FDA Issues Warning Letter to Austrofood

Published on August 19, 2024

FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.

For Immediate Release

YAVAPAI COUNTY, Arizona. –  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. 

On Aug. 9, the FDA issued a warning letter to Austrofood, the manufacturer of the apple cinnamon fruit puree pouches that were recalled last fall. The warning letter cites Austrofood for violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food Rule). Before the recall, Austrofood did not appropriately conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard (in this case, lead in cinnamon as an ingredient in apple cinnamon fruit puree pouches) to determine whether that hazard required a preventive control. The letter states that considering the known prevalence of lead in spices such as cinnamon and the intended consumers of the finished product, including susceptibility of young children to the negative health effects of lead exposure, a knowledgeable person at the Austrofood facility would identify lead in the cinnamon as a hazard requiring a preventive control.

The warning letter also states that the presence of the levels of lead in the apple cinnamon fruit puree pouches causes these products to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they bear or contain an added poisonous or deleterious substance which may render them injurious to health. This warning letter is one example of continued action to ensure the safety of cinnamon and other spices in our food supply.

Earlier this year, the FDA initiated targeted sampling and testing of cinnamon sold at discount retail stores. This effort led to the voluntary recall of certain ground cinnamon products sold by several brands at six different retail chains that were found to contain elevated levels of lead. Lead is often found in spices, including cinnamon, from the environment where it is grown or processed. Lead can also be present through the intentional addition to spices (e.g., turmeric, paprika, and cinnamon powder), likely for economic gain.

Protecting food supply, especially foods intended for babies and young children, is an agency priority – but also a task that requires partnership and collaboration. Colleagues in the FDA’s human foods program continue to remain steadfast in 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.

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FDA-Issues-Warning-Letter-to-Austrofood-and-Continues-Robust-Activities-to-Ensure-Safety-of-Cinnamon-Products-Sold-in-U.S.pdf(PDF, 201KB)