Understanding the UAE’s Final Draft Regulation for Nicotine Pouches: What It Means for Manufacturers

The Ministry of Industry and Advanced Technology (MoIAT) has recently issued the Final Draft Standard (FDS) UAE.S FDS 5061:2024, which sets out new regulatory requirements for tobacco-free nicotine pouches. With these regulations expected to come into effect in July 2025, manufacturers aiming to access the UAE market must ensure compliance with the outlined health and safety requirements.

Key Requirements of UAE.S FDS 5061:2024

The new regulation applies to nicotine pouches designed for oral use, which are placed between the gum and mucous membrane to allow nicotine absorption. It introduces stringent requirements to ensure consumer safety, including:

• Nicotine Quality Standards: The nicotine used must be of pharmaceutical grade and meet standards set by the European Pharmacopoeia or United States Pharmacopeia.
• Ingredient Restrictions: The use of certain substances, such as controlled drugs, psychotropic substances, or harmful chemicals, is prohibited.
• Packaging and Labelling: Packaging must be child-resistant, tamper-evident, and properly labelled with health warnings in Arabic and English.
• Shelf-Life Stability and Toxicological Safety Testing: Manufacturers must provide evidence of toxicological risk assessments (TRAs), analytical testing, and shelf-life stability testing to demonstrate product safety throughout its intended lifespan.

Broughton’s Testing Services for UAE Compliance

At Broughton, we offer a comprehensive testing package aligned with the UAE.S FDS 5061:2024 requirements, including:

• Toxicological Risk Assessments (TRAs): Evaluation of ingredients, pouch materials, and packaging to identify potential risks and ensure suitability for consumer use by ERT
• Analytical Testing: Detailed testing is done to confirm nicotine content, pH levels, and the absence of prohibited contaminants and toxins, which are fully validated and UKAS ISO/IEC 17025 accredited.
• Shelf-Life Stability Testing: Rigorous testing under controlled ICH conditions to ensure product safety and performance throughout the product’s shelf life.

Why Partner with Broughton?

Broughton’s services provide manufacturers with the expertise needed to navigate the UAE’s regulatory landscape with confidence. By offering a package of TRAs, analytical testing, and stability testing, we help clients ensure their nicotine pouch products are fully compliant with the new regulation, UAE.S FDS 5061:2024.

Our end-to-end support covers everything from initial testing to comprehensive documentation, ensuring a smooth and efficient process for regulatory approval.

Contact Us

If you are a nicotine pouch manufacturer looking to ensure compliance with the new UAE regulation, get in touch with our team today to find out how we can support you.