Why French Lentil & Leek Crumbles frozen Soup caused 393 illness and 133 hospitalizations
History of French Lentil & Leek Crumbles Frozen Soup
Rachel Drori founded Daily Harvest in 2015. The company’s mission was to make nourishing, plant-based foods ready in minutes built on organic fruits and vegetables. The French Lentil & Leek Crumbles Frozen Soup was launched nationwide in 2016 and has become one of the fastest-growing direct-to-consumer brands. In 2018 it was named one of Fast Company’s “World’s Most Innovative Companies.” In April of 2022, the French Lentil and Leek Crumble product was released as a food to sauté.
In June of 2022, shortly after introducing the product, the company said it had received ~500 reports of people getting sick after eating it. Symptoms included gastrointestinal illness and liver and gallbladder dysfunction. Many people that consumed the product were hospitalized, complaining on social media about alarming health issues, including agonizing stomach pain, liver and gallbladder damage, and vomiting—they claimed the symptoms started after eating the company’s French Lentil + Leek Crumbles. Tests showed elevated liver enzymes in the patients.
As a result, Daily Harvest initiated a voluntary recall of the product on June 23, 2022. The FDA said consumers, retailers, and others should not eat, sell, or serve the product. In part, Daily Harvest took action after social media influencers and others on iwaspoisoned.com, Reddit, TikTok, and other sites posted accounts of how they became ill and got hospitalized.
On June 23, 2022, the FDA announced that Daily Harvest, Inc. has recalled all French Lentil & Leek Crumbles due to reports from consumers of gastrointestinal illness and liver function problems.
From April 28 to June 17, 2022, ~28,000 boxes of the product were distributed to consumers in the continental US through online sales and direct delivery by the Daily Harvest store in Chicago, IL, and a “pop-up” store in Los Angeles, CA. Samples were also given to several consumers. Daily Harvest directly notified by email those consumers who were shipped the affected product and other consumers for whom the company had contact information, and consumers were issued a credit for the recalled product.
Initial search for answers
A progress report issued on October 2022 (https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-adverse-event-reports-french-lentil-leek-crumbles-june-2022) still did not identify the source of the problem. It did have the final count of 393 illnesses in 39 states (AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, ME, MD, MA, MN, MS, MI, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, and, WI), and 133 hospitalizations.
The Daily Harvest French Lentil + Leek Crumbles frozen soup was tested by the company and independent laboratories for all the common known food toxicants, microorganisms such as food pathogens, mycotoxins, allergens, heavy metals, pesticides, hepatitis A, and norovirus. All tests were negative.
The 27 ingredients revealed that tara flour was unique to this product (it had never before been used in any other product sold by Daily Harvest). Another important clue was that Revive Superfoods (Oakville, ON, Canada) Mango and Pineapple smoothies containing tara protein as an ingredient caused similar symptoms in patients.
Tara spinosa, commonly known as tara, is a plant native to Peru (the country is responsible for >80% of the world’s supply). Tara flour is a plant-based protein manufactured from the seeds of the Tara Spinosa. Tara is a rich source of tannins based on a galloyl quinic acid structure. Tara spinosa pods are an excellent source of environmentally friendly tannins (tara tannins).
A new article in Chemical Research in Toxicology did a thorough study to attempt to answer the question of the cause of illnesses due to the consumption of tara flour. The article entitled “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 2023”. Chittiboyina et al. Chemical Research in Toxicology. DOI: 10.1021/acs.chemrestox.3c00100 (https://pubs.acs.org/doi/pdf/10.1021/acs.chemrestox.3c00100) identified (S)-(−)-baikiain in tara as a compound that might be the causative agent of illnesses due to its abundance, possible metabolic fate, and close resemblance to irreversible inhibitors of L-pipecolate oxidase. Oral administration of baikiain to ND4 mice showed a statistically significant increase in blood alanine transaminase (ALT) levels and a reduction in liver glutathione (GSH). The study was led by Dr. Ikhlas Khan (a Distinguished Professor of Pharmacognosy at the University of Mississippi).
The study found no toxic effects for tara extracts and isolated compounds using the in vitro bioassays. It is probably due to the limitation of the test systems. Therefore, a mouse model was used to evaluate the potential in vivo toxicity of oral administration of baikiain. High oral dosage levels (e.g., 1 g/kg) are used in rodent models investigating acetaminophen overdose toxicity.
A statistically significant increase in blood ALT levels (2-, 4- and 6-h postadministration) and depletion of liver total glutathione was observed in baikiain-treated mice compared to the control group. Markers of liver and kidney toxicity (BUN, CRE, and AMY) were also significantly higher at the 4- and 6-h time points.
Therefore, the study indicates that the adverse health problems reported by individuals consuming the Daily Harvest Crumbles product originate from the tara flour ingredient and are due, at least in part, to high levels of nonprotein amino acids (e.g., baikiain).
The researchers hypothesized that in vivo metabolism of metabolically unstable baikiain results in a toxic metabolite(s) 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.
On May 2023, Daily Harvest (https://www.daily-harvest.com/content/french-lentil-leek-crumbles-advisory#) published an update acknowledging the publication and reaching two conclusions:
1. “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.”
2. “The adverse effects appear to be experienced by only some people, likely the result of a genetic predisposition which was not previously medically known.”
Daily Harvest agrees that the report results from months of extensive research focused on identifying the specific cause of some people’s adverse reactions from consuming products with tara protein flour, including the French Lentil + Leek Crumbles.
The latest scientific hypothesis is that the reason for so many people getting ill after the consumption of Daily Harvest Crumbles soup resulted from using tara flour as an ingredient. The product’s high levels of nonprotein amino acids (e.g., baikiain) caused the problem.
The hypothesis from the publication indicates that in vivo metabolism of metabolically unstable baikiain results in a toxic metabolite(s) 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.
This is the hypothesis from the latest study. However, more data is needed to determine that it is the only reason for the illnesses.
This incident demonstrates that food companies must be cautious when using novel product ingredients. Such ingredients need to be thoroughly investigated before their incorporation into foods.