Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It primarily ensures the safety, effectiveness, and security of food, animal feed additives, and human and animal drugs under the regulatory authority of the FFDCA (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 201 et seq;ensures safe food and feed.
The FDA regulates the presence of allergens ('food allergens') and any changes in composition or levels of nutritional and anti-nutritional substances. This means that any food with nearly identical composition to the regular version is not considered “adulterated,” therefore it is not regulated by the FDA.
The Center for Food Safety and Nutrition (CFSAN) regulates food and color additives and has been the primary regulatory focus for GE crops.
The FDA regulations are applied to all foods derived from all new plant varieties, including varieties that are developed using rDNA technology (e.g., bioengineered foods).
After careful review, the FDA issues a “memo” indicating the characteristics of the new food and summarizing the possible safety concerns. They do not formally approve the new food or feed to be safe per se. Instead, they indicate it is not materially different from the unmodified version with respect to composition or safety as it is “as safe as its non-modified counterparts”.