In light of the ongoing baby formula shortage in the United States, a recently released report is recommending major changes at the Food and Drug Administration (FDA).
After the agency faced serious criticism for its handling of the formula shortage, FDA Commissioner Dr. Robert Califf commissioned a review of the Human Foods Program in July from the Reagan-Udall Foundation, an independent group of experts.
The FDA has been accused of being too focused on the medicine side of its responsibilities, often hiring leaders with medical backgrounds but no food industry experience, and the report proposes to remedy this with its most radical change: creating separate food and drug administrations.
Califf, for his part, acknowledged this criticism as partially valid, but did not go so far as to agree that a separation into two agencies was warranted: “The Human Foods Program is a top priority for the agency. America’s food supply is as safe as it’s ever been,” he said. “That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change, and rapid advances in the science underlying many of the foods we eat today.”
According to the 51-page report, the FDA’s leadership and culture will also need to be restructured in order to better respond to food safety crises and chronic public health problems, and the agency will need to make changes to become more responsive to safety threats.
For instance, four months elapsed between the first whistleblower complaint about unsafe conditions at Abbott Laboratories’ Michigan baby formula plant and that complaint reaching the desks of top food safety officials, during which time at least four babies got sick and two died after drinking formula made at the plant.
When that plant was shut down, shelves were left bare in many stores, causing families to struggle to find formula over the summer and prompting the Biden administration to enact Operation Fly Formula, which flew in hundreds of thousands of pounds of formula from Europe.
The report also accuses the FDA of being too fearful of lawsuits and pushback from industry, which causes it to be too cautious when enforcing regulations.
“They’ve got to take charge and make sure that authority is understood, so that industry can’t undercut the FDAs mission of the safe and effective food supply for Americans,” said Peter Pitts, a former associate commissioner for the FDA, who has proposed the creation of a new enforcement arm of the FDA to take back control of the regulatory process.
“They need basically a whole new arm of enforcement to make sure that when they’re dealing with industry, they are the first among equals and industry says ‘yes, sir,’ when the FDA tells them to do something rather than litigating or dragging their feet,” Pitts said.