The FDA recognizes that many consumers are interested in whether food ingredients are derived from genetically engineered plants, and has issued guidance for manufacturers who wish to voluntarily label their foods as containing or not containing such ingredients.
If manufacturers wish to label their food as not being produced using genetic engineering, we recommend they use terms such as “not genetically engineered,” “not bioengineered,” or “not genetically modified through the use of modern biotechnology.”
Foods derived from genetically engineered plants must meet the same safety, labeling, and other regulatory requirements that apply to all foods regulated by FDA.
As articulated in its 1992 “Statement of Policy: Foods Derived from New Plant Varieties,” the agency is not aware of any information showing that foods derived from genetically engineered plants, as a class, differ from other foods in any meaningful or uniform way. These foods also don’t present different or greater safety concerns than their non-genetically engineered counterparts. However, if a food derived from a genetically engineered plant is materially different from its traditional counterpart, the labeling of that food must disclose such differences.
FDA has required additional labeling of food derived from a GE source where it found that compositional differences resulted in material changes. 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.” Also, soybean oil containing significant levels of stearidonic acid must be labeled “stearidonate soybean oil” because stearidonic acid is not found in conventional soybean oil.
On July 29, 2016, the President signed into law the National Bioengineered Food Disclosure Standard (Public Law No. 114-216) which, in part, directs USDA to establish a national standard to disclose certain food products or ingredients that are "bioengineered." As a result, the regulations USDA issues will establish requirements for labeling of human food products derived from biotechnology. Questions regarding such requirements should be directed to USDA's Agricultural Marketing Service.
Guidance for Industry
Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon
- Guidance on Consultation Procedures under FDA's 1992 Statement of Policy - Foods Derived from New Plant Varieties