What’s next for nicotine pouch regulation?

Modern Oral Nicotine Pouches (MONPs) currently sit in a regulatory void. With the disposable vape ban looming, could MONPs be next in line for regulatory restrictions? Here Emily Saunders, Regulatory Associate at regulatory consultancy and analytical testing specialist Broughton, discusses regulating MONPs to support adult smokers, while mitigating youth appeal.

MONPs are small, permeable pouches that contain either tobacco-derived or synthetic nicotine. Users place them between their gum and cheek, and the nicotine is absorbed into the bloodstream via the oral mucosa. Nicotine pouches are a convenient and discrete method of consuming nicotine, and are growing in popularity worldwide. According to Euromonitor surveys, 6.8 billion nicotine pouches were sold in 2021 and 20.8 billion in 2023, demonstrating the rapid growth of this new product category.

MONPs do not contain tobacco and are not therefore not covered under the same regulatory framework as tobacco-containing products - their regulation therefore falls under the General Consumer Product Safety Regulations. So, while they must be sold in child-resistant packaging, contain health warnings, and include a list of ingredients and information on safe usage, it is not illegal to sell nicotine pouches to those under the age of 18. Essentially, MONPs sit in a regulatory loophole.

What’s next for MONPs?

Many in the industry are concerned about over-regulation and the impact on adult smokers. Nicotine pouches represent an extraordinary opportunity to support tobacco harm reduction in adult smokers looking to quit combustible cigarettes. For context, Sweden is the world’s most advanced nicotine pouch market and has the lowest smoking prevalence in Europe.

We must not however let MONPs fall into the same traps that disposable vapes did — youth-oriented colours, flavours, and marketing, in particular. If youth use becomes an issue, the most straightforward regulatory action would be a ban, with MONPs potentially added to the upcoming revision of the Tobacco Products Directive.

An alternative approach to a ban would be to recategorise MONPs in the same way as Snus, which would make them illegal. The Netherlands, for example, has already taken this approach, and Belgium announced a total ban on nicotine pouches in March 2023.

Alternatively, MONPs could be regulated as medicines for nicotine replacement therapy via the Medicines and Healthcare Products Regulatory Agency (MHRA). This would mean categorising them not as a consumer product, but as a healthcare one.

Leading a responsible path forward

With responsible manufacturing, design, and marketing, regulatory action will likely be less severe — bringing regulations for nicotine pouches in line with pod- and tank-based e-cigarettes. This would see specific age restrictions, health warnings, and packaging requirements introduced, and nicotine pouches moved behind the counter in shops. We may also see new limits for MONP nicotine content, expected to be anywhere from 4 mg to 18 mg, and restrictions on flavours.

In the absence of regulatory action, the MONP industry is self-regulating — current measures such as the creation of voluntary guidelines for responsible manufacturing, testing, and distribution, PAS 8877:2022 for example, specifies how to make and test MONPs to help producers, distributors, and retailers consistently assess and assure product safety and quality. It is aimed at manufacturers, laboratories and testing providers, regulators, distributors, retailers, and consumers, and specifies requirements for nicotine limits, pH characteristics, and water activity.

Also included in PAS 8877:2022 are requirements for ingredients and materials, product information and labelling, and guidelines on test methods. Following this standard can help ensure safety, quality, and consistency. This could help underpin new regulations, instil greater confidence in products, and strengthen risk management.

To ensure that nicotine pouches are safe, high-quality, and compliant, manufacturers can work with a reputable analytical testing provider such as Broughton. We have developed test methods specific to MONPs covering nicotine content, ingredients, and more. With our knowledge of the regulatory and testing landscape, we can help you achieve a streamlined route to market.

Are you looking for regulatory or testing support with your modern oral nicotine product? Get in touch with Broughton’s regulatory specialists or visit our website.