How might FDA’s determination of tara flour as ‘unsafe’ impact the reputation of tara gum, which the agency underscores has a ‘well established’ safety profile?

28-May-2024 - Last updated on 29-May-2024 at 13:08 GMT

Source: Getty/ Mirwanto Muda

FDA’s determination that tara flour, a plant-based protein that could have sickened hundreds of people who consumed it in a Daily Harvest dish two years ago, is not Generally Recognized As Safe could have negative consequences for tara gum, a hydrocolloid that is safe and was determined GRAS by an expert panel.

The two ingredients are derived from different parts of the Caesalpinia spinosa tree, which could cause confusion and require suppliers and brands proactively to educate manufacturers and consumers, cautions Nesha Zalesny, partner with IMR International, a hydrocolloid information center that provides worldwide market research into food thickeners, stabilizers and gelling agents.

She explained to FoodNavigator-USA that while she has not heard “anything specifically about consumers worried about tara gum,” yet, she said she believes “it is just a matter of time,” especially as FDA’s decision follows what she characterizes as misinformation about tara gum recently posted by the International Food Additives Council (IFAC).

FDA: There is not enough data on the use of tara flour … to consider it GRAS’

In an April 10 memo posted on FDA’s website earlier this month, FDA's Center for Food Safety and Applied Nutrition (CFSN) determined that 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.”

It added that “there is no food additive regulation establishing safe conditions of use of tara flour,” and it does not meet the experience based on common use in food criterion for it to be GRAS for use in food.

“Accordingly, when tara flour is added or intended for addition to conventional food, it constitutes the use of an unapproved food additive and, therefore renders it an unsafe food additive” and adulterant, CFSAN added.

FDA’s review of tara flour came after the agency was alerted in June 2022 to several illnesses associated with consumption of Daily Harvest Inc.’s French Lentils and Leek Crumbles. Within four months, FDA received almost 400 reports and consumer complaints of gastrointestinal pain and hepatoxicity, which included more than 130 hospitalizations and surgeries.

Daily Harvest promptly initiated a voluntary recall of the product, and later publicly identified tara flour as the cause of the outbreak. FDA, however, was not able to determine conclusively that the tara flour was the source of illness. In the agency’s view, “no ingredient has been definitively determined to be the source,” CFSAN notes in the memo.

FDA underscores safety of tara gum

In taking action against tara flour, CFSAN specifically underscored the safety of tara gum.

It explains in the memo: “Tara gum is distinct from tara flour, as it is predominantly composed of galactomannan polysaccharides, and its safety profile is well established supporting its use as a thickening agent and/or stabilizer in human foods.”

Conflicting interpretations of available information could compound confusion

Even with FDA’s reassurance, some worry that tara gum’s reputation could be tarnished without proactive action by the industry – especially in light of conflicting interpretations of tara gum's regulatory status in the US.

According to IFAC's website, tara gum is not permitted for use in the US -- a determination that IFAC told FoodNavigator-USA is based on information from FDA's Code of Federal Regulations and GRAS notices website.

Zalesny and others in the hydrocolloid industry argue the ingredient has been legally and safely used for about 30 years following the Foreign Domestic Chemical’s initial GRAS petition acknowledged by FDA in a Federal Register notice in 1993. The ingredient was determined GRAS by an expert panel, the review from which was published in the Journal of the American College of Toxicology in 1993.

"It is unfortunate that the GRAS affirmation petition for tara gum submitted by Foreign Domestic Chemicals in 1993 did not result in its inclusion in the CFR list of GRAS-affirmed substances (21 CFR 184 and 186), and there is currently no GRAS Notice for tara gum on FDA's website," IFAC told FoodNavigator-USA in an email. It added, "Ingredient suppliers have been able to commercialize the use of tara gum in foods in the US through self-GRAS conclusions that are on file with each manufacturer."

IFAC added that it "welcomes FDA's recent memo recognizing the well-established safety of tara gum for use in human foods," noting that the document is "a significant public record of the agency's recognition of the well-established safety of tara gum that supports its use as a thickening agent and stabilizer in human foods."

It added, "The food ingredients business is complex and nuanced. It is more important than ever to ensure the science of food ingredients and additives is sound."

A Joint FAO/WHO Expert Committee on Food Additives and the EU Scientific Committee for Food (now the European Food Safety Authority) determined tara gum has a very low toxicity and does not present a hazard to human health at typical levels, according to IFAC's website.

“Tara gum has been used in ice cream in the US for about 30 years with no incident,” added Zalesny.

While IMR is pro-actively trying to give IFAC the correct information about tara gum’s status in the US, Zalesny said the one-two punch of the IFAC’s description and potential confusion between tara gum and tara flour could have a negative impact on tara gum.

“I have not heard of a negative impact, but … the confusion with the nomenclature ‘tara flour’ vs ‘tara gum’ plus this bit of misinformation from IFAC is likely to confuse food manufacturers and formulators, let alone consumers,” said Zalesny.

Proactive education could be the key, but is a challenge for ingredient suppliers

She added educating consumers about ingredient safety and function is a challenge for many manufacturers and ingredient suppliers that are business-to-business and not business-to-consumer.

“Communication directly with consumers is so difficult. I have heard from many hydrocolloid suppliers that they would like to do better,” she said. “One thing I would love to see is a QR code on food labels that would enable interested consumers to interact with the ingredient deck, select the ingredient they were interested in, and get an explanation of that ingredient. It would be fantastic to teach consumers about ingredients and why they are used in various foods."