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The Saudi Food and Drug Authority (SFDA) is the principal Regulatory body in Saudi Arabia responsible for overseeing the safety, efficacy, and quality of food, drugs, medical devices, Cosmetics, and related health products. Established in 2003, the SFDA operates under the authority granted by the Saudi Food and Drug Authority Law, which outlines its mandate and operational framework.

Key Provisions of the SFDA Law

1. Establishment and Legal Status

The SFDA is established as an independent Regulatory authority with legal personality, enabling it to act in its own name, contract with third parties, and manage its own budgetary and organizational matters. It reports directly to the President of the Council of Ministers, reinforcing its institutional stature and ensuring that it operates with the authority and independence necessary to fulfill its mission.

2. Mandate and Responsibilities

The SFDA's primary objective is to regulate, monitor, and ensure the safety, quality, and efficacy of food and drug products within its jurisdiction. Its mandate extends beyond human consumption to include animal health, biologicals such as vaccines and serums, cosmetics, health-related products, and medical devices. The Authority is also responsible for overseeing bottled and non-bottled water, diagnostic and electronic medical equipment, and pesticides used in agriculture and public health.

3. Core Functional Domains

The Law delineates the SFDA's functions into three core domains:

  • Regulatory: Developing policies, frameworks, and standards that govern the entire lifecycle of regulated products, from manufacturing and importation to market clearance and post-market surveillance.
  • Executive: Implementing the Law and its accompanying regulations, including conducting laboratory testing and analysis of food, water, drugs, and medical devices to verify their conformity with approved standards.
  • Monitoring: Supervising the implementation of all relevant licensing procedures and monitoring compliance with Good Manufacturing Practices (GMP) and international safety standards.

4. Enforcement and Compliance

The SFDA is empowered to enforce the Law and its regulations, including conducting inspections, imposing penalties, and taking corrective actions to ensure compliance. This includes the authority to shut down facilities, suspend production lines, and seize non-compliant products.

5. Training and Capacity Building

The SFDA is mandated to conduct and accredit training programs for professionals in food and drug-related fields, ensuring that compliance extends beyond technical product specifications to include human capital development. Businesses are encouraged to invest in workforce training to remain ahead of Regulatory expectations.

Recent Developments and Updates

As of October 2025, the SFDA continues to enhance its Regulatory framework to ensure public health and safety:

  • Crackdown on Non-Compliant Facilities: In July 2025, the SFDA shut down 54 facilities, suspended 52 production lines, and seized expired and counterfeit products, including 40 tons of contaminated poultry, in a major food safety crackdown.
  • Implementation of New Food Rules: Starting July 1, 2025, food establishments are mandated to display detailed nutritional information on their menus to enhance transparency and consumer health.
  • Updated Table of Food Law Violations: The Ministry of Municipalities and Housing, in cooperation with the SFDA, launched an updated schedule of food law violations to strengthen food safety and enhance Regulatory compliance.

Conclusion

The Saudi Food and Drug Authority Law ensures robust regulation of food and drug safety in Saudi Arabia. To stay compliant and safeguard public health, businesses must align with SFDA regulations.

Freyr can help you navigate SFDA requirements, streamline Regulatory submissions, and ensure full compliance—contact us today.