Should Food Finally be Removed from FDA Oversight?
While removing FDA’s responsibilities for food safety has been kicked around on Capitol Hill for years, a new Politico investigation into CFSAN’s handling of food safety oversight and regulatory activities may draw renewed interest in restructuring the agency to mainly oversee medical products. The investigation examined a number of mishandled contaminated food outbreaks and other food safety initiatives and slow-to-fruition regulatory projects.
“The food program is on the back burner. To me, that's problem No. 1,” said former FDA commissioner Stephen Ostroff, “There are a lot of things that languish,” he said. “There's nobody really pushing very hard to get them done in the same way that you're pushing very hard to get the Covid vaccines out there and authorized. We don't have that imperative and that pressure to actually make things happen on the food side of the Food and Drug Administration.”
Recently, more attention has been drawn to FDA’s oversight of food makers after an outbreak of Cronobacter sakazakii – a rare but deadly bacteria – led to a huge recall of infant formula. The agency is still probing the outbreak, but so far four hospitalizations and two deaths have been linked to formula produced by Abbott Nutrition at a single plant in Sturgis, MI.
To date, FDA has not explained why it took months to inspect the plant and subsequently recall the affected product. As Politico first reported, the first infant illness was reported to federal health officials in September, but investigators were not sent to the plant to investigate until late January. A year ago, FDA was dealing with other baby food issues, such as heavy metals and other neurotoxins in some baby food.
Meanwhile, Politico notes that some Democrats on Capitol Hill are now pressing for answers. Rosa DeLauro, the House Appropriations chair, recently requested an inspector general investigation into the agency’s response. And a handful of food trade groups are starting to talk internally about how to press for a reorganization to make the agency work better.
And former FDA deputy commissioner for foods and veterinary Michael Taylor has just penned a Politico opinion piece that calls for separating foods into a new agency. “The food side of FDA is approaching failure mode, however, not because of its people or just one unit — but because of the low priority of food within FDA, the agency’s fragmented organizational structure for food and the lack of sustained and empowered leadership from the top,” he says.