FDA’s Policy on Food Biotechnology

Abstract

The Federal Food, Drug, and Cosmetic Act (FFDCA) provides the United States Food and Drug Administration (FDA) with broad authority to regulate the safety and wholesomeness of food. Developers of new foods have a responsibility to ensure that the foods they offer to consumers are safe and in compliance with all requirements of the FFDCA. FDA stated its policy on foods derived from new plant varieties, including bioengineered plants, in the Federal Register (FR) in 1992 (57 FR 22984, May 29, 1992). FDA recognized in its policy statement that it is prudent practice for developers of new plant varieties to engage in premarket consultations with the agency on safety and regulatory questions, especially with regard to food products developed through new technology. In 1996 (revised October 1997), FDA published guidance on consultation procedures for foods derived from new plant varieties, including bioengineered plants. FDA has completed premarket consultations on over forty bioengineered plants. In 1999, FDA held three public meetings to share its current approach and experience regarding bioengineered foods and to solicit views on whether FDA’s policies or procedures should be modified. In 2001, FDA published in the FR (66 FR 4706, January 18, 2001) a proposed rule that would require the submission to the agency of data and information regarding plant-derived bioengineered foods that would be consumed by humans or animals. FDA proposed that this submission be made at least 120 days prior to the commercial distribution of such foods. This proposed action, if finalized, would enhance the Agency’s ability to assess whether plant-derived bioengineered foods comply with the safety standards of the FFDCA on an ongoing basis.