WASHINGTON, DC, US — Chair of the House Appropriations Committee Rosa DeLauro and US Senator Dick Durbin introduced legislation that would remove food safety oversight functions from the Food and Drug Administration (FDA). The Food Safety Administration Act would establish the Food Safety Administration under the Department of Health and Human Services. The single food safety agency would remove existing food programs within FDA, and leadership appointments would require Senate confirmation.

The legislation does not include the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA).

“Food safety is currently a second-class citizen at the Food and Drug Administration,” DeLauro said. “Right now, there are no food policy experts in charge of food safety at the FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices and, in many cases, result in consumer illness and death. Look no further than the recent infant formula crisis to understand the need to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market.”

In remarks to the 2022 FDLI Annual Conference held in June, FDA Commissioner Robert Califf acknowledged the agency’s challenges and said the infant formula crisis highlighted the need for the FDA to “revamp and restructure” the agency’s food program.

“I want to be clear: The infant formula shortage on our shelves was multifactorial, including loss of focus on quality by a major company, market concentration, supply chain resilience issues and inadequate federal authorities to assure vital supply chains,” Califf said. “However, the crisis also reveals shortcomings at the FDA, including structural and organizational deficiencies, process insufficiencies, communication barriers, technological inadequacies, chronic underfunding and in some cases a lack of congressional authority to allow us to do what is needed to assure an adequate supply of safe and nutritious infant formula.   

“We are currently conducting both a focused after-action review on infant formula and a comprehensive review of the entire food program to determine the best course of action. And when these reviews are completed, we will make whatever changes are necessary and that we have the ability to do.”

The single food safety agency proposed by DeLauro and Durbin would remove existing food programs within the FDA, and leadership appointments would require Senate confirmation. The Food Safety Administration would consist of the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA). The agency would be headed by the administrator of Food Safety and appointed by the president.

The FDA would be renamed the Federal Drug Administration and would retain oversight of drugs, cosmetics, devices, biological products, color additives and tobacco.

“In recent years, FDA has been plagued by one failure after another — from a failure to properly recognize the dangers of prescription opioids, to a failure to protect children from e-cigarette products, to a failure to properly ensure the safety of our nation’s food supply,” Durbin said. “The sad reality is that FDA seems unwilling or unable to use their authority to protect Americans from preventable illness and death. For that reason, Congresswoman DeLauro and I are introducing legislation to transfer all of FDA’s food responsibilities to a new agency that, we hope, will have more success in protecting the foods in our kids’ lunch boxes and on our dining room tables.”

The legislation is endorsed by the Center for Food Safety, the Consumer Federation of America, Consumer Reports, Defend Our Health, the Environmental Working Group, Friends of the Earth, Healthy Babies Bright Futures, STOP Foodborne Illness and the Center for Environmental Health.