FDA identifies cinnamon supplier for recalled applesauce

A root cause analysis furthers the hypothesis that cinnamon is the source of the elevated lead levels in recalled applesauce products, FDA revealed in an email on Nov. 30. The analysis, conducted by WanaBana USA, the distributor of the lead-tainted applesauce, and Austrofood, the manufacturer, aligns with FDA’s initial theory.

The supplier of the cinnamon used in the contaminated products has been identified as Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador. The distributor’s source of cinnamon has not been named. FDA is working with Equadorian authorities to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA stated Negasmart does not import cinnamon directly to the United States.

The agency is continuing its investigation to determine the actual point of contamination. To date, FDA has not seen evidence that the issue with lead extends beyond the recalled products.

As a precaution, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. As of Nov. 30, no samples have tested positive for high levels of lead.

Additionally, an import alert was issued for apple cinnamon fruit puree pouch products exported to the U.S. by Austrofood Cia. Lda. The alert calls for detention without physical examination of foods due to heavy metal (toxic element) contamination.

As of Nov. 30, there have been 57 reports of adverse events in children less than 1 to 5 years of age that are potentially linked to recalled products submitted to FDA. The exact number of cases, however, may be higher, as there are different ways of reporting lead exposure. For instance, rather than an individual contacting FDA, state health departments may file a report with CDC. To further complicate traceback, there is not a method to link lead exposure to a specific source, as is the case with identification of genetically linked pathogens involved in foodborne illness outbreaks.