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

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. 

The harmful levels of lead prompted us to work with Austrofood to quickly voluntarily recall the impacted product. Austrofood is the manufacturer of the recalled pouches and manufactured the pouches at the company’s Ecuadorian facility. The FDA’s leading hypothesis is that the contamination of the cinnamon was an act of economically motivated adulteration. The FDA has initiated additional efforts to prevent future lead-related incidents, including taking a closer look at cinnamon and other spices in our food supply, especially those in foods that are often consumed by babies and young children. 

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 particular 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. By shipping the apple cinnamon fruit puree pouches to the U.S., Austrofood caused the introduction or delivery for introduction into interstate commerce of adulterated food in violation of section 301(a) of the FD&C Act.

This warning letter is one example of our 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 a number of brands at six different retail chains that were found to contain elevated levels of lead. 

Our state partners have also been continuously sampling and testing pure ground cinnamon products in the marketplace for levels of lead. These surveillance activities uncovered the elevated levels of lead in certain ground cinnamon products sold at retail stores, which led to additional ground cinnamon recalls and the issuance of two public health alerts in late July. We appreciate our state partners who continue to monitor cinnamon in the marketplace across the country. 

Protecting our food supply, especially foods intended for babies and young children, is an agency priority – but also a task that requires partnership and collaboration. Industry is the first line of defense when it comes to upholding the safety of the products that make it to store shelves. That’s why in a letter sent in March, we also reminded manufacturers, processors, distributors and facility operators who process or handle cinnamon of their responsibility to follow the PC Human Food Rule. 

The March letter to industry further explains that 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. Manufacturers of such products are required to appropriately analyze hazards and take steps to prevent hazardous products from entering the U.S. food supply.

Our work in this space is also focused on implementing a strategic, long-term iterative approach to reducing childhood dietary exposure to lead, arsenic, cadmium and mercury through the FDA’s Closer to Zero initiative. We’re focused on reducing dietary exposure to environmental contaminants to as low as possible, while maintaining access to nutritious foods. As part of this initiative, in Jan. 2023, the FDA published draft action levels for lead in foods intended for babies and young children and is aiming to issue a final guidance in 2024. 

Additionally, we are asking Congress for the authority to establish binding contamination limits in foods, including those consumed by infants and young children, via an administrative order process. Such binding limits would require industry to ensure only an allowable amount or less of a contaminant such as lead, arsenic, cadmium and mercury be in a food product. This new authority would not only provide us a faster way to establish binding limits but also an expeditious way to update limits as new scientific information becomes available.

The FDA is also seeking authority to require industry to test final products for contaminants and to maintain records that the FDA could remotely access and review. Additionally, the FDA is seeking to expand the agency’s mandatory recall authority to mandate recalls for more contaminated foods or ingredients. This new authority would help us to better understand levels of contaminants in foods, allow the FDA to monitor industry progress in reducing levels over time and identify where we should devote more time and resources to better protect infants and young children.  

In addition, the FDA is continuing oversight of foreign firms and imported foods, including through increased and more targeted import screening. As such, the agency has also placed Negasmart, the distributor of the cinnamon used in the contaminated applesauce products, on multiple import alerts, including Import Alert 99-47 regarding products that appear to be adulterated for economic gain and Import Alert 99-42 for products that are contaminated with heavy metals and appear to be adulterated under section 402(a)(1) of the FD&C Act.  

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. We will continue to provide additional updates on our post-incident response page. 

Related Information

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Source: U.S. Food and Drug Administration (FDA.gov)