WASHINGTON (CBS) — An investigation has yielded some troubling results concerning the way the Food and Drug Administration handles recalls. Some recalled foods aren’t immediately pulled from store shelves, leaving the public at risk.
The Office of the Inspector General reviewed 30 voluntary recalls out of 1500 overseen by the FDA over a two-and-a-half year period, and found deficiencies — the “FDA could not always ensure that firms initiated (food) recalls promptly.”
“I think any time you have a situation where people’s lives are at risk, I don’t know how lightly you can take that,” said investigator George Nedder.
He says it can be a critical failure.
“Twenty-three of the 30 recalls we looked at were Class One — by definition can cause a serious, irreversible medical condition, or potentially can cause death,” said Nedder.
For example, in a salmonella outbreak in 2014 linked to nut butter, investigators found it took 165 days from the date the problem product was identified to the date of the firm’s voluntary recall. There were 14 illnesses in 11 states.
During a listeria outbreak later that same year linked to cheese products, auditors determined a series of recalls took 81 days to complete. At least nine people became ill, including an infant who died and two pregnant women lost their fetuses. The company owner later plead guilty to a felony.
“We have to be planned and we have to prepare for the worst case scenario,” says Nedder. “That’s why it’s important for the FDA to drive the boat and always put themselves in position where they can use their authorities and enforce these recalls when necessary.”
In another case, a Class One recall of an adulterated dietary supplement, the FDA and the firm disagreed over whether the product was lawful. Investigators said “the firm did not recall the product until 303 days after receiving a warning letter from FDA.”
“At three places for one recall, that stuff was still on the shelf when they went out there 303 days later. That meant people could’ve been buying it up till that 303 days,” said Nedder.
The OIG first issued an alert on their findings in 2016. The FDA responded by putting a special team in place to handle challenging high-risk recalls.
But for this report, FDA also said the 30 cases selected were “extreme outliers” and claimed “in the highest-risk recalls…recall initiation took place, on average, in less than three days.”
In a statement to CBS News, FDA commissioner Scott Gottlieb said the agency has “worked quickly to put in place measures to address the proposals they outlined.” Though he said a lot has changed since then, he added, “I know that much work remains to be done if we’re going to provide the highest assurance of safety.”
Nedder believes lives depend on it.
“Every day that a recall is not initiated, every single day that goes by, a person could potentially get seriously ill or die from eating a product,” he said.
FDA officials say they know there are some things to work on here. In that statement, the commissioner said the agency will announce some new measures in 2018, not only in regard to the recall process itself, but ways to get more information out to the public more quickly.