Food and Drug Administration Commissioner Robert Califf said Tuesday that he has taken a closer look at the FDA food program and concluded that “fundamental questions about the structure, function, funding and leadership need to be addressed.” The statement comes as criticism of the agency, spurred by the recent shortage of infant formula, has mounted.
Califf said the food division “has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain.” The FDA, through its Human Foods Program, regulates about 80 percent of the nation’s food supply, including areas as diverse as genetic engineering and food-borne pathogens. It shares regulatory oversight of the food system with the USDA.
“The agency’s inspectional activities related to the program also need to be evaluated, particularly in light of stresses related to the Covid-19 pandemic,” Califf said.
The statement came after a series of missteps involving shortages of infant formula in May, largely due to the shutdown of a mammoth Abbott Nutrition plant in Michigan. President Biden was forced to use his executive powers to address the situation and clear the way for foreign imports of formula. The food division has also come under fire for mismanagement that left some regulatory issues unresolved for years.
“A common refrain in food policy is that the ‘F’ in FDA is silent, and a significant reason for this is the lack of a single, full-time, fully empowered expert leader of all aspects of the FDA food program,” Democrats Sen. Dick Durbin of Illinois and Rep. Rosa DeLauro of Connecticut said in a recent statement. “This has resulted in serious problems within the program related to organizational structure, governance, and performance.”
Along with Democratic Sen. Richard Blumenthal of Connecticut, they have proposed the Food Safety Administration Act, which would establish the Food Safety Administration under the Department of Health and Human Services (HHS) by incorporating the existing food programs within FDA into a separate agency. The agency head would be confirmed by the Senate.
Califf said that the Reagan-Udall Foundation, an independent partner organization for the agency, will be working with an external group of experts to evaluate the agency. The Foundation will report its findings, including an initial assessment, to the FDA within 60 business days.