The recalled WanaBana cinnamon applesauce pouches potentially linked to lead poisonings in hundreds of people across the United States were likely contaminated by a single cinnamon processor in Ecuador, the Food and Drug Administration said Tuesday.
Ecuadorian officials have identified Carlos Aguilera, a cinnamon processor, as “the likely source of contamination” of the applesauce pouches, the FDA said.
Aguilera sourced his cinnamon from Sri Lanka. According to Ecuadorian officials, the cinnamon sticks were free from lead contamination before they were processed.
Aguilera is just one part of supply chain for the Florida-based WanaBana cinnamon applesauce pouches. The pouches are made at a facility in Ecuador called Austrofoods, which sources its cinnamon from another Ecuadorian supplier called Negasmart. Negasmart, in turn, got its cinnamon from Aguilera, according to Ecuadorian officials.
The investigation and legal proceedings by officials in Ecuador to determine ultimate responsibility for the contamination are still ongoing, the FDA said, but Aguilera's business is not operating at this time.
In an interview with the Ecuadorian newspaper El Universo, Aguilera denied the accusation, saying he did not contaminate the cinnamon. He said that officials sampled products processed in three of his mills and did not find lead.
WanaBana did not immediately respond to a request for comment. NBC News was unable to reach Negasmart.
WanaBana has previously said it is working with the FDA on its investigation.
Since late last year, the FDA has been investigating lead contamination in WanaBana apple cinnamon fruit puree, along with two other products made by WanaBana: the supermarket brands Schnucks apple sauce pouches with cinnamon and Weis cinnamon apple sauce. The FDA had homed in on the cinnamon as the most likely source of contamination and the agency had said that the contamination may have been intentional.
As of Feb 2., the Centers for Disease Control and Prevention had received 413 reports of elevated blood lead levels linked to the pouches in 43 states.
It’s unclear what regulatory or legal action, if any, the FDA can take against Aguilera. The FDA did not immediately respond to a request for additional comment.
However, the agency said in the release Tuesday that it has “limited authority” over foreign ingredient suppliers who do not directly ship products to the U.S., meaning the agency “cannot take direct action” against Negasmart or Aguilera. It is Austrofoods, not Negasmart or Aguilera, that ultimately ships products to the U.S.
An FDA spokesperson told NBC News last week that if the agency determines that applesauce pouches had been adulterated, it can take regulatory action, which may include “working with the manufacturer to resolve the issue, and, as appropriate, taking steps to prevent the product from entering, or remaining, in the U.S. market.”
The FDA noted that it is working with U.S. Customs and Border Protection to screen for any products from Negasmart or cinnamon being imported from Ecuador.
To date, the spokesperson said, the FDA has confirmed that Negasmart does not ship products directly to the U.S., nor do Negasmart’s customers. The statement did not mention products from Aguilera.
