Novel Nicotine

Novel Nicotine Regulatory Compliance — Europe and the Middle East

EU Tobacco Products Directive (TPD). UK Tobacco and Related Products Regulations (TRPR). UK Tobacco and Vapes Bill. UAE regulatory compliance (MoIAT).

We understand these markets because we have worked closely within them.

The nicotine market is not a frontier any more.

It is a fully regulated, actively enforced commercial environment. Which means the era of building fast and sorting compliance later is over. The brands who did that are the ones that enforcement authorities are now focused on.

Arcus has been active in this space since the early stages of nicotine pouch regulation. We have supported the development and interpretation of regulatory frameworks and hold England's first Primary Authority Assured Advice on nicotine pouch packaging, endorsed by the Global Institute for Novel Nicotine.

We work across the full novel nicotine spectrum.

Products We Cover

Vape & E-Cigarettes

TPD and TRPR compliance for the European and UK markets. Submission, strategy, and the enforcement intelligence that turns a filing into a competitive position.

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Nicotine Pouches

The fastest-growing category in the market and the most complex to navigate. We hold the Primary Authority Assured Advice. Start here.

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Markets We Serve

Europe: UK & EU

Full compliance with the EU Tobacco Products Directive (TPD) and UK Tobacco and Related Products Regulations (TRPR). MHRA notifications for the UK market and EU-CEG submissions for EU market access. Regulatory strategy for the enforcement era.

UAE & Middle East

UAE product registration and conformity requirements (MoIAT), 20 mg/mL nicotine limits, excise compliance including Digital Tax Stamps (FTA), and GCC standards. European brands entering this market without local regulatory intelligence consistently pay for it.

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A credential No One Else Has

In 2024, Arcus authored England's first Primary Authority Assured Advice on nicotine pouch packaging requirements, endorsed by GINN. Referenced by enforcement authorities across England.

This is not a white paper. It is formally recognised Assured Advice issued under the Primary Authority framework. Brands that align with this guidance are better positioned to meet regulatory expectations. Those that do not may face increased compliance risk. If you are in the nicotine pouch category, this is the most important compliance document in the UK market.

Enforcement does not invent its own standards. It uses what already exists. In this category, the Assured Advice plays a central role.

"The brands that will dominate this market in five years are the ones building their regulatory foundation now."

The Primary Authority Tell us what products you make