Transparency and Effectiveness: Acting Deputy Commissioner of Food Discusses the Latest Regulatory Frontiers

With increased attention on food additives, food processing, ultra-processed foods, and how they’re regulated, the U.S. Food and Drug Administration (FDA) has renewed its focus following an agency-wide reorganization.

Donald Prater, DVM, who was recently appointed acting deputy commissioner for food at FDA, discussed high-priority deliverables at IFT FIRST in Chicago, IL, in July.

Modernizing Regulations

FDA is taking several measures to update its regulations in a way deemed in line with the modern dietary supplements market. Perhaps the most consequential is its plan to eliminate the self-affirmed Generally Recognized as Safe (GRAS) pathway to market for dietary ingredients, which it plans to do by the end of this year. “Closing the so-called self-GRAS loophole is a move to a more proactive and transparent process,” Prater said. “Provisions around GRAS allowed companies to self-affirm GRAS status for certain substances, but that’s been in place for a long time; the landscape has changed rapidly. International regulatory agencies and our own states are taking interest in substances that have been self-affirmed GRAS, and we recognize the associated challenges that come with this. We’re working on a science-based, systematic level, and will be as transparent as possible, willing to take on more feedback.”  

 In addition to this, “we want to make strides in the post-market reassessment of chemicals used in food, in light of evolving science and consumption patterns … Our current work builds upon last year’s proposal to develop a method for ranking chemicals in the food supply, and the finalized post-market assessment program, which outlines how FDA plans to evaluate the safety of food substances, how the public can participate, and how FDA will decide which substances get reviewed.

When asked about the tension between the public’s desire for swift policy change, despite the slow pace it takes to reach scientific consensus, Prater said that more collaboration between the agency and the industry is needed.

“We regulate; that’s our particular role, interpreting science and matching it with the regulations, but we need to work together to address the speed of innovation and consumer demand. But we still need to take the time we need in order to maintain credibility in our decision-making … (HHS) Secretary Kennedy challenged us to prioritize work on food chemical safety and nutrition, and, of course, we need to bring on new talent, so we’re hiring people from a wide variety of disciplines, including chemists, toxicologists, food scientists, behavioral specialists, and more.”

Inspection and Enforcement Capacity

Prater emphasized the agency’s new approaches to enforcement and detection of issues within facilities that operate under its jurisdiction, such as the BRIDGE Project, a pilot federal-state partnership program for food safety oversight, as well as the use of AI and machine learning to better prioritize inspection activity.

The BRIDGE (Better Regulatory Inspections for Dynamic Government Efficiency) Project, introduced in April, is being trialed with a number of state co-regulators and other partners; FDA plans to work with regional authorities with comparable public health programs to “rely on one another’s inspections, data, and regulatory actions to strengthen oversight and avoid unnecessary duplication.”

“We’re integrating food safety systems to give state partners more authority … This frees FDA investigators to focus on complex or high-risk issues and outbreak response; it’s our chance to prove that collaborative governance works in this century,” said Prater.

“States will function as true partners, not just coordinated entities, combining expertise and leveraging capacities,” he added. “Chronic risks will get the attention they deserve alongside more acute risks like foodborne illnesses. State partners can do more of the routine food safety systems inspections while we can maintain focus on international, high-risk, complex, and targeted inspection activity … We’re working with a few states for proof of process ahead of implementation, and those state investigators are trained using the same framework, so inspections are the same from state to state. Information is collected and presented in the same structure and format.”

Beyond the BRIDGE Project, FDA hopes to achieve a more significant level of reciprocal data sharing with the food industry. For example, “we established a memorandum of understanding with the Western Grocers Union for the purpose of data sharing. We’re receiving anonymized aggregated data far exceeding what we could collect on our own.”

This form of data sharing can inform government and industry alike about challenges in production. With industry and government both “sitting on mountains of data” that would respectively benefit one another, “how do we unlock it? The industry does a tremendous amount of testing, and it’s hard to share that with your regulator. But our MOU makes it anonymized, aggregated, and de-identified to learn about trends … I’m not suggesting a one-way sharing process. We want to make our data known to consumers and the industry so they can improve.” 

Prater also noted the rapid development of AI and machine learning tools across the agency.

“Supply chains are incredibly complex, and the volume of data we manage has grown exponentially,” he said. “So much of our seafood, for instance, comes from international waters, and we developed AI and machine learning tools to analyze import data for a predictive model. The third phase of this enhanced screening method was introduced in 2023, making access to U.S. soil for safe products easier … We’re applying the lessons we’ve learned here … Again, inspections and sampling remain essential, but these activities are resource intensive, so improving their efficiency is a game changer. It will put resources toward the highest area of risk, and reduce burdens on facilities with strong records of compliance.”

Focus on Diet-Related Chronic Disease

“We’re not looking to ban ultra-processed foods, but to ensure that the food supply is safe, labeling is truthful, and consumers have the information they need to make informed choices,” said Prater, noting FDA’s plans to make calorie and added sugars information more prominent in the Nutrition Facts panel, along with other measures to help consumers quickly identify key nutritional information.

The major point of contention for the dietary supplement and functional food and beverage industries has been whether FDA will appropriately characterize ultra-processed foods in a way that doesn’t mischaracterize health-promoting products.

“It’s a fair question, and a complex answer. As the science develops around ultra-processed foods, a variety of definitions are being used out there. Finding a definition that makes sense from a regulatory perspective is a tough challenge, but we’re not shying away from it,” Prater said.