A New Day at the FDA

Last September, at the request of U.S. Food and Drug Administration Commissioner Robert Califf, the Reagan-Udall Foundation for the FDA (FDA Foundation) launched an external evaluation of the agency’s Human Foods Program. The goal was simple: to examine ways to better secure the nation’s food systems and supply chain. The far-reaching evaluation examined everything from structure and leadership to resources and culture.

By December, the Foundation shared its recommendations on steps the FDA could take to improve how it executes its regulatory responsibilities and strengthen its relationships with state and local governments. The 51-page report called for sweeping changes, and its impact has been swift.

Media, activists, and the public alike viewed the report as highly critical of the FDA. And indeed, the report cites the lack of a single, clearly identified person to lead as one of the biggest deterrents to the Human Foods Program’s effectiveness. The report also recommends the FDA be restructured so that policy and enforcement are more closely aligned.

Since the report’s release, many have been left to wonder what the future will look like for an agency charged with overseeing 78 percent of the U.S. human food supply and promoting optimal nutrition for all.

Next Steps 

The FDA has played a critical role in ensuring the United States has one of the safest food supplies in the world. But that food supply is evolving, and the FDA must evolve as well. This idea is widely accepted; the only question is, what should that evolution look like? 

To start, there must be an even greater emphasis on incorporating science and technology to better protect our food supply. The creation and roll-out of the Food Safety Modernization Act (FSMA) and, most recently, the FSMA Sec. 204 Traceability Rule as well as the Agricultural Water Rule are positive steps toward a new era of smarter food safety. The Traceability Rule, for example, will enhance record-keeping standards for producers, manufacturers, processors, packers, food service operators, retailers, and other supply chain participants with foods identified on the FDA’s Food Traceability List. It identifies critical tracking events in the supply chain, such as cooling, initial packing, shipping, receiving, and transforming the goods that would require records to be captured containing key data elements. The Agricultural Water Rule focuses on a key risk point for some foods. In short, these regulatory systems seek to address foods known to cause foodborne illness outbreaks and subsequent recalls. 

But that is only one part of the food safety puzzle the FDA must solve. Realizing FSMA’s food safety prevention goals requires a nimble and forward-looking organization. To further improve the delivery of an even safer food supply for U.S. consumers, the FDA must evaluate and increase resourcing levels while anticipating growing challenges and complexities. This means prioritizing food safety risk assessment and honing in on what processes can be employed in identifying areas of concern, such as toxic elements and allergens.  

The new version of the FDA must also drive a greater level of resiliency through global harmonization of U.S. regulations on key components in the food supply. Harmonization of regulations ensures that foods can be delivered from other countries when resiliency issues arise.

Inter-agency collaboration must also continue to evolve. The FDA has worked closely with federal agencies such as the USDA and CDC, as well as other departments at the state and local levels, but there are opportunities to further advance these efforts. These federal, state, and local agencies look to the FDA for its leadership and coordination. One area where further coordination is needed is in food and nutrition research. While the FDA has a limited research budget, its expertise is critical in driving food and nutrition research decision-making in other agencies.

Finally, the FDA must continue improving its consumer awareness and education efforts as it seeks to earn or regain the public’s trust. Updating the Nutrition Facts Label, the 2020 launch of the national consumer education campaign, the pending “healthy” claim, and front-of-pack labeling research are all positive steps, but there’s much more work to be done. Increasing the timeliness of decisions on proposed rules and standards aimed at addressing significant public health-related concerns is critical to building public trust and an FDA better prepared for the future of food.

The FDA’s January 31, 2023, announcement aligns well with these outlined priorities. Emphasizing clear organizational structure and leadership focused on operational efficiencies will unlock resources as the first step in meeting future food system challenges. The important role of science and technology, nutrition science, and stakeholder partnerships across state, local, and non-governmental organizations is clearly highlighted in Commissioner Califf’s announcement.

Despite its standing as a global leader in food safety, the FDA faces big challenges with a food system that is constantly changing. It must evolve to address current and future food safety challenges, as well as deliver on its public health mission. It must also continue to work closely with leading organizations like IFT to ensure the global food supply is the safest it can be, especially during this current period of change.
 
IFT proactively serves as an objective voice in public dialogue on food and nutrition-related issues and remains committed to bringing the interests of the science of food community to the forefront by advocating for an expanded role for food science and technology in food and nutrition security, food safety, and sustainable food systems.

For more information on Califf’s announcement, check out the FDA's Vision for a Reimagined FDA Human Foods Program.

The above article is adapted from an editorial published on February 1, 2023, in Food Safety News.

About the Author

Bryan Hitchcock is IFT’s chief science and technology officer.