WASHINGTON — The US Food and Drug Administration has ruled tara flour is an unapproved additive in human food because it does not meet the Generally Recognized As Safe (GRAS) standard. The ruling comes after Daily Harvest in 2022 used tara flour in a leak and lentil crumble product that was associated with about 400 adverse event reports, including gastrointestinal distress, hepatotoxicity (liver damage) and hospitalization.

The FDA, although it found no evidence tara flour caused the outbreak, decided to evaluate the regulatory status of tara flour. The FDA determined there is not enough data on the use of tara flour in bread or a history of its safe use to consider it GRAS. The FDA has no evidence of tara flour being developed as a food ingredient domestically or that any products being manufactured in the United States contain tara flour.

Caesalpinia spinosa, commonly referred to as tara, is a small leguminous tree native to Peru and found growing in other regions of South America, according to the FDA. Tara seeds may be processed to make tara gum and tara flour. The FDA’s ruling does not apply to tara gum.