Safety Studies Become a Key Pillar of Market Authorization

In recent years, the landscape of novel nicotine products has changed dramatically. E-cigarettes, nicotine pouches, and heat-not-burn (HnB) devices have not only captured a significant share of the market but have also had a strong impact on consumer behaviour—particularly among younger users. The dynamic growth of this category has created an urgent need for regulators in Europe and the United States to establish precise and rigorous oversight frameworks. At the core of these efforts are safety studies, encompassing both toxicological assessments and the actual exposure of users to harmful substances.

In Europe, the most alarming data concern younger age groups. According to the WHO, nearly one in five 15-year-olds reports using an e-cigarette. In the United Kingdom, the number of young e-cigarette users has reached approximately 400,000, and awareness and availability of nicotine pouches continue to grow year-on-year. The trend is equally visible in the United States. FDA data indicate that around 480,000 teenagers used nicotine pouches in the past 30 days, while other analyses show an increase in youth use from 3% to over 5% year-over-year. At the same time, the FDA classifies HnB products as tobacco products and requires a full Premarket Tobacco Product Application (PMTA)—one of the most demanding regulatory processes in the world.

The growing popularity of novel nicotine products, combined with their flavour appeal and ease of use, has led to intensified legislative activity. Within the European Union, work is underway on the next revision of the Tobacco Products Directive (TPD), with increasing discussion around bringing nicotine pouches fully into the regulatory framework and tightening requirements for e-cigarettes and heated tobacco products. Existing study obligations already include toxicological analyses of ingredients, aerosol emissions testing, nicotine pharmacokinetics, and behavioural studies of product use. Future regulations will likely be even more detailed and driven by clinical data.

The United States is also tightening its approach. The FDA is intensifying actions related to youth access to nicotine products, and the PMTA process requires a comprehensive safety dossier, including toxicological, pharmacokinetic, emissions, and comparative analyses. For manufacturers, this means the need for solid, credible, and auditable data—regardless of the geographic market they aim to enter.

A shared trend across both regulatory systems—European and American—is the shift from manufacturer declarations to hard scientific evidence. Regulators increasingly expect that nicotine products entering the market will be supported by clear, independent studies demonstrating real user exposure to toxic substances, levels of risk, and potential health impacts. There is growing consensus that in the coming years, safety studies will become a fundamental prerequisite not only for market entry but also for maintaining a product’s presence on the market.

In this context, research centres capable of conducting professional, internationally compliant clinical studies are gaining critical importance. BioResearch Group (BRG) is one such centre, offering a comprehensive range of tobacco-related studies, including safety, exposure, pharmacokinetic, and user-behaviour assessments. The centre has successfully undergone FDA inspection, confirming that its processes meet the highest quality standards required in the United States—a benchmark that is expected to become a global requirement for this product category. The research team is led by Dr. Katarzyna Jarus-Dziedzic, an experienced principal investigator with extensive background in nicotine-product studies across both European frameworks and FDA-aligned projects. BRG not only conducts studies but also supports manufacturers in designing them, selecting the appropriate study model, and preparing dossiers that meet regulatory expectations in both the EU and the U.S.

As regulatory pressure increases, manufacturers need partners capable of ensuring study reliability and full regulatory compliance. BRG is an example of such a centre—a place where innovation meets scientific rigor, and where studies are conducted in a way that enables nicotine products to remain on increasingly demanding markets.