There are around 400 adverse event reports. The company voluntarily recalled the product and conducted an analysis, identifying tara flour as a possible cause of the illnesses.
The U.S. Food and Drug Administration (FDA) announced on its website that tara flour in human food does not meet the Generally Recognized As Safe (GRAS) standard and is classified as an unapproved food additive. This determination, detailed in a memo added to the agency’s public inventory, aligns with the FDA's effort to enhance food chemical safety by increasing transparency.
According to the Federal Food, Drug, and Cosmetic (FD&C) Act, any ingredient intended for use in food must be authorized by the FDA unless it is GRAS by qualified experts or meets a specific exception. Unapproved food additives are considered unsafe under the FD&C Act.
Indicated in the memo, Caesalpinia spinosa, commonly referred to as tara, is a small leguminous tree native to Peru and found growing in other regions of South America. The fruiting body of the tara plant is a flat yellow to orange oblong pod that contains four to seven round black seeds that redden with maturation. Tara seeds are composed of both an endosperm and germ component which can be processed to generate tara gun and flour respectively.
On June 17,2022, tara flour was identified by the food company, daily harvest inc, as the likely causative agent in a food borne illness outbreak related to consumption of a French Lentil and Leek Crumbes product which resulted in hundreds of reports of adverse events in consumers including gastrointestinal distress, hepatotoxicity and hospitalization.
There are around 400 adverse event reports. The company voluntarily recalled the product and conducted an analysis, identifying tara flour as a possible cause of the illnesses. Although the FDA found no conclusive evidence that tara flour caused the outbreak, this prompted the agency to review its regulatory status.
The FDA's evaluation concluded that there is insufficient data on the safe use of tara flour in food, and no regulation authorizes its use. Therefore, uses of tara flour that are not GRAS or authorized as food additives are considered unapproved and result in adulterated food products.
Manufacturers considering using tara flour must ensure its use is safe and lawful and are encouraged to consult with the FDA. Currently, the FDA has no evidence of tara flour being developed or used in products manufactured in the U.S.
The FDA has also started screening tara flour at ports of entry and has not detected any recent imports. The agency remains dedicated to monitoring new food ingredients to ensure they meet safety standards as part of its commitment to food safety and public health.
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