In February 2024, the U.S. Food and Drug Administration (FDA) clarified the regulatory pathway for foods produced from genome-edited plants in a final guidance titled Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.¹ The Guidance addresses the regulatory approach for both human and animal foods produced from genome-edited plants. Toward this end, FDA introduces a streamlined, premarket meeting option for lower-risk plants. In this sense, the Guidance is consistent with the 2017 update to the Coordinated Framework for the Regulation of Biotechnology,² as well as the Biden Administration's 2022 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation,³ which included a promise to clarify—and potentially simplify—regulatory pathways for products of biotechnology.

The Guidance is timely as genome editing is now the dominant tool for targeted modification of plants to produce desired traits and novel proteins for both human and animal use. Moreover, the Guidance may have significance in providing an up-to-date list of FDA's key safety concerns regarding novel ingredients that may be useful not only in developing foods from genome-edited plants, but also in considering the use of genome editing in microorganisms. Additionally, it will be worth monitoring FDA to see whether the agency takes steps to introduce a similarly streamlined path to market for other, lower-risk, novel foods. 

FDA has expansive regulatory authority under the Federal Food, Drug, and Cosmetic Act to ensure that human and animal food is safe and properly labeled. Under the 1986 Coordinated Framework for the Regulation of Biotechnology, FDA shares jurisdiction over products derived from biotechnology with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). The Coordinated Framework seeks to strike a balance between regulation that protects public health and the environment, while maintaining flexibility to avoid impeding innovation. It considers biotechnology to be an extension of traditional methods of production and concludes that existing laws administered by these federal agencies are adequate to provide regulatory oversight based upon product uses. As such, regulatory authority is distributed among these agencies depending on the product being developed. 

The vast majority of foods reviewed by FDA pursuant to the Coordinated Framework have been derived from genetically engineered plants and microorganisms, and have been reviewed under FDA's 1992 Statement of Policy: Foods Derived from New Plant Varieties⁴ ("New Plant Variety policy"). The New Plant Variety policy directs developers of such products to voluntarily submit a robust safety assessment for FDA review, and this submission and review are published on FDA's website. In 2017, FDA asked for stakeholder input⁵ on the appropriate approach to evaluate foods derived from genome-edited plants, including whether there are specific risks that should be considered and categories of products that may pose less risk than others. FDA issued the Guidance in response to this request. 

Fundamentally, the Guidance confirms that FDA's New Plant Variety policy premarket consultation also applies to human and animal foods from genome-edited plants. At the same time, the Guidance represents a sharp change from the New Plant Variety policy because it introduces a second voluntary premarket notification pathway specifically for foods from genome-edited plants. This "premarket meeting" requires less information than what is required for a premarket consultation offered under the New Plant Variety policy. 

The net result is that developers of foods from genome-edited plants are encouraged to engage with FDA either through a premarket consultation, as outlined in the New Plant Variety policy and currently conducted⁶ by FDA, or through the newly-introduced "premarket meeting" pathway. Both of these pathways are voluntary. FDA also makes clear that the allergen labeling requirements for all foods under the Food Allergen Labeling and Consumer Protection Act of 2004,⁷ which was enacted after the New Plant Variety policy, must be met.

In developing the Guidance, it appears that FDA has crystallized its key safety concerns regarding this category of products. FDA notes that the vast majority of New Plant Varieties "only very rarely" raise safety issues. At the same time, the agency identifies issues of specific concern, foremost the potential allergenicity risk from foods from genome-edited plants. Thus, consistent with its April 2023 Letter to Industry on the Food Safety Risks of Transferring Genes for Proteins that are Food,⁸ FDA makes clear that developers transferring genes for proteins that are food allergens into new plant varieties must be acutely aware of safety risks, as well as adhere to allergen labeling requirements. 

FDA also recommends premarket consultation for other foods from genome-edited plants that potentially raise safety questions or regulatory considerations. In this context, the Guidance recommends premarket consultation for, among other things, plants that have been modified through genome editing resulting in an increase in levels of potentially harmful components, an increase in the level and/or bioavailability of a nutrient, a change in how the plant or food from the plant is used, and/or the introduction of new genes and/or genetic elements that do not naturally occur in that species.

The Guidance significantly abbreviates the voluntary regulatory process for notifying FDA about lower-risk foods from genome-edited plants. These lower-risk foods seem to be those that do not fall in the identified categories above. The premarket meeting is significant as a noteworthy change in FDA policy, and is intended to familiarize FDA with the types of foods from genome-edited plants entering the market and the steps taken to ensure safety. Critically, the premarket meeting does not require the level of information associated with a consultation and does not appear to result in the same level of transparency. 

Significant questions remain, including the scope of the premarket meeting pathway, and whether it is also available for foods from genome-edited microorganisms, foods from genetically engineered plants, or other foods currently subject to a voluntary premarket consultation program, such as the Generally Recognized As Safe (GRAS) notification pathway. It may be worth submitting or reviewing comments focused on such information.

Note

The views expressed in this article are exclusively those of the authors and do not necessarily reflect those of Sidley Austin LLP and its partners. This article has been prepared for informational purposes only, and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer–client relationship. Readers should not act upon this without seeking advice from professional advisers. 

References

1. U.S. Food and Drug Administration (FDA). Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry. February 2024. https://www.fda.gov/media/176427/download.  
2. U.S. Department of Agriculture (USDA). "Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology." 2017. https://usbiotechnologyregulation.mrp.usda.gov/2017_coordinated_framework_update.pdf. 
3. The White House. "Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy." September 12, 2022. https://www.whitehouse.gov/briefing-room/presidential-actions/2022/09/12/executive-order-on-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy/.  
4. FDA Center for Food Safety and Applied Nutrition (CFSAN). Statement of Policy—Foods Derived from New Plant Varieties. May 1992. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statement-policy-foods-derived-new-plant-varieties.  
5. FDA. "Genome Editing in New Plant Varieties Used for Foods; Request for Comments." Federal Register. January 19, 2017. https://www.federalregister.gov/documents/2017/01/19/2017-00840/genome-editing-in-new-plant-varieties-used-for-foods-request-for-comments. 
6. FDA. "New Plant Variety Consultations." https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=NewPlantVarietyConsultations. 
7. FDA. "Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)." Content current as of November 29, 2022. https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa. 
8. FDA. "FDA Issues Letter to Industry on the Food Safety Risks of Transferring Genes for Proteins that are Food Allergens to New Plant Varieties Used for Food." April 13,2023. https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-letter-industry-food-safety-risks-transferring-genes-proteins-are-food-allergens-new.