Released on Dec. 16, FDA’s recent guidance on genome-edited plants introduces a new premarket process – the premarket meeting – for lower-risk foods, offering a flexible option for developers with products that do not require the same level of data submissions as the consultations outlined earlier this year.
“The agency expects this voluntary premarket meeting pathway to take less time than a voluntary premarket consultation, including because the meeting pathway is recommended for foods that are less likely to raise safety questions,” according to FDA.
The agency released a new inventory of voluntary premarket meetings for foods derived from genome-edited plants, such as mustard greens genetically modified for reduced pungency and fewer trichomes.
The new guidance builds on to the Feb. 2024 guidance regarding voluntary premarket consultations for foods exhibiting certain risk-based characteristics, such as foods that undergo significant modifications that could impact safety or nutritional content, according to the agency.
The February guidance on new plant varieties applies to foods from genome-edited plants and emphasizes a product-based assessment that evaluates the food’s characteristics, regardless of the genetic modification method used. This guidance clarified FDA’s 1992 Statement of Policy: Foods Derived from New Plant Varieties (NPV policy).
“Advancements in the field of biotechnology are bringing new food products to the marketplace,” contributing to meeting the needs of a growing global population and address food insecurity worldwide, according to FDA.
FDA’s Plant Biotechnology Consultation Program streamlines regulatory pathways for new food products derived from genome-editing and ensures they meet the same safety requirements as traditionally bred plants, according to the agency.
FDA, USDA, EPA collaborate to streamline regulatory pathways for genome-edited food products
US Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) will work closely with FDA to establish a unified framework that addresses the safety and approval of products made from biotechnology-derived plants, including genetically engineered and genome-edited products.
Comments about the guidance can be submitted at any time at http://www.regulations.gov/ under the docket number FDA-2019-D-4658.
