June 14, 2016
FDA Criticized Over Recall Timeline
The inspector general’s office of the Department of Health and Human Services reports that the FDA has been taking its sweet time using its power to force recalls on tainted food items showing pathogens that can kill people or make people very sick.
An “early alert” by the HHS’s watchdog sector said the FDA needs to pay “immediate attention” and use the established protocols forcing manufacturers to recall harmful foods. George Nedder, the lead investigator, said “Months and weeks when people’s lives are on the line? It needs to be done faster.”
The FDA Has “Finite Resources”
The FDA says the cases cited by the IG of HHS are the exception to the rule – only a few of many. But Stephen Ostroff, Deputy Commissioner of the FDA established a food safety officials group to review slow-moving cases every week dealing with current challenges faced by the FDA. To be fair, the FDA has finite resources and is tasked with overseeing the safety of 80 percent of the U.S.’s food supply, including vegetables, fruits, seafood, and dairy.
Since the FDA’s resources are stretched so thin, they’ve always relied on voluntary recalls by the companies involved. In 2011, the agency was given legal power to force recalls where serious harm to people is a factor, to this point, however, that has not really been used. The IG of the HHS concluded a survey of 30 recalls between 2012 and 2015, one of those was salmonella-tainted peanut and almond products from nSpired Natural Foods Inc., issuing a voluntary recall. But the FDA had proof of the hazard 167 days before the recall happened.
According to Ostroff, that case was the first time the FDA used DNA mapping to determine a problem with a product. But at least three months passed between the FDA finding a verifiable link and the recall. He said, “I won’t tell you this went as quickly as we would like it [to] go. Now that we have more experience with this technology, we hope we don’t see similar timelines.”
Previous Incidents of Tardy Recalls by the FDA
Another incident in 2014 involving cheese products by Oasis Brands Inc. saw nine people sick in six states and one infant death. These covered three separate incidents. The last recall didn’t happen until 81 days after Virginia’s agriculture department reported listeria in the products to the FDA. In this situation, the FDA inspected the company’s manufacturing operations twice during the 81 days, found listeria both times and some products were recalled three times – finding that with the first two recalls some listeria-filled products were not included in earlier recalls.
Clearly the FDA needs to be doing a better job, but then again, there’s no way to know how many problems Never happened because they’ve been doing their job. Given new DNA testing advantages, they must do better – and not only do better – but be seen to do better. People are watching and reporting, they must use the tools they’ve been given and force recalls when needed, keeping the public in the loop as they move forward.