FDA Provides Update on Lead Contamination Issue in Apple Cinnamon Sauce Product

In the most recent update on the lead poisoning associated with cinnamon apple pouches, FDA states that there as of Nov 30, there are 57 reported cases (there were 34 reported on Nov 16). To date, confirmed complainants are aged less than 1 to 5 years of age. FDA also identified the supplier of the cinnamon, thought to be the source of the lead in the finished product. The product was produced in Ecuador by Austrofood and was distributed by Wanabana USA, the distributor of WanaBana products.  "The cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador."

"The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S."

Adverse Event Overview
Total FDA Adverse Events: 57*
Report Date Ranges: October 17, 2023 – November 28, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2) IA (1), IL (2), KY (3), LA (4), MA (3), MD (4), MI (3), MO (1), NC (5), NE (1), NH (1), NM (1), NY (8), OH (2), PA (1), SC (2), TN (1), TX (3) VA (1), WA (3)
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.

Current Update
November 30, 2023

On November 30, 2023, Austrofood, along with Wanabana USA, the distributor of WanaBana products in the United States, released a statement that reports that Wanabana has conducted a root cause investigation. Based on this investigation, the firm’s leading hypothesis to date is that the cinnamon is the source of the elevated lead levels in the recalled products. The statement released today by Wanabana USA and Austrofood states that the cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador.

The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S.

As of November 30, 2023, there have been 57 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 5 years of age.




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, there is no method to link lead exposure to a specific source, which can make establishing a causal relationship complicated.




While our total reports included in this advisory represent complaints that have been reported to FDA, we recognize there are other avenues for reporting of elevated lead levels. For example, through case reporting from the state health departments to CDC which is routinely done for cases of childhood lead exposure. Because these different avenues for reporting represent two different mechanisms of collecting data, we are currently not including them in our advisory. 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. At this time, FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. As of November 30, 2023, there have been no screening results that have tested positive for higher levels of lead. Separately, Austrofood CIA LDA’s apple cinnamon fruit puree pouch products exported to the U.S. were added to Import Alert 99-42, detention without physical examination of foods due to heavy metal (toxic element) contamination.




FDA will update the advisory as information becomes available.