The FDA has declared tara flour as a not “Generally Recognized As Safe” food and banned its use and importation in the United States. The action comes almost two years after an outbreak linked to the ingredient.
The flour was the implicated ingredient in Daily Harvest French Lentil + Leek Crumbles, and Revive Superfoods’ Mango & Pineapple Smoothies that sickened about 500 people in the United States and Canada in 2022.
The determination of tara flour as not Generally Recognized As Safe (GRAS) means that it or any food made with it is considered adulterated and therefore illegal for sale or use in the United States.
Congress created the GRAS designation in 1958 for food additives with a long history of safe use in food. The GRAS designation allows food companies to bypass the traditional premarket approval process for ingredients by showing that there is a consensus among scientific experts that a substance is safe for its intended use.
The action by the Food and Drug Administration on May 15 comes after a letter from a toxicologist at the agency’s Center for Food Safety and Applied Nutrition (CFSAN) was sent to a CFSAN division director on April 10 this year that outlines problems with tara flour.
“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,” according to the toxicologist’s letter. “… Currently, there are no internationally recognized food standards or specifications to support the safe processing and consumption of tara flour as an ingredient in food.”
Similar findings in Canada resulted in the ban of use of tara flour in that country in September of 2023.
About 470 people across 39 U.S. states became ill after consuming Daily Harvest French Lentil + Leek Crumbles in 2022. Additional people reported becoming ill after consuming Revive Superfoods’ Mango & Pineapple Smoothies made with tara flour that year. At that time, no other foods had been or were manufactured with tara flour for consumption in the United States.
The patients developed food poisoning symptoms plus liver and gallbladder problems. More than 40 people had to have their gallbladders removed.
On July 19, 2022, Daily Harvest communicated with its customers, informing them that internal investigations pinpointed tara flour sourced by Smirk’s from Molinos Asociados, Peru, as the root cause of the illnesses associated with its Crumbles product.
In December 2023, food safety attorney Bill Marler sent a letter to FDA’s Deputy Commissioner for Foods Jim Jones about tara flour and urging the agency to take action against it. Marler represents some patients who became sick after consuming the foods containing tara flour.
“Scientific studies published in peer-reviewed journals report that exposure to, and consumption of, tara flour has already caused bodily injury to hundreds of American and Canadian consumers. In response, the Canadian Food Inspection Agency (CFIA) issued a notice on September 28, 2023, advising businesses to cease the sale and procurement of tara flour or any products incorporating it, citing its classification as a ‘novel food’ that ‘has not been assessed for safety by Health Canada,’ ” Marler wrote.
“I urge the Food and Drug Administration to take similar action in response to these findings. The evidence shows that the cause of the Daily Harvest outbreak was tara flour, an ingredient manufactured by Molinos Asociados in Peru. This tara flour was imported from Peru to the United States by Smirk’s, a Colorado company, and then supplied to Stone Gate Foods, a Minnesota-based manufacturer. Stone Gate Foods used this tara flour in the production of the Daily Harvest French Lentil + Leek Crumbles implicated in the outbreak.”
Several studies about the outbreaks and the safety of tara flour were conducted in the United States after the outbreak. They all found problems with the ingredient.
According to Marler’s letter to the FDA deputy commissioner, the manufacturer of the tara flour, Molinos Asociados in Peru, conducted one small study before exporting the product to the U.S. market.
“It has come to our attention that Molinos conducted its sole study on tara flour’s potential for toxicity in January 2021 at the Universidad Peruana Cayetano Heredia. The study involved feeding tara to rats over a span of six weeks. It encompassed an evaluation of the rats’ liver function through liver profile testing and an examination of the histology of their liver and kidney tissues,” according the letter.
“The study begs the question as to how Molinos knew to specifically test for liver function and whether there were prior indications or concerns about the potential for tara to cause liver injury. It also raises questions as to why Smirk’s (the importer) proceeded with the import and distribution of tara flour, especially given the absence of GRAS status for tara flour, the restricted scope of Molinos’ study, and the paucity of other studies at the time.”
Tara, is a small leguminous tree native to Peru and found growing in other regions of South America. The fruiting body of the tara plant is a flat yellow to orange oblong pod that contains four to seven round black seeds that redden with maturation. Tara is cultivated and its pods are harvested as an industrial source of hydrolyzable tannins utilized in leather production, according to the letter from the CFSAN toxicologist.
“Notably, 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,” according to the letter.
“Tara flour derived from the tara seed germ has not been adequately characterized nor previously utilized as a human food ingredient in the United States. On June 17, 2022, tara flour was identified by the food company, Daily Harvest Inc., as the likely causative agent in a foodborne illness outbreak related to consumption of a French Lentil and Leek Crumbles product which resulted in hundreds of reports of adverse events in consumers, including gastrointestinal distress, hepatotoxicity, and hospitalization (Daily-Harvest, 2022). FDA has not provided comment or confirmation on these statements made by Dailey Harvest Inc.”
At this time, the FDA is not aware of evidence that shows that tara flour is a food ingredient being developed domestically or that there are any products containing tara flour that are currently being manufactured in the U.S., according to the agency’s May 15 announcement.
The FDA instituted screening at ports of entry for tara flour used as an ingredient in imported food or imported for sale in bulk. The agency has not detected any recent shipments of tara flour in imported products as of May 15.
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