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

Area of Science:

• Food Safety Regulation
• Public Health Policy
• Regulatory Science

Background:

• The Food and Drug Administration (FDA) faces resource limitations and authority gaps in ensuring food safety and proper labeling.
• Significant concerns exist regarding the pre- and postmarket oversight of food ingredients, particularly those in ultraprocessed foods.
• Many food ingredients lack adequate safety data or are unknown to the FDA and the public.

Purpose of the Study:

• To analyze the FDA's existing food-related authorities for potential user fee program implementation.
• To identify policy domains where new or enhanced user fees could strengthen the FDA's oversight capabilities.
• To evaluate the feasibility and potential benefits of a comprehensive user fee program for food regulation.

Main Methods:

• Legal and policy analysis of the FDA's current food-related authorities.
• Review of successful user fee programs in other FDA-regulated areas.
• Examination of policy domains suitable for new or enhanced user fees.

Main Results:

• The FDA's food-related authorities are amenable to a new user fee program.
• User fees can generate targeted resources to address critical oversight gaps.
• A comprehensive food user fee program could benefit both industry and public health.

Conclusions:

• Enhanced FDA authorities and resources are crucial for safeguarding public health through improved food safety.
• A well-designed user fee program presents a viable mechanism to generate necessary funding for the FDA's food program.
• Implementing a food user fee program can strengthen the FDA's ability to ensure safe, wholesome, and properly labeled foods.