The U.S. Food and Drug Administration is investigating whether recalled cinnamon-flavored applesauce pouches, which had high lead concentrations and have sickened at least 65 children, were intentionally contaminated.

In late October, the FDA issued a public health alert advising against consuming or buying WanaBana apple cinnamon fruit puree pouches because they may contain elevated levels of lead. Subsequently, the agency added Schnuck brand and Weis brand products to the recall. The agency has gotten 65 reports of illnesses potentially linked to the products and all impacted have been under 6 years old, the FDA said this week.

During its investigation, the agency has found that the lead may have been added as "an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out,” Jim Jones, the FDA’s deputy commissioner for human foods, told Politico, which first reported the development.

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How would recalled applesauce pouches get contaminated with lead?

The FDA is focusing on lead-contaminated cinnamon being potentially added as an “economically motivated adulteration,” NBC News reported.

Food makers may use "economically motivated adulteration" or EMA, by substituting an ingredient "to make it appear better or of greater value," according to the FDA. But the agency also says that such actions may be food fraud and result in "lead poisoning from adulterated spices and allergic reactions to a hidden, substituted ingredient that contains even just one food allergen."

The FDA has been inspecting the Austrofoods facility in Ecuador, where the WanaBana apple cinnamon fruit puree pouches, Schnucks cinnamon-flavored applesauce pouches and variety packs, and Weis cinnamon applesauce pouches were produced.

The agency is working with officials in Ecuador in its investigation of the cinnamon. The spice, supplied to Austrofoods by Ecuador-based Negasmart, had higher levels of lead than allowed by Ecuador and the company is "currently under an Ecuadorian administrative sanctions process to determine the responsible party for the contamination," the FDA said Dec. 5.

The FDA's Jones told Politico that manufacturers likely "didn’t think this product was going to end up in a country with a robust regulatory process."

How many have been affected in the applesauce product recall?

The Centers for Disease Control and Prevention has received 125 reports of cases in 22 states in its tracking of the cinnamon applesauce lead poisoning outbreak. Of those cases:

• 46 are confirmed
• 68 are probable
• 11 cases are suspect.

To be included in those numbers, the person must have high blood levels within three months of eating one of the products after November 2022. (The CDC and FDA can have different case numbers because they gather data differently.)

The FDA has said that consumers should not eat or buy the WanaBana apple cinnamon fruit puree pouches, which are sold nationally through Amazon, Dollar Tree, and other online stores, the Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, and Weis-brand cinnamon applesauce pouches.

Contributing: Saleen Martin

Follow Mike Snider on X and Threads: @mikesnider & mikegsnider.

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