An appropriations bill from a committee in the U.S. House of Representatives would direct the FDA to unify its food program under one person.
The move echoes the sentiment from a House committee, former FDA leaders, and experts in the field of food safety.
In recent years members of the House have been urging the Food and Drug Administration to unify its food programs under an empowered deputy commissioner.
The topic came to the forefront a year ago when a House committee held a hearing related to the infant formula shortage crisis and an outbreak of cronobacter infections in babies. At that point, House members told FDA Commissioner Robert Califf that the lack of a clear chain of command in the foods program was obviously responsible, in part, for the infant formula situation and outbreak.
Califf initiated an in-house review as well as a review by the Reagan Udall Foundation for the FDA. The Reagan Udall report said a unified foods program with one person at the top was crucial for the food safety operations of the agency. That person, said the report, should be a deputy commissioner for foods who reports directly to the FDA Commissioner. The deputy commissioner should have authority over all foods and feed programs in the agency.
The review was lauded by consumer protection groups and former FDA leaders who called the move a common-sense approach to problems at the agency. Among those problems are a scattered approach to food safety, which is spread across the Center for Food Safety and Applied Nutrition, the Office of Regulatory Affairs, and the Deputy for food policy and Response, among other FDA entities.
However, people who are closely watching the process say that the plan put forth by Califf does not go far enough because it does not ensure that the deputy commissioner’s post would have full authority over all of the aspects of the food programs at the FDA.
The language in the Appropriations Bill 2024 for the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, has a paragraph about the unification of the FDA’s foods program:
“Human Foods Program Restructuring. — The Committee directs FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all the food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-re-lated laboratories, import oversight, State partnerships, training, and information technology.”
Brian Ronholm, food policy director at Consumer Reports, said the move by the committee is good news, but he is not confident that it will make a difference.
“It’s very encouraging that the committee has sent a strong signal to the FDA on what the unification of the foods program should look like. They clearly believe that the current plan by the FDA is inadequate and won’t achieve the desired goal of increased transparency and accountability, and better governance” Ronholm told Food Safety News.
“Unfortunately, the agency has an extensive history of ignoring report language from Congress, so the language likely will not have an immediate effect, but it does establish a foundation for how meaningful reform should proceed.”
Two former FDA leaders, Mike Taylor, who is a former deputy commissioner, and Frank Yiannas who is the former deputy commissioner for food policy and response, are cautiously optimistic about the committee’s direction. They, along with Consumer Reports and other consumer protection groups and food safety experts, want to make sure that a unification plan includes an FDA deputy commissioner who has full authority to run the human foods programs instead of the starburst chain of command that is currently in place.
The FDA’s top three human foods operations — the Center for Food Safety and Applied Nutrition, the Deputy for food policy and Response, and the Office of Regulatory Affairs (ORA) — currently work separately and report directly to the FDA Commissioner. This setup is different the operations of the food programs that once reported to s single deputy commissioner for foods who had power over both operations and reported directly to the commissioner.
Taylor, who served as the most recent deputy commissioner and had authority over all of the foods programs told Food Safety News that “incorporating the food elements of ORA into a truly unified food program is key to the cultural and programmatic overhaul needed to fulfill the Food Safety and Modernization Act’s (FSMA’s) prevention vision. The traditional approach to inspection and enforcement that works for drugs won’t suffice for the much different challenge of food safety.”
Yiannas was most recently deputy commissioner for food safety and response but did not have authority over the Center for Food Safety and Applied Nutrition. He resigned earlier this year after voicing concerns about the lack of a direct line of a chain of command at the food program. During the infant formula crisis, he said he had not received information about the cronobacter outbreak even though the center officials had.
Yiannas told Food Safety News that he is “so grateful for the congressional language that includes an empowered deputy commissioner of foods.” He added that he hopes the FDA Commissioner follows the direction of elected officials.
“It is not a recommendation, it is a direction,” Yiannas said.
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