About the Author: Madiha Baaj
The SFDA registration for food supplements in Saudi Arabia has more than one procedure, and it is always tricky for foreign manufacturers who get confused by the different requirements. According to the SFDA regulations, food supplements can be approved as advanced food or health products.
In this article, we will try to simplify it for fellow regulatory professionals.
Table of contents
Types of Food Supplements
They are products with one of the following ingredients:
- Food that is rich in vitamins and/or minerals.
- Products of proteins, carbohydrates, and amino acids used as food supplements.
- Powdered products used as food supplements for athletes or for people who exercise.
- Products contain collagen that comes in a powder or liquid form.
- Products contain royal jelly, pollen or propolis that come in a powder or liquid form.
- Energy drinks products.
Application Types
Supplements can be registered in Saudi Arabia as food products in the SFDA Food Sector or as health or herbal products in the Drug Sector. This depends on ingredients, medical claims, dosage forms, or other labelling information.
If the product is unclear, an expert must review the procedure it should be registered under. Alternatively, the applicant can apply for SFDA classification before they apply for registration.
Requirements
Special Food Application
Supplement registration through the special food application is generally more straightforward. However, it is still tricky; inexperienced applicants might waste fees and months in the wrong direction.
The required files are simple and mostly available with all food manufacturers, such as the ISO certificate, safety data sheets, label, and artwork, in addition to other certificates that ensure the safety of the product ingredients. However, working on the label claims and substance concentrations requires an expert regulatory professional.
Examples of special foods are vitamin Candy, Gummies, powder sachets, and even capsules or tablets are allowed.
Allowed Vitamines
Vitamin A (μg RE)
Vitamin D (μg)
Vitamin E (mg α-TE)
Vitamin K (μg)
Vitamin B1 (mg)
Vitamin B2 (mg)
Niacin (mg NE)
Pantothenic acid (mg)
Vitamin B6 (mg)
Folic acid (μg)
Vitamin B12 (μg)
Biotin (μg)
Vitamin C (mg)
Allowed Minerals
Calcium (mg)
Magnesium (mg)
Iron (mg)
Copper (μg)
Iodine (μg)
Zinc (mg)
Manganese (mg)
Sodium (mg)
Potassium (mg)
Selenium (μg)
Chromium (μg)
Molybdenum (μg)
Fluoride (mg)
Health Product Application
Suppose the food supplement you want to register in the SFDA has an ingredient concentration exceeding the daily limit or has a non-accepted food claim. In that case, it must be done through the drug sector as a health or herbal application. This type of application requires a CTD or eCTD file as per ICH guidelines, similar to drug registration requirements. In addition, SFDA will GMP inspect the manufacturer.
Examples are Vitamin D 5,000IU, sexual health products, and all other herbals with therapeutic effects.
Cost and Time
You may refer to our articles: SFDA Fees and Timelines.
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