Milwaukee Journal Sentinel

Inspector: FDA must speed up food recalls

But agency head says process has improved since study

- Jayne O’Donnell

The federal recall process for about 80 percent 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 being released Tuesday by the Department of Health and Human Services’ inspector general office.

Much has changed since the recalls between 2012 and 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 U.S. Department of Agricultur­e 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 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, an appointee of President Donald Trump, noted this 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, Gottlieb says.

The FDA will also offer 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 the FDA has claimed is confidenti­al business informatio­n. The USDA releases it, as do other agencies including the Consumer Product Safety Commission.

If the FDA doesn’t have enough authority, Gottlieb says he will ask Congress for it.

The FDA has had the power to mandate recalls since 2011 but has very rarely used it, says Sandra Eskin, who directs Pew Charitable Trusts’ Safe Food Project.

Of the 30 recalls reviewed by the inspector general, 23 were Class 1, which report author George Nedder says means they could cause death or irreversib­le health problems like kidney failure. The other seven were Class 2, which could cause reversible issues that could require up to monthslong hospital stays, he says.

Of these 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. Eskin says the seriousnes­s levels of the slow recalls is “very concerning.”

“When people’s lives are at risk ... every day matters,” Nedder said.

One infant and two fetuses died in the recalls examined between October 2012 and May 2015 and illnesses were reported. Hazards included Hepatitis A in pomegranat­e seeds, cadmium in frozen spinach and listeria in pistachios.

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