FDA Recall Process Too Slow, Causing Illness And Death, Official Report Finds

The Food and Drug Administration's food recall process is too slow and in some cases has led to injuries and even death that could have been prevented, according to an inspector general report released Thursday.

The report contains incomplete findings of an investigation into the FDA's food recall procedures. A complete report will be issued later, but the inspector general's office felt the preliminary findings were urgent enough to issue an "early alert," detailing how the recall procedures could put people in danger.

Here's what they found.

The inspector general looked at 30 voluntary recalls issued between October 2012 and May 2015. In two cases, 81 and 165 days passed from the time the FDA became aware of the problem until a recall was issued.

In one instance, 14 people became ill because of salmonella contamination in nut butter. It took 165 days from the time the FDA identified the product for a voluntary recall to be sent out, the report said.

In the other, listeria was discovered in cheese products that had caused an infant to die. The FDA began an investigation, and during the 81 says it took before the recall was sent out, two fetal deaths were linked to the contamination.

"FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls," the report's conclusion says. "As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain."

In a statement, the FDA said that during the time frame of the inspector general's investigation, "the FDA oversaw thousands of food recalls, with an average time for recall initiation of less than a week."

But it called the major delays "unacceptable."

"While some food recalls are more complicated than others due to the nature of the product(s), contamination, and investigation, the recall process should be as swift as possible and the FDA is already taking concrete steps to address the OIG’s concerns," the statement says.

So why is this happening?

The FDA generally relies on companies themselves to issue voluntary recalls, the report says. In 2011, the FDA was given the power to order recalls in food that "will cause serious adverse health consequences or death to humans or animals," but it has only used that power twice — once for pet food that had salmonella and another in a dietary supplement that had a possibly harmful ingredient in it.

Otherwise, companies usually want to pull bad products off the shelves themselves. But that doesn't always happen as quick as it should.

So the inspector general is recommending that the FDA set stricter timelines with companies to make sure the recalls happen in a timely manner.

"We fully agree with the OIG that we must move as expeditiously as possible," a blog post by two FDA officials says. "We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations."

You can read the inspector general's report here.