Austrofood and Wanabana USA, distributors behind recalled applesauce pouches, say that cinnamon used to manufacture the products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador.
FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine whether 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, there have been 57 reports of adverse events potentially linked to recalled product submitted to FDA. To date, those who have been confirmed to be impacted are younger than 5 years old.
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 whether 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.
FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the agency 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 and, as of November 30, there have been no screening results that have tested positive for higher levels of lead.
The list of recalled products can be found on FDA’s website.