Report: Food recalls are dangerously slow
FDA delays can put public’s heath at risk
The federal recall process for about 80% of the nation’s food is so slow it can take up to 10 months to get unsafe products off all store shelves — even when people are getting sick, says a report released Tuesday by the Department of Health and Human Services’ inspector general office.
Much has changed since the recalls from 2012 to 2015 that were analyzed by the inspector general, says Food and Drug Administration Commissioner Scott Gottlieb.
“Delay is deeply concerning to me as well,” Gottlieb, a physician, said in an interview. “I think it’s working a lot better now.”
The FDA is in charge of all food recalls except for meat and poultry, which the Agriculture Department handles.
The FDA must evaluate health hazards in food and diet supplements, such as vitamins, more quickly to force reluctant companies to do recalls, the report recommended. The FDA’s electronic tracking system also needs to improve, the report said, along with its process for monitoring recalls.
The recalls studied were worrisome enough that the inspector general issued an “early alert” about them in June 2016. That prompted the FDA to establish a team to speed up processes. Gottlieb, a Trump appointee, noted that the new team helped block two facilities’ ability to distribute food.
More will change soon, he says, including its own look at what else can be done to improve recalls.
FDA also will release guidance in the first half of 2018 on what information it can release about where recalled food and diet supplements were sold. A coalition of safety advocates urged Gottlieb in August to release the names of the stores that sell recalled food items, which FDA has claimed is confidential. The Agriculture Department releases it, as do other agencies including the Consumer Product Safety Commission.
If the FDA doesn’t have authority, Gottlieb says he will ask Congress for it.
The FDA has had the power to order recalls since 2011 but has rarely used it, says Sandra Eskin of the Pew Charitable
Trusts’ Safe Food Project.
Of the 30 recalls reviewed by the inspector general, 23 were class 1 recalls, which report author George Nedder says means they could cause death and irreversible health problems such as kidney failure. The other seven were Class 2, which could cause reversible illnesses that could require up to months-long hospital stays, he says.
Of those recalls, it took a median of 29 days and an average of 57 days for the recall to start after the FDA became aware of the hazardous condition.
One infant and two fetuses died in the recalls examined from October 2012 to May 2015, and multiple illnesses were reported.
The FDA relies primarily on voluntary recalls, which makes timeliness, oversight and its system of assessing risk crucial, says Nedder, an HHS assistant regional inspector general based in Boston. It is required to do “health hazard evaluations,” which determines the severity of risk to the public.
How time matters:
Diet supplements. Nutrex received a warning letter that a diet supplement was “adulterated” because it had an ingredient the FDA wasn’t notified about. It took more than 10 months for the company to pull the product, and it gave out free samples for about eight months after the letter.
Cheese. In a series of recalls of “cheese products” contaminated with a type of listeria, it was 81 days from the time the FDA learned of the adulterated food before Oasis Brands recalled it. During that time, the firm’s owner, Christian Rivas, agreed to suspend manufacturing and temporarily halt distribution. Although he knew it tested positive for listeria, he still had the food packaged and distributed. Rivas pleaded guilty to a felony and was sentenced to 15 months in prison.
Nut butter. The FDA knew about salmonella in products sold by nSpired Natural Foods for more than five months before the firm agreed to a recall in August 2014. Consumers began getting ill in late 2012, but it wasn’t until March 2014 that the FDA found that samples were contaminated.
Though the FDA has “upped their game,” since last year, Eskin says, the report shows it “can go farther to better protect public health when it comes to recalls.”