Why nicotine pouches need a clearer regulatory framework to thrive

Nicotine pouches are exciting products that can help support worldwide tobacco harm reduction. However, the current understanding and support for them differs across countries, with regulatory frameworks in these markets still unclear, with some passing more legislation than others. Here we outline how this uncertainty could reduce investment in the nicotine pouch sector when consumer interest and sales are growing.

While the nicotine pouches sector is expected to grow in all key international markets in the coming years, regulatory support for such products is still fragmented. Many countries, such as Canada, Norway, Russia and Australia, have banned nicotine pouches as consumer products and they are only now available as pharmaceutical products.

Nicotine pouches in the US

In the US, nicotine pouches are included in the Premarket Tobacco Product Application (PMTA) regulatory framework, and the market is expected to reach $11.03 billion by 2027, according to GII Research[1] - while the global market is anticipated to reach $26.42 billion by 2030.

Tobacco-derived MONPs were included in the PMTA process by the Food and Drug Administration (FDA)’s in 2016. This created a regulatory loophole for synthetic nicotine products leading to a significant rise in the number of synthetic nicotine MONPs launched on the US market.

Subsequent regulatory changes made in 2022 by the FDA have brought synthetic nicotine products into the PMTA process, with manufacturers required to submit PMTAs by May 14^th, 2022 – within 60 days of the new bill being announced. The FDA is currently reviewing 9,500 applications that were submitted for synthetic nicotine products.

From 14^th July 2022, the FDA ordered all synthetic nicotine products removed from the market until additional planned studies to demonstrate the appropriateness of their product for the protection of the public health (APPH) were completed.

The closing of the synthetic nicotine loophole clarifies that the FDA doesn’t recognise any difference between tobacco-derived nicotine and synthetic nicotine and forced manufacturers who create synthetic nicotine products that are now subject to the PMTA process.

Nicotine pouches in Europe

Currently, nicotine pouches are not regulated under the European Tobacco Product Directive (TPD). It has been suggested that the European Union (EU) is assessing the tobacco legislative framework to address the growing popularity of MONPs. They may be assessed as part of the third iteration of the directive, TPD3, however, this has not been confirmed and, currently, these products are outside the scope of TPD legislation. The timeline and detail of future TPD requirements are not yet confirmed.

Initially, the proposed target deadline for TPD3 set by the European commission was May 2021. However, this has been pushed back. It had been suggested that a more realistic date for discussions to start was in 2022, but these haven’t materialised, and there are currently no EU-level rules on the levels of nicotine allowed in pouches because they do not contain tobacco.

However, many EU member states have banned the products, including Belgium and the Netherlands, along with some regions in Germany.

Nicotine pouches in the UK

Regulation of nicotine pouches in the UK currently sits under the General Product Safety Regulations (GPSR) 2005 – this change occurred in 2023. Prior to the change, when MONPs were free from regulation, most advocates for tobacco harm reduction agreed that some level of regulation is needed to control the quality of products on the market, to protect consumers and ensure an efficacious, consistent user experience.

The UK government, having set out an ambitious target for England to be smoke-free by 2030, may need Nicotine Pouches to help deliver this. As they’re now part of a regulatory framework, it can help drive smokers to reduced-risk products.

Nicotine Pouches role in tobacco harm reduction

Nicotine Pouches are a welcome innovation to help support tobacco harm reduction. The products do not contain tobacco and, therefore, are considered lower risk in the tobacco risk continuum. While often containing only pharmaceutical-grade ingredients, nicotine pouches are an extremely reduced-risk way of delivering nicotine.

Nicotine pouches are often considered ‘crude’ products compared to e-cigarettes and heated tobacco products. However, they have a high potential for reducing smoking rates on a global scale when considering the challenges associated with cost and infrastructure within low and middle-income countries.

The new nicotine pouch technology highlighted at the recent Global Nicotine Forum (GFN) from Amplicon is one example of the innovation taking place in nicotine pouches. The company has introduced bio-ceramic technology which helps create a sustained release of nicotine.

How Broughton can help

Having supported several manufacturers that have received Marketing Authorizations for PMTA applications, Broughton is in a unique position to understand where the bar has been set by FDA. Through the application outcomes received, we have also strengthened our understanding of what is needed to demonstrate APPH and have validated scientific methods for measuring the chemistry of MONPs.

To discuss regulatory compliance for MONPs, and to learn more about PMTAs for next generation products (NGPs), get in touch our visit Broughton’s nicotine testing page for more information.

[1] https://www.giiresearch.com/report/grvi1553682-modern-oral-nicotine-products-market-size-share.html#:~:text=Modern%20Oral%20Nicotine%20Products%20Market%20Size%2C%20Share,to%20reach%20USD%2026.42%20billion%20by%202030%2C