Food and Drug Administration


In the United States the Food and Drug Administration (FDA) is responsible for safety of food and feed, and for the safety of human and veterinary drugs and human biologics.


For genetically engineered plants to be used as food and feed, FDA suggests but does not require producers to conduct a safety evaluation of the protein of interest. The main concerns for Food and Feed Safety (ppt) evaluation are toxicity and allergenicity. FDA encourages and expects that the producers will participate in biotechnology consultation for full characterization of the protein and the engineered plant to be used as food and feed.



Human and Veterinary Drugs and Human Biologics

Human and veterinary drugs and human biologics obtained from genetically engineered plants must be regulated and approved for their safety and efficacy by FDA as for other drugs and human biologics produced by any other means.

FDA also hold the responsibility for regulation of manufacturing process of such products for assuring their safety, purity, and continued efficiency.