The Food and Drug Administration is finally on record with some key information related to hundreds of illnesses linked to the Daily Harvest product French Lentils & Leek Crumbles.

The outbreak began in April 2022 and the last person to become ill developed symptoms in September 2022, according to the FDA. Symptoms included a variety of gastrointestinal issues and liver problems. about 30 people had to have their gallbladders removed. According to government figures, 393 people from 39 states were involved.

“based on component ingredient analysis, FDA identified tara protein flour and sacha inchi powder as ingredients of interest,” the FDA reported in a 508-page document released in recent days through a Freedom of Information Act request. Portions of the document were redacted by the FDA before it was released. Those redactions are indicated by (b)(4) in the text of the document.

It has been known since early summer 2022 that tara protein flour was unique to Daily Harvest products. It was added to the recipe for frozen French Lentil & Leek Crumbles in mid-spring this past year. Tara flour, the suspect ingredient in the crumbles, comes from the seeds of the tara plant grown in the higher altitudes of Peru.

The crumbles product also included sacha inchi powder, but that ingredient was also used in other Daily Harvest products. Consumers did not report illnesses related to the products with sacha inchi powder, except for the French Lentil & Leek Crumbles.  

FDA’s report does not name the country of origin or supplier of the tara flour or sacha inchi powder used in the crumbles product.

The crumbles product was sent to selec individuals in mid-spring and made available for online sales shortly thereafter.

In the spring of this past year, the Daily Harvest company started receiving complaints of illnesses from customers who had eaten the crumbles. In response to those reports, the company recalled, on June 23, 2022, its French Lentil and Leek Crumbles product. Some consumers may have had the product in their freezers and been unaware of the recall, thus continuing to use the crumbles.

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 (CARES) in June 2022.

Symptoms reported, according to the FDA’s report, included gastrointestinal illness, such as vomiting in 54 out of the 393 illnesses recorded, diarrhea in 24/393, and nausea in 99/393. Fatigue, body aches, fever, elevated liver enzymes (193/393), jaundice (23/393), and liver damage were also reported. Some “adverse event” reports also resulted in gallbladder removal.

“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” according to the FDA report.

Following the initial reports of the illnesses, the FDA began a joint inspection with the Minnesota Department of Agriculture (MDA) at Stone Gate Foods dbasecond Bite Foods Inc. in Shakopee, MN. No significant observations were noted, according to the FDA report.

The FDA also collected 32 samples of the crumbles but the analysis did not show a “causative agent” for the illnesses, according to the agency. However, the FDA document states that the crumbles were likely the causative agent for the illnesses.

“. . . no results of public health significance were obtained from testing of finished French Lentil and Leek Crumbles and (b)(4) product collected from warehouses and/or consumers.,” according to the report.

“As of 10/18/2022, there were 393 adverse illness reports in 39 states with 133 hospitalization and 0 deaths. based on CC and CAERS reports, the estimated illness onset dates range from 4/19/2022 – 9/4/2022. 

“Information from reported adverse illness events identified French Lentil and Leek Crumbles manufactured by Stone Gate Foods dbasecond Bite Foods and distributed by Daily Harvest as the confirmed vehicle in this incident, however, the specific cause or route of contamination could not be determined.”

The FDA did not conduct any traceback investigations on the tara flour.

It was unable to be determined which regions, countries, or fields the tara protein flour lot codes used in the Daily Harvest Lentil and Leek Crumbles products were sourced from, the agency reported. 

“These ingredients (tara flour and sacha inchi powder)  were both supplied by (b)(4) companies and were used in a maximum of two other Daily Harvest products — the Sacha niche powder supplied by (b)(4) or were unique; tara powder supplied by (b)(4) to the Lentil and Leek Crumbles.”

“. . . FDA will connect inspections of the manufacturing firms (b)(4) for both the tara protein flour and Sacha inch powder after the CORE Outbreak Close-out meeting with the Office of Food Safety and Core Outbreak evaluation to determine if a source of contamination for either ingredient can be determined. based on information from reported adverse illness events and traceback data, it was determined that consumption of Daily Harvest Lentil and Leek Crumbles was the likely source of the adverse illness events during this incident, but a cause or source of contamination could not be identified.”

The FDA planned to begin foreign inspection programs, including sample collection for the “(b)(4)” suppliers of tara protein flour and sacha inchi powder, beginning in November 2022, but the report did not say whether those testing programs have been initiated.

Prior to and during the FDA’s inspection, Daily Harvest and Stone Gate Foods were conducting their own investigation, which included product testing to determine the root cause of illnesses. 

“According to Stone Gate Foods, finished product sample reports indicated the product was tested for several bacteria, yeasts and molds, allergens, and aflatoxin. All tests were negative,” the FDA report states.

There were other products suspected to be linked to some illnesses, but the FDA said it does not find any definitive issues. Those products included smoothies of various flavors, including but not limited to, Strawberry Peach and Mint cacao.

“Between 7/5/2022 – 10/7/2022, FDA received nine CCs and 10 CAERS reports associated with Revive Superfoods products, according to the FDA report. “Of the 19 CCs and CAERS reports, 9 complaints referenced Revive Mango & Pineapple Smoothies, and 10 referenced multiple other flavors of Revive smoothie products as a cause for their illness. The Revive Superfoods Mango & Pineapple Smoothie also contained tara protein flour as a component ingredient, which was also used in the Daily Harvest product of interest. However, the number of reported illnesses for Revive Superfoods products was not comparable to those reported for the Daily Harvest Lentil and Leek Crumbles.”

The Minnesota Department of Health conducted an epidemiologic investigation related to adverse illness events reported after consumption of Daily Harvest products from April 1 to July 20, 2022. Multiple analytical studies were conducted, including a case-control study at the category, product, and ingredient levels. French Lentils & Leek Crumbles were statistically associated with illness. Ingredient-level analyses did not statistically implicate tara protein flour or sacha inchi powder but did find a statistical association between (b)(4) and illness, though analyses were limited by the small number of cases. The investigation provides further evidence that the French Lentil and Leek Crumbles were the sources of illness, according to the FDA report.

The FDA tested individual ingredients, including tara flour, for the crumbles and found toxic metals. The toxic metals screen included the following metals above the reporting limit (200 ng/g): vanadium, chromium, cobalt, nickel, arsenic, selenium, cadmium, mercury, thallium, and lead.

“No additional results of public health significance that could be definitively linked to reported illnesses were noted from the analysis of these samples. In addition to the above analyses, two finished product samples tested negative for mycotoxins and microbes including Salmonella spp., Listeria spp., Hepatitis A virus, and norovirus. Given the rapid onset of symptoms and frequent reports of liver injury for reported adverse events, microbiological testing of collected samples was not further pursued,” according to the FDA report.

In the concluding portion of the report, the FDA again said the tara flour in the Daily Harvest French Lentil & Leek Crumbles was the suggested source of the 393 illnesses, “however, a definitive source or single point of contamination was not identified.”