After a contaminated factory led to an infant formula shortage last year, the U.S. Food and Drug Administration's ability to keep the most vulnerable populations safely fed was called into question. In its proposed budget for 2024, the agency is seeking more money and more ways to monitor food safety — but attorneys wonder if the proposals go far enough.
The FDA has faced criticism from lawmakers about why it took so long to inspect the contaminated Abbott Laboratories facility in Michigan. In response, the FDA in recent months has floated the appointment of a new deputy commissioner for human foods, a recommendation advanced by the Reagan-Udall Foundation, an outside panel tasked with evaluating the agency's food program.
And in its announcement last week of a proposed $7.2 billion budget for 2024, the agency said it was seeking a little over $128 million for food safety programs. That represents an $85 million increase over what the agency requested a year ago and includes funding to update its oversight of infant formula and improve responses to food shortages.
In the meantime, the FDA's 2024 budget request also seeks to expand the agency's authority over food safety, including the ability to set maximum limits for toxic elements in baby foods.
"I think those are FDA's attempts to show the administration there's good use to the dollars that [they're] requesting here," said Jonathan Havens of Saul Ewing LLP, a former FDA regulatory attorney. "[They're] asking for the changes in laws, but [they're] doing that in order to accomplish the things that everyone agrees are important to accomplish."
For years, food safety advocates have called for improvements to the FDA's food safety program, according to Paul Benson of Michael Best & Friedrich LLP, who represents food companies. Benson told Law360 that those advocates have been frustrated by the slow pace of change at the agency and the comparative lack of focus and resources on food safety, as compared to drug safety.
With the commissioning of the Reagan-Udall Foundation — a nonprofit dedicated to advancing the agency's mission — to evaluate the FDA's food safety program, there was hope that there would finally be substantive changes to the food safety program after the agency's handling of a crisis affecting one of the country's most at-risk populations, Benson said.
The panel released its 51-page report in December, laying out recommendations to clarify leadership structure, promote a transparent culture and boost personnel hiring, among others. Onlookers, however, have been disappointed that FDA Commissioner Dr. Robert Califf has taken up only one: the appointment of a deputy commissioner for human foods.
And that's not even a fully empowered position, Benson said, noting that the deputy commissioner has no final say over food regulation.
"This seems to be how it seems to be kind of a recurring theme," Benson said. "They promised to do something about it, and they do something about it, but it's not that significant of a change."
It's not just consumer advocates who are frustrated with the agency; it's industry groups as well, Benson said.
"It doesn't surprise me that Bill Marler thinks that they're not going far enough, but I am surprised when organizations like the Consumer Brands Association are saying the same thing," Benson said.
Marler, who has been representing victims of foodborne illness for 30 years and testified before the Reagan-Udall panel, said Califf ignored the group's findings.
"This infant formula fiasco just to me underscored how broken the FDA is," Marler said...
...But despite the infant formula disaster and knowing that millions are sickened by foodborne illness in the U.S. every year, Michael Best's Benson admits that he still takes the safety of the food for granted — as he suspects most people do, including in the federal government.
"That's what poses that question, right?" Benson said. "What has to happen before we stop taking safety of our food for granted and we start making the kind of structural changes at the federal level that will result in a safer food system for our country and for other countries?"