‘Constant confusion’ at food regulatory agency FDA, report says

In response to the report, the FDA said in a statement that it plans to issue a “new review” in January 2023 and a public update by February 2023 of any changes to leadership, as well as internal processes and procedures. The “new vision and structure” will be based on the RUF report, an 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 Food 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 illness.

Details: The report says the “current culture” in the Human Food Program “hinders” the agency’s ability to protect public health.

“The lack of a clear overall leader of the Human Food Program has contributed to a culture of indecision and inaction and created barriers to collaboration,” wrote the report’s authors, including former agency staff and scientists. The FDA relies heavily on “consensus,” which can cause decision-making times to be “unacceptably slow.”

Employees often work in “silos” within the FDA instead of collaborating to achieve food safety goals. The result is “overlapping roles” and “competing priorities” that lead to “what is perceived as constant confusion.” An example of this is the overlapping responsibilities of the Office of Food Policy and Response and the Center for Food Security and Applied Nutrition.

Also, despite the majority of the FDA’s Regulatory Affairs Budget being devoted to the Human Food Program, there is no “clear, collaborative decision-making” and funds are not spent transparently.

The report’s authors also point to apparent “risk aversion” that has “sixfolded” the effectiveness of the Human Food Program. In terms of enforcement, this means regulators will only act if they are confident it can “survive legal challenges”.

Despite gains, acute foodborne illnesses still sicken millions and kill thousands each year. According to the report, 46 percent of foodborne illness outbreaks in 2019 were attributed to products regulated by the FDA. Chronic diseases such as cardiovascular disease, diabetes and some cancers are also “diet related” and kill more than a million Americans each year. Some defenders they called to focus more on food-related chronic diseases.

The report recommends that the FDA create an “organizational structure with clear leadership” and develop a “clear and compelling vision.” The report also encourages regulatory decision-making that is “based on scientific evidence and FDA’s legal framework,” along with increased transparency and timeliness in decision-making. The report also calls for the creation of a new Nutrition Center, which requires Congress to act.

Food safety advocates generally agreed that the report identified problems at the FDA, but the report did not fully outline what solutions are needed for improved regulation.

“The report says there should be a solution to raise nutrition and then kill it,” said Jerold Mande, deputy food safety adviser for the Food Safety and Inspection Service of the Department of Agriculture under the Obama administration. “The loopholes in the recommendation appear when it fails to emphasize the need for funding for malnutrition/chronic foodborne illness.”

“The right size of increased funding for food security and nutrition programs is what is needed to achieve a safer and healthier food supply. All other comparisons are distracting,” said Steven Grossman, executive director of the Alliance for a Strong FDA. He added that there is a “strong consensus” that the FDA needs to “substantially” improve its food programs.

Roberta Wagner, vice president of the Consumer Brands Association, called the report “a first step” but said more is needed.

“We believe that both policy reform and fundamental structural and management changes are necessary to rebuild and modernize the FDA’s food program,” he said.

“Structure is important, but more important are resources, leadership and culture,” said Peter Lurie, executive director of the Center for Science in the Public Interest. He pointed to an emphasis on nutrition as one of the more impactful changes the report called for. According to him, more lives are lost each year from chronic food-related diseases than from acute food-borne diseases.

Katherine Ellen Foley contributed to this report.

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