The U.S. Food and Drug Administration has issued a stern warning to Austrofoods, the Ecuador-based manufacturer of pouches of apple-cinnamon fruit puree that were recalled last year after they were found to contain dangerously high levels of lead and chromium.
The August 9, 2024 warning letter just released by the FDA is part of the agency’s ongoing efforts to ensure the safety of cinnamon and other spices, especially in products consumed by infants and young children.
The FDA investigation, conducted in collaboration with the state health and agriculture departments in North Carolina, Maryland and Pennsylvania, began in the fall of 2023 after harmful levels of lead and chromium were discovered in the bags of apple cinnamon puree. These pouches, manufactured at Austrofood’s facility in Ecuador, were distributed in the United States by WanaBana USA LLC. The FDA’s main hypothesis is that the contamination is the result of economically motivated adulteration of the cinnamon used in the product.
“Protecting our food supply, especially food intended for infants and young children, is an agency priority,” said Jim Jones, FDA deputy commissioner for human nutrition. “The safety of cinnamon and other spices in our food supply is something we take very seriously, and we are committed to working with our state partners and industry to ensure these products do not pose a risk to public health.”
Outbreak linked to lead-contaminated applesauce
The contamination found in Austrofood’s apple-cinnamon fruit puree pouches wasn’t just a regulatory problem; it resulted in a significant public health crisis. The lead poisoning outbreak in the fall and winter of 2023 sickened at least 519 children in 44 states, according to the Centers for Disease Control and Prevention.
The recall involved three brands of cinnamon applesauce sold in pouches and marketed to children: WanaBana, Schnucks and Weis. All affected products contain lead-contaminated cinnamon. The FDA was first notified of the lead contamination in mid-September 2023 by public health officials in North Carolina, who had identified the contaminated applesauce as a common factor in children with elevated blood lead levels.
On October 28, 2023, the FDA formally warned US consumers about the contamination after discussing the analytical findings with Austrofood. The agency urged consumers to avoid the recalled products, which include pouches of WanaBana apple-cinnamon fruit puree, pouches of Schnucks brand cinnamon-flavored applesauce and pouches of Weis brand cinnamon-applesauce.
Violations of federal food safety regulations
The warning letter to Austrofood cited multiple rule violations of the current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (PC Human Food Rule). Before the recall, Austrofood failed to conduct an appropriate hazard assessment to identify and evaluate lead in cinnamon as a potential risk requiring preventative control. This surveillance is especially concerning given the known prevalence of lead in spices and the vulnerability of young children to the negative health effects of lead exposure.
The FDA letter emphasized that the presence of lead at the levels found in the apple-cinnamon puree bags made these products adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). By shipping these contaminated products to the U.S., Austrofood violated Section 301(a) of the FD&C Act, which prohibits the introduction of adulterated foods into interstate commerce.
Continued industry efforts and responsibilities
As part of its broader efforts to improve food safety, the FDA has initiated targeted sampling and testing of cinnamon sold in discount stores. This initiative led to the recall of certain ground cinnamon products found to contain elevated levels of lead. The FDA has also placed Negasmart, the distributor of the contaminated cinnamon used in Austrofood’s products, on multiple import warnings, including warnings related to economic adulteration and heavy metal contamination.
The FDA is also seeking new authorities from Congress to set binding limits on the contamination of foods, especially those consumed by infants and young children. This would allow the FDA to more quickly mandate recalls and update limits as new scientific information becomes available. In addition, the agency is asking for the authority to require industry to test finished products for contaminants and maintain data that the FDA can access and review remotely.
“Our work in this area is also focused on implementing a strategic, iterative, long-term approach to reducing children’s exposure to dietary lead, arsenic, cadmium and mercury through the FDA’s Closer to Zero initiative,” said Jones . “We are focused on minimizing dietary exposure to environmental pollutants while maintaining access to nutritious food.”
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