FDA announcing premarket engagement guide for genome editing plants

26 Feb 2024 --- The US Food and Drug Administration (FDA) has released industry guidance for foods derived from plants produced using genome editing, describing how companies may voluntarily work with the FDA prior to marketing such foods.

Issued by the FDA’s Center for Food Safety and Nutrition, the new guidance asserts that the US 1992 Statement of Policy on Foods Derived from New Plant Varieties (NPV Policy) applies to new plant varieties produced through genome editing and provides clarifications on how it accommodates such products.

The guidance document further describes the two processes companies can use to voluntarily inform the FDA of the actions taken to ensure their genome-edited plant-derived products are safe. These processes are an endeavor to ease the market release path for such foods, while ensuring their safety.

The FDA states that the document reaffirms its risk-based approach to foods derived from genome-edited plants and all new plant varieties.

Guidance for industry
The two processes for companies interested in voluntarily informing the FDA of the steps they have taken to ensure the safety of their products containing new genome-edited plant varieties.

Which of the processes the company should consider depends on the objective characteristics of the new food, particularly in relation to food safety.

A voluntary premarket consultation using the FDA’s current consultation process is recommended for foods from genome-edited plants that are more likely to raise food safety regulatory considerations because of having one or more of the several characteristics detailed at length in the guide.

The other process is aimed at food products from gene-edited plants that do not have any of the characteristics outlined in the document, and are therefore seen as less likely to raise food safety questions. In the case of such products, the FDA recommends only a voluntary premarket meeting.

The FDA defines genome editing as a tool that plant breeders can use to introduce new, desirable traits into plants, asserting that it is needed “to address the needs of a growing global population.”

Meanwhile, the EU is set to relax its genetically modified organisms (GMO) legislation, as soon it will no longer consider foods made from plants edited through new genomic technologies as GMO, as experts argue this will help ensure the resilience and competitive edge of the EU agricultural sector on the global stage.

By Milana Nikolova

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