The FDA Shifts From Food Safety to Public Safety

In recent years, food-related illnesses followed by highly publicized product recalls have created concerns that food product regulation in the United States is inadequate. The food industry has a complex regulatory structure, divided among many federal, state, and local authorities, with the U.S. Food and Drug Administration (FDA) handling almost all federal food inspections other than meat products.

If something goes wrong, though, the FDA has little mandatory recall authority—usually, recalls are producer-initiated actions, and the FDA has been seen as a primarily reactive agency. The FDA’s reactive role may be changing, however, as a new generation of political leadership, combined with new inspection standards, increasingly creates a proactive and preemptive regulatory approach.

Illustrating this approach was a March 2009 recall—or “pre-call”—of pistachios and pistachio products by a leading processor. The recall was not related to any reports of consumer illnesses. Instead, the FDA urged the processor to initiate a recall after government inspectors at the processing plant found that roasted pistachios were not being kept separate from raw nuts that can carry Salmonella and other pathogens. In its comments about the recall, the FDA’s leadership made it clear that it was trying to minimize the likelihood of consumer exposure to health problems. The agency’s goal was to warn consumers not to eat pistachios until the implications of any possible contamination were clear.

In effect, this is a new regulatory approach that could signal a change in the formerly collaborative approach to food safety that the food industry and regulators have taken, shifting toward a preemptive philosophy more often used by public health officials. Of course, almost any agency charged with protecting public health and safety has both regulatory and enforcement sides.

Some, like the FDA and the Environmental Protection Agency, for example, concentrate on both the slow work of promulgating policies and regulations and the immediate need of public health response. Others, such as the Centers for Disease Control and Prevention (CDC), focus on public health response and have a smaller regulatory role. The FDA’s new leaders seem to want to shift the FDA toward a public health response mode. Not surprisingly, the FDA’s new senior leaders, selected by the Obama Administration, both come from a public health background.

Public Health Philosophy

Margaret A. Hamburg, MD, confirmed by the Senate in May as the twenty-first Commissioner of Food and Drugs, served during the 1990s as commissioner of New York City’s Department of Health and Mental Hygiene, making her the top public health official in the nation’s largest city. Subsequently, she was assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. The FDA’s principal deputy commissioner, Joshua M. Sharfstein, MD, served as acting commissioner before Dr. Hamburg’s appointment and oversaw the agency’s actions in the pistachio recall. Before that, he was the commissioner of health for Baltimore.

Drs. Hamburg and Sharfstein, shortly after assuming their new positions, co-authored an editorial in the New England Journal of Medicine titled “The FDA as a Public Health Agency.” In the editorial, they declared that their agency should define success in terms of its ability “to promote health, prevent illness, and prolong life” rather than “such intermediate measures as the number of facilities inspected.” In food safety, the two commissioners stated, the FDA should use its public health clout to “partner with . . . other authorities to establish a modern food-safety system focused on prevention of contamination . . . [and] strive to build safeguards into every step of the production and distribution process.”