The FDA report a total of Adverse Events: 64
Report Date Ranges: October 17, 2023 – December 1, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2), IA (1), IL (3), KY (3), LA (4), MA (3), MD (6), MI (3), MO (1), NC (5), NE (2), NH (1), NM (1), NY (8), OH (3), PA (1), SC (2), TN (1), TX(3), VA(2), WA (3), WI (1)
Product Distribution: Nationwide
The CDC has received the following reports from state and local health departments:
- Total Cases: 52
- Confirmed Cases: 18
- Probable Cases: 30
- Suspect Cases: 4
- States: CO, FL, ID, IL, KS, KY, LA, MN, NE, OH, OR, TX, WV
- Recall: Yes
- Investigation status: Active
FDA has initiated an onsite inspection at the Austrofoods facility located in Ecuador. Ingredient sample collection is underway.
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 December 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 3 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 3 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.
While our total reports included in this advisory represent adverse event reports that have been submitted to FDA, we acknowledge that there are other avenues for reporting of lead exposure. However, we are working with our state partners and CDC to gather and evaluate as much data as possible, while recognizing there are different mechanisms being leveraged.
FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. FDA will update the advisory as information becomes available.