Food Supplement Registration in Saudi Arabia

Saudi Arabia’s health and wellness market is expanding rapidly, driven by the growing demand for nutritional and functional foods. However, the Saudi Food and Drug Authority (SFDA) enforces stringent regulations to ensure safety, efficacy, and product integrity making expert Food Regulatory Services in Saudi Arabia essential for successful market access.

At DDReg, we offer end-to-end Food Supplement Registration in Saudi Arabia, covering classification, formulation review, dossier preparation, and post-approval compliance ensuring every product aligns with SFDA and Gulf Standardization Organization (GSO) requirements.

Saudi Food & Drug Authority (SFDA) responsible for regulating, licensing, and monitoring all food, dietary supplement registration, and health supplement products marketed in Saudi Arabia.

1. Classification and Pre-Assessment – confirm category, ingredient compliance, and applicable regulation.
2. Establishment and Product Registration – via SFDA’s Food Registration System (FIRS) portal.
3. Scientific Evaluation – dossier reviewed by SFDA’s food supplements panel.
4. Approval and Listing – upon SFDA’s acceptance; the product is authorized for sale in the Kingdom.

There is no separate “notification” route for food supplements in Saudi Arabia. All products must undergo registration and evaluation prior to market entry.

• + Product Classification
  • Determine if the product qualifies as a Food Supplement under SFDA.FD 55 or another category.
  • Review vitamin/mineral levels per defined limits.
  • Align product claims with SFDA.FD 2333 (Health & Nutrition Claims).
• + Ingredient and Formula Compliance
  • Verify ingredients against SFDA/GSO-approved lists.
  • Check for prohibited or restricted substances per FD 55 and FD 5013.
  • Provide reformulation guidance for borderline products.
• + Label and Claims Review
  • Review label content, nutrition info, and warnings.
  • Ensure inclusion of mandatory statements (e.g., “Not intended to diagnose, treat, cure, or prevent any disease”).
  • Validate claims as per SFDA.FD 2333.
• + Dossier Preparation and SFDA Submission
  • Prepare and submit the dossier via SFDA’s Food Registration System (FIRS).
  • Coordinate with SFDA’s scientific reviewers.
  • Support with ISO, Halal, and manufacturer licensing.
• + Local Representation and Liaison
  • Appoint a Saudi-based representative or MAH.
  • Manage communications during review and approval stages.
• + Post-Market Regulatory Support
  • Monitor updates to SFDA and GSO regulations.
  • Handle renewals, label changes, and variations.
  • Advise per the 2025 Borderline Products Classification Guidance.

• 16+ years of global and GCC regulatory expertise.
• Proven experience in SFDA Food Supplement Registration and Nutraceutical registration in Saudi Arabia.
• Local representation and regulatory liaison with SFDA.
• Expert claim substantiation and reformulation support.
• Complete Food Product Registration Services in Saudi Arabia from pre-market to post-approval.