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A U.S. inspection of a facility in Ecuador that produced bags 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 tested samples of cinnamon from the plant contained lead levels more than 2,000 times higher than proposed international limits for lead in food. Federal officials confirmed they are investigating whether the poisoning was intentional.
However, the FDA said it has “limited authority” over foreign suppliers that do not ship their products directly to the United States and that its investigations are ongoing.
The FDA began investigating the plant after lead was discovered in squeezable bags of cinnamon-flavored applesauce sold under the brand names WanaBana, Schnucks and Weis. About three million of the pouches, marketed as snacks for babies and toddlers, have been recalled.
A Washington Post investigation this month found that more than 100 cases of suspected lead poisoning in children linked to the bags were being investigated at the state level, but those cases were not included in the federal counts. Since then, the Centers for Disease Control and Prevention has updated its estimates and says it has now received 125 confirmed, probable or suspected cases of lead poisoning linked to fruit snack bags.
The recall has once again raised 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 foods for babies and young children contained significant levels of the toxic heavy metals lead, arsenic, cadmium and mercury – but an action plan to set voluntary limits by April 2024 appears to have stalled. The concern is particularly great for young children, who often have limited diets, and metals such as lead can damage brain development.
Sen. Richard Blumenthal (D-Conn.) said the lead contamination shows the FDA needs to take “more comprehensive action” to prevent future contamination. Citing the Post's investigation, he said the FDA must act quickly once the immediate “crisis” is resolved.
“The agency should issue regulations that establish action levels, increase targeted compliance and enforcement activities, and monitor contaminant concentrations over time to determine necessary adjustments,” Blumenthal said in a statement.
Here's what you should know about the spoiled fruit pouches
The plant where the lead contamination occurred is part of Austrofood, which produces pouches of applesauce and apple puree sold under the brand names WanaBana, Schnucks and Weis.
A third sales company in Ecuador, which operates under the name Negasmart, supplied the cinnamon to Austrofood. “To date, the FDA has confirmed that Negasmart does not ship products directly to the United States and that of Negasmart's direct customers, only Austrofoods ships products to the United States,” the FDA said, adding that this means the agency “will not take any direct action can take”. Negasmart.”
“However, we continue to work closely with Ecuadorian officials as they conduct their own rapidly evolving investigation into the source of the contamination,” the agency continued.
The source of the contamination was revealed after an investigation into two North Carolina toddlers who were exposed to high levels of lead. State investigators determined that both children regularly ate the fruit contained in the pouches. The North Carolina Department of Health and Human Services notified the FDA, which issued the first of several public health alerts on October 28.
The FDA said the contamination at the facility may have been “economically motivated.” Lead can be added as a dye or to increase the weight of spices.
“The FDA can confirm that one of the theories the agency is investigating regarding the high levels of lead in the recalled cinnamon applesauce bags is that the cinnamon contamination may have resulted from commercially motivated adulteration,” a spokesperson said Authority. “Additional research must be conducted before the FDA reaches any conclusions. The FDA will continue to keep the public informed as the investigation progresses.”
Cases of applesauce in children are increasing as questions are raised about FDA oversight
While lead is toxic to people of all ages, children are more susceptible and may not show immediate symptoms, according to the FDA. Anyone who thinks their child may have been exposed to lead should speak to their doctor about getting a blood test.
The FDA said it was still investigating whether the cinnamon processed at the plant was used in other products that may have entered the United States, and that U.S. and Ecuadorian officials were also working to inform other countries about the investigation and theirs to inform results.
The FDA's deputy commissioner for human foods, Jim Jones, told Politico last week that signals so far appear to indicate an “intentional act” of contaminating the cinnamon with lead.
“My instinct is that they didn't think this product would end up in a country with a strict regulatory process,” Jones said. “They thought it would end up in places where something like that couldn’t be detected.”
Amanda Morris, Laura Reiley and Jenna Portnoy contributed to this report.
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