Implementing User Fees Could Enhance FDA Food Safety Oversight

The Food and Drug Administration (FDA) is examining the possibility of establishing a user fee program for food companies, similar to those already in place for the drug and medical device industries. This initiative could provide crucial funding to bolster the FDA's food safety oversight capabilities, as highlighted in a recent analysis published in Health Affairs.

Currently, the FDA is responsible for regulating approximately 78% of the U.S. food supply, which encompasses packaged foods, food additives, and infant formula. However, the agency faces significant challenges due to chronic underfunding and staffing shortages, which hinder its ability to effectively ensure food safety.

Experts argue that a comprehensive user fee framework could not only benefit the food industry but also enhance the FDA's ability to review products and ingredients before and after they enter the market, ultimately leading to improved public health outcomes.

As it stands, the FDA's oversight of food ingredients is limited by insufficient resources. Food and color additives require manufacturers to submit petitions for approval before they can be introduced to the food supply. However, many companies utilize the 'generally recognized as safe' (GRAS) designation, allowing them to self-determine the safety of new ingredients without FDA oversight. This loophole has raised concerns about the safety of the food supply, with reports indicating that over 99% of new ingredients enter the market through this self-regulation.

The analysis notes that the FDA's existing food program budget, which amounts to approximately $1.1 billion, receives only about 1% of its funding from user fees, in stark contrast to the drug regulation budget, where user fees account for 66% of the $2.1 billion budget. Introducing a user fee for food would require congressional authorization, but such fees have historically garnered support from industries due to the benefits they provide in terms of efficiency and stability.

For instance, following the implementation of user fees for generic drugs, the annual approval rate by the FDA more than doubled. Advocates for the user fee initiative argue that it is time for the FDA to prioritize food safety, given the significant health implications associated with the food supply compared to pharmaceuticals.

The current system's inefficiencies are further emphasized by the lengthy timelines involved in the FDA's post-market review processes. For example, harmful ingredients like partially hydrogenated oils were classified as safe for decades before their GRAS status was revoked. Such delays underscore the urgent need for enhanced resources to expedite both pre-market and post-market reviews.

To address these issues, the researchers suggest not only implementing user fees but also closing the GRAS loophole by mandating that companies notify the FDA of new ingredients before they enter the market. This change could be enacted through FDA action or with more explicit congressional directives.

Ultimately, the analysis underscores the critical gaps in FDA oversight that could jeopardize public health. By establishing a user fee program, the FDA could secure the necessary resources to bolster its food safety efforts, thereby increasing consumer confidence in the safety of the U.S. food supply.