In the summer of 2022, Rep. Rosa DeLauro and Sen. Dick Durbin introduced the Food Safety Administration Act, which essentially calls for FDA to be divided into two agencies: one responsible for food and one responsible for drugs/medical devices.
“Food safety is currently a second-class citizen at the FDA,” DeLauro said when she introduced the bill. “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.”
One needs only to look at 2022’s infant formula crisis, in which Abbott Laboratories’ Sturgis, Mich., facility was allegedly responsible for producing formula contaminated with Cronobacter sakazakii, to understand the Senator’s concern.
This type of issue is one reason the bill is looking to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market.
Tyler Williams, CEO of ASI Food Safety, which oversees the certification process in more than 3,000 audits annually and has trained and consulted with numerous major food and beverage companies around the world to help improve their food safety practices, notes that longtime critics of FDA have been pushing for a split in the agency for several years. “Food safety experts argue that food safety and security is a secondhand thought after drugs and medical devices, whereas the pharmaceutical industry feels drug approvals are slowed down by the FDA being distracted by food industry recalls,” Williams says. “It feels like the food sector has been the red-headed stepchild of the FDA, or maybe the agency just simply has too much on its plate, but either way, the legislation being introduced by food policy experts calls for a division of power that will hopefully prioritize food safety and protect consumers.”
Cassandra LaRae-Perez, a food and beverage attorney at Gravel and Shea in Burlington, Vt., notes that proponents of the bill argue that a separate agency would bring leadership more focused on food safety, more accountability, and a unified and efficient structure, but it is unclear how a separate agency would perform better, and whether additional resources would be devoted to ensuring its success. “In short, the bill seeks to tighten regulation on food producers and to increase credibility and autonomy of the regulators responsible for food safety, but without a significant, perhaps outsized dedication of monetary and human resources and willing participation in the Senate to swiftly appoint a leader for the agency, it’s not clear how its aims can be achieved,” she says.
Reagan-Udall Foundation Report
Brian Ronholm, director of food policy for Consumer Reports, says that FDA has inadequately responded to outbreaks and missed deadlines for implementing critical food safety initiatives, which has undermined consumer confidence in the agency’s food program. “One of the big proposals that gets support is creating an empowered deputy commissioner position that would have oversight authority over the foods program at the agency,” he says. “That would put someone in charge of food, because that’s what is lacking.”
In July 2022, a few months after the infant formula crisis that was responsible for the death of at least two infants, FDA commissioner Robert Califf, MD, commissioned a review of the Human Foods Program by the Reagan-Udall Foundation, an independent group of experts. Their findings, released in December 2022, recommended a major overhaul and reform of FDA, essentially backing up the bill.
David Acheson, founder and CEO of The Acheson Group and former FDA associate commissioner for foods, notes that a split isn’t a new idea, but legislation has never gained much traction before. He says Dr. Califf’s call for the Reagan-Udall Foundation report is a good sign—much needed—that change is possible.
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