What Is a Drug? Enabling the Bioeconomy Through Updated Food and Drug Administration Policy

Abstract

There are several emerging biotechnology and biomanufacturing innovations designed to improve the sustainability of the livestock and related commercial sectors. These include gene-edited animals, feed additives to reduce methane production, and cultivated meats. In the United States, disparate regulatory policies govern the commercialization of these products. Intentional genomic alterations (IGAs) in animals, and feed additives intended to reduce methane emissions, trigger federal regulatory oversight using the expensive and time-consuming new animal drug-approval pathway. Conversely, animal cells, with or without IGAs, cultured for human food production are evaluated using a “voluntary pre-market consultation” process. The current drug-centric regulatory policies for bioengineered animals and feed additives disincentivize investment, and the United States is starting to lag behind the rest of the world when it comes to the approval, and subsequent adoption of these innovations by farmers and ranchers at a time of increasing concern regarding the environmental footprint of animal agriculture.