Adverse Illness Event Series/Lentil and Leek Crumbles/Jun 2022 (CARA #1076) 

Incident Summary Report 

October 18, 2022 

Lead CORE Coordinators: 

CORE Signals & Surveillance Team: Ashley Grant 

CORE Response Team 2: Tem Jemaneh 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 
ABSTRACT 

On 6/21/2022, CORE Signals was notified by ORA partners about several illnesses associated 

with Daily Harvest’s French Lentil and Leek Crumbles. The implicated food product associated 

with the illness series was identified as a frozen ready-to-cook product manufactured by Stone 

Gate Foods dba Second Bite Foods. Daily Harvest’s French Lentil and Leek Crumbles was noted 

to be sold nationwide via online subscriptions and were also distributed through traditional retail 

channels. In response to consumer complaints submitted to the company, on 6/23/2022 Daily 

Harvest issued a voluntary recall of the French Lentil and Leek Crumbles product. At the time of 

transfer on 6/23/2022, this incident consisted of 35 complaint-based illnesses from 12 states: CA 

(6), CO (1), CT (6), IL (2), MA (4), NJ (4), NY (3), OR (1), RI (1), TX (2), VA (1), WI (3), and 

Unknown (1) with 20 hospitalizations. It should be noted that this information was obtained from 

FDA CFSAN Adverse Events Reporting System (CAERS) and Consumer Complaint (CC) 

reports. In response to submitted CC and CAERS reports reporting complaints of illness, on 

6/22/2022, ORA HAFW1 initiated a joint inspection with the Minnesota Department of 

Agriculture (MDA) at Stone Gate Foods dba Second Bite Foods, Inc in Shakopee, MN. No 

significant observations were noted and no 483 was issued. No major deviations were observed 

during MDA’s PC inspection. FDA collected 32 finished product and ingredient samples of 

Daily Harvest French Lentil and Leek Crumbles and findings were unable to determine a 

potential causative agent for this incident. Based on component ingredient analysis, FDA 

identified tara protein flour and sacha inchi powder as ingredients of interest. Analyses of 

collected samples of these ingredients did not identify any results of public health significance 

that could be definitively linked to reported illnesses for non-specific toxin tests, mycotoxin 

tests, and microbial tests. Similarly, 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. 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 dba Second 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. 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

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SIGNALS AND SURVEILLANCE ACTIVITIES 

On 6/21/2022, CORE Signals was notified by ORA partners about several illnesses associated 

with Daily Harvest’s French Lentil and Leek Crumbles. This notification did not mention a 

specific diagnosis or etiology and only described complaint-based illness reports. Daily Harvest 

is a subscription-based food delivery service that delivers frozen, easy to prepare foods. The 

implicated food product associated with the illness series was identified as a frozen ready-tocook product, French Lentil and Leek Crumbles, manufactured by Stone Gate Foods dba Second 

Bite Foods (4218 Valley Industrial Blvd S. Shakopee MN 55379: FEI 3003908115). Daily 

Harvest’s French Lentil and Leek Crumbles was noted to be sold nationwide via online 

subscriptions and were distributed through some traditional retail channels. Daily Harvest 

Corporate is located at 99 Hudson, St., New York City, NY 10013 (FEI: 3016119687). 

Daily Harvest operates a direct-to-consumer business model, and on 6/17/2022 directly contacted 

all customers (via email), notifying them of a recall and potential issue with the French Lentil 

and Leek Crumbles product. On 6/20/2022, Stone Gate Foods filed a Reportable Food Registry 

(RFR; EON-494212) for the French Lentil and Leek Crumbles. Based on the RFR, the recall was 

issued due to customer complaints of gastrointestinal illness related to consumption of the 

product. Several customers reported hospital visits after consuming the French Lentil and Leek 

Crumbles. At the time the RFR was filed, all finished goods were put on hold and Daily Harvest 

stopped shipping the product. 

Six implicated lots were included in the recall, with production dates occurring between 

3/31/2022 and 5/19/2022. Recalled lots included: L02-VEGBN French Lentil + Leek Crumbles 

9/27/2022; L5-A L02-VEGBN French Lentil + Leek Crumbles 10/10/2022; L5-A L02-VEGBN 

French Lentil + Leek Crumbles 10/23/2022; L5-A L02-VEGBN French Lentil + Leek Crumbles 

11/6/2022; L5-A L02-VEGBN French Lentil + Leek Crumbles 11/14/2022; and L5-A L02-

VEGBN French Lentil + Leek Crumbles 11/15/2022. 

On 6/22/2022, ORA Human and Animal Foods (HAF) Division W1 (HAFW1; MIN-DO) 

initiated a joint inspection with the Minnesota Department of Agriculture (MDA) at Stone Gate 

Foods dba Second Bite Foods, Inc. During the inspection, Stone Gate Foods was noted as a 

Manufacturer/Re-packer/Packer of the product and was also noted to be registered as a dual 

jurisdiction USDA facility. Per the investigators who conducted the inspection, Stone Gate also 

manufactures (b)(4) . 

Prior to and during the inspection, Daily Harvest and Stone Gate Foods were simultaneously 

conducting their own investigation, which included product testing to determine the root cause of 

illness. According to Stone Gate Foods, finished product sample reports indicated product was 

tested for several bacteria, yeasts and molds, allergens, and aflatoxin. All tests were negative. 

On 6/23/2022, at the time of transfer, this incident consisted of 35 complaint-based illnesses 

from 12 states: CA (6), CO (1), CT (6), IL (2), MA (4), NJ (4), NY (3), OR (1), RI (1), TX (2), 

VA (1), WI (3), and Unknown (1). Estimated illness onset dates ranged from 5/9/2022 to 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

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6/18/2022, and approximately 20 cases had been hospitalized. It should be noted that this 

information was obtained from FDA CFSAN Adverse Events Reporting System (CAERS) and 

Consumer Complaint (CC) Reports. 

At the time of transfer, 20 CAERs reports had been received from ill people. All 20 reports 

referenced Daily Harvest, and specifically mentioned the French Lentil and Leek Crumbles. 

Among the CAERS reports, 13 mentioned various liver-associated ailments and 16 noted 

gastrointestinal ailments. In addition to the CAERS reports, 13 FDA CCs had been received from 

ill patients. All 13 complaints referenced Daily Harvest French Lentil and Leek Crumbles. 

Among the CC reports, 10 reported various liver-associated ailments and 11 reported 

gastrointestinal ailments. 

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. 

At the time of transfer, information related to Daily Harvest’s French Lentil and Leek Crumbles 

had become heavily publicized. Reports pertaining to the adverse events were circulated online 

via social media platforms and across various reporting agencies. This incident was transferred to 

CORE Response Team 2 on 6/23/2022 based on the following rationale: 

• An FDA regulated product, Daily Harvest’s French Lentil and Leek Crumbles, was linked to 

a series of adverse events reported to FDA as consumer complaints. 

• Response coordination was needed for sampling and inspectional activities, public messaging 

and coordination of consumer complaint follow up. 

• This was an incident of significant public interest and warranted additional follow-up by 

FDA. 

• An FDA CORE coordinated response was requested by ORA. 

RESPONSE ACTIVITIES 

ADVERSE ILLNESS EVENT SERIES SUMMARY 

ADVERSE ILLNESS EVENT CASE FINDING THROUGH CONSUMER 

COMPLAINTS (CC) AND CFSAN ADVERSE EVENS REPORTING SYSTEM (CAERS) 

REPORTS 

FDA received adverse illness event reports via the National Consumer Complaint Coordinator 

and also via CAERS. The CCs and CAERS reports were sent to CORE on daily basis for review 

and CFSAN Medical Officers used this information to follow up to collect additional medical 

records for select adverse illness events of interest. 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

4 
 

As of 10/18/2022, this incident included 393 adverse illness reports from complainants in 39 

states: AZ (3), CA (75), CO (5), CT (14), DE (1), FL (9), GA (7), IL (11), IN (2), IA (2), KS (1), 

ME (1), MD (6), MA (19), MN (8), MS (2), MI (2) MO (2), MT (1), NV (1), NH (3), NJ (29), 

NM (1), NY (48), NC (14), OH (6), OK (2), OR (12) PA (10), RI (4), SC (3), SD (1), TN (4), 

TX (13), UT (1), VT (1), VA (9) WA (20), WI (9), and Unk (31) 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. The adverse illness events associated with the Daily Harvest French Lentil and Leek 

Crumbles were reported to FDA between 6/18/2022 to 10/5/2022. 

The 393 adverse event reports received (comprising 175 CCs and 215 CAERS reports) were 

reviewed during the period 6/18/2022 to 10/5/2022. Symptoms, as reported by complainants, 

included gastrointestinal illness, such as vomiting (54/393), diarrhea (24/393), and nausea 

(99/393) reports); 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. Twenty-three medical records associated with CAERS, and CC reports 

were reviewed by CFSAN Medical Officers. 

Medical Records Review 

As of 10/6/2022, 23 cases who had adverse events attributed to Daily Harvest were released for 

medical review. Twenty-two cases ate French Lentil and Leek Crumbles. Eighteen were female 

(78%) and the average age was 42.7 years (range 29 – 62 years). 

A typical presentation of cases involving dietary exposure to Daily Harvest Lentil and Leek 

Crumbles and higher-level medical care would be an individual who complained of sharp 

epigastric or right upper quadrant pain, often with nausea and vomiting, within 24 hours after 

consuming the product the first or second time. Fever, rigors and fatigue frequently follow the 

abdominal pain, and within a few days, many develop jaundice, scleral icterus, and dark urine 

(presumably bilirubinuria). Symptoms would improve slowly once consumption of the crumbles 

stopped (dechallenge). However, 10 cases reported the rapid recurrence of symptoms 

(rechallenge) upon resuming the consumption of the crumbles. 

Initial lab work typically identified a hyperbilirubinuria with elevated total bilirubin (mean 2.9 

mg/dL, range 0.2 – 8 mg/dL) and transaminitis with elevated ALTs (mean 315.3 U/L, range 0.3 

– 8.7 U/L, and mean 7.3 times upper limit [x UL], range 0.3 – 8.7 x UL) with general downward 

trends for those who avoided re-exposure to the product. R factors ranged from mid ones up to 

the low teens, with a majority in the 2-8 range. Some of the patients with higher R factors 

appeared to have a borderline leukopenia and/or high-normal eosinophil counts. Some of the 

patients with lower R factors had some trace hematuria and/or trace proteinuria. Most cases had 

extensive work-up to rule out hepatitis from infectious diseases or autoimmune diseases. Nearly 

all had imaging (ultrasound, cat scan [CT], magnetic resonance imaging [MRI]) of the abdomen 

to rule out obstruction of bile ducts or other gallbladder or liver pathology. Six cases had 

cholecystectomies, although only one had imaging suggesting a biliary obstruction. The 

gallbladder pathology diagnosis for the five other cases were chronic cholecystitis (n=4) and 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

5 
 

 

 

cholesterosis (gallbladder polyps) (n=1). Four had upper endoscopies, partly to rule out 

Helicobacter pylori infection: chronic gastritis was the typical pathology diagnosis. Two cases 

had liver biopsies. One liver biopsy result identified "liver-mixed portal and lobular 

inflammation with prominent portal eosinophils in keeping with injury secondary to drug/herbal 

supplements". The other liver biopsy showed “bland cholestasis, [with] no evidence of acute 

cholangitis or significant ductular reaction... The differential includes drug-induced cholestasis.” 

Complaints associated with other Daily Harvest Products 

Between 6/21/2022 - 9/6/2022, FDA received 24 CCs and 16 CAERS reports indicating adverse 

illness events associated with Daily Harvest products other than the Lentil and Leek Crumbles. 

All 40 adverse illness complaints referenced various Daily Harvest products as a cause for their 

illness. As demonstrated Table 1, no single product stood out or received a comparable number 

of complaints compared to the French Lentil and Leek Crumbles product. 

Table 1: Other Daily Harvest Products Reported by Consumers Through CC and CAERS 

Reports 

Daily Harvest Product Name Number of products 

reported by 

CC CAERS 

Smoothies (various, including, but not limited to, 

Strawberry Peach, Mint cacao) 

5 11 

Flatbreads (various) 5 4 

Other products (bowls, Squash and Wild Rice Gratin, 

soups, Hazelnut Chocolate Bites, mixed meals, pizza) 

9 9 

Unspecified Daily Harvest products 1 1 

Of the 40 CC and CAERS reports, 10 mentioned various liver-associated ailments and 21 noted 

gastrointestinal ailments. 

(b)(4) 

Between 4/4/2022 - 10/18/2022, (b)(4) received 24 complaints associated with Daily Harvest 

product. Among the consumer complaints reports, 10 (42%) reported various liver associated 

ailments and 14 (58%) reported gastrointestinal ailments. Of these complaints, 7 mentioned 

French Lentil and Leek Crumbles, 8 various Daily Harvest products, and 9 unspecified products. 

Complaints reported to (b)(4) were also reported through CAERS/CC to FDA. 

Revive Superfoods 

Between 7/5/2022 - 10/7/2022, FDA received 9 CCs and 10 CAERS reports associated with 

Revive Superfoods products. Of the 19 CCs and CAERS reports, 9 (47%) complaints referenced 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

6 
Revive Mango & Pineapple Smoothies, and 10 (53%) 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. 

Minnesota Department of Health Epidemiological Study 

The Minnesota Department of Health (MDH) conducted an epidemiologic investigation related 

to adverse illness events reported after consumption of Daily Harvest products from 4/1 to 

7/20/2022. Multiple analytical studies were conducted, including a case-control study at the 

category, product, and ingredient levels. French Lentil and 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. Their investigation provides 

further evidence that the French Lentil and Leek Crumbles were the source of illness. 

LABORATORY 

FDA Samples 

Between 6/21/2022 and 8/18/2022, investigators from ORA HAF East 2 (NWJ-DO), HAF East 6 

(CHI-DO), HAF West 2 (KAN-DO), and HAF West 5 (SAN-DO) collected six samples of 

finished French Lentil and Leek Crumbles from several warehouses and 16 samples of leftover 

French Lentil and Leek Crumbles from complainants that had filed CC and CAERS reports. 

Investigators also collected 10 samples of raw ingredient used to make the product of interest, 

including cremini mushrooms, red lentils, French green lentils, hemp hearts (two samples), sacha 

inchi powder, tara protein flour (two samples), quinoa, and butternut squash. All samples were 

analyzed for general toxins, including metals, pesticides, cannabinoids, poison, etc, using nontargeted methods, a variety of mycotoxins and bacteria pathogens. 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. 

Six samples of Daily Harvest (b)(4) and five samples of French Lentil 

and Leek Crumbles finished product were submitted to FDA’s National Center for Toxicological 

Research (NCTR), and one sample of sacha inchi was to CFSAN/ORS for further analytical 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

7 
 

 

 

studies to try and determine/characterize the causative agent of illness for these adverse events. 

The proposed studies include, but are not limited to, in vitro and in vivo toxicological studies. 

Based on CCs and CAERS reports, FDA investigators collected three samples of leftover Revive 

Superfoods Mango and Pineapple smoothie finished products from complainants. All Revive 

Superfoods product samples were analyzed for general toxins, including metals, pesticides, 

cannabinoids, poison, etc, using non-targeted methods. No results of public health significance 

that could be definitively linked to reported illnesses were reported from the analysis of these 

samples. 

Firm Samples 

Prior to and during HAFW1’s joint inspection, Daily Harvest and Stone Gate Foods were 

simultaneously conducting their own investigation, which included product testing to determine 

the root cause of reported illnesses. According to Daily Harvest, between 6/22/2022 and 

8/16/2022, the firm tested 10 finished products and seven ingredients (cremini mushrooms, red 

lentils, French green lentils, sacha inchi powder, tara protein flour, quinoa, butternut squash) of 

the French Lentils and Leek Crumble for mycotoxins, Salmonella spp., Listeria spp., E. 

coli/Coliforms, and yeast and mold. All results for these samples were reported as negative. 

Canadian Samples 

Canada indicated they had received six adverse illness reports associated with Revive 

Superfoods products. Due to one Revive Superfoods product (e.g., Revive Superfoods Mango & 

Pineapple Smoothie) containing tara protein flour, an ingredient in common with the Daily 

Harvest product of interest, the Canadian Food Inspection Agency (CFIA) began an investigation 

of Revive Superfoods. CFIA collected two samples of tara protein flour sourced from(b)(4) (b)(4) (b)(4) via different suppliers from Revive and submitted them to FDA for further 

analysis. These samples will be subjected to the same analyses described previously and may be 

used for additional research purposes. 

TRACEBACK 

Formal traceback was not conducted during this investigation, but CORE Response Team 2 did 

review collected information to narrow down the ingredients in the Daily Harvest Lentil and 

Leek Crumbles that were unique to this product or seldom used in other products manufactured 

at the same facility. The thought was that if an ingredient was unique or used in very few other 

Daily Harvest products that it was more likely to have been the source of reported adverse illness 

events. HAFW1 collected a list of ingredients used in the product of interest and information on 

which ingredients were used in other Daily Harvest products. Through this information, it was 

determined that tara protein flour was an ingredient unique to the product of interest and sacha 

inchi powder was only used in a maximum of two (one being the (b)(4) ) 

other Daily Harvest products. This information, combined with the relatively limited amount of 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

8 

 

 

 

 

 

 

 

 

 

 

 

protein flour has only been on the market for about two years, making it a relatively new product 

for the firm. The firm also manufactures several other products from the tara crop, not all of 

which are food grade, though they reported these products were made on different 

lines. However, 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. 

Table 2: Lot Codes for the Ingredients of Interest Used in the Finished Product by Best By 

Date 

Product Finished Product Best By Date 

9/27/2022 10/10/2022 10/23/2022 11/6/2022 11/14/2022 11/15/2022 

Tara Protein 

Flour 

GP-211003, 

GP-211211 

GP-211211 GP-211211, 

GP-220401 

GP-220401 GP-220401, 

GP-211003 

GP-211003 

Sacha Inchi 

Powder 

PPSO040520007, 

PPSO021 

PPSO021 PPSO040520007, 

PPSO021 

PPSO021 PPSO021 PPSO021 

Sacha Inchi Powder 

Second Bite Foods Inc dba Stonegate Foods (Shakopee, MN; FEI: 3003908115) 

While sacha inchi powder was not unique to the product of interest, its limited use in other Daily 

Harvest products also made it an ingredient of interest in the investigation. Documents received 

from HAFW1 indicated that two lots of sacha inchi powder were used in the product of 

interest. However, it should be noted these same lots were also used in other Daily Harvest 

products, making neither lot code unique to the any products. The product of interest was made 

over the course of six production dates and BBDs were used as the lot codes for the finished 

product. One lot of sacha inchi powder was used in all the BBDs and the other was only used in 

two BBDs (Table 2). Based on documentation provided by HAFW1, it was determined that both 

lots of sacha inchi powder were imported by (b)(4) , FL) and supplied 

(b)(4) by (b)(4) ).

Traceback Limitations 

There were a number of limitations encountered during this investigation. While there was a 

strong signal and distinctive symptomology reported by adverse illness events related to the 

Daily Harvest Lentil and Leek Crumbles product, FDA and CDC were unable to determine the 

cause of the adverse illness events (toxin, chemical, etc). This inability to identify a causative 

agent meant that nonspecific testing had to be used on all samples, and ultimately it was unclear 

where in the supply chain contamination may have occurred. Some ingredients were able to be 

ruled out based on their use in other products, but thus far analytical testing of ingredients have 

not revealed a substance that would explain the adverse illness events reported. Both ingredients 

(b)(4) of interest were also imported from , a country that does not have an information sharing 

agreement or systems recognition with FDA. The lack of such an agreement or equivalency 

meant that FDA could only share public information with the (b)(4) authorities and were 

unable to provide additional investigational details. The location of both suppliers also meant 

that inspections could not be conducted as quickly. However, inspection assignments were 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

10 


 

 

On 7/19/2022, (b)(4) ) was added to Import Bulletin 99-B54 for 

tara protein flour. 

COMMUNICATIONS 

On 6/30/2022, FDA issued a Consumer Advisory related to the ongoing incident. Webpost 

updates were issued on 7/14/2022, 7/28/2022 and 8/25/2022. 

CDC did not issue any communications about this incident. 

CONCLUSIONS 

All 393 adverse illness event reports received by FDA from consumers indicated that ill people 

consumed Daily Harvest French Lentil and Leek Crumbles, manufactured at the Stone Gate, MN 

facility, prior to illness. In response to illness complaints submitted to the company, on 

6/23/2022, Daily Harvest initiated a voluntary recall of the French Lentil and Leek Crumbles. In 

response to numerous reports of adverse illness events submitted to FDA via CCs and CAERS, 

on 6/22/2022, HAFW1 initiated an inspection at Stone Gate Foods Shakopee, MN, the 

manufacturer of the French Lentil and Leek Crumbles product for Daily Harvest. In addition to 

component ingredient samples collected during the inspection at Stone Gate Foods, finished 

French Lentil and Leek and (b)(4) , leftover French Lentil and 

Leek Crumbles obtained from consumers reporting adverse illness events, and additional 

samples of both tara protein flour and sacha inchi flour were collected and analyzed. To date, all 

product samples tested negative for mycotoxins, and no results of public health significance that 

could be definitively linked to reported illnesses were identified for the non-specific toxin 

analyses conducted. Additionally, two product samples tested for microbiological pathogens 

were also reported as negative. Tara protein flour was an ingredient unique to the product of 

interest and sacha inchi powder was only used in a maximum of two other products. This 

information, combined with the relatively limited amount of information about these specific 

ingredients, led to these two products them being identified as ingredients of interest. The 

information and records provided to CORE indicated two ingredients of interest could be the 

potential source of adverse illnesses events associated with the Daily Harvest French Lentil and 

Leek Crumbles. Foreign inspection assignments including sample collection for the (b)(4)

suppliers of tara protein flour and sacha inchi powder are anticipated to be initiated in November 

2022. 

Adverse illness event series information suggested the Daily Harvest French Lentil and Leek 

Crumbles manufactured by Stone Gate Foods dba Second Bite Foods was the source of reported 

adverse events during this incident. However, a definitive source or single point of 

contamination was not identified. 

This incident was transferred to the CFSAN, Office of Food Safety on 10/18/2022. 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

13 
ACKNOWLEDGMENTS 

FDA/CORE would like to acknowledge the thorough response activities conducted by local/ 

county and state partners from 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, WI and by FDA/ORA staff from HAFE1, HAFE2, HAFE6, HAFW1, 

HAFW3, and HAFW4, HAFW5, HAFW6 and DSWI. Additionally, the contributions and 

guidance provided by subject matter experts from CDC, FDA’s Center for Food Safety and 

Applied Nutrition, National Center for Toxicological Research (NCTR) and Office of Regulatory 

Affairs were also appreciated; given the level of analytical resources required during this 

incident, the coordination and/or assistance provided by CFSAN, and ORA Office of Regulatory 

Science was also appreciated. 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

14 
 

 

 

 

 

 

 

 

 

INCIDENT COORDINATION GROUP 

FDA/Office of Coordinated Outbreak Response & Evaluation (CORE) 

CORE Signals & Surveillance Team – Ashley Grant, Tyann Blessington 

CORE Response Team 2 – Tem Jemaneh, Margaret Kirchner, Pamela Mokoko, Marvin Mitchell, 

$VPDௗ0DGDG1DWDOLHCotaldo DQG0RQLTXH6DOWHUௗௗ

CORE Outbreak Evaluation Team – Karunya Manikonda 

CORE Communications – Julia Mangia 

FDA/Office of Regulatory Affairs (ORA) 

ORA HQ Division of Domestic Human and Animal Food Operations (DDHAFO) (Program 

Operation Branch) – Linda Stewart, Nicole Clausen, Martha Myrick 

ORA HQ Division of Foreign Human and Animal Food Operations (DFHAFO) - Vinetta 

Howard King, Yvette Arline, Roxanne Adeuya 

ORA/OEIO/DE/ROB (Recall Operations Branch) - Lisa Gilliam 

Senior Emergency Response Coordinators – Kim Livsey, Chris Yee. 

Produce Safety Network – Shannon Hoehna, Alex Goodman, Kate Allen. 

Office of Regulatory Science –ௗ$QJHOD6ZLQIRUG-HQQLIHU.LQQH\<DQ[XDQ7LQD&DL3URJUDP

coordinator for Mycotoxins) Mohamed Islam. Hawk, Heather D. 

Division of Import Operations –ௗ-HIIHU\+LOJHQGRUf, Ashley Abraham 

Forensic Chemistry Center - Doug Hietkemper, Catherine Dasenbrock, Jonathan Litzau 

Office of Human and Animal Foods Operations – 

Human and Animal Foods (HAF) Divisions/District Offices: 

• HAFE1 (New York, New England) Nicole Vaught, Kimberly Langello, Maura Squire, 

DIB Lori Holmquist, Ronald Pace, Scott Izyk 

• HAFE2 (Baltimore, New Jersey, Philadelphia) Valerie Moore, Linda Price (CCC), 

William Muszynski, Bradley Bensautti 

• HAFE6 (Chicago)/Detroit - Joe Cooper, Marlon Turner 

• HAFW1 (Minneapolis) - Sana Elassar, Kristy Zuroski, DRC (Stone Gate/DH Recall) 

• HAFW3 (Dallas)-Travis Hunt 

• HAFW4 (Denver) Holly Miller 

• HAFW5 (Los Angeles, San Francisco) Linda Gilchrist (CCC), Steven Galvez, Nicole 

Yuen, Hermie Francisco 

• HAFW6 (Seattle) Kelsey Volkman 

• DSWI (Southwest Imports) – Lawrence Harmon, CAPT Monique Frazier, Mary Reed 

FDA/Center for Food Safety and Applied Nutrition (CFSAN) 

Office of Compliance – ௗௗ Marco Esteves, Rose Sexton, Lisa Thursam, Renu Kapoor, Leslie 

Hintz 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

15 
 

 

 

 

 

 

 

 

Office of the Center Director – Dr. Suzanne Fitzpatrick, Dr. Steve Hermansky – Toxicologist 

Office of Food Additive Safety 

• Dr. Troy Hubbard – Toxicologist 

• Dr. Renata Kolanos – Chemist, Natural Food Expert 

• Dr. Mical Honigfort - Regulatory Review Branch Chief 

• Dr. Jason Downey - Compliance expert, Toxicology 

• Mary Ditto, 

• Susan Carlson, 

• Kristi Muldoon 

Office of Food Safety –ௗ-HQQ\Scott, Tim Jackson 

• OFS/Plant Products Branch – Lauren Robin, Anthony Adeuya 

• OFS/Division of Produce Safety - Gordon Davidson 

• OFS/Multi Commodity/Refrigerated Frozen Foods – Andreas Keller, Diane 

Jeang, Guy Skinner, Brett Podoski 

Office of Analytics and Outreach – Medical Officers - Karl Klontz, Cecile Punzalan, Andrew 

Karasick. 

Office of Analytics and Outreach – CAERs – Oliver Ou, Nichole Nolan, Stephanie Kenez 

Office of Regulatory Science – Christine Parker, Shaun MacMahon 

Office of Applied Research and Safety Assessment – Zhihui Yang 

Office of International Engagement – Teresa Fox, Jeffrey Read, Ken Nieves 

FDA/Office of the Commissioner (OC) 

Office of the Chief Counsel – Becky Goldberg, Vivian (Shiyu) Tao, Carie Jasperse 

Office of Emergency Operations/National Consumer Complaint Coordinator – Sheila 

vanTwuyer 

Latin American Office - Nicole Conklin, Michelle Rodriguez 

National Center for Toxicological Research (NCTR) 

Goncalo Gamboa, Donna Mendrick 

Centers for Disease Control and Prevention (CDC) 

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)- Megan 

Hofmeister. 

National Center for Emerging and Zoonotic Infectious Diseases/ORPB- Laura Gieraltowski, 

Colin Schwensohn, Ben Schneider 

National Center for Environmental Health/CDC Health Studies - Fuyuen Yip, Johnni Daniel, 

Erik Svendsen, Art Chang, Michael Yeh 

State/Local Regulatory Partners 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

16 
 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 

Only for use by internal FDA, FDA Commissioned Officials, and those with signed 20.88 agreements with FDA. 

This report contains protected, privileged, confidential, and commercial information and may only be released 

outside FDA with appropriate redaction. This document was prepared by the Coordinated Outbreak Response and 

Evaluation Network (CORE). 

17 

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