The label of a product speaks for the product. It states what is contained in the health supplement product, how to use it, when to use it, and all other such details. Since this is a crucial part of the product, it must comply with certain standards and requirements.
The UAE has federal and emirate-level regulatory requirements for health supplements. Read more to learn about the health supplement labeling requirements in the UAE.
UAE Health Supplement Regulatory Authority
EDE regulates healthcare products falling within its federal marketing-authorization framework, which includes dietary supplements and certain other healthcare products. EDE’s current healthcare-product marketing authorization service specifically includes dietary supplements. The service covers products used for the promotion of general human health that are not intended for the diagnosis, treatment, cure, or prevention of disease.
Dubai Municipality regulates consumer products placed on the Dubai market. It maintains a dedicated Technical Guideline for Health Supplements, DM-HSD-GU29-TGHS2. The current version listed by Dubai Municipality is Version 2.0, issued on 4 May 2024.
Why Labeling Matters for Health Supplements in the UAE?
Labelling matters for every product. It gives all the essential information about health supplements. That covers the dose, usage, ingredients they contain, and the benefits they bring to us. Every consumer should know what they are putting inside when consuming orally and its advantages.
Product composition and labeling must comply with the applicable UAE regulatory requirements. This includes requirements concerning restricted or prohibited substances and, where applicable, halal requirements. EDE’s current marketing-authorization requirements specifically include a halal certificate issued by certified authorities or organizations and additional declarations concerning specific substances.
Health Supplement Claims Regulations in the UAE
Claims made on dietary supplements must be truthful. They shouldn’t mislead and should stay consistent with the regulatory status and intended use of the product.
Dubai Municipality’s health-supplement compliance requirements divide claims into health, structure/functional, and prohibited claims. The first two require the claim to be specifically validated with proper scientific evidence to back its accuracy. It means the effect on health or any function of the body should have science to support it.
The prohibited claim pertains to health supplements being represented as products intended to prevent, treat, cure, or alleviate the symptoms of medical diseases or conditions. Dubai Municipality’s definition and EDE’s healthcare-product marketing authorization service cover this.
Difference Between Structure & Health Claims
Here’s a tabular representation of structure and health claims provided by Dubai Municipality:
| Aspect | Health Claims | Structure/function claim |
| Focus | Link a nutrient or ingredient to health. In other words, it states that there exists a relation between health and the product or its ingredients. | Describe the role of a nutrient or ingredient in maintaining normal bodily functions and structure. |
| Wording | Use language that connects the product to improving health | Focus on supporting or maintaining normal biological functions without referencing disease. |
| Scientific Justification | Health claims must be backed by scientific evidence and by significant scientific consensus | Must be based on the known role of nutrients and do not need extensive scientific validation. |
| Examples |
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Health Supplement Regulatory Labeling Requirements in UAE
The labeling requirements given here are according to Dubai Municipality’s guidance. Actual labeling regulations by EDE may vary or be extensive.
One of the main health supplement labeling requirements in the UAE is the language in which it must be written. The contents of the label must be printed in English and/or Arabic. The label must contain the following, and here’s a breakdown of each requirement:
- Trademark: Clearly display the product’s brand or trade name.
- Product Name: A concise description of the product. The trade name or brand name cannot replace the product name.
- Manufacturer Details: Include details of the manufacturer or the agent acting in the UAE—covering name, address, and Email ID.
- Product Barcode or Industrial Code Number: Each product must have a barcode that’s clear and distinct for every product.
- Dosage and Instructions for Use: Provide clear instructions on how to use the product, including recommended daily dosage.
- Production & Expiration Dates: Indicate the production date and the expiration date or the period after opening. This information shall be included with non-removable ink or non-removable stickers.
- Pack Size, Net Weight, or Volume: State the net weight or volume of the product.
- Medical Claims: Ensure no medical claims are made on the label, leaflet, brochure, etc.
- Batch Number or Lot Identification Number: Include the batch number or lot identification number.
- Storage Conditions: Specify storage conditions if they affect the product’s validity.
- Ingredients List: Provide a comprehensive list of ingredients, both active and inactive ingredients, highlighting any that may cause hypersensitivity. Use INCI or botanical names and international nomenclature from where the ingredient is extracted.
- Product Indications and Intended Use
- Health/General Warnings: Any warnings and precautions related to the health supplement regulation in general or specific to any of the ingredients must be specified.
- Country of Origin: Clearly declare the country of origin, ensuring specificity and proper format.
- Avoid Illustrations, Images & Drawings that are incompatible or inappropriate and do not follow customs and prevailing social values.
- Dietary Supplements Fact Sheet – Must include explaining active ingredient per serving and other added ingredients
- Do not present the product as sole component of the meal/diet or traditional food.
- Disclose vitamins and minerals in numerical form along with percentage RDV.
- Make only permissible health/functional claims on the label.
- Indication of “Food Supplement”: A clear indication must be provided on the label that it is a food supplement or dietary supplement. An example of this is in the image below.
Products making medicinal/curing claims may be considered as medicinal products subject to stringent regulations with more detailed registration requirements.
EDE Requirements Relevant to Health Supplement Labelling in the UAE
For health supplements falling within EDE’s healthcare-product marketing authorization framework, applicants must submit product information and supporting documentation that includes labeling-related materials. EDE currently requires a copy of the outer and inner cover and a leaflet, printed on letterhead and stamped and signed by the authorized person. The application also requires a detailed composition certificate identifying active and inactive ingredients and their quantities.
EDE’s requirements also include a halal certificate issued by a certified authority or organization. Where animal-derived substances are present, the applicant must provide details of the animal type and the part extracted, together with information concerning alcohol used, if applicable.
Conclusion
Health supplement labeling in the UAE requires attention to both federal and emirate-level requirements. EDE’s federal healthcare-product framework covers health supplements, while Dubai Municipality has specific requirements for dietary supplements placed on the Dubai market.
Companies entering the UAE should assess product classification, marketing authorization or registration, labelling, composition, claims, and import requirements. They should check it according to the product and the emirate in which it will be marketed.
This process can be challenging if it is carried out without complete comprehension. With thorough navigation and a proper regulatory plan, safe, quality, and compliant health supplements can be released.
Know more about health supplement registration in the UAE
Artixio, with 30+ years of experience, supports health supplement companies with labelling, claims, registration and market-entry requirements. Explore our nutrition regulatory services for expert support across the UAE and other markets.
Connect with us through info@artixio.com
FAQs
Q. What are the claims that are not allowed on the health supplement label in UAE?
A. Medical claims stating the prevention, cure, or treatment of any kind of medical disease should not be on the label. This is applicable not only to labels but also to brochures, advertisements, leaflets, or any other possible way.
Q. How are ingredients derived from plant or animal sources kept in labels for UAE health supplements?
The active ingredients derived from plant or animal sources must be stated in the scientific or INCI name. This is because it is recommended to use internationally accepted nomenclature to name the ingredients. For example, instead of keeping it as Ginseng extract, use Panax ginseng extract.
Q. Are health supplements required to be registered with Dubai Municipality before being placed on the Dubai market?
Yes. Under Dubai’s current public-health framework, health supplements are classified as consumer products, and consumer products must be registered with Dubai Municipality before being placed along the product chain in the Emirate. Dubai Municipality uses the Montaji platform for consumer-product registration.
Q. What documents are required to register a health supplement in Dubai Municipality’s Montaji system?
For health supplements, Dubai Municipality’s technical guidance lists product artwork/image, a product conformity certificate from an approved source, an ingredient report, and a test report from a Dubai Municipality-approved laboratory among the required documents. Additional documents, such as a halal certificate, may be requested where necessary.
