'Constant turmoil' at FDA food regulatory agency, report says

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

In response to the report, the FDA said in a statement that it plans to issue a public update on the “new vision” in January 2023 and any changes in direction and internal processes 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.

An April POLITICO investigation detailed the FDA’s failure to protect Americans from foodborne illness.

Details: The Human Foods Program’s “current culture” “impedes” the agency from protecting public health, the report said.

“The lack of a clear leader for the Human Foods Program has contributed to a culture of indecision and inaction and created disincentives to collaboration,” write the report’s authors, who include former staff members of the agency and scientists. The FDA relies too heavily on “consensus,” which can lead to “unacceptably slow” decision-making times.

Staff often work in “silos” within the FDA, rather than collaborating to achieve food safety goals. This results in ‘overlapping roles’ and ‘competing priorities’ which lead to ‘what is perceived as constant restlessness’. An example is the overlapping responsibilities of the Office of Food Policy and Response and the Center for Food Security and Applied Nutrition.

Additionally, although the majority of the FDA’s Office of Regulatory Affairs budget is dedicated to the human nutrition program, there is no “clear and collaborative decision-making” and funds are not spent transparent.

The report’s authors also point to an apparent “risk aversion,” which “undermines” the effectiveness of the Human Foods Program. In terms of enforcement, this means regulators only step in when they are confident they can “stand up to legal challenges”.

Despite advances, acute foodborne illnesses continue to affect millions of people each year and kill thousands. According to the report, 46% of foodborne illness outbreaks in 2019 were attributed to FDA-regulated products. Chronic diseases, such as cardiovascular disease, diabetes and certain cancers are also “food consumption associated” and kill more than a million Americans each year. Some defenders called for greater attention to chronic diseases attributed to diet.

The report recommends that the FDA create “an organizational structure with a clear leader” and develop a “clear and compelling vision.” The report also advocates for regulatory decision-making “rooted in scientific evidence and the FDA’s legal framework,” as well as greater transparency and timeliness in decision-making. The report also calls for a new Center for Nutrition, which would require congressional action.

Food safety advocates generally agreed that the report identified FDA problems, but that the report did not fully reflect the solutions needed to improve regulation.

“The report says nutrition should be improved and then offers a solution that would kill it,” said Jerold Mande, deputy undersecretary for food safety at the Department of Agriculture’s Food Safety and Inspection Service under the Obama administration. “The void in their recommendation is revealed when they fail to highlight the need for funding for nutrition/chronic dietary disease.”

“The right measure to increase funding for food security 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 there was still a long way to go.

“We believe that policy reform and key structural and governance changes are needed to reframe and modernize the FDA food program,” she said in a statement.

“Structure is important, but what’s more important are resources, leadership and culture,” said Peter Lurie, executive director of the Center for Science in the Public Interest. He pointed to the focus on nutrition as one of the most influential changes called for by the report. More lives are lost each year from chronic nutrition-related illnesses than from acute foodborne illnesses, he said.

Katherine Ellen Foley contributed to this report.

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