Advancing The FDA’s Human Foods Program Through Additional Authorities And User Fees

The Food and Drug Administration (FDA) lacks certain authorities and is persistently underresourced to fulfill its mission of protecting the public by ensuring that foods are safe, wholesome, sanitary, and properly labeled. Particularly concerning gaps exist in pre- and postmarket oversight of food ingredients that are often found in ultraprocessed foods. Numerous substances either have evidence of harm or are unknown to the FDA and the public. Additional authorities and resources are necessary. User fees have been successfully implemented to provide resources to the FDA for other programs under its purview. This legal and policy analysis evaluates the FDA's food-related authorities that would be amenable to a new user fee program. It reviews policy domains where new or enhanced user fees may be warranted. We find that a new comprehensive FDA user fee program for food may benefit industry and generate targeted new resources to strengthen the agency's oversight.