FDA determines that taramal is not safe; 500 were sick from the ingredient

The FDA has declared tarame a not “generally recognized as safe” food and banned its use and import into the United States. The action comes almost two years after an outbreak linked to the ingredient.

The flour was the implicated ingredient in Revive Superfoods’ Daily Harvest French Lentil + Leek Crumbles and Mango & Pineapple Smoothies, which sickened about 500 people in the United States and Canada in 2022.

The determination that tara flour is 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 pre-market approval process of ingredients by demonstrating that there is consensus among scientific experts that a substance is safe for its intended use.

The Food and Drug Administration’s May 15 action 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 of this year, detailing the problems with tara flour are outlined.

“The serious side effects and liver damage associated with food products containing tara flour raise serious safety questions. Overall, the available data are insufficient at this time to support the safety of tara flour for use as a food ingredient that will be consumed by the general public,” the toxicologist’s letter said. “…Currently, there are no internationally recognized food standards or specifications that support the safe handling and consumption of tara flour as an ingredient in food.”

Similar findings in Canada resulted in the ban on the use of tara flour in that country in September 2023.

About 470 people in 39 US states became ill after consuming Daily Harvest French Lentil + Leek Crumbles in 2022. Even more people reported becoming ill after consuming Revive Superfoods’ Mango & Pineapple Smoothies made with tara flour that year. There were or were no other foods manufactured with tara flour for consumption in the United States at that time.

The patients developed symptoms of food poisoning and liver and gallbladder problems. More than forty people had to have their gallbladder removed.

On July 19, 2022, Daily Harvest sent a message to its customers, informing them that internal investigations revealed that tara flour, sourced from Smirk’s of Molinos Asociados, Peru, was the root cause of the illnesses associated with the Crumbles product.

In December 2023, food safety attorney Bill Marler sent a letter to Jim Jones, the FDA’s deputy food commissioner, about tara flour and urged the agency to take action against it. Marler represents a number of patients who became ill after consuming foods containing tara flour.

“Scientific studies published in peer-reviewed journals report that exposure to and consumption of tara flour has already caused physical harm in hundreds of U.S. and Canadian consumers. In response, the Canadian Food Inspection Agency (CFIA) issued a notice on September 28, 2023 advising businesses to discontinue the sale and purchase of tara flour or products containing it, citing its classification as a ‘novel food’ that ‘has not been processed’. have 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 to the United States from Peru 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 involved in the outbreak.”

Following the outbreak, several studies were conducted in the United States on the outbreaks and the safety of tara flour. 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 a small study before exporting the product to the U.S. market.

“It has come to our attention that Molinos conducted his only study on the toxicity potential of tara flour at the Universidad Peruana Cayetano Heredia in January 2021. The study involved feeding rats tara for a period of six weeks. It included an evaluation of the liver function of the rats through liver profile tests and an examination of the histology of their liver and kidney tissue,” the letter said.

“The study raises the question of how Molinos was able to specifically test for liver function and whether there were prior indications or concerns about the potential for tara to cause liver damage. It also raises questions as to why Smirk’s (the importer) continued to import and distribute tara flour, especially given the lack of GRAS status for tara flour, the limited scope of Molinos’ research, and the lack of other studies at the time. .”

Tara is a small legume tree native to Peru and also grows in other regions of South America. The fruiting body of the tara plant is a flat yellow to orange oblong pod containing four to seven round black seeds that turn red when ripening. Tara is cultivated and the pods are harvested as an industrial source of hydrolyzable tannins used in leather production, according to the letter from the CFSAN toxicologist.

“Tara gum is particularly distinguished from tara flour because it consists primarily of galactomannan polysaccharides, and its safety profile is well established and supports its use as a thickener and/or stabilizer in human nutrition,” the letter said.

“Tara flour, derived from the tara seed germ, has not been adequately characterized nor previously used as a human food ingredient in the United States. On June 17, 2022, tara flour was purchased by the food company Daily Harvest Inc. identified as the likely causative agent of a foodborne illness outbreak linked to the consumption of a French lentil and leek crumb product, resulting in hundreds of adverse event reports. in consumers, including gastrointestinal complaints, hepatotoxicity and hospitalization (Daily-Harvest, 2022). The FDA has not commented or confirmed these statements from Dailey Harvest Inc.”

At this time, the FDA is not aware of any evidence showing that tara flour is a domestically developed food ingredient or that there are any products containing tara flour currently manufactured in the U.S., according to the agency’s May 15 announcement .

The FDA has instituted screening at ports of entry for tara flour used as an ingredient in imported foods or imported for sale in bulk. The agency has not detected any recent shipments of tara flour in imported products since May 15.

(To sign up for a free subscription to Food Safety News,Click here)