Tara Flour Safety Concerns Prompt FDA Action

Tara flour has come under scrutiny following a US Food and Drug Administration (FDA) declaration that it is unsafe, marking a rare assertive action against a food ingredient by the agency. This decision could expose involved manufacturers to criminal liability.

The FDA’s assessment comes over two years after Daily Harvest’s French Lentil + Leek Crumbles product containing tara flour sickened nearly 400 people. This ruling, dated May 15, 2024, is only the 15th such declaration by the agency since 2010. The FDA stated that tara flour does not meet the standards of “generally recognized as safe” (GRAS), which food manufacturers can use to avoid a lengthy food additive approval process.

The FDA’s declaration means that meal delivery service Daily Harvest Inc., and its supplier, Smirk’s Ltd., could face criminal charges for distributing adulterated food.

While the timeline for potential further action remains unclear, there are precedents. For example, when the FDA ruled in 2010 that caffeinated alcoholic beverages like Four Loko were unsafe, the agency issued a warning letter and threatened to seize products if sales didn’t stop.

Related: Food Additive Ban? States Uphold Science Over Fear

What is Tara Flour?

Tara flour is derived from tara trees, also known as Peruvian carob or spiny holdback, which are grown in South America. A relative of alfalfa, beans, carob, clover, lentils, peas, peanuts and tamarind, tara is grown for a number of purposes, including as a food additive that acts as a stabilizer or thickening agent.

Tara flour is also high in protein — about 43 percent protein by weight — making it an ideal source of plant-based protein. This is likely why Daily Harvest used tara flour as a protein source in its French Lentil + Leek Crumbles product.

The GRAS System and Its Flaws

A Bloomberg Law report in December highlighted how the GRAS system allows manufacturers to self-regulate on food safety, often keeping regulators uninformed. Manufacturers can notify the FDA of a GRAS determination but are not required to do so. This means that there could be thousands of unidentified chemicals in food, potentially causing adverse reactions or long-term health effects.

Additionally, a 2023 study published in the journal Environmental Health evaluated a total of 403 GRAS notices between 2015 and 2020 with the goal of determining whether the industry was adhering to the FDA’s Guidance on Best Practices for Convening a GRAS Panel. The study found that none of the GRAS notices voluntarily submitted to the FDA for review followed the draft guidance. 

Daily Harvest used tara flour in its product without first obtaining FDA approval, leading to 133 hospitalizations and a $23 million settlement with victims. Despite recalling the product in June 2022 and identifying tara flour as the cause, the FDA found no evidence supporting this claim.

Importer Accountability

The tara flour safety determination underscores the FDA’s willingness to act on safety concerns but does not change the overall food oversight system. Currently, every company in the supply chain has a responsibility to ensure food safety, with a particular focus on importers.

Smirk’s, based in Colorado, imported the tara flour from Peru. Importers must ensure their foreign suppliers comply with safety standards. The FDA’s Foreign Supplier Verification Programs (FSVP) rule requires importers to perform risk-based verification activities, including ensuring food is not adulterated.

Legal Battles Over Liability

Liability for the damage caused by tara flour is currently being contested in several lawsuits. Smirk’s claims Daily Harvest owes it $226,000 for refused products, while Daily Harvest asserts that Smirk’s was responsible for ensuring ingredient compliance with laws. Despite the legal disputes, both companies share responsibility for ensuring food safety. 

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