U.S – The U.S. Food and Drug Administration (FDA) has released a guidance aimed at providing clarity for firms intending to market food derived from genome-edited plants.

This voluntary engagement initiative outlines pathways for manufacturers to collaborate with the FDA before introducing such products to the market.

The FDA, in conjunction with other U.S. government agencies, regulates products derived from biotechnology-derived plants, including those developed through genetic engineering and genome editing.

The guidance accentuates the agency’s commitment to a risk-based approach, ensuring the safety of foods derived from new plant varieties, including genome-edited plants.

The guidance introduces two voluntary engagement processes for manufacturers to inform the FDA about the safety measures implemented for foods from genome-edited plant varieties.

The first process, Voluntary Premarket Consultations, allows manufacturers to formally engage with the FDA by providing detailed information about the safety of their food products derived from genome-edited plants.

Alternatively, the second process, Voluntary Premarket Meetings, is recommended for foods that do not require a formal premarket consultation based on their risk-based characteristics. This voluntary pathway aims to expedite the regulatory review process for foods deemed less likely to raise safety concerns, providing a streamlined approach for assessment.

Aligned with Executive Order 14081, which promotes biotechnology innovation, the guidance aims to streamline regulatory processes for biotechnology products.

By leveraging the voluntary premarket Plant Biotechnology Consultation Program, developers can collaborate with the FDA to navigate appropriate oversight pathways, ensuring the introduction of safe and innovative plant-based products to the market.

Foods from genome-edited plants are held to the same rigorous safety standards as those derived from traditionally bred plants. The FDA emphasizes the importance of meeting established food safety requirements to safeguard public health and consumer confidence.

Stakeholders are encouraged to provide feedback on the guidance through electronic submission to regulations.gov or written comments to the FDA’s Dockets Management Staff.

All comments should reference the docket number FDA-2019-D-4658 and the title of the guidance, facilitating a comprehensive review process.

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