The FDA is continuing to coordinate with Ecuadorian authorities on the investigation of the source of elevated lead levels in cinnamon apple pouches. In addition, the Ecuadorian authorities report that Negasmart's cinnamon had higher levels of lead than allowed by Ecuador and that Negasmart, the supplier of cinnamon to Austrofoods, is currently under an Ecuadorian administrative sanctions process to determine the responsible party for the contamination.
As of Dec. 5, 2023, FDA has received 64 reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people who an adverse event was submitted for, are under 6 years of age.
To date, the FDA has included adverse event reports submitted directly to the FDA that note blood lead levels at or above 3.5 micrograms of lead per deciliter of whole blood (µg /dL) within three months after consuming recalled product. The FDA is continuing to evaluate incoming adverse reports of illnesses. For background, the Centers for Disease Control and Prevention’s (CDC) blood reference level of 3.5 µg /dL is the level at which the CDC recommends clinical monitoring of lead exposure in children.
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. As of December 1, CDC has received reports of 18 confirmed cases, 30 probable cases and 4 suspected cases from 13 different states through their reporting structure. For more information, please visit CDC’s page to review their case reporting methodology and findings.
CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond. In addition, some people who were affected by the contaminated product might be reflected in both the numbers reported by the FDA and the numbers reported by CDC, so the numbers should not be added together.
The FDA relies on self-reported information submitted by healthcare providers, consumers and some state partners who submitted an adverse event report to FDA as an initial step in determining if a product is a potential shared source of exposure amongst complainants. Unlike outbreaks of foodborne illnesses that are genetically linked to pathogens, lead exposure in an individual can result from several sources. There is no established method to link lead exposure in an individual to a specific source, which can make establishing a causal relationship difficult.
FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.