FDA unveils guidelines for pre-market engagement on genome-edited plant foods

In a move aimed at fostering innovation and expanding food options for consumers, the US Food and Drug Administration (FDA) has released a comprehensive guidance for the industry on how companies can voluntarily engage with the agency before marketing foods derived from plants produced using genome editing techniques. The guidance, which emphasizes a risk-based approach, ensures that the same safety standards applied to foods from new plant varieties also extend to foods derived from genome-edited plants.    

The newly released guidance places a strong emphasis on voluntary premarket engagement with the FDA, tailored to the risk profile of each food product. Developers are encouraged to utilize two distinct processes to inform the FDA about the safety measures they have implemented for foods derived from genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings.    

The voluntary premarket meeting pathway is particularly recommended for foods that pose lower safety concerns, as it enables developers to provide necessary information to the agency in a more streamlined manner. In contrast, voluntary premarket consultations remain the preferred option for foods with higher risk-based characteristics, as outlined in the guidance.    

Stakeholders and interested parties are invited to provide their feedback on the guidance.    

The FDA's release of these guidelines aims to facilitate the responsible development and commercialization of foods derived from genome-edited plants. By establishing a transparent and collaborative framework, the agency works towards a balance between innovation and safety, ensuring that consumers have access to a diverse range of high-quality and safe food options.