FDA Identifies Suspect in Lead Contamination Investigation

On Tuesday, the FDA announced a suspect in the WanaBana cinnamon-applesauce pouch contamination investigation. Per the FDA, Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, the processor of the ground cinnamon supplied by Negasmart to Austrofoods and later used in recalled apple cinnamon products, is the likely source of contamination. According to ARCSA, the unprocessed cinnamon sticks used in recalled products were sourced from Sri Lanka and were sampled by ARCSA and found to have no lead contamination. ARCSA’s investigation and legal proceedings to determine ultimate responsibility for the contamination are still ongoing.

The FDA noted that it has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera.

As of February 2, there were 100 confirmed cases of lead poisoning, 277 probable cases and 36 suspected cases of for a total of 413 cases from 43 different states. As of February 5, 2024, no additional cases had been reported, and the FDA stated that it has no indication that this issue extends beyond these recalled products nor has it received any confirmed reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon. Confirmed complainants, or people for whom a complaint or adverse event was submitted and met FDA’s complainant definition, are between zero and 53 years of age and the median age is one year old.

CDC’s National Center for Environmental Health is conducting case finding efforts in collaboration with state and local health departments. CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within three months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022.

 

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