Through product testing by state programs and confirmed by the FDA, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products.
Source: Food and Drug Administration
The FDA has recommended that the firms voluntarily recall these products. The FDA will update this notice with the communications from firms that voluntarily agree to recall as we receive them. Please see our previous alerts on ground cinnamon products, March 6, 2024 alert, and July 25, 2024 alert, for a list of additional ground cinnamon products previously recommended for recall.
The FDA is continuing to analyze cinnamon and review sample results received from state partners who have been continuously sampling ground cinnamon at retail for elevated levels of lead. This public health alert will be updated as necessary if the FDA finds that additional products contain elevated levels of lead and that exposure to these products may be unsafe.
Purpose
The FDA is advising consumers to throw away and not to buy the ground cinnamon products listed above because samples of these products were found to contain elevated levels of lead. Based on the FDA’s assessment, prolonged exposure to these products may be unsafe and could contribute to elevated levels of lead in the blood. No illnesses or adverse events have been reported to date in association with these products.
While the ground cinnamon products in this alert may not be a food targeted to young children, cinnamon is used in many foods young children consume. Consistent with the agency’s Closer to Zero initiative, which focuses on reducing childhood exposure to lead, the agency is recommending voluntary recall of the products listed above because prolonged exposure to the products may be unsafe. Removing the ground cinnamon products in this alert from the market will prevent them from contributing elevated amounts of lead to the diets of children.
Summary of Problem and Scope
The FDA is taking the additional step in issuing a third public health alert this year for ground cinnamon to ensure the safety of ground cinnamon used in foods that are frequently consumed by babies and young children. In this third alert, the FDA is recommending recalls of nine brands of ground cinnamon products with elevated lead levels ranging from 2.03 to 7.01 parts per million (ppm) (see table above for a full list of lead levels in these products). These levels are significantly lower than the levels of lead associated with the WanaBana cinnamon apple puree and applesauce products recalled in the fall of 2023, which had between 2,270 ppm to 5,110 ppm lead in the cinnamon.
During the last year, prior to the recall of WanaBana apple puree and applesauce products containing elevated levels of lead and chromium, the FDA asked states to prioritize testing of ground cinnamon and other spices. Following the FDA’s targeted assessment of ground cinnamon products for lead and chromium and the FDA public health alert issued earlier this year, several states provided the FDA with data for samples of ground cinnamon collected through the Laboratory Flexible Funding Model (LFFM). This is a cooperative agreement with states to help investigate, monitor and remove adulterated foods from commerce and aid regulatory programs. California, Maryland, Missouri, Connecticut, and Virginia collected ground cinnamon samples through the LFFM, in addition to samples collected outside the LFFM from the New York State Department of Agriculture and Markets, all included in this public health alert. The FDA is continuing to review sample results received from state partners who have been continuously sampling ground cinnamon at retail for elevated levels of lead and will update this alert as necessary if the FDA finds that additional products contain elevated levels of lead and that exposure to these products may be unsafe.
FDA Actions
The FDA continues to work with states to test cinnamon sold directly to consumers at retail and to test cinnamon at import. The FDA will continue our activities at import to prevent unsafe cinnamon from reaching consumers in the U.S., including adding firms and products to import alert where appropriate.
For ingredient suppliers and final products that contain cinnamon, the FDA advises both domestic and foreign food suppliers to voluntarily test their products to ensure safety. Ultimately, it is the responsibility of the manufacturers and the importers to ensure the safety of the products that enter into the U.S. market. In March 2024, the FDA 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.
The FDA is also continuing its Toxic Elements monitoring program, which includes testing of a variety of foods, including colored spices offered for sale in the U.S. In addition to sampling, as part of the FY2025 Legislative proposal, the FDA is seeking to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expressly require industry to conduct testing of final products, including those marketed for consumption by infants and young children, for contaminants and maintain such records of these testing results for FDA inspection.
