The FDA regulates human and animal food from plants, including plants produced through use of genetic engineering and genome editing, under the Federal, Food, Drug, and Cosmetic Act (FD&C Act) and holds them to the same standards as all foods produced, processed, stored, shipped or sold in the United States.
Our regulation of plant biotechnology products is part of a coordinated framework that includes the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA). Each of these regulatory agencies has developed regulations and guidance documents to implement its authority under existing laws to help ensure the safety of plant biotechnology products. The USDA's Animal and Plant Health Inspection Service (APHIS) oversees the agricultural and environmental safety of planting and field testing of genetically engineered plants. The EPA registers pesticides, including those genetically engineered into food crops. As part of its process, the EPA reviews the safety of pesticides and sets tolerances or tolerance exemptions for their presence in or on food. To view information about the regulation of certain biotechnology products at USDA and EPA, please visit: Unified Website for Biotechnology Regulation.
For additional information, please visit:
- Modernizing the Regulatory System for Biotechnology Products
- 2017 Update to the Coordinated Framework for the Regulation of Biotechnology
FDA’s Plant Biotechnology Guidance
In 1992, the FDA clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to human and animal foods derived from new plant varieties. The FDA provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties produced through traditional plant breeding as well as those developed using recombinant deoxyribonucleic acid (rDNA) technology. In 1996, to help developers of foods derived from new plant varieties comply with their obligations under the FD&C Act and FDA regulations, the FDA provided a set of procedures for voluntary premarket food safety consultations with the FDA.
These procedures describe a process in which a developer who intends to commercialize food from a new plant variety meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the food. The developer then submits to FDA a summary of its scientific and regulatory assessment of the food. The FDA evaluates the submission and responds to the developer by letter.
This voluntary premarket consultation process enables firms to engage with the FDA on the safety and legality of foods from their new plant varieties and helps to ensure that any safety or regulatory issues associated with a food from a new plant variety are resolved prior to commercial distribution.
- To learn more about how the premarket consultation process supports innovation, please visit: FDA's Voluntary Plant Biotechnology Consultation Program Eases Pathway to Marketplace
- To view the guidance documents, please visit: Statement of Policy-Foods Derived from New Plant Varieties (1992) and Consultation Procedures under FDA's 1992 Statement of Policy for Foods Derived from New Plant Varieties
- To view the inventory of completed consultations, please visit: Consultations on Food from New Plant Varieties
In 2017, the FDA published a notice titled “Genome Editing in New Plant Varieties Used for Foods” seeking public input to help inform its regulatory approach to human and animal foods derived from plants produced using genome editing. This request was in response to the development of new techniques to modify the deoxyribonucleic acid (DNA) sequences of plants and to characterize such modifications. These newer methods, collectively referred to as genome editing, include the use of nucleases and/or oligonucleotides intended to modify the plant’s DNA sequence by insertion, deletion, or substitution of nucleotides at specific locations in a plant’s genome. These methods can be used to produce a range of changes from as little as a single base-pair to the introduction of a gene from an exogenous source. The agency also asked for information on how best to engage small businesses, including those that may be considering using genome editing to produce new plant varieties for use in human or animal food.
To view additional information on this topic from the FDA, please visit:
- Biotechnology Guidance Documents & Regulatory Information
- CFSAN Online Submission Module (COSM)
- Biotechnology Products at CVM: Animals and Animal Food
Labeling of Foods from New Plant Varieties
Foods derived from new plant varieties must meet the same safety, labeling, and other regulatory requirements that apply to all foods regulated by the FDA.
If a food derived from a new plant variety has compositional differences that make it materially different from its traditional counterpart, the FDA requires that the labeling of that food disclose such differences. For example, when FDA learned during a consultation that a new canola oil had increased lauric acid content compared to conventional canola oil, we required the oil to be labeled “laurate canola oil.” Similarly, soybean oil containing higher levels of oleic acid than conventional soybean oil must be labeled “high oleic soybean oil.”
In 2016, Congress passed the National Bioengineered (BE) Food Disclosure Standard Law, directing the United States Department of Agriculture, Agricultural Marketing Service (USDA-AMS) to establish a national mandatory standard for disclosing foods that are bioengineered. The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature. The implementation date of the Standard is January 1, 2020, except for small food manufacturers, whose implementation date is January 1, 2021. The mandatory compliance date is January 1, 2022. To learn more, please visit the BE Disclosure page on the USDA-AMS website.
Prior to the passage of the BE Disclosure law, the FDA issued guidance on voluntary labeling indicating whether foods have or have not been derived from genetically engineered plants. In light of the passage of this law, FDA is reviewing this guidance to consider what additional or new recommendations may be needed for the kinds of products or statements, including claims of non-GE content, that are not covered by the BE Disclosure law. To view the guidance, please visit: Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.
International Activities on Foods from New Plant Varieties
The FDA participates in international activities related to foods derived from new plant varieties including the safety assessment and regulation of foods from genetically engineered and genome edited plants. As part of these activities, FDA actively shares information with other participating countries.
- To review international guidelines for risk analysis and safety assessments of foods from Genetically Engineered (recombinant-DNA) Plants, from Codex Alimentarius, please visit: Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants
- To view the Food and Agriculture Organization of the United Nations’ database of safety assessments for food from genetically engineered Plants, please visit FAO GM Foods Platform