WARNING LETTER

Jule's Foods MARCS-CMS 615218 — October 19, 2021

Delivery Method:: United Parcel Service
Product:: Food & Beverages

Recipient:: Recipient Name

Julie Van Dam; Recipient Title

CEO; Jule's Foods; 252 Acacia Ave. #210
Carlsbad, CA 92008
United States

Issuing Office:: Office of Human and Animal Food Operations- West Division 5; United States

WARNING LETTER

WL 615218

Dear Ms. Van Dam:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) vegan cashew brie products manufacturing facility, located at 2790 Loker Ave. West, Suite 115, Carlsbad, CA 92010, from April 21 to May 24, 2021. The inspection was initiated as part of a Salmonella multi-state outbreak investigation, where the Centers for Disease Control and Prevention (CDC)’s outbreak definition included 6 Salmonella serotypes (Duisburg, Urbana, Leiden, Vinohrady, Chester and Typhimurium). According to CDC, as of July 7, 2021, 20 people from 4 states have been infected with the outbreak Salmonella serotypes. Four of the same Salmonella serotypes (Urbana, Leiden, Vinohrady and Chester) were also found in an environmental swab taken from your vegan cashew brie (b)(4) during FDA’s inspection, your vegan cashew brie varieties, and/or your incoming cashew pieces used to manufacture your vegan cashew brie products. CDC and FDA have determined, based on the epidemiologic and laboratory evidence, that the RTE vegan cashew brie products produced at your facility are the likely source of the multi-state Salmonella outbreak.

Based on FDA’s inspectional findings and analytical results for the environmental samples collected during the inspection, we determined that the RTE vegan cashew brie products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. The presence of Salmonella in your RTE vegan cashew brie products, as evidenced by the laboratory analysis and the recent foodborne outbreak, causes the products to be adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. It is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)] to introduce or deliver for introduction into interstate commerce any food that is adulterated. You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

During FDA’s inspection and the multi-state outbreak investigation, the following Salmonella outbreak strains were isolated from samples:

• Salmonella Leiden:

o FDA laboratory analysis of the environmental sample 1160509, collected on April 22, 2021, confirmed one (1) out of fifty-one (51) environmental swabs collected was positive for Salmonella Leiden. The positive swab was collected from the top of a table that holds the (b)(4) mixer in Kitchen (b)(4). This mixer is used to mix ingredients together during the manufacturing of your RTE vegan cashew brie products after the fermentation process. You stated during the inspection that you do not regularly clean this table and do not know the cleaning frequency by others who share the use of this kitchen. Your response states that you have sanitation operating procedures in place specific to cleaning and sanitizing the mixer (b)(4) and (b)(4), as well as the table holding the mixer, but the sanitation operating procedures provided with your response only pertain to food contact surfaces. Appropriate control of Salmonella in a food processing environment requires knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to control this pathogen.

• Salmonella Urbana:

o FDA isolated Salmonella Urbana from two (2) intact samples of incoming raw organic cashew pieces, Lot (b)(4), at your facility on April 21 and 26, 2021.
o California Department of Public Health (CDPH) isolated Salmonella Urbana from four (4) samples of your ready-to-eat (RTE) vegan cashew brie products (1 “Jule’s Brie” and 3 “Jule’s Truffle Brie”).
o Tennessee Department of Health (TN DOH) isolated Salmonella Urbana from one (1) sample of RTE “Jule’s Truffle Brie.”

WGS analysis was conducted on the FDA, CDPH, and TN DOH Salmonella Urbana isolates. The current WGS analysis determined that the four isolates from the CDPH vegan cashew brie samples and the TN DOH truffle brie sample isolate are all genetically identical to each other and to the two FDA cashew samples taken from your facility. The current WGS analysis determined that these isolates were genetically identical to two (2) clinical isolates. There is currently no food history or traceback information available for the clinical isolates. We advised you of the initial WGS results via a conference call on May 7, 2021.

• Salmonella Chester:

o CDPH isolated Salmonella Chester from one (1) sample of your RTE “Jule’s Brie.”

FDA’s WGS analysis confirmed that four (4) clinical isolates were genetically identical to the strain of Salmonella Chester found in this sample of RTE “Jule’s Brie.” There is currently no food history or traceback information available for the clinical isolates. We advised you of the initial WGS results via a conference call on May 7, 2021.

• Salmonella Vinohrady:

o FDA isolated Salmonella Vinohrady from one (1) sample of your RTE “Jule’s Black Garlic Brie” product that was undergoing aging at your facility.
o CDPH isolated Salmonella Vinohrady from one (1) sample of your RTE “Jule’s Brie” product which was collected at a retail location.
o TN DOH isolated Salmonella Vinohrady from a sample of RTE “Jule’s Truffle Brie” collected a retail location.

FDA’s WGS analysis confirmed that the FDA black garlic brie sample isolate was a genomic match to other isolates from samples of your RTE “Jule’s Brie” product collected by CDPH as well as a sample of RTE “Jule’s Truffle Brie” collected by TN DOH. We advised you of the initial WGS results via a conference call on May 7, 2021.

Modified Requirements for Qualified Facilities (Subpart D)

Your facility meets the definition of a qualified facility¹ under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (CGMP & PCHF rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117), and therefore is subject to the modified requirements in 21 CFR 117.201. A qualified facility is required to submit an attestation to FDA that the facility is a qualify facility (21 CFR 117.201(a)(1)). You submitted this attestation to FDA on May 21, 2021 (after the outbreak had been identified and the inspection had begun). In addition, a qualified facility is required by 21 CFR 117.201(a)(2) to submit one of the two following attestations to FDA:

An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or

An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight.

To date you have not submitted such an attestation.

Current Good Manufacturing Practice (Subpart B):

Raw materials and other ingredients must either not contain levels of microorganisms that may render the food injurious to the health of humans, or they must be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated, to comply with 21 CFR 117.80(b)(2). However, the cashews you received were contaminated with Salmonella, and you did not treat them so that they no longer contained Salmonella that would cause your product to be adulterated. Specifically, FDA identified Salmonella Urbana in two intact samples of incoming raw organic cashew pieces at your facility that was genetically identical to Salmonella Urbana identified in samples of your products taken by the California and Tennessee Departments of Health.

We received your 483 response, dated June 3, 2021, which includes a cashew supplier Certificate of Analysis (COA). The COA provided appears to be for a different lot of cashew pieces than the subject lot referenced above from which FDA isolated Salmonella Urbana ((b)(4) vs (b)(4)). Further, your response references FDA‘s draft guidance², “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals,” in regard to use of a COA. That draft guidance states that “[t]esting of . . . the food produced by the supplier may be an appropriate supplier verification approach if such testing provides meaningful results relating to control of a hazard requiring a control.” (Emphasis added). However, your supplier was not controlling the hazard of Salmonella in the raw cashews; therefore, it was not appropriate for you to rely on testing (as reported on the COA) to address the Salmonella hazard. Because the hazard of Salmonella was not controlled by your supplier, it was necessary for you to control the hazard.

In addition, your response includes an “SOP and Health and Safety Plan Cashew Cheese.” Your plan includes a process control for Salmonella in cashews, as well as monitoring of critical limits, corrective action, verification, and records associated with the control. However, you did not include supporting documentation to show implementation of your plan. Further, it is not clear whether your cashew supplier is also applying a kill step for Salmonella. Specifically, your plan refers to receiving pasteurized cashews (pages 2, 4, and 7) but also to storing raw cashews (pages 5 and 7). We will evaluate implementation of your process control for Salmonella during a future inspection of your facility.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of Federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Notification that May Withdraw Your Qualified Facility Exemption

FDA may withdraw your qualified facility exemption under 21 CFR 117.5(a) in the following circumstances: 1) in the event of an active investigation of a foodborne illness outbreak that is directly linked to your facility; or 2) if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conditions or conduct associated with your facility that are material to the safety of the food manufactured, processed, packed, or held at your facility (21 CFR 117.251(a)). Pursuant to 21 CFR 117.251(b)(2), FDA is notifying you that it may withdraw your qualified facility exemption based on the circumstances described above and is providing you with 15 calendar days from receipt of this letter to respond. Specifically, your response should include documentation to show that you are implementing your “SOP and Health and Safety Plan Cashew Cheese,” such as monitoring records for your Salmonella kill step and, consistent with implementation of your plan, an attestation that you have identified the potential hazards associated with your RTE vegan cashew brie products, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective. If the qualified facility exemption is withdrawn, your facility would no longer be subject to the modified requirements for qualified facilities in Subpart D and instead would be subject to the relevant requirements in Subparts A, C, E, F, and G of 21 CFR Part 117.

To the extent not addressed in your response referenced above regarding possible withdrawal of your qualified facility exemption, please notify FDA in writing within 15 working days from your receipt of this letter, of the specific steps you have taken to address the violations described in this letter. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.

Section 743 of the Act, (21 U.S.C. § 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Your written response should be directed to:

Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612

Refer to the Unique Identification Number CMS 615218 when replying.

If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5

cc:

Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435

_____________________________

1 See definition of “qualified facility” in 21 CFR 117.3

2 Note that the draft guidance provides as follows: “This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public.”