Has FDA approved transgenic animals to enter the food supply?
A. No. Most transgenic animals under development are regulated by one or more FDA Centers. There are procedures to request approval to enter transgenic animals into the food or feed supply. No approvals have been granted for entry into the human food supply. The procedures for biopharm animals (producing drugs or biologics) are described in the 1995 Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals. For these types of animals, as well as others generated by biomedical research, the Center for Veterinary Medicine (CVM) serves as a consulting group to the other FDA Centers in the food and feed safety evaluation. Gene-based modifications of animals for production or therapeutic claims fall under CVM regulation as new animal drugs. Investigational applications are filed for these modifications where, with a showing of adequate safety data, the sponsor may request disposition of animals by slaughter for food or for proces
