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This image provided by the U.S. Food and Drug Administration on Thursday, Nov. 17, 2023, shows three recalled applesauce products - WanaBana apple cinnamon fruit puree pouches, Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, and Weis-brand cinnamon applesauce pouches. In December 2023, the U.S. Food and Drug Administration launched an inspection of a plant in Ecuador that made the cinnamon applesauce pouches linked to dozens of cases of acute lead poisoning in U.S. children.

This image provided by the U.S. Food and Drug Administration on Thursday, Nov. 17, 2023, shows three recalled applesauce products - WanaBana apple cinnamon fruit puree pouches, Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, and Weis-brand cinnamon applesauce pouches. In December 2023, the U.S. Food and Drug Administration launched an inspection of a plant in Ecuador that made the cinnamon applesauce pouches linked to dozens of cases of acute lead poisoning in U.S. children. (FDA via AP)

A U.S. inspection of a plant in Ecuador that manufactured pouches of contaminated applesauce linked to at least 125 cases of suspected lead poisoning in children found “extremely high” levels of the metal in a key ingredient: cinnamon.

The Food and Drug Administration said Monday that samples of cinnamon from the plant that were tested contained levels of lead more than 2,000 times higher than proposed international limits for lead in food. Federal officials confirmed that they were investigating whether the poisoning was intentional.

However, the FDA said that it had “limited authority” over foreign suppliers that do not directly ship their products to the United States and that its investigation was continuing.

The FDA began investigating the plant after lead was detected in squeezable pouches of cinnamon-flavored applesauce sold under the brand names WanaBana, Schnucks and Weis. About 3 million of the pouches, which are marketed as snacks for babies and toddlers, were recalled.

A Washington Post investigation this month found that more than 100 cases of suspected lead poisoning in children linked to the pouches were being investigated at the state level, but those cases had not been included in federal tallies. Since then, the Centers for Disease Control and Prevention has updated its estimates, and it says it now has received 125 confirmed, probable or suspected cases of lead poisoning linked to the pouches of fruit snacks.

The recall has renewed questions about whether the FDA is doing enough to regulate toxic metals in baby and toddler foods. In 2021, two congressional reports found that many popular food products made for babies and toddlers contained significant levels of the toxic heavy metals lead, arsenic, cadmium and mercury - yet an action plan to establish voluntary limits by April 2024 appears to have stalled. The concern is especially high for young children who often eat a limited diet, and metals such as lead can harm developing brains.

Sen. Richard Blumenthal (D-Conn.) said the lead contamination shows that the FDA needs to take “more comprehensive action” to prevent future contaminations. Citing The Post’s investigation, he said the FDA needs to move swiftly once the immediate “crisis” has been resolved.

“The agency should issue regulations that establish action levels, increase targeted compliance and enforcement activities and monitor levels of contaminants over time to determine necessary adjustments,” Blumenthal said in a statement.

The plant where the lead contamination occurred belongs to Austrofood, which produces the pouches of applesauce and apple puree sold under the brand names WanaBana, Schnucks and Weis.

A third-party distribution company in Ecuador, operating under the name Negasmart, supplied the cinnamon to Austrofood. “To date, FDA has confirmed that Negasmart does not ship product directly to the U.S. and that, of Negasmart’s direct customers, only Austrofoods ships product to the U.S.,” the FDA said, adding that this means the agency “cannot take direct action with Negasmart.”

“However, we are continuing to work closely with Ecuadorian officials, as they are conducting their own rapidly evolving investigations into the source of contamination,” the agency continued.

The source of the contamination came to light after an examination of two North Carolina toddlers who had been exposed to high levels of lead. State investigators discovered that both children regularly ate the fruit contained in pouches. The North Carolina Department of Health and Human Services informed the FDA, which on Oct. 28 issued the first of several public health warnings.

The FDA said the contamination of the plant may have been “economically motivated.” Lead can be added as a coloring agent or to increase the weight of spices.

“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,” an agency spokesman said. “Additional investigation needs to occur before the FDA reaches any conclusions. The FDA will continue to keep the public updated as the investigation unfolds.”

While lead is toxic to people of all ages, children are more susceptible and may present no immediate symptoms, according to the FDA. Anyone who believes their child may have been exposed to lead should speak to their health provider to arrange a blood test.

The FDA said it is still investigating whether the cinnamon processed at the plant was used in any other products that may have entered the United States, and that U.S. and Ecuadorian officials also are working to inform other countries about the investigation and its findings.

The FDA’s deputy commissioner for human foods, Jim Jones, told Politico last week that the signals so far appeared to indicate “an intentional act” of contaminating the cinnamon with lead.

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

Amanda Morris, Laura Reiley and Jenna Portnoy contributed to this report.

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