The Food and Drug Administration (FDA) will undergo an independent external review of its tobacco and food safety programs, Commissioner Robert Califf announced Tuesday.
The announcement comes as the agency faces scrutiny from lawmakers and the public over its role in the infant formula shortages and its regulation of e-cigarettes, particularly Juul.
Without citing any specific issues, Califf cited broad “challenges” that have prompted a look at how the agency conducts its operations.
“Since my return, the agency has taken many significant actions that benefit the public health. Yet at the same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business,” Califf said in a statement.
Califf said the FDA will work with the Reagan-Udall Foundation, along with “an external group of experts.” The foundation is an independent organization established by Congress as an advisory group for the FDA to help the agency modernize its regulations.
Part of the review will center on FDA’s Human Foods Program, with a focus on the Office of Food Response and Policy, the Center for Food Safety and Applied Nutrition, as well parts of the Office of Regulatory Affairs.
Califf noted the food program has been stressed by the COVID-19 pandemic, as well as by the increasing complexity of the nation’s food systems and supply chain.
“Fundamental questions about the structure, function, funding and leadership need to be addressed,” Califf said, especially the agency’s inspectional activities.
The FDA is under fire from lawmakers of both parties because of its response to the infant formula shortage. Califf has admitted the agency was too slow to respond to reports that infants were being hospitalized after consuming formula that was manufactured at Abbott Nutrition’s plant in Michigan.
In May, Califf told the Senate Health Committee that “systemic issues at FDA” led to the slow response.
Califf said the review will also encompass the Center for Tobacco Products.
“Even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health,” Califf said.
Lawmakers, in particular Senate Majority Whip Dick Durbin (D-Ill.), have pressed the FDA for much stronger action regulating vaping products.
The agency missed a court-ordered deadline last September to determine which e-cigarettes are allowed to remain on the market. The lagging reviews include some of the industry leaders. Durbin has gone so far as to call for Califf’s resignation over the issue.
According to Califf, the Foundation will report its findings, “including an initial assessment of the processes and procedures, resourcing, and organizational structure for the Foods program and Center for Tobacco Products,” to the agency within 60 business days of initiation.
“It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner,” Califf said.
