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FDA warns that tara flour does not meet its safety standards

The FDA has issued an official warning that tara flour in human foods does not meet the Generally Recognized as Safe (GRAS) standard, making it an unapproved additive.

Tara flour is derived from the seeds of the tara spinosa tree and is commonly farmed and sourced in mountainous regions throughout South America. The tara tree is native to Peru, but the flat yellow-orange pods bearing the seeds are also farmed as far afield as Venezuela and southern Argentina.

While the tara pods are processed into a number of compounds for industrial purposes, most commonly tannins for leather, one part of the seed can be processed into a gum that is used as a thickening agent in foods, while another part has traditionally been milled into a flour that contains a high level of protein.

Insufficient data to prove tara flour safety

But while there is extensive data to prove the efficacy and safety of the gum, the FDA says that data on the safety of tara flour is lacking. The FDA was contacted for comment about its ruling but did not immediately respond.

The FDA was prompted to assess the safety of tara flour after more than 400 cases of adverse reactions were reported by consumers of a leek and lentil crumble product manufactured by Daily Harvest. The company identified tara flour ingredient as the most probable cause for the adverse reactions.

“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. 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,” the FDA stated in an official post to its website.

Tara flour is now an unapproved food additive

On 15 May, 2024, the FDA took the decision to declare tara flour as an unapproved food additive, after the assessment period, which it detailed in a memorandum posted in April, 2024.

The memorandum made reference to several documented cases in the US of tara flour as the cause of various adverse symptoms in consumers, including the Daily Harvest crumble product and Revive Superfoods Mango & Pineapple Smoothie. Symptoms ranged from irritable bowel syndrome to liver damage.

“The serious adverse events and liver injury with food products containing tara flour raise serious safety questions. Overall, at this time, the available data are insufficient to support the safety of tara flour for use as a food ingredient that will be consumed by the general public,” the memorandum stated.

Was the FDA slow to react over tara flour ruling?

While the US FDA says that it is not currently aware that any food product is being sold in the country that contains tara flour, the organisation’s slow reaction has been criticised, especially in light of the fact that Canadian authorities chose to ban the ingredient in September 2023, following an extensive independent investigation.

In the US, the debate over loopholes in GRAS has led to several legislations at a state level in an attempt to plug perceived gaps. The California Food Safety Act has successfully banned a number of potentially toxic additives that are either manufactured or sold in the state. The bill was passed at the beginning of 2023 and is expected to come into force at the beginning of 2027.

New York state followed suit, introducing a bill in February of this year that aims to prevent the food industry from exploiting GRAS determination and using food additives that do not have proven safety for human consumption. If the bill is approved, it would require businesses to notify the State of New York when using a GRAS approved substance and marketing it for human consumption in the state of New York.