Monday, February 10, 2025

Wisconsin Sprout Operation Recalls Sprouts After State Testing Finds Listeria

Jack and the Green Sprouts, Inc. of River Falls, WI is recalling 5oz packages of Alfalfa sprouts that expired on 1/29/25 because they have the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing by the State of MN which revealed the presence of Listeria monocytogenes in expired 5oz package Alfalfa sprouts. Even though Jack and the Green Sprout’s tests from an independent lab had negative results confirmed on spent irrigation water & finished Product for the Alfalfa Lot #687 before release.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jack-and-green-sprouts-recalls-expired-alfalfa-sprouts-because-possible-health-risk
Jack and the Green Sprouts Recalls Expired Alfalfa Sprouts Because of Possible Health Risk
Summary
Company Announcement Date:  February 07, 2025
FDA Publish Date:  February 08, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Jack and the Green Sprouts, Inc.
Brand Name:  Jack & the Green Sprouts
Product Description:  Alfalfa Sprouts

NJ Firm Recalls Imported Tahini Paste After State Lab Detects Salmonella

Turkana Food Inc. Kenilworth, NJ is recalling 858 cases OF Aleppo Tahini Sesame Paste because it has the potential to be contaminated with Salmonella.  The recall was the result of a routine sampling performed by the Ohio Department of Agriculture which revealed that the finished products contained Salmonella. The company has ceased production and distribution of the products as FDA and the company continue their investigation to what caused the problem.  Product is imported from Turkey.
             
                                                
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/turkana-food-inc-recalls-aleppo-tahini-sesame-paste-1lb-16oz-because-possible-health-risk
Turkana Food Inc. Recalls Aleppo Tahini Sesame Paste 1lb (16oz) Because of Possible Health Risk
Summary
Company Announcement Date:  February 06, 2025
FDA Publish Date:  February 06, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness - Salmonella
Company Name:  Turkana Food Inc.
Brand Name:  Aleppo
Product Description:  Tahini Sesame Paste

Friday, February 7, 2025

Salmonella Outbreak Linked to Imported Mini Pastries

The FDA and CDC, in collaboration with state, local, and international partners, are investigating illnesses in a multistate outbreak of Salmonella Enteritidis infections linked to Sweet Cream-brand mini pastries manufactured in Italy and exported into the United States by Importations Piu Che Dolci Inc. of Quebec, Canada.  As of January 29, 2025, a total of 18 people infected with the outbreak strain of Salmonella have been reported from seven states. Of the 18 people for whom information is available, one person has been hospitalized

On January 21, 2025, FDA was notified about an outbreak of Salmonella in the United States, which is the same strain investigated in Canada. Canadian Food Inspection Agency (CFIA) informed FDA that their investigation linked their outbreak to Sweet Cream-brand mini pastries,

The recalled products were imported by two distributors in the U.S. who were contacted about the recall. One distributor had no product on hand, and the second distributor quarantined all product on hand and informed all of their downstream customers of the recall. As part of this investigation, FDA conducted traceback for one of the U.S. cases and identified that they were served recalled Sweet Cream-brand mini pastries at a restaurant prior to becoming sick. The restaurant received the pastries from one of the U.S. distributors.

The FSVP (Foreign Supplier Verification Program) was put in place to ensure that importer of this product can verify the foreign producer is meeting US standards including having a Food Safety Plan.  In this case, the FSVP importer would conduct a hazard analysis, determine significant hazards, and then put in verification procedures to ensure that supplier is controlling the significant hazards.  In a pastry product such as this, Salmonella would have been determined to be a significant hazard to be controlled through process control and then through sanitation control to prevent recontamination of the RTE pastry before packaging.

Case Counts
Total Illnesses: 18
Hospitalizations: 1
Deaths: 0
Last Illness Onset: December 6, 2024
States with Cases: CA, IL, MA, NC, NJ, NY, and PA
Product Distribution*: FL, NJ, NY, and PA

*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states



https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-mini-pastries-january-2025
Outbreak Investigation of Salmonella: Mini Pastries (January 2025)
Do not sell or serve recalled Sweet Cream-Brand Mini Pastries. FDA’s investigation is ongoing.

Monday, February 3, 2025

Rushing to Judgment on the FDA 483 Inspectional Observations of Onion Facility

It can be difficult in determining the exact cause of a foodborne illness outbreak, even for inspectors.  But it seems that it can be too easy to jump to conclusions, especially for the media, based upon pieces of information that become available.  A recent posting from Food Safety Strategy titled The Mischaracterization of a 483  provides a good analysis of the FDA's 483 report of Inspectional Observations and how they can be difficult to judge, especially for those who are not familiar with food observations.  While this analysis did not reference a specific 483 report, I immediately thought of the report of the facility that was responsible for the 2024 E. coli outbreak linked to sliced onions sold at McDonalds.

To read through this, one can easily say the inspector is leaning to environmental contamination issue due to lack of cleaning.  Certainly some of the media conveyed that thought.  However, while this facility had 'potential' issues based upon what he inspector observed, there is no hard evidence provided and plenty of questions that are not answered.

As pointed out in the article cited above, fresh operations are going to have pooling water.  It is a wet operation.  The 483 cites 'apparent biofilm',  but there was no analysis to determine if it was bacteriological in origin.  In fact, no environmental testing was mentioned in the report.   

The presence of Listeria and other pathogens in these types of facilities is going to happen.  There needs to be recognition of whether that contamination is endemic or transient.

It is important to recognize that this is a process with no lethality / kill step.  The biggest issue with contamination is just as much or more of a raw material issue than a facility issue.  And the 483 does not delve into this fact that contamination may likely have been on the product.  And there has been some research evidence for internalization of pathogenic organisms in produce including onions that are grown in soil.  

Not to argue with what the inspector observed, but one must be cautious about jumping to conclusions based upon these observations without additional information including field testing, product testing, etc.

https://www.koaa.com/news/covering-colorado/inspectors-find-dozens-of-violations-at-taylor-farms-in-colorado-springs
FDA 483 Inspectional Observations
Taylor Farms Colorado, Inc.

6th &  Kipling St. (P.O. Box 25087)
Denver, CO 80225-0087
(303)236-3000  Fax:(303)236-3100

OBSERVATION 1
You did not implement your sanitation preventive control, monitoring, corrective action and verification procedures.

NC Raw Pet Food Company Continues to Issue Recalls For Pathogens Found by State Testing

Blue Ridge Beef, of Statesville, NC is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054.  Samples of the product was collected on 01/08/25 by the North Carolina Department of Agriculture and tested by the North Carolina Department of Agriculture Food and Drug Protection Laboratory. The product tested positive for Salmonella.  On 01/27/2025 the firm was notified by the FDA that the product tested positive for Salmonella.

This company has a significant history of recalling product due to the presence of pathogens.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-ridge-beef-issues-recall-blue-ridge-beef-natural-mix-due-salmonella-contamination
Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination
Summary
Company Announcement Date:  January 31, 2025
FDA Publish Date:  January 31, 2025
Product Type:  Animal & Veterinary  Food & Beverages   Pet Food
Reason for Announcement: Salmonella contamination
Company Name:  Blue Ridge Beef
Brand Name:  Blue Ridge Beef
Product Description:  Natural Mix

Baby Teething Chew Stick Recalled and Discontinued After Choking Incidents

Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children.  The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm.

Consumers who may have purchased GERBER® SOOTHE N CHEW® TEETHING STICKS should not feed this product to their child and can return the product to the retailer where it was purchased for a refund. Anyone concerned about an injury or illness should contact a health care provider.

According to the Gerber website, This voluntary recall and discontinuation is isolated to GERBER® SOOTHE N CHEW® TEETHING STICKS – STRAWBERRY APPLE and GERBER® SOOTHE N CHEW® TEETHING STICKS – BANANA. It does not impact any other Gerber products such as Gerber® Teethers Gentle teething wafers and Gerber® TEETHER WHEELS.

It seems to me that this product design would be a bad idea.  Anyone with a dog knows that chew sticks can be an issue with choking for some dogs, so the same issue would apply to this.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gerber-products-company-announces-recall-and-discontinuation-all-batches-gerberr-soothe-n-chewr
Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To Choking Hazard
Summary
Company Announcement Date:  January 31, 2025
FDA Publish Date:  January 31, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential choking hazard for babies and young children
Company Name:  Gerber Products Company
Brand Name:  Gerber
Product Description:  Gerber® Soothe N Chew® Teething Sticks

Friday, January 31, 2025

Chocolate Covered Pretzels Recalled for Undeclared Milk

United Natural Trading LLC, Edison, NJ, is voluntarily recalling Fresh Direct Dark Chocolate Covered Pretzels due to the presence of an undeclared milk allergen.  The issue was discovered during an internal review of label management system as an action item from an internal nonconformance.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/united-natural-trading-llc-announces-allergy-alert-undeclared-milk-fresh-direct-dark-chocolate
United Natural Trading LLC Announces Allergy Alert for Undeclared Milk in Fresh Direct Dark Chocolate Covered Pretzels
Summary
Company Announcement Date:  January 30, 2025
FDA Publish Date:  January 30, 2025
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared milk
Company Name:  United Natural Trading LLC
Brand Name:  Fresh Direct
Product Description:  Dark Chocolate Covered Pretzels

Some Media Headlines on Recalls Do Nothing More than Cause Confusion and Fear

Reading the daily headlines, I find that these new releases for recalls are just over the top.  Today, an article titled Why Lay’s Potato Chip Recall Was Elevated To FDA’s Deadliest Category was published in Forbes online.  To read this, you are thinking that these are some truly dangerous chips.  But then when actually read the article, you realize this is an milk allergen issue (and there were people affected) with the recall occurring over a month (Dec 18, 2024) ago and that product's distribution was limited to Oregon and Washington state.

As the recall category be classified Class 1, this is more of just an administrative function that sometimes takes longer to get applied.  So not like FDA had a revelation a month later.

From the FSPCA manual, Preventive Controls for Human Foods
Recalls are actions taken by a facility to remove a product from the market that may be adulterated, misbranded, or violate regulations in some way. In other words, a product for which the FDA or a state could take legal action against the facility would be subject to a recall. It is important to note that a recall is different from a market withdrawal and stock recovery. In a market withdrawal, it is the  company’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation. A stock recovery is when the company corrects or removes a product where that product has not left direct control of the facility.

 The numerical designation (i.e., I, II, or III) [is] assigned by FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled (FDA Hazard Guide, Chapter 14, 2018).

(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death (21 CFR 7.3(m)(1));
(2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or
medically reversible adverse health consequences or where the probability of serious health
consequences is remote (21 CFR 7.3(m)(2)); and
(3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause illness or injury (21 CFR 7.3(m)(3)).

Thursday, January 30, 2025

Three Importers Issued Warning Letters for Failure to Develop FSVP for Imported Foods

Food imported into the United States must meet same standards as products produced in the United States.  The Foreign Supplier Verification Program (FSVP) is a regulation that must be complied with by importers of food into the US.   This ensures that someone here in the US has verified compliance of the foreign producer to US standards.  However, there has been a continuing issue where importers do not comply.    And this is not that they have a bad program, it is that they have no FSVP program.

Premium Fresh Growers LLC of McAllen, Texas did not develop an FSVP for any of the foods imported, including each of the following foods:
Limes imported from, (b)(4)
Cilantro imported from, Carlos Alberto Toto Cortes, located in Mexico
Carrots imported from, (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/premium-fresh-growers-llc-698646-12182024

Candymar Produce Inc of McAllen, TX did not develop an FSVP for any of the foods imported, including each of the following foods:
Carrots imported from (b)(4)
Squash imported from (b)(4)
Cabbage imported from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/candymar-produce-inc-697780-12042024

George Food Specialties Inc. of Ballston Lake, NY did not develop an FSVP for any of the foods imported. Including each of the following foods:
Mayonnaise imported from (b)(4) located in (b)(4)
Mayonnaise imported from (b)(4) located in (b)(4)
Hot Sauce imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/george-food-specialties-inc-697738-12232024