FDA Warning Letter - Fresh Cut Produce Facility

FDA issued a Warning Letter to Onofrio's Fresh Cut of New Haven CT, a produce processing facility for RTE fresh-cut produce (e.g., onions, peppers, celery, broccoli, cantaloupe, watermelon, and kiwi).  The FDA collected environmental samples from various areas in the processing facility and found Listeria monocytogens in several areas.

FDA stated issues with the Preventive Control Plan as well as with GMPs.  With regard to the Food Safety Plant, while the hazard analysis considered pathogen contamination at the cutting and assembling processing steps. it determined that a preventive control was not necessary due to CGMPs/SSOPs and a prior wash step. However, "RTE fresh-cut produce is exposed to the environment during cutting and assembly and does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Thus, environmental pathogens are a hazard likely to occur in the absence of preventive controls (i.e., sanitation controls)."

FDA’s current inspection included the collection of environmental swabs on July 13, 2021, during the production of RTE fruits and vegetables; four (4) of seventy-one (71) swabs were confirmed positive for L. monocytogenes. The positive findings include a mixing room floor drain adjacent to a table where RTE celery was being cut, forklift wheels, a wheel on a rolling cart holding shrimp and seafood salad ingredients, and a packing room broom handle

One item stated in the Warning Letter was a bit surprising in that FDA seems to be suggesting a Supplier Preventive Control for the produce.  The report stated that the company "did not establish supply-chain controls for pathogens such as L. monocytogenes, pathogenic E. coli, and Salmonella at the receiving step for incoming produce. [The] hazard analysis indicated that pathogens will be controlled at a later wash step. However, [the] produce wash does not effectively destroy pathogens on the whole produce, as indicated by an email on July 20, 2021, from a representative of [the] supplier of (b)(4) sanitizer, which is used in your produce wash."  This may be difficult if the company is bringing in raw, unwashed produce.

The facility had a number of GMP issues which would exasperate the situation.  Condensation, poor plumbing, inadequate cleaning of equipment (both contact and non-contact surfaces),  and poor food handling practices.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/onofrios-fresh-cut-inc-618502-01102022
WARNING LETTER
Onofrio's Fresh Cut, Inc.
MARCS-CMS 618502 — JANUARY 10, 2022

Birthday Cakes Recalled for Allergens After Packaged Wrong

Siren of San Francisco, CA is issuing a voluntary recall of Siren Birthday Cake 1.7oz Bites because they may contain undeclared cashews and almond butter.  Due to a consumer notification about an allergic reaction, the recall was initiated after it was discovered that product containing cashew and almond butter was distributed in packaging that did not reveal the presence of cashew and almond butter on the ingredient deck.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/siren-issues-voluntary-allergy-alert-undeclared-cashews-and-almond-butter-birthday-cake-bites
Siren Issues a Voluntary Allergy Alert on Undeclared Cashews and Almond Butter in Birthday Cake Bites
Summary
Company Announcement Date:  January 27, 2022
FDA Publish Date:  January 27, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Cashews and Almond Butter
Company Name:  Siren Snacks
Brand Name:  Siren
Product Description:  Birthday Cake Bites

Two Importers Receive Warning Letters for Lack of FSVP

FDA issued Warning Letters to two import companies for not having FSVP programs in place for the products they import.

Green Food Ingredients, LLC of Burr Ridge IL did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities in accordance with 21 CFR 1.506(d).

HK Produce Group Inc. DBA Y2S Trading Inc. of  Long Island City, NY 11101 received an inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms.  Inspectors found the company did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods imported.

"This inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms, three (3) of which were from (b)(4) located in (b)(4) and one (1) from (b)(4) located in (b)(4). The samples were collected from entries B7S-2105311-2, 677-0332940-8, 677-0332919-2 and B7S-2106092-7, all imported by your firm. We placed fresh enoki mushrooms from (b)(4) under Import Alert (IA) #99-23 “Detention Without Physical Examination of Produce Due to Contamination With Human Pathogens,” on July 20, 2021 and IA #99-35 “Detention Without Physical Examination of Produce That Appears To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on November 1, 2021. "

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-food-ingredients-llc-616669-10212021
WARNING LETTER
Green Food Ingredients, LLC

Gogi Berry Snacks Recalled After State Lab Finds Undeclared Sulfites

BCS International Corp. Long Island City, NY, is recalling its 4.5 ounce, 6 ounce and 9 ounce containers and 5 pound packages of “Dr. Snack Goji Berry” food treats because they contained undeclared sulfites.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in “Dr Snack Goji Berry” which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics.  Analysis of the “Dr. Snack Goji Berry” revealed they contained 13.6 milligrams per serving.

CFR Title 21 Chapter I Subchapter B Part 130 Subpart A § 130.9 
(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the finished food at a detectable level is misbranded unless the presence of the sulfiting agent or agents is declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food.

FARP 
"Sulfites are also prohibited from certain uses in the U.S. Sulfites may not be used in products such as meats that serve as a good source of vitamin B1 because sulfites can scavenge that vitamin from foods. In 1986, following the identification of numerous cases of sulfite-induced asthma occurring on ingestion of green or fruit salads treated with sulfites, FDA prohibited the use of sulfites on fruits and vegetables intended to be served raw or presented fresh to the public (Fed. Regist. 51:25021-25026, 1986). The only exception is sulfite use on minimally processed potatoes sliced or shredded for frying where sulfite use is still permitted (although FDA has a long-standing, though never finalized, proposal to ban that use also). Sulfite use as a fungicide during the shipment of fresh table grapes is regulated by the U.S. Environmental Protection Agency, but the concentration of SO2 residues on the table grapes as consumed must be <10 ppm total SO2."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bcs-international-corp-issues-alert-undeclared-sulfites-dr-snack-goji-berry
BCS International Corp. Issues Alert on Undeclared Sulfites in “Dr. Snack Goji Berry”
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 21, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sulfites
Company Name:  BCS International Corp.
Brand Name:  Dr. Snack
Product Description:  Goji berry

Frozen Chopped Spinach Recalled After Testing Finds Listeria

Frozen Food Development is voluntarily recalling specific lots of Lidl branded 12-ounce packages of Frozen Chopped Spinach because the product has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing revealed the presence of Listeria monocytogenes in 12-ounce packages of Lidl Frozen Chopped Spinach.  The production of the product has been suspended while FDA and Frozen Food Development continue to investigate the source of the problem.  The recalled Frozen Chopped Spinach was distributed in Lidl retail stores in GA, SC, NC, VA, MD, DE, NY, NJ, and PA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frozen-food-development-recalls-lidl-branded-chopped-spinach-because-possible-health-risk
Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 19, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria Monocytogenes
Company Name:  Frozen Food Development
Brand Name:  Lidl
Product Description:  Frozen Chopped Spinach

Organic Mac n' Cheeze (Fake Cheese) Recalled After Third Party Testing Finds Milk Allergen

Amy’s Kitchen of Petaluma, California is initiating a voluntary Class I recall of Lot 60J0421 of the Vegan Organic Rice Mac & Cheeze due to the potential of having trace amounts of milk, which is not declared on the product label.  The recall was issued "After receiving a test result from a third-party laboratory indicating one of the meals in the lot contained trace amounts of milk protein,"

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amys-kitchen-voluntarily-issues-allergy-alert-undeclared-milk-single-lot-vegan-organic-rice-mac
Amy’s Kitchen Voluntarily Issues Allergy Alert on Undeclared Milk in a Single Lot of Vegan Organic Rice Mac & Cheeze
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 19, 2022
Product Type:  Food & Beverages  Organic Food / Home Grown   
Reason for Announcement:  Undeclared Milk
Company Name:  Amy’s Kitchen
Brand Name:  Amy’s
Product Description:  Amy’s Vegan Organic Rice Mac & Cheese

FDA Issue Report on Salmonella Outbreak Linked to Leafy Greens from Indoor Growing Facility

FDA released their report on a 2021 Salmonella outbreak that was linked to packaged leafy greens produced at a Controlled Environmental Agriculture (CEA) indoor hydroponic operation [a fancy indoor greenhouse].  The outbreak occurred in July and August of 2021 and was caused by Salmonella Typhimurium which infected 31 people and resulted in 4 hospitalizations.

One would think that product produced in a controlled setting would be free from pathogens.  However, there were many opportunities for contamination and a lack of control.  And an indoor greenhouse is not much different than a processing facility where controls are needed.  While a definitive source was not found, here is a brief summary of some of the issues"

• The operation stored its nutrient-rich growth media used in an outdoor location that was not adequately protected from potential sources of contamination such as animal intrusion, bird droppings, or water runoff.
• The use of production pond water, while not intended to be an issue with leafy greens final product, but control of the water was questioned and there were inadequate controls for the water itself, with FDA isolating a different strain of Salmonella (not the one involved in the outbreak.
• Harvesting equipment lacked adequate control, and condensate with the facility.
• Inadequate validation support for cooling greens after packaging.
• Issues with storm water retention pond in close proximity to the facility (25ft).  This pond did test positive for the outbreak strain.
• The firm did not adequately document that cleaning and sanitizing of equipment, tools, and buildings used in growing operations is routinely conducted in accordance with the firm’s procedures

FDA highlighted the recommendations that focused on the need to better understand the microbial risks and put in place better controls.
The full report can be found here - https://www.fda.gov/media/155402/download

Investigation Report: Factors Potentially Contributing to the  Contamination of Packaged Leafy

Greens Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2021

https://www.fda.gov/media/155402/download

Peppermint Baking Chips Recalled for Allergens After Packing Error by Co-Packer

Lily’s Sweets, is voluntarily recalling 18,855 cases of 7-ounce Peppermint Flavor Baking Chips due to the presence of soy lecithin.  "The error was discovered after consumers contacted the company and reported finding the white candy pieces mixed with Lily’s Peppermint Flavor Baking Chips. We have determined that the error occurred at a co-manufacturer. The white disc-shaped candy pieces contain soy lecithin, sugar, and other ingredients that are not present in Lily’s Peppermint Flavor chips." 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lilys-sweets-voluntarily-recalls-lilys-peppermint-flavor-baking-chips-due-undeclared-presence-soy
Lily’s Sweets Voluntarily Recalls Lily’s Peppermint Flavor Baking Chips Due to Undeclared Presence of Soy Lecithin
Summary
Company Announcement Date:  January 14, 2022
FDA Publish Date:  January 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared soy lecithin
Company Name:  Lily’s Sweets
Brand Name:  Lily’s
Product Description:  Peppermint Flavor Baking Chips

Review Article - Kombucha

In this months Journal of Food Science , a review of Kombucha was published titled, Kombucha: A review of substrates, regulations, composition, and biological properties (Jan 2022). The article is a good review of what we know, and what we don't know, about the increasing popular drink Kombucha.

Kombucha is a beverage traditionally obtained by the fermentation technique of tea with added sugar by a SCOBY (symbiotic culture of bacteria and yeast).

The article discusses the evolution of Kombucha to include additional substrates.  This type of research is good to have for those who push the boundaries of this fermented product.  The article also details many of the benefits, but points out "According to literature data, there are many benefits attributed to kombucha, however, it is important to emphasize that the studies are carried out predominantly in animals, or in vitro in cell cultures of animals or humans, with no evidence yet to support these benefits to human health (Kapp & Sumner,2019). Still, despite not being able to receive any official claims about its health effects, kombucha can be considered a high-value food product in a healthy diet (Jayabalan et al.,2014)."

There is still a lot of research needed to better understand the science - organisms involved in the ferementation, the benefits to human health, and potential toxic affects.

IFT Journal of Food Science
https://ift.onlinelibrary.wiley.com/doi/epdf/10.1111/1750-3841.16029
Kombucha: A review of substrates, regulations,composition, and biological propertiesJeniffer Ferreira de Miranda1Larissa Fernandes Ruiz1Cíntia Borges Silva1Thais Matsue Uekane1Kelly Alencar Silva1Alice Gonçalves Martins Gonzalez1Fabrício Freitas Fernandes2Adriene Ribeiro Lima

Abstract: