Revive Superfoods Contains Peruvian Tara Flour – Patrons Report Illnesses
In the summer of 2022, Toronto-based Revive Superfoods began receiving complaints of illnesses linked to consumption of certain flavors of its smoothies. This came on the heels of similar reports of illnesses linked to consumption of Daily Harvest French Lentil + Leek Crumbles. In its investigation, the FDA reported the that the illnesses included gastrointestinal illness, such as vomiting, diarrhea, and nausea, fatigue, body aches, fever, elevated liver enzymes, jaundice, and liver damage. Some “adverse event” reports also resulted in gallbladder removal. The FDA, based on component ingredient analysis, identified tara protein flour as the ingredient of interest as tara protein flour was unique to Daily Harvest products. On June 23, 2022, Daily Harvest recalled 28,000 units of its French Lentil + Leek Crumbles product produced between April 28 and June 17, 2022. The recall followed reports of more than 470 consumers who experienced illness or adverse reactions after consuming its tara flour containing French Lentil + Leek Crumbles. On July 19, 2022, Daily Harvest issued a communication to its customers advising them that its internal investigations identified tara flour sourced from Molinos Asociados as the cause of the illnesses linked to its Crumbles.[1]
On the heels of the Daily Harvest outbreak, Revive Superfoods was involved in a separate foodborne illness outbreak linked to one flavor of its smoothie-line of products, Mango & Pineapple Smoothies. It quickly became clear that Tara flour had also been used in the Revive Superfoods Mango & Pineapple Smoothies, an ingredient supplied by Miski Organics. Over thirty-five individuals who consumed Revive Superfoods’ Mango & Pineapple Smoothies developed symptoms identical to or substantially like those symptoms experienced by individuals sickened in the Daily Harvest outbreak. The only common ingredient between Daily Harvest’s French Lentil + Leek Crumbles and Revive Superfoods’ Mango & Pineapple Smoothie was tara flour. Revive Superfoods traced its tara flour through its importer, Miski Organics, to middleman Peruvian Nature, and ultimately to Molinos Asociados, the same end supplier of Daily Harvest’s tara flour.
History and Use of Tara Flour – Is it Safe?
Tara flour is an ingredient made from the seeds of a legume grown in South America, which Revive Superfoods used as a plant-based protein in its Mango & Pineapple Smoothies. Tara gum, a different product made from the same plant, has been used as a thickener in foods like ice cream, and is “Generally Recognized As Safe” (“GRAS”) by the FDA. The FDA created the designation GRAS in 1958 for those food additives with a long history of safe use in food which allows food companies to bypass the traditional premarket approval process for ingredients by showing that there is consensus among scientific experts that the substance is safe for its intended use. Tara flour milled from the germ of tara seeds, however, is not GRAS, and there is no evidence that the FDA received GRAS documentation for tara flour before Revive Superfoods’ Mango & Pineapple Smoothies were designed, manufactured, promoted, and sold to the public.[2]
As noted, Miski Organics supplied tara flour to Revive Superfoods, just one of Miski’s customers: Miski also sold tara via its e-commerce store, Amazon Canada, Amazon USA, and to independent retailers, distributors, and direct customers. Miski imported the tara from Peruvian Nature who obtained it from Molinos Asociados, the same company from which Daily Harvest sourced its tara flour. The tara flour that Molinos supplied to both Daily Harvest and Revive has been identified as the source of illnesses in the outbreak linked to the consumption of Revive’s Mango & Pineapple Smoothies and the outbreak linked to consumption of Daily Harvest’s French Lentil + Leek Crumbles.
Investigations and Research into Tara Flour
While there was almost no significant research into tara flour prior to this outbreak, Molinos itself sponsored a rather limited study on Tara germ and its protein derivatives at the Universidad Peruana Cayetano Heredia in January 2021. This study involved feeding tara to 60 Sprague-Dawley rats over a span of six weeks. It encompassed a comprehensive evaluation of the rats’ liver function through liver profile testing and an examination of the histology of their liver and kidney tissues.[3] The study itself raises serious concerns because it indicates that Molinos knew to specifically test for liver function and was hence aware of prior indications or concerns about the potential for tara to cause liver injury. The short-term study involved only a small sample of just 60 rats, and the authors were quick to draw inappropriate conclusions about the safety of tara flour based upon this study alone.
After the outbreak, on May 31, 2023, a scientific publication titled “Is Baikiain in Tara Flour a Causative Agent for the Adverse Events Associated with the Recalled Frozen French Lentil & Leek Crumbles Food Product? – A Working Hypothesis” appeared in the peer-reviewed scientific journal Chemical Research in Toxicology. The results of this study support a working hypothesis that the adverse events reported by individuals that consumed the Daily Harvest and Revive products were caused by the tara flour ingredient and were due, at least in part, to high levels of nonprotein amino acids (baikiain) in the tara flour. The study further hypothesized that in vivo metabolism of metabolically unstable baikiain results in a toxic metabolite that depletes glutathione and/or is an irreversible enzyme inhibitor (for L-pipecolate oxidase), resulting in adverse events which are dependent on the dose consumed and potentially exacerbated for individuals that have specific genetic predispositions.[4]
On September 14, 2023, another post-outbreak study titled “A food product as a potential serious cause of liver injury” was published in Clinical Toxicology. This research, conducted by the Department of Internal Medicine in Kingston, Canada, involved two patients who had consumed a “new smoothie product” containing tara flour in the same month. Both patients independently presented at the hospital with epigastric pain and acute liver injury, and they experienced a recurrence of acute liver injury upon further consumption. While the study refrains from identifying the smoothie, it appears to reference the Revive’s Mango & Pineapple smoothie. The authors of the study concluded that tara flour, a “natural ingredient” in the smoothie, was the cause of hepatotoxicity.[5]
Shortly thereafter, on September 28, 2023, the Canadian Food Inspection Agency (CFIA) issued a notice to the industry, advising businesses to refrain from selling and purchasing tara flour or products containing tara flour due to its classification as a “novel food” that “has not been assessed for safety by Health Canada.”[6]
FDA CC and CAERSs Reports Collected in the Midst of the Outbreak
Reports of illnesses related to the crumbles started being recorded by the FDA’s Consumer Complaints (CC) portal and its CFSAN Adverse Events Reporting System (CAERS) in June 2022. Shortly thereafter, the FDA’s CC portal and CEARS began recording adverse events linked to Revive Superfoods. According to the FDA between 7/5/2022 – 10/7/2022, they received nine CCs and 10 CAERS reports associated with Revive Superfoods products. “Of the 19 CCs and CAERS reports, 9 complaints referenced Revive Mango & Pineapple Smoothies, and 10 referenced multiple flavors of Revive smoothie products as a cause for their illness. According to the FDA: “Medical records associated with the CAERS and CCs reports were reviewed by CFSAN medical officers and were found to be suggestive of symptoms consistent with toxin poisoning, directly impacting the liver. Product testing was advised and included mass spectrometry for liver toxins, aflatoxins, ochratoxin, deoxynivalenol, CBD derivatives, mycotoxins, microcystins, and pyrrolizidine alkaloids.”
[1] https://www.daily-harvest.com/content/french-lentil-leek-crumbles-advisory#
[2] Neal D. Fortin. “The Legal Status of Tara in Food in the United States.”
[3] Universidad Peruana Cayetano Heredia. 2021. Proyecto: Valor nutricional, energizante, no tóxico y no alergénico de prototipos de concentrados proteicos, proteína aislada y concentrados. PIEC1-1-P-187-014-17
[4] Chittiboyina, A.G., et al. 2023. Is Baikiain in Tara Flour a Causative Agent for the Adverse Events Associated with the Recalled Frozen French Lentil & Leek Crumbles Food Product? – A Working Hypothesis. 36(6):818-821. https://doi.org/10.1021/acs.chemrestox.3c00100
[5] Chan, S. E., Smith, C.A. 2023. A food product as a potential serious cause of liver injury. https://doi.org/10.1080/15563650.2023.2256469
[6] Notice to industry: Tara protein powder (tara flour) not assessed for safety by Health Canada – Canadian Food Inspection Agency
