK, EU, and global markets to support science-backed policies.
🔹 Submitting written evidence to government bodies, such as the UK Parliament’s Tobacco and Vapes Bill Committee.
🔹 Developing a Code of Practice for manufacturing and labeling standards, ensuring high product quality and consumer protection.
As regulations continue to evolve, GINN remains committed to fostering responsible policies that prioritize harm reduction and public health.
