FDA declares tara flour unsafe following outbreak

In a recent announcement, the US Food and Drug Administration (FDA) has determined that tara flour, a previously used ingredient in human food, does not meet the safety standards required for Generally Recognized As Safe (GRAS) status. The decision comes after an outbreak in 2022, which affected more than 400 individuals who consumed products containing tara flour.    

The affected individuals exhibited symptoms of food poisoning, along with liver and gallbladder problems. Promptly responding to the outbreak, the producer voluntarily recalled the product and conducted an analysis, which identified tara flour as a potential contributor to the illnesses.    

Although the FDA has not definitively established a causal relationship between tara flour and the outbreak, it prompted a comprehensive evaluation of the ingredient's regulatory status. The examination revealed a lack of historical safe use and data supporting the GRAS designation for tara flour. Consequently, the FDA has classified tara flour as an unapproved food additive, rendering any food containing it adulterated.    

The FDA underlines the responsibility of manufacturers considering the use of tara flour in food to ensure its safety and legality. The agency recommends consulting with the FDA during the formulation process. Currently, there is no evidence of domestic development or manufacturing of tara flour-containing products in the United States. To ensure compliance, the FDA has implemented screening procedures at ports of entry to detect imported tara flour used as an ingredient in food or sold in bulk. However, no recent shipments of tara flour have been detected thus far.    

The FDA's decision aligns with the actions taken by the Canadian Food Inspection Agency (CFIA), which banned the use of tara flour in Canada in September 2023. The CFIA's decision was based on similar findings of safety concerns associated with tara flour.    

The determination that tara flour is not GRAS emphasizes the importance of thorough scientific evaluation and consensus among experts regarding the safety of food ingredients. Established in 1958, the GRAS designation allows food companies to bypass the traditional premarket approval process by demonstrating a long-standing history of safe use.    

With the banning of tara flour in the United States, the food industry is expected to adjust its formulations and source alternative ingredients that comply with the FDA's safety standards. This development serves as a reminder of the continuous efforts required to maintain a safe and reliable food supply chain.      



US Food and Drug Administration

Canadian Food Inspection Agency