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  1. Food from New Plant Varieties

New Plant Variety Regulatory Information

Feed Your Mind Education and Outreach Initiative

Better understand genetically engineered foods (GMOs)

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.

For additional information, please visit:

FDA’s Plant Biotechnology Guidances

The FDA’s guidance documents describe processes in which a developer who intends to commercialize food from a new plant variety voluntarily engages with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the food. These processes enable 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 before commercial distribution.

  • In 2024, the FDA issued a guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, this guidance describes two processes through which they may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings.
  • 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. To view the guidance documents, 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.

For more information about our programs and public inventories of consultations and meetings for new plant varieties, see Programs on Food from New Plant Varieties.

To view additional information on this topic from the FDA, please visit:

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. The labels of foods made from new plant varieties should accurately identify and describe the food. If a food derived from a new plant variety is materially different from its traditional counterpart, the labeling of that food should disclose the differences. For example, a word or phrase like “laurate” may be needed as part of a name to accurately identify or describe a new canola oil with increased lauric acid content compared to conventional canola 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.

Before 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.

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