REGULATION AND REGISTRATION OF HEALTH SUPPLEMENTS IN THE UAE

The health supplement industry is growing rapidly worldwide, including in the United Arab Emirates (UAE), where consumers are increasingly seeking dietary and nutritional products to support their well-being. However, to ensure the safety, efficacy, and quality of these products, the UAE has established stringent regulations governing their registration and sale.

Regulatory Authority

The primary authority responsible for regulating and registering health supplements in the UAE is the Ministry of Health and Prevention (MOHAP). Additionally, the Dubai Municipality (DM) and the Abu Dhabi Agriculture and Food Safety Authority (ADAFSA) oversee health supplement registration in their respective jurisdictions.

Key Regulations Governing Health Supplements

• UAE Federal Law No. 10 of 2015 – Governs pharmaceuticals and health products, including dietary supplements, ensuring they are safe for human consumption.
• Ministerial Decree No. 239 of 2012 – Establishes guidelines for the registration and classification of health supplements.
• GSO Standards and Guidelines – The UAE follows Gulf Cooperation Council (GCC) regulations and standards established by the Gulf Standardization Organization (GSO) to regulate ingredients, labeling, and product claims.

Definition and Classification of Health Supplements

Health supplements in the UAE are defined as products intended to complement the diet and provide additional nutrients, such as vitamins, minerals, amino acids, and herbal extracts. These products are classified based on their composition, claims, and intended use:

• Dietary Supplements – Products containing vitamins, minerals, herbs, or other substances intended to supplement the diet.
• Herbal Supplements – Products derived from botanical sources with medicinal or nutritional benefits.
• Sports Nutrition Products – Supplements designed for athletes and fitness enthusiasts to support performance and recovery.

Registration Process for Health Supplements in the UAE

To place a health supplement on the UAE market, companies must undergo a thorough registration process with the relevant regulatory authority. Below are the key steps involved:

Step 1: Appointing a Local Representative

Foreign manufacturers must partner with a UAE-based company holding a valid trade license for the distribution of health supplements. This local representative will act as the official liaison with regulatory authorities.

Step 2: Product Classification

The product is classified based on its ingredients, claims, and intended use. Misclassification can lead to delays or rejection of the application.

Step 3: Document Submission

Applicants must provide a comprehensive dossier, including:

• Product Composition & Formula – Detailed information about active and inactive ingredients.
• Labeling & Packaging Details – Labels must comply with UAE regulations, including Arabic and English translations.
• Certificate of Free Sale (CFS) – Issued by the health authority in the country of origin, proving the product is legally marketed there.
• Good Manufacturing Practice (GMP) Certificate – Evidence that the manufacturer complies with international quality standards.
• Lab Test Reports – Analytical and microbiological test results confirming product safety.
• Manufacturer’s Authorization Letter – Proof of the manufacturer’s agreement to allow the UAE-based entity to distribute the product.

Step 4: Product Testing and Evaluation

The regulatory authority may require laboratory testing to verify the product’s safety, composition, and compliance with UAE standards.

Step 5: Registration Approval

Once the product meets all requirements, the authority grants registration, and the supplement can be legally marketed in the UAE.

Labeling and Claims Compliance

The UAE strictly regulates health supplement labeling and claims to prevent misleading information. Key requirements include:

• Labels must be in both Arabic and English.
• Clear identification of ingredients, dosage, and storage conditions.
• No misleading claims – Statements such as “cures diseases” or “prevents specific illnesses” are prohibited.
• All claims must be scientifically substantiated and supported by evidence.

Post-Market Surveillance and Compliance

Even after approval, health supplements in the UAE are subject to continuous monitoring to ensure compliance. Regulatory authorities conduct:

• Random Market Inspections – Checking for counterfeit or non-compliant products.
• Consumer Complaint Investigations – Addressing safety concerns reported by consumers.
• Advertising and Marketing Review – Ensuring claims in advertisements comply with UAE regulations.

Challenges in Health Supplement Registration

• Stringent Documentation Requirements – Extensive paperwork and compliance requirements can be time-consuming for manufacturers.
• Ingredient Restrictions – Some ingredients permitted in other countries may be restricted in the UAE.
• Regulatory Changes – Frequent updates to regulations require companies to stay informed to maintain compliance.

Maven’s Approach to UAE Health Supplement Registration

Maven specializes in regulatory compliance and registration for health supplements in the UAE. Our approach ensures seamless market entry and compliance with UAE regulatory requirements.

1. Regulatory Intelligence & Strategy Development – Keeping up with evolving regulations and developing tailored compliance strategies.
2. End-to-End Product Registration Support – Assisting with dossier preparation, submission, and regulatory approvals.
3. Ingredient & Label Compliance Review – Ensuring formulations meet UAE standards and labels adhere to Arabic-English bilingual requirements.
4. Scientific Substantiation of Claims – Supporting claim validation with scientific evidence and expert toxicological assessments.
5. Local Representation & Liaison – Acting as a trusted partner for international brands entering the UAE market.
6. Post-Market Surveillance Support – Assisting in maintaining compliance through monitoring, reporting, and addressing regulatory inquiries.

Conclusion

The UAE offers a well-regulated market for health supplements, ensuring high standards of safety, efficacy, and quality. While the registration process can be complex, proper planning and adherence to regulations can facilitate smooth market entry. Companies looking to register their health supplements in the UAE should work with experienced regulatory professionals like Maven to navigate the process efficiently and ensure compliance with MOHAP, Dubai Municipality, and other relevant authorities.

By following UAE’s regulatory framework and leveraging Maven’s expertise, businesses can successfully introduce safe and high-quality health supplements to consumers while maintaining compliance with government standards.