‘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.

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.

https://news.yahoo.com/constant-turmoil-fda-food-regulatory-193915572.html