GR2E Golden Rice, a provitamin-A biofortified rice variety, has completed its third positive food safety evaluation, this time from the U.S. Food and Drug Administration (FDA). In an official response received by the International Rice Research Institute (IRRI), the FDA concurred with IRRI’s assessment regarding the safety and nutrition of Golden Rice.
The FDA statement comes on the heels of the safety and nutrition approvals from Food Standards Australia New Zealand (FSANZ) and Health Canada in February 2018 and March 2018, respectively. These three national regulatory agencies carry out their assessments based on concepts and principles developed over more than two decades by international organizations such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO) of the United Nations, the Organization for Economic Co-operation and Development (OECD), and the Codex Alimentarius Commission. Once Golden Rice receives all necessary national approvals, a sustainable deployment program will ensure that Golden Rice is acceptable and accessible to its target communities.
“Each regulatory application that Golden Rice completes with national regulatory agencies takes us one step closer to bringing Golden Rice to the people who need it the most,” said IRRI Director General Matthew Morell. “The rigorous safety standards observed by the FDA and other agencies provide a model for decision-making in all countries wishing to reap the benefits of Golden Rice.”
Vitamin A deficiency remains a pervasive public health problem worldwide. Golden Rice is intended as a complementary, food-based solution to existing nutritional interventions, such as diet diversification and oral supplementation. It achieves this by providing 30%–50% of the estimated average requirement for vitamin A of women and children.
FDA letter (pdf)