Applesauce pouch lead contamination may have been intentional, FDA says

The U.S. Food and Drug Administration is investigating whether recalled applesauce pouches with high levels of lead, which have sickened at least 65 children, were intentionally contaminated, according to agency officials.

The FDA first issued an alert about the issue in late October regarding WanaBana apple cinnamon fruit puree pouches over concerns of elevated levels of lead. Soon after, Schnucks and Weis cinnamon applesauce pouches were also added to a recall. 

To date, the agency has received 65 reports of illnesses potentially linked to the recalled pouches and all are under 6 years old, according to its most recent notice.

"The FDA can confirm that one of the theories the agency is exploring regarding the high lead levels in the recalled cinnamon applesauce pouches is the potential that the cinnamon contamination occurred as a possible result of economically motivated adulteration," the agency said in a statement to FOX Television Stations. "As this is an ongoing investigation, the FDA can only confirm this is one of the theories at this time."

FDA Deputy Commissioner for Human Foods Jim Jones previously told discussed the theory with Politico, which was first to report the development

"We’re still in the midst of our investigation," Jones told Politico. "But so far, all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain, and we’re trying to sort of figure that out."

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The impacted pouches, sold online and in stores, have all been linked to a manufacturing facility in Ecuador – which the FDA said it’s investigating.

"My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process," Jones told Politico. "They thought it was going to end up in places that did not have the ability to detect something like this."

The FDA currently believes the adulteration was "economically motivated," which can mean food ingredients being altered in order to make it appear better or of greater value, according to the agency’s website.

There’s no safe level of lead exposure, but the U.S. Centers for Disease Control and Prevention uses a marker of 3.5 micrograms per deciliter to identify children with higher levels than most. The affected children's blood lead levels ranged from 4 to at least 29 micrograms per deciliter, according to the CDC.

The reported symptoms included headache, nausea, vomiting, diarrhea, a change in activity level and anemia.

Lead exposure can lead to serious learning and behavior problems. Heavy metals like lead can get into food products from soil, air, water or industrial processes, according to the American Academy of Pediatrics.

Despite the recall, the FDA said WabaBana Apple Cinnamon Puree products were found on Dollar Tree store shelves in multiple states as of Dec. 13, according to its website. Schnucks-brand applesauce pouches are only sold at Schnucks and Eatwell Markets grocery stores. Weis-branded pouches are only sold at Weis grocery stores, the FDA said.

Regardless, people should not purchase, eat, or store the recalled products. Since they typically have a long shelf life, parents should check their homes for the recalled products and throw them away.

And despite existing food safety laws, Jones said intentional contamination "is always going to be tricky to absolutely stop, if somebody has intent to purposefully do something like this."

"We’re going to chase that data and find whoever was responsible and hold them accountable," Jones added.

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This story was reported from Cincinnati.