WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has intensified its efforts to ensure the safety of cinnamon products sold in the United States. This follows the issuance of a warning letter to Austrofood, the manufacturer of apple cinnamon fruit puree pouches recalled last fall due to contamination with harmful levels of lead and chromium.
Jim Jones, FDA’s Deputy Commissioner for Human Foods, emphasized the gravity of the situation. “Last fall, the U.S. Food and Drug Administration and our regulatory health partners at the North Carolina Department of Health and Human Services, the North Carolina Department of Agriculture & Consumer Services, the Maryland Department of Health and the Pennsylvania Department of Agriculture initiated an investigation of apple cinnamon fruit puree pouches that were recalled after they were found to be contaminated with harmful levels of lead and chromium,” he stated. Jones added, “The harmful levels of lead prompted us to work with Austrofood to quickly voluntarily recall the impacted product.”
On August 9, the FDA issued a warning letter to Austrofood, citing violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food Rule). The letter highlighted Austrofood’s failure to conduct a proper hazard analysis to identify lead in cinnamon as a foreseeable hazard, particularly given the susceptibility of young children to lead exposure.
The FDA’s actions are part of a broader initiative to prevent lead-related incidents. Earlier this year, the FDA initiated targeted sampling and testing of cinnamon sold at discount retail stores. This led to the voluntary recall of certain ground cinnamon products found to contain elevated levels of lead. State partners have also been actively sampling and testing pure ground cinnamon products, resulting in additional recalls and public health alerts.
Protecting the food supply, especially for babies and young children, remains a priority for the FDA. In March, the agency reminded manufacturers and distributors of their responsibility to follow the PC Human Food Rule. The FDA’s Closer to Zero initiative aims to reduce childhood dietary exposure to contaminants like lead, arsenic, cadmium, and mercury to the lowest possible levels.
In January 2023, the FDA published draft action levels for lead in foods intended for young children, with final guidance expected in 2024. The FDA is also seeking new authority from Congress to establish binding contamination limits in foods and to require industry testing of final products for contaminants. This would enable the FDA to monitor industry progress and enforce compliance more effectively.
Moreover, the FDA has increased oversight of foreign firms and imported foods. Negasmart, the distributor of the contaminated cinnamon, has been placed on multiple import alerts, including those for economically motivated adulteration and contamination with heavy metals.
Jones reiterated the FDA’s commitment to food safety: “Myself and colleagues in the FDA’s human foods program continue to remain steadfast in our dedication to enhance the safety of cinnamon, ground spices, and other products sold in the U.S., reduce dietary exposure to heavy metals and work with federal and state partners to reduce contaminant levels in food products particularly those consumed by babies and young children.”
The FDA’s robust actions accentuate the importance of industry compliance and collaboration with state partners to safeguard public health. The agency states that it will continue to provide updates on its post-incident response efforts.
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