Post- Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches
Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches
Investigation Summary
In October 2023, the FDA, in collaboration with state and local partners, initiated an investigation into reports of children with elevated blood lead levels, indicating potential acute lead toxicity. The investigation led to the FDA issuing a safety alert and a firm – WanaBana – initiating a recall of their Apple Cinnamon Fruit Puree products in late October 2023. In November 2023, WanaBana expanded their recall announcement to include additional brands of products. Also subject to recall were: 1) certain Schnucks cinnamon-flavored applesauce pouches and variety packs and 2) certain Weis cinnamon applesauce pouches.
To determine the source of the lead contamination, the FDA led an investigation, which is detailed here: Investigation of Elevated Lead and Chromium Levels: Cinnamon Applesauce Pouches and Chromium Levels: Cinnamon Applesauce Pouches.
Through FDA’s processes for incident response and investigation, and in conjunction with our regulatory partners and industry, we identified the source of the lead contamination and ensured that the unsafe product was removed from the U.S. market. As a result of our investigation, the FDA’s leading hypothesis is that this contamination event was the result of economically motivated adulteration of the cinnamon used in the applesauce. Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food, or when a substance is added to a food to make it appear better or of greater value. In some cases, EMA can result in negative health impacts for those who consume the adulterated product.
The FDA has transitioned from its initial response activities to contain the event so that no additional illnesses occurred and to identify the source of the issue. The agency is now focused on post-incident response actions and activities, which may include additional surveillance, as well as prevention and compliance activities. The FDA will continue to update this page with additional actions that occur related to this incident.
FDA Complaint/Adverse Event Report Overview
As of March 2024, the FDA has received over 200 reports of adverse events potentially related to the cinnamon apple sauce pouches in the CFSAN Adverse Event Reporting System (CAERS); however, the agency has only been able to confirm 90 as of January 31, 2024, as noted in the investigation page. For reference, the FDA defined confirmed complaints as those reports submitted directly to the FDA that note elevated blood lead levels of 3.5 µg/dL or higher, detected through laboratory testing in a person within three months after consuming apple cinnamon puree pouches manufactured by AustroFood S.A.S (Ecuador) after November 2022.
Both healthcare providers and consumers may submit reports voluntarily to CAERS. While the FDA reviews every report submitted, at times there may not be enough information to follow up or to confirm the source or scope of the issue. The agency will continue to work with the Centers for Disease Control and Prevention (CDC), which is also tracking reports related to this incident.
FDA Post-Incident Response Activities and Actions
On March 6, 2024, the FDA issued a safety alert advising consumers not to buy or eat certain ground cinnamon products because samples of these products were found to contain elevated levels of lead and because prolonged exposure to these products may be unsafe and could contribute to elevated levels of lead in the blood. The alert followed FDA’s targeted lead analysis survey that focused on discount ground cinnamon products from discount retail stores, and additional testing by states under the Laboratory Flexible Funding Model Cooperative Agreement (LFFM). The FDA initiated this testing to evaluate the presence of lead in cinnamon following the October 2023 voluntary recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children.
Details about our sampling, testing and the safety alert can be found at the following links:
- FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead
- A Conversation with FDA on Steps the Agency is Taking to Address Unsafe Levels of Lead Found in Cinnamon
As part of our response to the findings in the retail sampling assignment, the FDA also sent a letter to cinnamon manufacturers, processors, distributors and facility operators in the U.S. reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including in ground cinnamon products. The FDA will continue to work with firms to ensure they are meeting their responsibilities under provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.
Additional Activities
The FDA is continuing work to optimize oversight of foreign firms and imported foods, including through increased and more targeted import screening. The agency will continue to explore additional surveillance, as well as prevention and compliance activities.
In addition to continued work with manufacturers, distributors, and retailers to remove unsafe products from the market and further investigation into the sources of lead contamination, the FDA is also continuing to sample through its Toxic Elements monitoring program, targeted assignments, and through testing by states. This testing of a variety of foods includes colored spices offered for sale in the U.S. Imported foods with levels of toxic elements that may be unsafe can be placed on Import Alert 99-42 and detained without physical examination. In addition, our previous and ongoing sampling at import has prevented some cinnamon with elevated lead levels from entering U.S. commerce; however, like all of our surveillance activities, these monitoring programs only evaluate a small subset of the commodity being imported. Ultimately, it is the responsibility of the manufacturers and the importers to ensure the safety of the products entering the U.S. market. The FDA also works on several fronts to combat economically motivated adulteration, especially adulteration that leads to food safety hazards. Our efforts include signals monitoring, risk prioritization, surveillance, and enforcement actions.
The FDA is also looking to work with the spice industry to provide awareness about these findings so that the spice industry can make informed decisions that help ensure the safety of their products. FDA staff are participating in an international Codex Alimentarius (Codex) Commission meeting in the spring of 2024 to work toward development of a recommended international maximum level for lead in bark spices like cinnamon. The purpose of Codex is to protect the health of consumers and promote fair trade practices by adopting scientifically based standards, guidelines, and codes of practice across all areas of food safety and quality. The FDA will follow up on these findings as well as continue our surveillance activities concerning imported spices to prevent unsafe cinnamon from reaching consumers in the U.S., including adding firms and products to import alerts such as Import Alert 99-42 where appropriate.