SFDA Food Supplements Registration

food supplements saudi SFDA

The SFDA registration for food supplements in Saudi Arabia is in more than one procedure and it is always tricky for foreign manufacturers who get confused with the different requirements than most countries. Food supplements, as per SFDA, can be approved as advanced food or health products.

In this article, we will try to simplify it for fellow regulatory professionals.

What is Food Supplement?

They are products with one of the following ingredients:

  • Food supplements that are rich in vitamins and/or minerals.
  • Products of proteins, carbohydrates, and amino acids that are used as food supplements.
  • Powdered products used as food supplements for athletes or for people who play exercise.
  • Products contain collagen that come in a powder or liquid form.
  • Products contain royal jelly, pollen or propolis that come in a powder or liquid form.
  • Energy drinks products.

How to register food supplements in Saudi Arabia?

Food supplements in the form of food such as candy, biscuits, gummies, and other usual food forms (non-pharma dosage forms) are considered advanced food products in SFDA. They require registration in the food sector in the SFDA. It is a simple procedure and faster in timelines.

On the other hand, food supplements that come in a pharmaceutical form (Tablets, capsules, etc) are considered health products in Saudi Arabia. This is according to SFDA guidelines. Therefore, a more complex file that is similar to drug files is required. It is called a health application and needs to be in CTD or eCTD format to be accepted. Note that health products that contain higher amounts of vitamins and minerals than the allowed daily consumption will be rejected and forced to reapply as a pharmaceutical drug products. For more information read SFDA Drug Registration Requirements.

To identify which class your products fall under and how to change their classification from health to food or from drug to health, you may contact us for a consultation.

SFDA Food Supplements Registration Requirments

As a Special Food Application

Food application is considered one of the simplest and the shortest procedures compared to other registration procedures in the SFDA. A Saudi SFDA licensed company for Food activity is accepted to apply. The required files are transparent and mostly available with all food manufacturers, such as ISO and other certificates that ensure the safety of the product ingredients. Claims on the labelling could be hectic and tricky to have approved.

The timeline for food supplement registration as an advanced food application is 2 to 12 weeks, and the SFDA fees are SAR5000/application.

As a Health Product Application

If the food supplements are in a pharmaceutical shape, they will be treated differently in the SFDA as we highlighted above. The marketing company has to file a CTD file as per ICH guidelines adopted in Saudi Arabia. Module 1 and Module 3 are the only sections required. However, most files are necessary, although some parts have specific standards for health files, such as stability studies.

The additional challenges for this classification of food supplements are the longer timelines, as it takes 155 working days for file review (on top of preparation time and time to respond to inquiries).

In addition, higher fees are applicable for health product registration, starting from SAR24,000 per application. Also, a manufacturer license by SFDA is needed, which requires SFDA GMP visits and payment of high SFDA fees for GMP.

More Insights