FDA Issues Final Guidance on Regulating GE Animals

The FDA has issued its final guidance on regulating genetically engineered (GE) animals under the new animal drug provisions of the Food, Drug and Cosmetic Act. The guidance clarifies FDA’s regulatory authority “and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.” It is intended to apply to GE animals with heritable rDNA constructs. According to the guidance, GE animals are being developed for a number of purposes, including the enhancement of production or food quality traits, improvements to animal health, the production of products for human therapeutic uses, and enhancement of animals’ interactions with humans (e.g., hypoallergenic pets). The FDA explains when GE animal producers must comply with labeling and record-keeping requirements or submit information for agency approval.