FDA Announces New Direction and Structure for Food Safety Agencies

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The Food and Drug Administration commissioner said Wednesday that the agency is preparing for an overhaul of its food safety program, four months after a national infant formula shortage drew attention to program shortcomings.

At a Senate Appropriations Committee hearing, Commissioner Robert M. Califf said the agency has launched a review recommend changes in light of the growing number of food-producing industries, as well as the role of climate change and war in Ukraine. Califf didn’t cite formula shortages as the main reason for the overhaul, but spoke of an increasingly complicated food system that requires a new approach.

“We have to look at the big picture: it’s structure, it’s function, it’s leadership. We do a top-down assessment. It’s hard to pick one or two things, it’s a multidimensional industry,” Califf said Wednesday during a hearing of the Senate Appropriations Agriculture Subcommittee. “There is a consensus that everything that has been done in the past has not been successful.”

Critics have long complained that the FDA is prioritizing drugs and drugs over food safety, despite a steady stream of high-profile outbreaks of foodborne illnesses in recent years, including romaine lettuce contaminated with e-coli and salmonella in peanut butter. The Centers for Disease Control and Prevention estimates that 128,000 people in the United States are hospitalized each year for foodborne illnesses.

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Concern reached new heights after several babies fell ill or died after drinking formula produced at an Abbott Nutrition factory in Sturgis, Michigan, last year. Although the illnesses could not be traced to the factory and the company said the bacteria linked to the illnesses did not originate there, the factory was shut down for months after the FDA ruled. cited unsanitary conditions.

The shutdown has led to a nationwide formula shortage, which continues even though the plant reopened in June. According to data from IRI Worldwide, a market research firm, the last in-stock figure for powdered baby formula was 70% for the week ending July 3, compared to 77% the week ending July 5. June. The shortage also raised questions about why the FDA did not act sooner on a whistleblower complaint about conditions at the Abbott plant.

At Wednesday’s hearing, Sarah Gallo, vice president of product policy for the Consumer Brands Association, a grocery industry group, urged the FDA to immediately unify its food programs under one umbrella. . His recommendation echoes that of consumer associations, which have been calling for a single “food czar” within the agency for months. This appointee would have direct line authority over the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the food-related components and operations of the Office of Regulatory Affairs.

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“The lack of a single, full-time, fully empowered expert leader affects every aspect of the FDA food program,” Gallo said. “Inefficient decision-making has slowed reviews, hindering progress and even rendering innovation obsolete. Inexperienced and insufficiently trained inspectors are sent to the field. A divided and siled food program undermines communication and collaboration to the detriment of efficiency and responsiveness.

Beyond unifying food program leadership, Gallo called on the FDA to convene a panel of independent experts to address modernization of inspections, labeling and recall processes, e-commerce, emerging technologies and new models of collaboration with industry.

Califf said the agency was underfunded and suffered from high staff turnover.

“My appreciation is [the agency] is made up of very dedicated people, but they work in a sub-optimal environment that needs reform, including structure, function, leadership and funding,” Califf said. “Several key issues need to be addressed. Hiring and retaining food safety staff has long been a concern.

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Not all senators were convinced that additional funding was the clear answer to the agency’s woes.

Over the past decade, the agency’s budget has grown 37 percent, Sen. John Hoeven (RN.D.) said. “We have provided the FDA with great budget flexibility.”

Ida M. Morgan