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Efforts to ensure recalled ByHeart infant formula is removed from store shelves have been hampered across the country because of bureaucratic delays by the U.S. Food and Drug Administration in sharing product distribution lists with state and local officials, according to the head of the Association of Food and Drug Officials.
“I’m not sure they recognize the sense of urgency,” Steven Mandernach, the association’s executive director, told Healthbeat on Friday, amid the nationwide outbreak of infant botulism cases linked to ByHeart’s baby formula. “You expect all hands on deck. This is infants.”
Mandernach said the FDA didn’t start fully sharing ByHeart’s product distribution lists with all state and local food safety officials until a teleconference held 6 p.m. Nov. 14 – nearly a week after the formula was linked to the outbreak and the company announced its initial recall on Nov. 8.
“We wasted almost a week,” Mandernach said. He said recall effectiveness inspections have been finding recalled ByHeart formula offered for sale at about 10% of stores that had been checked as of earlier this week.
On Wednesday and Thursday, the FDA warned the public that recalled ByHeart formula is still being found on the shelves of major retailers, including Walmart, Target and Kroger stores. The FDA did not immediately respond to Healthbeat’s questions Friday about why it took so long for the agency to share distribution lists with local food safety officials.
At least 31 infants who have been fed ByHeart Whole Nutrition infant formula have been hospitalized in 15 states with suspected or confirmed infant botulism as of this week. ByHeart has announced that its independent testing has found the bacteria that causes infant botulism in some of its formula.
Federal health officials have warned consumers worldwide to not feed any ByHeart infant formula to babies because of the potential for it to be contaminated with botulism bacteria spores. It can take up to 30 days between when a baby ingests botulism spores until they start showing signs of illness.
Disjointed sharing of ByHeart sales locations delays removal
Mandernach, in an interview with Healthbeat, described what he said were the FDA’s delayed, limited and disjointed sharing of critical information needed by local food safety officials about what stores and distributors received ByHeart’s formula.
Part of the issue has been bureaucratic, he said.
In recent years, he said, the FDA’s legal team has reinterpreted the agency’s authority. The FDA now considers a food manufacturer’s list of where it sent its recalled products to be confidential business information that cannot be shared with local food safety officials unless they have signed a privacy agreement.
The FDA can also go through an internal process to allow it to justify sharing the information with local departments, Mandernach said, which the agency ultimately completed on Nov. 14.
“No one expects the law to prohibit the agency from trying to share information in this type of event,” he said. “For it to take four days for them to figure out how to use that exemption, that’s just not normal.”
Mandernach said there has been a bipartisan effort in Congress for some time to address the bureaucratic hurdles to sharing distribution lists for recalled products with local officials, but the fix hasn’t happened.
While some states that had federal data-sharing agreements with the FDA received ByHeart distribution lists on Nov. 11 and 12, Mandernach said they were not allowed to share the lists with others. And not all of the departments who had agreements with the FDA were given the information at that time, he said.
“Finally, Friday night [Nov. 14] at 6 p.m., FDA holds a call with all the state partners and some of the large health department partners and says we’re officially able to share the list with you,” Mandernach said.
By that late hour, it meant that many local and state food safety programs were not able to start visiting stores and other locations on the lists until Monday. “Wow. We waited from Tuesday to Friday night at 6,” he said.
In its outbreak updates to the public this week, the FDA emphasized that all ByHeart infant formula products, including cans and single-serve “anywhere pack” sticks have been recalled, and they should not be available for sale in stores or online.
“FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations,” the agency said in an announcement on Thursday. “FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country.”
Walmart said in a statement on Friday it has removed ByHeart formula from its stores and clubs as well as online sites. The retailer also said it has a “sales restriction” in place on ByHeart products, which electronically stops the products’ barcode from being scanned and sold to a customer when they check out.
Sprouts, which said it took “immediate action” to remove ByHeart products from its shelves, told Healthbeat the stores have also taken “additional measures” with vendors to ensure no remaining product is available for sale.
Recalled products have been left on store shelves during previous outbreaks
Food safety advocates said Friday it’s not surprising that ByHeart infant formula continues to be found on store shelves in multiple states, nearly two weeks into a recall and amid a nationwide nationwide outbreak of infant botulism
“This is part of a pattern we’ve seen in recalls, where products are often left on store shelves well after the recall announcement,” said Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, a food and health watchdog organization based in Washington, D.C.
“It’s just a lot of dysfunction in how recalls are managed in this country,” she said.
The delays in FDA sharing ByHeart’s distribution lists with state officials is an example of this, Sorscher said.
“That slows the recall check because states can’t go out and check on the effectiveness of the recall unless they have that list,” she said. “FDA has repeatedly asked Congress to give it the authority to share more freely with states.”
During 2023 and 2024, after nationwide recalls of certain brands of cinnamon applesauce pouches that were linked to elevated lead levels in children, the FDA continued to find the product being sold on the shelves of Dollar Tree stores.
The FDA issued a formal warning letter to Dollar Tree in June 2024.
“In the weeks and months that followed the manufacturer’s voluntary recall of apple cinnamon fruit puree pouches, public health officials across many states reported continuing to see recalled WanaBana apple cinnamon fruit puree pouches on Dollar Tree store shelves,” the FDA said at the time it issued the warning letter.
“When a food is recalled, retailers play a crucial role in carrying out the recall by ensuring that recalled products are not available to consumers at their stores,” the FDA said at the end of the recall.
Still, it’s not uncommon for products to remain on store shelves, said Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University.
The current issues with ByHeart formula remaining on store shelves deserves further scrutiny, she said.
“It’s not surprising to me, but it’s saddening. We know recall effectiveness is not as good as it should be,” Kowalcyk said. But this particular product involved such a vulnerable population – infants who often rely on formula as their only source of nutrition. “I think there needs to be an assessment of why that happened,” she said.
ByHeart officials on Friday said they have been working “with urgency” to recall their formula. The company told Healthbeat it has notified all of its retail customers to remove all ByHeart formula from shelves.
“Since November 9, ByHeart has notified retailer partners four times, and they have confirmed communication has been sent to stores. The FDA has also shared notifications with retailers,” the company said.
ByHeart also said it has taken action to notify members of its OpenHearted formula donation program of the recall. “All OpenHearted partner organizations have been notified, and ByHeart has helped aid recall implementation with them. We have shared all necessary information on our donation programs with the FDA and other regulatory bodies, as needed,” the company said.
Alison Young is Healthbeat’s senior national reporter. You can reach her at ayoung@healthbeat.org or through the messaging app Signal at alisonyoungreports.48
