Oral Nicotine Pouches: Trends to Watch in the U.S. and Global Markets during 2025

Oral nicotine pouches have become a disruptive force in the reduced-risk nicotine product landscape. As the market matures, both in the U.S. and globally, several key trends are shaping the future of this innovative category.

Rising Popularity and Consumer Appeal

Nicotine pouches are gaining traction as a smokeless, discreet alternative to traditional tobacco products. Their appeal lies in their convenience, lack of combustion, subtlety in use and the availability of a variety of flavours. In the U.S., the category has seen double-digit percentage growth, driven by consumers seeking reduced-risk products. Globally, markets in Europe and parts of Asia are also embracing pouches, supported by evolving regulatory landscapes and increased awareness of harm reduction.

Regulatory Developments

In the U.S., the FDA’s Premarket Tobacco Product Application (PMTA) process plays a pivotal role in determining market access for nicotine pouches. As companies navigate this regulatory pathway, identifying a Contract Research Organisation (CRO) with the knowledge of the regulations and the ability to design cost-effective risk-based submission strategies to guide you on your PMTA project is key to a successful outcome. Even better, engage with a CRO that has a track record of delivering Marketing Granted Orders (MGOs) already.

Globally, countries are taking varied approaches—some integrating nicotine pouches into existing frameworks for smokeless products, while others are crafting new policies altogether. For instance, recent debates on nicotine pouch regulation in Europe suggest potential harmonisation through the upcoming TPD3 that could further expand market understanding, confidence, and business opportunities.

Innovation in Product Development

Manufacturers are focusing on optimising user experience through enhanced flavours, nicotine delivery, and packaging. Sustainability is also becoming a priority, with companies exploring biodegradable materials for pouches and packaging. Additionally, innovation in manufacturing processes is helping meet the growing demand while maintaining product quality and regulatory compliance.

Our CEO, Chris Allen and Chief Commercial Officer, Andy Mooney will be attending the Keller and Heckman Tobacco Law and Total Product Expo (TPE) conferences in Las Vegas during January 2025. As the conferences approach, the oral nicotine pouch sector stands at the crossroads of innovation and regulation. Stakeholders must stay informed on these trends to harness the category’s potential for growth while navigating an evolving global regulatory landscape.

Get in touch to arrange a meeting with Andy or Chris at the event