~ Pharmaceutical-grade nicotine among regulations enforced from July 2025 ~
As the tobacco-free nicotine pouch market expands across the Middle East, the United Arab Emirates (UAE) is introducing tighter regulations to safeguard consumers. In early 2024, the Ministry of Industry and Advanced Technology (MoIAT) issued UAE.S FDS 5061:2024, setting new compliance standards for manufacturers. With enforcement set for July 2025, early preparation is essential for those entering or staying in the market. As demand continues to rise, analytical and consultancy firm Broughton highlights what the new regulation means and how manufacturers can stay compliant.
Understanding UAE.S FDS 5061:2024
This new compliance standard sets out a regulatory framework for tobacco-free oral nicotine pouches; products designed for placement between the gum and lip which allow nicotine absorption without tobacco.
Developed by the MoIAT, the regulation aims to enhance consumer safety, build market trust and align UAE standards with global benchmarks.
It introduces stringent requirements covering nicotine purity, including a maximum pH level of 9.1, alongside strict controls on prohibited ingredients, toxicological risks and packaging safety.
First published in early 2024, the standard will be enforced from July 2025, giving manufacturers a limited window to adapt formulations, complete testing and prepare documentation for market entry or continued sales.
Key regulatory requirements
At the core of this framework is the use of pharmaceutical-grade nicotine, which must comply with standards set by the European or United States Pharmacopeias.
All formulations must exclude controlled substances, psychotropic agents and harmful ingredients such as lead, formaldehyde and ethylene glycol. This places increased pressure on manufacturers to carefully review ingredient sourcing and make formulation adjustments where necessary.
Packaging must be both child-resistant and tamper-evident, with clear health warnings displayed in both Arabic and English to ensure accessibility and consumer awareness. The regulation also requires in-depth toxicological risk assessments to evaluate ingredient safety and potential exposure risks, with a strong emphasis on long-term consumer health.
To support product stability, manufacturers must conduct rigorous shelf-life testing under ICH conditions, ensuring product safety and performance throughout its intended lifespan.
Global harmonisation and the UAE’s regulatory shift
The introduction of UAE.S FDS 5061:2024 brings the UAE’s nicotine regulation closer to established EU and US frameworks, where pharmaceutical-grade standards, ingredient restrictions and toxicological assessments are the norm.
This reflects a broader regional shift toward tighter control and greater scrutiny of tobacco-free nicotine products. As demand grows, Middle Eastern regulators are prioritising consumer safety, product consistency and market accountability.
The UAE’s proactive stance signals a move toward globally harmonised standards and a clear expectation that only rigorously tested, responsibly formulated products will be allowed on the market.
The UAE hasn’t publicly stated that UAE.S FDS 5061:2024 is explicitly aligned with U.S. or EU regulations. However, its consistency with international standards, particularly the EU’s Tobacco Products Directive (TPD) and the U.S. FDA’s guidance for nicotine products, suggests a strategic regulatory approach. This alignment could ease market entry and facilitate trade for international tobacco and nicotine companies operating in or exporting to the Gulf region.
Broughton provides end-to-end support to help manufacturers meet the requirements of UAE.S FDS 5061:2024. Their expert team delivers toxicological risk assessments, UKAS-accredited analytical testing and shelf-life studies under ICH conditions, all backed by industry-recognised certifications. They also offer strategic regulatory guidance to streamline submissions and ensure ongoing compliance.
With the July 2025 deadline fast approaching, early action is essential to ensure your products meet evolving regulatory expectations. Broughton is your trusted partner for navigating the complex landscape of tobacco and nicotine regulation, with deep expertise in global pharmacopeial standards and toxicological profiling.
Their team understands the scientific and compliance challenges unique to this industry and is here to guide you toward safe, efficient and fully compliant market access. Book a free consultation today to learn more.
