FDA Refuses GRAS Designation for Tara Flour

The FDA on May 15 announced its determination that tara flour in human food does not meet the Generally Recognized As Safe (GRAS) standard and is an unapproved food additive.

The product of a South American tree, tara flour and tara gum began to appear in some U.S. products earlier this decade. However, in 2022, Daily Harvest used tara flour in a leek and lentil crumble product that was associated with approximately 400 adverse event reports.

“The firm took prompt action to voluntarily recall the product and conduct their own root cause analysis, during which they identified tara flour as a possible contributor to the illnesses,” the FDA wrote. “To date, the FDA has found no evidence that tara flour caused the outbreak; however, it did prompt the agency to evaluate the regulatory status of this food ingredient.”

Neither tara flour nor gum had been reviewed by FDA for safety.

“The FDA’s evaluation revealed that there is not enough data on the use of tara flour in food, or a history of its safe use, to consider it GRAS,” the agency continued. “There is no food additive regulation authorizing the use of tara flour in food. Uses of food ingredients that are not GRAS, not authorized as food additives, and not excepted from the Federal Food, Drug, and Cosmetic (FD&C) Act’s food additive definition are unapproved food additives. Food that is, or contains, an unsafe food additive is considered adulterated.”

At present, the FDA is not aware of any examples of tara flour being used as a food ingredient in the U.S. The agency’s screening at ports of entry also found no recent shipments of tara flour.