FDA Investigation into Lead Contamination in Apple Cinnamon Product, Cinnamon Identified as Probably Source

The FDA investigation into the lead contamination in the apple cinnamon fruit pouches continues. The product, manufactured in Ecuador, has resulted in lead poisoning in 34 reported individuals, primarily children. The company initially issued a recall on October 30, 2023, and then expanded the recall on November 13, 2023 to include additional brands of product.

To this point in time, FDA has not found lead in non-cinnamon product, which leads them to believe that the cinnamon is the source of the lead.  The FDA has not been able to test the specific cinnamon used in the product.

The importer is responsible for the safety of product brought into the United States.  As part of FSMA, companies must have FSVP (Foreign Supplier Verification Programs) in place for each imported food item.  As part of that program, importers must conduct a hazard analysis and then develop and implement verification activities for any significant hazard identified.  Foreign manufacturers must be in compliance with Preventive Controls for Human Foods regulations.  As part of that, they must conduct a hazard analysis for their operation and utilize programs that ensure GMP standards are met.

Total Adverse Events: 34*
Report Date Ranges: October 17, 2023 – November 15, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), IL (1), LA (3), MD (2), MI (1), MO (1), NC (5), NE (1), NH (1), NM (1), NY (4), OH (1), PA (1), SC (2), TN (1), TX (1), VA (1), WA (1), Unknown (1)
Product Distribution: Nationwide

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 16, 2023

FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.

 
As of November 16, 2023, there have been 34 reports of illness potentially linked to recalled product submitted to FDA. FDA is continuing to evaluate incoming adverse reports of illnesses.

FDA and other state partners collected and analyzed additional product samples of fruit puree and applesauce pouches. FDA detected elevated levels of lead in one finished product sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree. The level detected in the FDA sample of WanaBana apple cinnamon puree is 2.18 parts per million (ppm), which, for context, is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

To date, sample analysis of WanaBana, Weis, and Schnucks fruit puree pouches that do not contain cinnamon and are not part of the recall, have not shown elevated levels of lead.

FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination for these products; however, the FDA has not yet been able to collect and test samples of the cinnamon used in the recalled products. The FDA is continuing to work with Ecuadorian authorities to investigate the source of the cinnamon. 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.

In addition to determining the source of cinnamon, FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.

The FDA also reminds industry that it is the legal responsibility of companies distributing food products that are sold in the U.S., to comply with applicable requirements in the Federal Food, Drug, and Cosmetic Act and FDA's regulations.

By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed. This includes putting in place any needed preventive controls to reduce or eliminate the presence of lead in their products. Most food manufacturers and processors are covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards, such as lead, requiring a control. In addition, some manufacturers may conduct verification activities like testing the final product.

For more information please see FDA’s Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food.

FDA will update this advisory as information becomes available.

Adverse Event Overview
Total Adverse Events: 34*
Report Date Ranges: October 17, 2023 – November 15, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), IL (1), LA (3), MD (2), MI (1), MO (1), NC (5), NE (1), NH (1), NM (1), NY (4), OH (1), PA (1), SC (2), TN (1), TX (1), VA (1), WA (1), Unknown (1)
Product Distribution: Nationwide

*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.