FDA Deems Tara Flour Unsafe

Posted in Food Policy,Food Safety,Our Blog,Outbreaks & Recalls on May 23, 2024

Two years ago, nearly 300 consumers fell ill after eating a Daily Harvest brand product called French Lentil + Leek Crumbles containing tara flour as an ingredient. Last week, the United States Food and Drug Administration (FDA) deemed it unsafe and removed it from the approved list of “Generally Recognized as Safe” (GRAS) food additives.

What is Tara Flour and How Commonly Is It Used?

Tara is a plant in the legume family grown in South America. It also can go by the name of Peruvian carob or spiny holdback.

This plant is primarily grown as a food additive and commonly found in gum products where it acts as a thickener or stabilizer. This tara gum is different from flour.

When used as “tara gum” it can be seen in dairy products, meat-based products, fruit preparations, noodles, sauces, and more.

As a flour application, it was likely selected due to the protein content.

It is really high in protein. In fact, it is about 43% protein by weight. A hefty percentage when compared to the average 8% to 11% of all-purpose flour or 12% to 14% of whole-wheat flour.

It is unclear why this product produced such toxicity in consumers when used as a flour instead of a gum, though various treatments or manufacturing processes may contribute to the difference.

For this reason, when using a food additive in a different way, appropriate testing is necessary. For example, a product that is cooked may be perfectly safe. However, it could be toxic if consumed raw.

You never want to discover there is a difference the hard way – after people have become seriously ill.

How It All Started

The problem was discovered on June 17, 2022, when the FDA was alerted to a cluster of illnesses associated with the Daily Harvest Inc. product, French Lentil + Leek Crumbles.

This prompted an investigation.

During the course of the FDA investigation the manufacturing facility was inspected, and the agency collected samples to get a better understanding of what was making these people sick.

Daily Harvest initiated a recall for their French Lentil + Leek Crumbles product on June 23, 2022.

But the complaints kept rolling in. By October 21, 2022, the FDA received 393 reports of adverse effects, including 133 hospitalizations associated with this product. At least 39 people required surgery to remove their gallbladders.

Patients had gastrointestinal pain and hepatoxicity (a type of liver damage associated with medications and herbal supplements). They had jaundice, dark urine, and elevated blood biomarkers pointing to liver injury.

The company conducted their own root-cause analysis to track down the problem.

Daily Harvest indicated that the problem was caused by the tara flour used in the product. In a statement on the company’s website, they explain, “Baikiain, a naturally occurring compound in tara, which was not previously reported or thought to cause adverse effects, appears to be the cause of the issues reported with the French Lentil + Leek Crumbles.”

More Tara Flour Complaints Rolled in That Year

Daily Harvest, Inc. was not the only company receiving complaints that year linked to the food additive. According to the FDA, 19 consumer complaints were received referencing consumption of Revive Superfoods Mango & Pineapple Smoothie. Additional complaints were reported in Canada as well.

This product also contained tara flour.

These patients also showed liver damage.

These Serious Adverse Events Surrounding Tara Flour Raised Serious Safety Questions

These adverse events led the FDA to question the safety of tara flour as a safe food ingredient.

Significant research was performed to determine if studies have been conducted to prove the safety of this food additive. Insufficient data was available to make that call.

FDA Removes Eligibility as Use as a Food Additive

There are two criteria used to determine if a food additive is given the title “GRAS” and allowed for use in foods meant for human consumption.

The first is based on historical evidence. If it has historically been used commonly in food without any evidence of safety issues (as in used prior to 1958), it gets a pass.

If it is a new product not commonly used prior to 1958, then it must meet scientific evidence proving that it is safe for human consumption.

This food additive does not meet either criterion, prompting the FDA to make the following declaration.

“Based on a review of the available information, the use or intended use of tara flour in conventional food for humans is not eligible for a listed exception to regulation as a food additive [Section 201(s)(1)-(6) of the FD&C Act].

This means that the food additive can no longer be used in foods meant for human consumption and is illegal for sale in the United States.

So, What Happens Now? Is This the End of Tara Flour?

Does this mean that tara flour is banned forever?

Possibly.

Or, it could be a right now ban.

The take-away is that with the current scientific information and its current application as a flour, it cannot be used. For now, the FDA will continue monitoring for the use of tara flour in the United States food supply, as it is not a legal ingredient for human food. Imported foods will be screened at ports of entry and U.S. based products will be monitored.

However, the product may be granted approval later. It will require specific FDA approval with scientific studies backing up the safe application of the product. It could mean that a particular treatment could remove toxicity of the product. Or perhaps its use in another format is considered safe (as with tara gum).

But for now, tara flour remains banned.

With all of the available alternative flours on the market, it may not be profitable to do the research on this product.

This could likely be the end of the discussion.

Did You Become Sick from Consuming Daily Harvest French Lentils + Leek Crumbles?

If you became sick from eating Daily Harvest French Lentils + Leek Crumbles, you may have a legal case. The Lange Law Firm, PLLC is experienced in helping people with cases just like yours. Call (833) 330-3663 or click here for a free consultation.

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By: Heather Van Tassell (contributing writer, non-lawyer)