Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-50 Print Media: 202-205-4144
October 6, 2000
Consumer Inquiries: 888-INFO-FDA
On September 29, 2000, the United States District Court for the District of Columbia dismissed the challenge to the Food and Drug Administration's (FDA) regulatory policies concerning genetically engineered foods. The Alliance for Bio-Integrity and other public interest and religious groups had made allegations about the legality of FDA's 1992 Policy Statement, "Foods Derived from New Plant Varieties".
The court agreed with FDA that the policy statement was not a rule requiring notice and comment rulemaking. The court also ruled that the Agency was not required to prepare an environmental assessment or environmental impact statement because it was not a "major federal action" within the meaning of the National Environmental Policy Act.
The court deferred to FDA's view that genetically engineered foods as a class do not require premarket review and approval of a food additive petition. The court also accepted FDA's view that special labeling for genetically engineered foods as a class is not required solely because of consumer demand or because of the process used to develop these foods.
Finally, the court ruled that the plaintiffs' first amendment rights were not violated, nor does the 1992 policy violate the Religious Freedom Restoration Act.
Office of Public Affairs
Hypertext uploaded by tg 2000-OCT-06.