Overview of FDA’s Action Against Austrofood
In a decisive move, the U.S. Food and Drug Administration (FDA) has issued a warning letter to Austrofood, the manufacturer behind the recalled apple cinnamon fruit puree pouches. These pouches were found to contain harmful levels of lead and chromium, sparking concerns over the safety of cinnamon products sold in the U.S. This action is part of the FDA’s ongoing efforts to protect the food supply, particularly products consumed by babies and young children.
Investigation and Findings
The investigation, initiated last fall in collaboration with state regulatory partners from North Carolina, Maryland, and Pennsylvania, uncovered that the apple cinnamon fruit puree pouches produced by Austrofood at their Ecuadorian facility were contaminated with dangerous levels of lead and chromium. The FDA’s working theory is that the contamination may have been a result of economically motivated adulteration.
FDA’s Warning to Austrofood
On August 9, the FDA issued a warning letter to Austrofood, citing violations of the Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PC Human Food Rule). The letter noted that Austrofood failed to conduct a proper hazard analysis that would have identified lead in cinnamon as a foreseeable risk, especially given its prevalence in spices and the vulnerability of young children to lead exposure.
The warning letter further classified the presence of lead in these products as a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). By distributing these contaminated products in the U.S., Austrofood violated section 301(a) of the FD&C Act, which prohibits the introduction of adulterated foods into interstate commerce.
Continuing FDA Efforts
The FDA is not stopping at this warning letter. The agency has ramped up efforts to scrutinize cinnamon and other spices, particularly those used in products consumed by infants and young children. Earlier this year, targeted sampling and testing of cinnamon products from discount retail stores led to multiple recalls due to high levels of lead.
State partners have played a crucial role by continuously sampling and testing ground cinnamon products, leading to additional recalls and public health alerts. The FDA commends these ongoing efforts to keep the marketplace safe.
Responsibilities of the Industry
In March, the FDA reminded manufacturers, processors, distributors, and facility operators handling cinnamon of their obligation to comply with the PC Human Food Rule. The letter emphasized the risk of lead contamination in spices, including cinnamon, and the importance of conducting thorough hazard analyses to prevent contaminated products from entering the U.S. food supply.
Strategic Initiatives Under Closer to Zero
The FDA’s actions are part of a broader strategy under the Closer to Zero initiative, which aims to reduce dietary exposure to environmental contaminants like lead, arsenic, cadmium, and mercury in foods, particularly those consumed by young children. As part of this initiative, the FDA published draft action levels for lead in January 2023 and plans to issue final guidance in 2024.
Legislative Requests to Enhance Food Safety
To further strengthen food safety, the FDA is requesting authority from Congress to:
- Establish binding contamination limits in foods through an administrative order process.
- Mandate industry testing of final products for contaminants, with records that the FDA can remotely access.
- Expand mandatory recall authority to include a broader range of contaminated foods and ingredients.
These measures would enable the FDA to more effectively monitor and reduce contaminant levels, enhancing the protection of infants and young children.
Strengthened Import Oversight
The FDA is also increasing oversight of foreign firms and imported foods. Negasmart, the distributor of the cinnamon used in Austrofood’s contaminated products, has been placed on multiple import alerts for products suspected of being adulterated or contaminated with heavy metals.
Conclusion
The FDA remains vigilant in its efforts to ensure the safety of cinnamon, ground spices, and other food products in the U.S. The agency will continue working with federal and state partners to reduce contaminant levels in foods, particularly those intended for infants and young children. Updates on these efforts will be provided on the FDA’s post-incident response page.
Related Information
- Constituent Update: FDA Issues Warning Letter to Manufacturer of Apple Cinnamon Fruit Puree Products Containing Elevated Levels of Lead and Chromium
- Warning Letter to AUSTROFOOD S.A.S. (Austrofood)
- Post-Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches
- Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches
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