GOLDEN RICE: Okayed By US FDA, 2 Other Top Global Regulatory Agencies

GOLDEN RICE: Okayed By US FDA, 2 Other Top Global Regulatory Agencies

LOS BAร‘OS, Philippines – GR2E Golden Rice, a provitamin-A biofortified rice variety, completed its third positive food safety evaluation, this time from the United States Food and Drug Administration (US FDA). In an official response received by the International Rice Research Institute (IRRI) on May 24, the US FDA concurred with IRRI’s assessment regarding the safely and nutrition of Golden Rice.

The US FDA statement comes on the heels of the safety and nutrition approvals from Food Standards Australia New Zealand (FSANZ) and Health Canada in February and March 2018, respectively. These three national regulatory agencies carry out their assessments based on concepts and principles developed 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 of Economic Co-operation and Development (OECD) and the Codex Alimentarius Commission.

GOLDEN RICE: Okayed By US FDA, 2 Other Top Global Regulatory Agencies
Golden Rice is estimated to provide 30 – 50% of estimated average requirement for Vitamin A of women and children.

“Each regulatory application that Golden Rice completes with national regulatory gencies takes us one step closer to bringing Golden Rice to the people who need it most,” says IRRI Director General Matthew Morell. “The rigorous safety standards observed by the US FDA and other agencies provide a model for decision-making in all countries wishing to rep the benefits of Golden Rice.”

For those who struggle with Vitamin-A deficiency (VAD), including an estimated 250 million pre-school-age children, the announcement represents one more step forward to making the rice available to them. 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.

Vitamin A deficiency remains a pervasive public health problem worldwide. SHO estimates that alongside children under 5 years old, a substantial number of pregnant and lactating women are affected with FAC. South and Southeast Asia rank high among the regions where VAD is prevalent./ (IRRI Press Release)

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