‘Constant turmoil’ at FDA’s food regulatory agency, report says
Report recommends increased focus on nutrition, internal structural and cultural changes.
The Food and Drug Administration’s Human Foods Program lacks leadership and mission clarity, leading to slow decision-making and weak regulation of foodborne illness, according to a highly-anticipated, independent report on the FDA’s Human Foods Program.
The FDA commissioned an independent expert panel to review the Human Foods Program in July 2022, in part due to the ongoing infant formula crisis, which critics say demonstrated the agency’s pattern of slow responses. The formula crisis included nationwide shortages sparked by a key Abbott plant in Michigan shutting down and issuing a recall, after FDA belatedly took action after detecting strains of a bacteria at the facility that can be deadly to babies. An Abbott spokesperson said the investigations into the plant did not find a direct link between the formula produced there and a number of reported infections.
The report on FDA’s food regulatory agency was led by Jane Henney, former FDA commissioner, and conducted by the Reagan-Udall Foundation, which receives funding from the FDA, industry and private donations. A separate commissioner-mandated review will recommend changes to the FDA’s tobacco program by Dec. 19.
In response to the report, the FDA said in a statement that it plans to release a public update on the “new vision” in January 2023 and any changes to leadership as well as internal process and procedures by February 2023. The “new vision and structure” will be based on the RUF report, the internal review of the FDA’s response to the infant formula crisis as well as new advances in food science.
FDA Commissioner Robert Califf called the Human Foods Program a “top priority” for the agency in a statement.
A POLITICO investigation from April detailed the FDA’s failure to protect Americans from foodborne illnesses.
Details: The “current culture” in the Human Foods Program is “inhibiting” the agency from protecting public health, the report says.
“The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration,” write the report’s authors, who include former agency staff and scientists. The FDA relies too much on “consensus” which can lead to “unacceptably slow” decision-making times.
Staff often work in “silos” within the FDA, instead of collaborating to accomplish food safety goals. The result is “overlapping roles” and “competing priorities” which lead to “what is perceived as constant turmoil.” One example is the overlapping responsibilities of the Office of Food Policy and Response and the Center for Food Safety and Applied Nutrition.
Also, despite the majority of the FDA’s Office of Regulatory Affairs budget being dedicated to the Human Foods Program, there is no “clear, collaborative decision-making” and the funds are not transparently spent.
The report’s authors also point to an apparent “aversion to risk,” which “undercuts” the Human Foods Program’s effectiveness. When it comes to enforcement, this means regulators only take action when they are certain it can “withstand legal challenges.”
Despite gains, acute foodborne illness still sickens millions each year and kills thousands. According to the report, 46 percent of foodborne illness outbreaks in 2019 were attributed to FDA-regulated products. Chronic diseases, such as cardiovascular disease, diabetes and some cancers are also “associated with food consumption” and kill more than a million Americans each year. Some advocates have called for a greater focus on chronic diseases attributed to food.
The report recommends that the FDA create “an organizational structure with a clear leader” and develop a “clear and compelling vision.” The report also pushes for regulatory decision-making “rooted in scientific evidence and FDA’s legal framework” alongside greater decision-making transparency and timeliness. The report also calls for a new Center for Nutrition, which would require congressional action.
Food safety advocates generally agreed the report identified the problems at the FDA, but that the report didn’t fully capture what solutions are needed for improved regulation.
“The report says nutrition should be elevated and then proposes a solution that would kill it,” said Jerold Mande, deputy undersecretary for food safety at the Agriculture Department’s Food Safety and Inspection Service under the Obama administration. “The hollowness of its recommendation is revealed when they fail to highlight the need for nutrition/chronic food illness funding.”
“The proper metric for increased funding for food safety and nutrition programs is what is needed to achieve a safer and healthier food supply. All other comparisons are distractions,” Steven Grossman, executive director of the Alliance for a Stronger FDA, said in a statement. He added that there is a “strong consensus” that the FDA needs to “fundamentally” improve its food programs.
Consumer Brands Association Vice President Roberta Wagner called the report a “first step” but said that much more is needed.
“We believe both policy reform and key structural and governance changes are needed to reframe and modernize FDA’s food program,” she said in a statement.
“Structure is important, but what’s more important is resources and leadership and culture,” said Peter Lurie, executive director for the Center for Science in the Public Interest. He pointed to the emphasis on nutrition as one of the more influential shifts demanded by the report. More lives are loss on an annual basis from chronic disease related to nutrition than from acute foodborne illness, he said.
Katherine Ellen Foley contributed to this report.