- The FDA will conduct an independent investigation of its entire Human Foods program, Commissioner Robert Califf announced Tuesday afternoon. FDA is partnering with the Reagan-Udall Foundation for the evaluation. A report and recommendations will be issued within 60 days.
- Califf’s statement stresses the food supply is safe and the people who work for relevant divisions in FDA have brought nutritious food options to the people. However, he wrote, the program “has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain. Fundamental questions about the structure, function, funding and leadership need to be addressed.”
- The fractured food regulatory system in the U.S. — divided between FDA and USDA — has been a target of criticism and legislative reform efforts. But stresses to the department’s investigative capabilities during the COVID-19 pandemic — which became clear during a baby formula recall that led to a massive shortage — have led many to take a closer look at how the agency handles food.
While the incident that triggered this investigation has little to do with general CPG food and beverage, it could bring in wide-reaching recommendations that could inspire real change at the agency. Those who regularly deal with the FDA have experienced the structural challenges of the agency firsthand, but to others, it may outwardly seem like it has been doing its job.
The recall of several kinds of specialized baby formula made at the Abbott Nutrition plant in Michigan — the result of deadly Cronobacter bacteria in the factory, which ended up killing two and sickening four, according to the Centers for Disease Control and Prevention — brought the issues in FDA’s food division into the limelight.
Once the plant was forced to shut down in February after FDA inspectors found several problems — areas where safety protocols were not followed and formula was contaminated; hundreds of leaks; aging and cracked equipment; and personnel not wearing protective gear — stories trickled out that the agency had been made aware of these issues months before through a case of a sick infant and a whistleblower who worked at the plant.
In written FDA testimony at a May congressional hearing, the agency said the formula plant had been scheduled for inspection in December, but it was put off due to a COVID-19 outbreak among inspectors. The delay in inspecting the Abbott Nutrition plant stands out, but it isn’t the only food facility that has had its FDA inspection postponed because of the pandemic.
It’s not just the FDA’s food safety responsibilities that need another look. The agency — which tends to have more emphasis placed on its pharmaceutical regulatory duties — has a confusing chain of command when it comes to food. There is no one person who’s responsible for the division.
The Center for Food Safety and Applied Nutrition has its own director, as does the Office of Food Policy and Response. Both report directly to the FDA commissioner. According to Politico, the organizational change was made under President Trump to reduce bureaucracy, but it resulted in problems in the division and made it difficult for things to get done.
The announcement of the independent investigation came the afternoon before Califf and other FDA leaders are scheduled to testify in a hearing on food safety before the Senate Committee on Appropriations. The timing gives Califf the opportunity to fully expound on what he sees as issues with the structure, but also to deflect some scrutiny for the agency’s shortcomings.
The spotlight continually shining on the department may pave the way to some long-proposed changes — including the proposal from Rep. Rosa DeLauro and Sen. Dick Durbin to create a standalone food safety agency.