Navigating Health Supplement Regulations in the Middle East Countries

In recent years, the health supplement market in the Middle East has experienced rapid growth, driven by increasing health awareness among consumers. According to data from MarkNtel Advisors, the nutraceuticals market in Gulf Cooperation Council (GCC) countries, the most significant economic territory in the middle east, is projected to grow at a compound annual growth rate (CAGR) of approximately 9% from 2022 to 2027 (check Unlocking Health Supplement Market Opportunities in Middle East Countries for detailed analysis about health supplement market in the Middle East). 

Recognizing this substantial market potential, an increasing number of global stakeholders are investing in the Middle Eastern health supplement sector. To help remove market access barriers, this article summarizes the key regulatory requirements in GCC countries, including the United Arab Emirates (UAE), Saudi Arabia, Qatar, Oman, Kuwait, and Bahrain.

UAE

In the UAE, health supplements are defined as products intended for ingestion that contain dietary ingredients to provide additional nutritional value and supplement the diet. These supplements can be in various forms, including tablets, capsules, soft gels, gel caps, liquids, and powders.

At the federal level, the Ministry of Industry and Advanced Technology (MOIAT) is responsible for establishing laws and standards for food products including health supplements throughout the country. The local Municipalities of each Emirate are tasked with administering these federal regulations, ensuring that all imported and locally manufactured products are compliant with the national standards.

Take Dubai for example, according to the Local Order No. 11/2003, Dubai Municipality regulates the manufacture, sale and importation of health supplements. All health supplement products shall be registered before being sold in Dubai. It is noteworthy that the applicant must be a company incorporated in Dubai, or having a warehouse and trade license there indicating the business operation for health supplement. Foreign manufacturers are highly suggested to contact Health and Safety Department under Registration and Permits Section at Dubai Municipality for further information regarding product registration. 

Technical Guidelines for Health Supplement specifies requirements for registration, documents, as well as ingredients and labeling for health supplements. The content of vitamins, minerals and other ingredients used in products targeting at different age groups should be under the maximum levels set in Annex 1 of the Technical Guidelines for Health Supplement. In addition, Annex 3 lists prohibited ingredients for health supplements, such as 5-Hydroxy Tryptophan, Canabidiol CBD, Citrus aurantium. 

In terms of the labeling, the following items are mandatory in English and/or Arabic language:

• Brand name

• Product name

• Manufacturer details

• Country of origin

• Ingredients

• Pack size

• Production & expiry dates

• Storage condition

• Dosage and instruction of use

• Product indications/intended use

• Health waring

• Batch number

It's important to note images and illustrations that are inconsistent with prevailing social customs are prohibited on packaging. Additionally, claims that imply disease prevention or therapeutic functions are not allowed. Annex 4 of the Technical Guidelines for Health Supplements provides a comprehensive list of other prohibited claims for health supplements. 

Saudi Arabia

In Saudi Arabia, food supplements are defined as products intended to complement a normal diet. These supplements contain ingredients with nutritional and/or physiological effects, playing a role either individually or in combination. Common ingredients include vitamins, minerals, fatty acids, amino acids, enzymes, prebiotics and probiotics, collagen, dietary fibers, melatonin, propolis, pollen, herbs or herbal extracts. 

The Saudi Food & Drug Authority (SFDA) oversees the regulation of food supplements. Before entering the Saudi Arabian market, all food supplement products must be registered with the SFDA. The Registration Guide of Food Supplements and Energy Drinks outlines the registration process, required documentation, and associated fees. It's important to note that companies are not allowed to use the SFDA logo on product packaging as a safety guarantee. Instead, they are only permitted to indicate the reference number such as “P-3-N-000000-0000” or the registration number.

Food supplements must comply with both SFDA and GCC technical regulations. The most relevant product regulations are SFDA.FD 55 Food Supplements and GSO 2571/2021 Food supplements. Additionally, labeling should conform to GSO 9 Labeling of Prepackaged Foodstuffs, SFDA.FD. 2333 Requirements for Health and Nutrition Claims and SDFA.FD 2233 Requirements of Nutritional Labeling.

Note: You can search for the SFDA technical regulations/standard through SFDA Standards Web Store by inputting the regulation number. 

Oman

In Oman, dietary supplements are defined as concentrated sources of nutrients or other substances with a nutritional and/or physiological effect intended to supplement the diet. Their dosage forms include capsules, pastilles, tablets, pills, sachets of powder, ampoules of liquids, drop-dispensing bottles, etc.

The Ministry of Health in Oman is responsible for regulating dietary supplements. Product registration is mandatory for market access.

As per Oman’s Guidelines for Product Classification, certain ingredients are prohibited in dietary supplements, such as steroids or steroids-like substances, and aromatase inhibitors. Annex 1 and Annex 2 of this Guidelines list the permitted vitamins and minerals along with their corresponding minimum and maximum levels for different age groups. Annex 3 includes other ingredients permitted in dietary supplements, such as marine algae and botanical extracts.

In terms of claims, health claims (e.g. fibers may reduce the risk of coronary heart diseases), nutrient content claims (e.g. high Calcium level) and structure/function claims (e.g. calcium builds strong bones) are all permitted for dietary supplements. 

Kuwait

In Kuwait, health supplement belongs to health products. Health supplement refers to product that can offer not only nutrition value but also physiological benefits and/or protection again chronic diseases. The supplement comes in various forms, including capsules, soft gels, tablets, liquids, syrups, and lozenges. The ingredients used typically include vitamins, minerals, amino acids (natural and synthetic) and substances derived from natural sources.

The Ministry of Health is responsible for the supervision of health supplements. As per Minister of Health Resolution No. (532) of 2002 Approving the Regulation for Procedures and Controls for the Production and Import of Special Foods and Nutritional Supplements and their Circulation in the State of Kuwait, health supplement must be registered before being sold in Kuwait. The registration requirements, including the required documents, registration renewal & modification requirements, and situations for approval cancellation, are specified in Ministerial Decree for Registration and Release of Health Products.

Bahrain

According to the Pharmaceutical Product Classification Guideline issued by National Health Regulatory Authority (NHRA) of Bahrain, two types of products may fall under the term of “health supplement” discussed in this article. 

(1) Health products

Combination product (herbal/vitamin and minerals/others) is one of the subcategories of health products, referring to products which contain one or more herbal ingredients in addition to one or more vitamins and/or minerals and/or others that are indicated for adults/children (above 1 year of age)/adolescent.

In addition, health products include labeled products in pharmaceutical dosage forms (except for parenteral formulation) that contain ingredients like amino acids, charcoal, microorganism whole or extract, lipid, substance produced by or obtained from bees, natural enzyme products, glucosamine, etc.

Both of the above two products are supervised as pharmaceutical products in Bahrain. In this case, the products shall be registered with NHRA before being sold. The Health Products Licensing Guideline issued by NHRA introduces the application procedures, registration variation and renewal, as well as documents required for the registration. It is noteworthy that one of the premises for obtaining approval for new health product in Bahrain is that the product has been registered in its country of origin and marketed for not less than one year. Besides, any product registered by NHRA should have the standard statement that “To consult health care professional before use in case of pregnancy, lactation or under medication”on the package. 

(2) Food supplements

In Bahrain, food supplements are supervised as food products, including the following types:

• Vitamins and mineral supplements whose nutrient contents are within the maximum levels specified in Annex I of Pharmaceutical Product Classification Guideline.

• Food products that provide physiological benefits beyond basic nutritional functions (not in pharmaceutical dosage forms)

• Products registered as food supplements (multivitamin and mineral only) in designated countries

• Energy drink

• Sports supplements 

Food supplements shall be licensed with Ministry of Health (MOH), whose procedure and detailed requirements can be found in Guideline for Special Food Licensing. Same with Saudi Arabia, the registered food supplement cannot display the logo of the MOH.

The label of food supplements should conform to the GCC technical regulations or standards, and must include the following items:

• The name of the product

• List of active and inactive ingredients

• Nutritional data

• Net contents

• The name and the address of the manufacturer or the packing factory

• Country of origin

• Date marking

• Instructions for storage and use

In case of confusing about the correct product classification, enterprises can submit a classification query to NHRA for consultation.

Qatar

In Qatar, dietary supplements fall under the supervision of the Ministry of Public Health. Registration is mandatory for all dietary supplement products intended for sale in the local market. The Requirements for Registration of Herbal, Dietary Supplements, and Medicated Cosmetic Products stipulates documentation required for dietary supplement registration. For example, one of the key documents required is the Certificate of Composition, which should include the following information:

• Active and inactive ingredients, their uses, and concentrations

• Indications

• Dose

• Adverse effects

• Drug-drug and drug-food interactions (if any)

• Safety use in humans

• Storage conditions

• Shelf life

Dietary supplements in Qatar must comply with relevant GCC technical regulations. The most pertinent regulations include GSO 2571/2021 Food Supplements and GSO 9 Labeling of Prepackaged Foodstuffs. These standards govern both product formulation and labeling requirements for dietary supplements in the Qatari market.