Federal inspectors spot-checked several dozen recalls among 1,557 the agency conducted between 2012 and 2015, partly to see how the FDA used wider powers given to it under the Obama Administration to protect American consumers from food-borne illness.
The agency dawdled for weeks and even months, adding to delays that might increase the risks of harms to the public, said investigators under the inspector general of the Department of Health and Human Services. As the New York Times reported:
[I]t took the agency 165 days to start a recall of nut butters that may have been tainted with salmonella; 151 days to recall hazelnuts that also suspected of salmonella contamination; 82 days to recall frozen spinach suspected of high levels of cadmium; and 27 days to start a recall of cooked duck eggs carrying the bacteria that cause botulism.
Compounding the potential hazards was the vendors’ responses to the FDA’s lax oversight, with the newspaper reporting that, “Food companies took an average of 57 days to recall items after the FDA was apprised of the potential hazards. One recall did not begin for 303 days…”
George Nedder, an assistant regional inspector general at Health and Human Services and lead author of the report critical of the FDA told the New York Times that, each day of agency delay matters because “every day the product remains on the shelf, consumers are potentially at risk for serious illness or death.’’
The FDA itself says that 48 million Americans get sick from food-borne diseases each year, with 128,000 of them needing hospitalization and 3,000 dying.
FDA Commissioner Scott Gottlieb, saying oversight of the nation’s food supply is a “core consumer protection function” of his agency, defended the pokey recall process and said that regulators have made improvements in them and will keep doing so.
Consumer advocates criticized the agency, noting it has had a long time to make changes since President Obama signed a 2011 law giving the FDA expanded policing powers, including authority to order recalls when companies balked if asked to pull items from the shelves voluntarily. The agency has ordered such recalls only twice in recent times.
Douglas Stearns, director of FDA’s office of enforcement and import operations, offered an odd comment to the New York Times, noting, “We work cooperatively with industry in the overwhelming number of cases. At the same time, we are very dependent on what a firm tells us. Sometimes we do not get all the information we need, and sometimes the information provided is not accurate.”
In my practice, I see not only the huge harms that patients suffer while seeking medical services but also the big damages that can be inflicted on them by defective and dangerous products, including tainted or risky foods. Although Gottlieb hasn’t been in his post long, members of the congressional committees that oversee the FDA need to hold the commissioner and his staff accountable for stalled product safety recalls, whether they’re for contaminated foods or risky prescription drugs and medical devices.
The Trump Administration argues that too many sectors of the economy are over-regulated, and Washington needs to go lighter on companies to allow businesses to prosper more. But when it comes to the food we eat, drugs we must take, and medical devices that get put in our bodies, federal regulators should err on consumers’ side, especially to protect their safety. They also need to put the pedal to the metal in their oversight actions, and not wait around, especially for companies to help.