‘Constant turmoil’ at FDA’s food regulatory agency, report says

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 inspectors belatedly detected strains of a bacteria at the facility that can be deadly to babies.

The investigation 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.

Katherine Ellen Foley contributed to this report.