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What actually happens when a product is recalled?

The process often starts with companies and consultants. It involves federal, state, and local regulators too. 

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While the USDA has oversight over meat, poultry, and egg products, “FDA has oversight of about 80% of the food supply, and they have oversight of food safety at the retail level,” said Barbara Kowalcyk at GW.
While the USDA has oversight over meat, poultry, and egg products, “FDA has oversight of about 80% of the food supply, and they have oversight of food safety at the retail level,” said Barbara Kowalcyk at GW.
Issam Ahmed/AFP via Getty Images

Every week in the U.S., companies and regulators announce recalls of around 60 products, according to the claims company Sedgwick. That includes medical devices, pharmaceuticals, consumer products, foods and beverages, and automotive recalls.

But sometimes, products remain accessible to consumers, even after they have been recalled. 

Earlier this year, for instance, the baby formula company ByHeart recalled its product after reports that it may have been connected to a multistate outbreak of infant botulism.

And yet, in the weeks after the recall, regulators still found the formula for sale at more than 175 locations, according to the Food and Drug Administration, which has since sent retailers warning letters. 

Such recall effectiveness checks are a standard part of the recall process, explained Jennifer McEntire, founder of the consulting firm Food Safety Strategy.

Let’s start at the beginning.

When a food company identifies a problem that might require a recall and enlists her help, “it is a drop everything, very urgent situation,” McEntire said.

She starts by digging through documents, checking with regulators, and visiting the places where the product is made.

“Looking at things, talking to people, trying to understand when we think this event occurred, what was happening that doesn’t usually happen,” McEntire explained.

While government agencies can, and sometimes do, mandate recalls, McEntire said usually it’s the companies themselves that ultimately make the decision to recall their own products.

“Although the term ‘voluntary recall’ is used, a better term would be ‘firm initiated,’” she said. 

McEntire said the word “voluntary” can mislead customers. 

“It can send the message to consumers that, ‘well, if a company is voluntarily recalling this product, then I can choose to follow the directions or not,’” she explained. “And that is not the case.”

Generally, the decision to recall is not a difficult one to make, she said. The more time-consuming decision is how much to recall. 

Companies don’t want to toss safe products, but “it’s also not fantastic for companies to make an error and have to go back and re-recall something, so you want to be one and done,” she said. 

Even when companies initiate recalls themselves, they still work with regulators.

There are a lot of them, said Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University.

“We have 15 federal agencies that are charged with the oversight of food, and then thousands of state and local agencies,” she explained.

While the U.S. Department of Agriculture has oversight over meat, poultry, and egg products, “FDA has oversight of about 80% of the food supply, and they have oversight of food safety at the retail level,” Kowalcyk explained.

She said the FDA delegates some of that authority to state and local agencies. She described the system as “very complex, which makes it kind of burdensome sometimes to be able to navigate it quickly.” 

When a company recalls a product, it should notify everyone downstream in the supply chain, including distributors, retailers, and consumers.

The FDA says it’s the responsibility of all industry stakeholders, including retailers and distributors, to ensure recalled products don’t get to consumers.

Consumers may get the notice on their local news, signs at stores, or through their grocery shopping card account.

“I know a lot of people put a fake phone number in or a fake email address in, and I understand that you don't want more spam, but it also means that they can't contact you if you bought a recalled product,” Kowalcyk said.

Retailers are supposed to stop selling the product, and it's up to regulators to check and make sure that it’s actually off the shelves.

“It really involves going to those individual locations where the product was sold, ensuring that it’s no longer available, making sure that they’ve clearly indicated that it can’t be sold, so that it doesn’t accidentally get put back on the shelf,” said Steven Mandernach, executive director of the Association of Food and Drug Officials. 

To do this work, Mandernach said local agencies need to know where to look.

The company that's recalling the product tells federal regulators where it had been distributed and sold,  but sharing that information with local agencies to follow up can get complicated.

When all is said and done, the cost of recalls can vary greatly, said Sedgwick SVP of client services Chris Harvey.

“Sending out notification, collecting physically the recalled product back, destroying it, issuing reimbursement, there’s a cost associated with that,” he said. “Usually the highest cost, though, involves the loss of business.”

There is also risk to a company’s reputation. Do a recall wrong and civil penalties and lawsuits can add up.

But, in Harvey’s experience, if a recall is executed with speed, transparency, and empathy, “it can actually increase brand loyalty,” he said. “I’ve seen sales increase as well.”

Because, he explained, if consumers trust that a recall was handled well, they can actually be quite forgiving.

In a statement to Marketplace, baby formula maker ByHeart said it was investigating its process and has been cooperating with federal and state agencies.

“We have been working with urgency and care since we first learned of the outbreak to implement the recall quickly and effectively,” the company said. 

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