Minnesota Raw Pet Food Company Cited for Inadequate PAA Process Resulting in Pathogens in Finished Product

FDA issued a Warning Letter to Woody’s Pet Food Deli of  West Saint Paul, MN., a processor of raw pet food products.   During the inspection, FDA took samples and found that Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24, was contaminated with Salmonella Reading and Listeria monocytogenes.

The firm uses an acetic acid, PAA, and hydrogen peroxide (b)(4), as the method to eliminate pathogens from the raw pet food products. During the inspection, FDA collected an in-process sample (FDA sample #1214888) of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements, lot code 08/31/24,  at a location immediately after the application of the spray and immediately prior to finished product packaging.  This product tested positive for Salmonella Reading and Listeria monocytogenes. Thus the process is not adequate.  Further, the company could not provide any information indicating the use of PAA in pet food is considered GRAS by qualified scientific experts.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agila-corporation-dba-woodys-pet-food-deli-670835-01262024
Agila Corporation dba Woody’s Pet Food Deli
MARCS-CMS 670835 — JANUARY 26, 2024

Illinois Facility Received Warning Letter for Continued Allergen Related Recalls

FDA issued a Warning Letter to Gilster-Mary Lee Corporation of Chester, IL after they determined that the company's recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 oz. retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), was misbranded within the meaning of the regulation in that the finished product label did not declare a major food allergen, milk. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited.  The  firm had initiated three other recalls involving mislabeled products resulting in undeclared major food allergens since 2019.  Thus the reason they received a Warning Letter.

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023

Gilster-Mary Lee Corporation
MARCS-CMS 658271 — AUGUST 28, 2023

FDA Issues Warning Letter to CA Juice Company Processing Carrot Juice with Pasteurization

FDA issued a Warning Letter to Barsotti Juice Company, Inc. of Camino, CA after the investigation found that they were processing a low acid carrot juice product with a pasteurization process that creates a Clostridium botulinum issue if the product were to be temperature abused.  

Findings:

• "HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice."
• "Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice."

The pasteurization process would eliminate vegetative cells, but not spores including spores of Clostridium botulinum.  Those spores would survive the pasteurization, and if held at temperatures above refrigeration temperature for sufficient time, the spores would germinate, and then the cells would grow producing toxin.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/barsotti-juice-company-inc-676447-01302024
Barsotti Juice Company, Inc.

MARCS-CMS 676447 — JANUARY 30, 2024

Recipient:
Barsotti Juice Company, Inc.
2239 Hidden Valley Lane
Camino, CA 95709
United States

Maine Facility Recalls Gluten Free Doughnut Mix for Containing Wheat

Stonewall Kitchen of York, Maine is voluntarily recalling a limited amount of their Gluten Free Cinnamon Sugar Doughnut Mix because it may contain an undeclared allergen, wheat.  The recall was initiated after the company received a consumer report of a reaction. Subsequent investigation discovered that product containing wheat was distributed in packaging that did not reveal the presence of wheat due to a packaging process error.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stonewall-kitchen-issues-allergy-alert-wheat-limited-quantity-gluten-free-cinnamon-sugar-doughnut
Stonewall Kitchen Issues Allergy Alert for Wheat in Limited Quantity of Gluten Free Cinnamon Sugar Doughnut Mix
Summary
Company Announcement Date:  March 07, 2024
FDA Publish Date:  March 07, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Wheat
Company Name:  Stonewall Kitchen
Brand Name:  Stonewall Kitchen
Product Description:  Gluten Free Cinnamon Sugar Doughnut Mix

Wisconsin Establishment Recalls Turkey Kielbasa After Complaints for Pieces of Rubber

Salm Partners, LLC, a Denmark, Wis., establishment, is recalling approximately 35,430 pounds of Johnsonville turkey kielbasa sausage that may be contaminated with foreign materials, specifically pieces of rubber.  The problem was discovered after the firm received complaints from consumers reporting they found pieces of rubber in the ready-to-eat turkey kielbasa products.


https://www.fsis.usda.gov/recalls-alerts/salm-partners-llc-recalls-johnsonville-polish-kielbasa-turkey-sausage-products-due
Salm Partners, LLC, Recalls Johnsonville Polish Kielbasa Turkey Sausage Products Due to Possible Foreign Matter Contamination
SALM PARTNERS, LLC
FSIS Announcement

WASHINGTON, March 7, 2024 - Salm Partners, LLC, a Denmark, Wis., establishment, is recalling approximately 35,430 pounds of Johnsonville turkey kielbasa sausage that may be contaminated with foreign materials, specifically pieces of rubber, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

CA Company Recalls 60,000 Pounds of Product For An Uncontrolled Marker Pen

CJ Foods Manufacturing Beaumont Corporation, a Beaumont, Calif., establishment, is recalling approximately 61,839 pounds of steamed chicken soup dumpling products that may be contaminated with foreign materials, specifically hard plastic from a permanent marker pen.  The problem was discovered after the firm received complaints from consumers reporting they found hard plastic in Trader Joe’s steamed chicken soup dumplings.

A permanent marker pen?  A Sharpie?  Someone drops a Sharpie and the company is recalling over 60,000 lbs of product.  How much control do you have our your pens and markers?  That is one expensive Sharpie.




https://www.fsis.usda.gov/recalls-alerts/cj-foods-manufacturing-beaumont-corporation-recalls-trader-joes-chicken-soup
CJ Foods Manufacturing Beaumont Corporation Recalls Trader Joe’s Chicken Soup Dumplings Due to Possible Foreign Matter Contamination

CJ FOODS MANUFACTURING BEAUMONT CORPORATION

FSIS Announcement

WASHINGTON, March 2, 2024 – CJ Foods Manufacturing Beaumont Corporation, a Beaumont, Calif., establishment, is recalling approximately 61,839 pounds of steamed chicken soup dumpling products that may be contaminated with foreign materials, specifically hard plastic from a permanent marker pen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Issues Health Alert on Cinnamon Product Due to Elevated Lead Content, Recalls Issued

"Following the October 2023 recall of cinnamon apple puree and applesauce products due to elevated lead levels linked to the cinnamon in those products and the concern for lead toxicity in children, the FDA initiated a targeted survey of ground cinnamon products from discount retail stores and analyzed the samples for lead and chromium."

Companies producing product with elevated lead as determined by FDA testing issued recalls.

• El Chilar Rodriguez LLC of Apopka, FL is recalling 127 cases (12 bags/case) of El Chilar Ground Cinnamon “Canela Molida” (1.25 oz bag).
• Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER"
• Colonna Brothers of North Bergen, NJ is recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon 
• Raja Foods LLC of Skokie, Il is recalling its 3.5 ounce package of "SWAD CINNAMON POWDER"
• La Fiesta Food Products, La Mirada California is recalling Cinnamon Ground .87oz 

First, this is a great reminder of why it is important to pay attention to recalls and health alerts.  If you are an importer of a product or ingredient, that that ingredient was involved in major outbreak, it is just a matter of time before regulatory authorities are taking a broader look at other issues.  It does not have to be from the same supplier or originate from the same country.

The levels were not anywhere as high in these implicated products compared to the levels in the cinnamon apple sauce involved in the lead poisoning outbreak.

"Based on results from the survey, the FDA is recommending recalls of ground cinnamon from six distributors whose products had elevated lead levels ranging from 2.03 to 3.4 parts per million (ppm) (see table above for a full list of lead levels in these products). These levels are significantly lower than the levels of lead associated with the ongoing investigation into ground cinnamon from Ecuador supplied by Negasmart to Austrofoods, the manufacturer of the apple puree and applesauce products, which were between 2,270 ppm to 5,110 ppm in the cinnamon."

What level is unsafe?

FDA.gov - "Although no safe level for lead exposure has been identified, the FDA has calculated an IRL for lead based on the Centers for Disease Control and Prevention’s (CDC) blood reference level of 3.5 micrograms of lead per deciliter of whole blood (µg /dL). The blood reference level is the level at which the CDC recommends clinical monitoring of lead exposure in children."

"The IRL for lead includes a 10x safety factor. This means that it is nearly ten times lower than the amount of lead intake from food that would be required to reach the CDC’s blood reference level. The calculated IRLs are 2.2 micrograms (µg) per day for children and 8.8 µg per day for females of childbearing age. The IRL for females of childbearing age is to protect against possible fetal exposure in women who are unaware that they are pregnant and to protect against infant exposure during nursing:.

https://www.fda.gov/food/alerts-advisories-safety-information/fda-alert-concerning-certain-cinnamon-products-due-presence-elevated-levels-lead
FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead

March 6, 2024

What is the problem?

Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe.

The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA has been unable to reach MTCI to share our findings and request that the company initiate a recall. The FDA will update this notice with the communications from firms that voluntarily agree to recall as we receive them.

CA Department of Health Issues Advisory for Canned Foods Sold by Cannery Not Registered with State Cannery Program

Aji Mori Sauce Corp. DBA Sushi Koo of Los Angeles, CA, is voluntarily recalling its CHILLIMAMI SAUCE because product was manufactured and distributed without the California Department of Public Health (CDPH) Cannery Program oversight, making them just susceptible to contamination with Clostridium botulinum.

California has a Cannery Program that establishes requirements for California facilities that package both low acid and acidified foods in sealed containers.  

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/CanneryInspectionProgram.aspx

How is this different than FDA Acidified or Low Acid Canned food regulations?

According to the website, "Food processors (Canneries) manufacturing these types of foods must comply with California and federal requirements and operate under a valid Cannery License that is renewed every two years."  Although, outside of this blurb, the necessity is not stated on the procedures for obtaining a cannery license.

Does California has issues with canneries producing without oversight?

Another advisory was issued in February of 2024 for a canner of acidified products.  In 2023, CADPH issued a warning for pickled items for a botulism risk.

Why should a state like CA have a sperate program from what the FDA already does? Could it be that the State of California has stepped in to help the FDA?  Perhaps.   Or they may be trying to make it easier for people to make and sell canned foods.  But do we want that or need that?  Is it better to require canneries processing products where Clostridium botulinum is a risk, to have to jump through some hoops to prove they have the capabilities?  

What's worse is the sensationalized media reporting.  Sauce Recall as Contamination Fears Spark Warning of Toxins (Newsweek, Mar 06, 2024)

The interesting thing to note here is that this is probably an acid food, so neither an acidified food or a low acid food.   Looking at the ingredients, probably safe, but only a quick pH test would be needed to verify.

Tomato Paste, Water, Organic Brown Sugar, Lemon Juice, Japanese Mixed Chili Pepper, Oil, Salt, Allspice, Japanese Mirin, Garlic.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aji-mori-sauce-corp-dba-sushi-koo-issues-voluntary-recall-chillimami-sauce
Aji Mori Sauce Corp. DBA Sushi Koo Issues Voluntary Recall of Chillimami Sauce
Summary
Company Announcement Date:  February 29, 2024
FDA Publish Date:  March 06, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness - Clostridium botulinum
Company Name:  AJI MORI Sauce Corp. DBA Susi Koo
Brand Name:  AJI MORI
Product Description:  CHILLIMAMI SAUCE
Company Announcement  Product -Recall Important Information

A NC Facility Recalls Carrot Cake with a Chocolate Cake Ingredient Statement Resulting in Undeclared Soy

 KALO Foods, LLC of Stokesdale, NC is recalling Single Slice Carrot Cake UPC 8 53407 00418 4 due to a undeclared soy. Although the package is labeled Carrot Cake, the ingredient panel and UPC Code is for their Chocolate Cake. The Carrot Cake contains soy which is not listed in the ingredient statement.  On March 1, 2024, the firm was notified by one of their customers, that packages labeled as Carrot Cake, but the ingredient panel on the bottom is for Chocolate Cake.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kalo-foods-llc-recalls-single-slice-carrot-cake-due-undeclared-soy-allergen
Kalo Foods, LLC Recalls Single Slice Carrot Cake Due to Undeclared Soy Allergen
Summary
Company Announcement Date:  March 05, 2024
FDA Publish Date:  March 05, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy
Company Name:  KALO Foods, LLC
Brand Name:  KALO
Product Description:  Carrot Cake Slice