NY Firm Recalls Ice Cream for Undeclared Peanut After Mocked-up Case Enters Commerce

Van Leeuwen Ice Cream of Brooklyn, NY is voluntarily recalling its Vegan Pumpkin Cinnamon Roll Lot 24V094 pints sold at the 81 Bergen Street Brooklyn, NY location. These pints contain an undeclared allergen, peanuts.  The recall was initiated after it was discovered that 8 pints containing the peanut allergen were distributed in packaging that did not reveal the presence of peanuts. 4 pints have been recovered to date, leaving 4 pints remaining out in distribution. Subsequent investigation identified the problem was caused by a mock case sample which accidentally entered the distribution channel.

So how can this happen? A likely scenario - the company had developed the new packaging for Vegan Pumpkin Cinnamon Roll and decided to fill it with whatever was running that day to see what the packaging looked like full / try out the new packaging on the filler / etc.  So the containers were filled with peanut ice cream, but it was not destroyed after the trial.  Rather, this mock case made its way to the warehouse and was subsequently distributed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/van-leeuwen-ice-cream-issues-allergy-alert-undeclared-peanuts-vegan-pumpkin-cinnamon-roll-non-dairy
Van Leeuwen Ice Cream Issues Allergy Alert on Undeclared Peanuts in Vegan Pumpkin Cinnamon Roll Non-Dairy Frozen Dessert
Summary
Company Announcement Date:  July 30, 2024
FDA Publish Date:  July 30, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Peanut Allergen
Company Name:  Van Leeuwen Ice Cream
Brand Name:  Van Leeuwen
Product Description:  Vegan Pumpkin Cinnamon Roll Non Dairy Frozen Dessert

VA Establishment Expands Recall As Testing Determines Outbreak Strain in Liverwurst Product

CDC and USDA-FSIS have identified Boar's Head liverwurst as having the outbreak strain of Listeria that has resulted in 34 cases with 33 hospitalizations and 2 deaths. From the CDC, "As of July 26, 2024, a total of 34 people infected with the outbreak strain of Listeria have been reported from 13 states (see map). Sick people’s samples were collected from May 29, 2024, to July 12, 2024 (see timeline). Of 33 people with information available, all 33 have been hospitalized. One person got sick during their pregnancy and remained pregnant after recovering. Two deaths have been reported, 1 in Illinois and 1 in New Jersey."

Whole genome sequencing results show that a liverwurst sample collected by the Maryland Department of Health tested positive for the outbreak strain of Listeria monocytogenes.

Boar's Head Provisions Co., Inc., a Jarratt, Va., establishment, is expanding its July 26, 2024, recall of deli meat products that may be adulterated with Listeria monocytogenes. The establishment is recalling approximately 7 million additional pounds of ready-to-eat meat and poultry products.

https://www.cdc.gov/listeria/outbreaks/delimeats-7-24/index.html
Listeria Outbreak Linked to Meats Sliced at Delis
Posted July 31, 2024

Fast Facts
Illnesses: 34
Hospitalizations: 33
Deaths: 2
States: 13
Recall: Yes
Investigation status: Active (First posted on July 19, 2024).

USDA Proposes New Policy for Raw Poultry Establishments to Control Salmonella

The USDA proposed a new policy with the goal of reducing Salmonella in raw poultry products. Currently, the industry  performance standards in place, these did little to reduce poultry-related Salmonella outbreaks. One question will be whether this new policy will have any impact on the number of cases that are said to occur due to poultry. Secondly, how will the proposed testing be accomplished without major impacts on supply chain?  What are the costs?

Under the current system, facilities look at prevalence of Salmonella using an absence/presence analysis. and based on this, a facility is judged as meeting or not meeting the established standard. In the proposed system, establishments will look at number of Salmonella as well as determine if certain infectious strains are present.

"FSIS is proposing final product standards that would define whether certain raw poultry products contaminated with certain Salmonella levels and serotypes are adulterated as defined in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). Specifically, FSIS has tentatively determined that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey are adulterated if they contain any type of Salmonella at or above 10 colony forming units/per milliliter or gram (10 cfu/mL(g)) in analytical portion (i.e., mL of rinsate or gram of product) and contain any detectable level of at least one of the Salmonella serotypes of public health significance identified for that commodity."

"The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I 4,[5],12:i:-, and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. These are the most highly virulent Salmonella serotypes associated with these products identified in the FSIS chicken and turkey risk assessments."

USDA would conduct sampling of products from the facility.

"The Agency intends to conduct a routine sampling and verification testing program for Salmonella in chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey in which the Agency would collect samples of raw final products and analyze them for Salmonella levels and serotypes to determine whether the final product is adulterated. Under the proposed Salmonella verification testing program, FSIS intends to only collect and analyze samples of the final raw poultry products produced by an establishment, i.e., chicken carcasses to be shipped in commerce as whole chickens, chicken parts to be shipped in commerce as chicken parts, comminuted chicken to be shipped in commerce as comminuted chicken products, and comminuted turkey to be shipped in commerce as comminuted turkey products."

USDA would require facilities to establish controls, and as part of that, verification testing.

USDA will "establish new requirements pertaining to how establishments monitor and document whether their processes for preventing microbial contamination are in control. The proposed revisions are intended to clarify existing regulatory requirements related to process control monitoring in 9 CFR 381.65(g) and (h). Under this proposal, establishments would be required to incorporate statistical process control (SPC) monitoring principles into their microbial monitoring programs (MMPs). The proposed revisions would require that establishments use only validated and fit for purpose microbial sampling and analysis procedures, generate and record statistically meaningful microbial monitoring data, set benchmarks by which to evaluate microbial monitoring data, and otherwise define the statistical methods the establishment will use to evaluate the recorded data against the predefined limits."

"FSIS is proposing to specifically require establishments to, at a minimum, implement written corrective actions, including a root cause assessment, when microbial monitoring results deviate from the predefined criteria in the MMP, the other process control monitoring results, or the process control determination made for the entire HACCP system. FSIS has developed new guidance to help establishments meet the proposed updated sampling and analysis requirements under 9 CFR 381.65(g). The new guidance includes a SPC sampling plan based on paired sampling for Aerobic Count (AC) at the rehang and post-chill locations, with a one-sided process control statistical model that charts and calculates against minimum monitoring criteria at the minimum required frequency. Establishments that incorporate the guidance into their MMPs would not be required to provide FSIS with additional scientific or technical information to support their chosen statistical methods."

"FSIS is proposing to amend the recordkeeping requirements under 9 CFR 381.65(h) to require that establishments submit their microbial monitoring sampling results to FSIS electronically. FSIS is developing a web portal that will allow external partners to securely upload sampling information and submit it to FSIS electronically in a machine-readable format."

July 29, 2024
Special Alert
USDA Proposes New Policy to Reduce Salmonella in Raw Poultry Products

Today, FSIS issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. This is the culmination of FSIS’ three-year effort to reevaluate their strategy for controlling Salmonella rates in poultry and protect American consumers from foodborne illness linked to consumption of poultry products.

Three Food Companies from NY and NJ Recall Cinnamon Products After Testing Finds Elevated Lead Levels, FDA Updates

Updated on 7/31/24

FDA has updated the page listing different cinnamon products with lead that have been removed from commerce.  Overall, these products had levels ranging from 2 to 7ppm.

Two New York food companies and one from NJ issued recalls for cinnamon because the products have the potential to be contaminated with elevated levels of lead.

• American Spices, LLC. of Ozone Park, NY is recalling Spice Class brand Ground Cinnamon
• Advance Food International, Inc. of Maspeth, NY is recalling Shahzada brand Cinnamon Powder in 7oz packing 
• Colonna Brothers of North Bergen, NJ is voluntarily recalling its 1.5oz Marcum Ground Cinnamon & 2.25oz Supreme Tradition Ground Cinnamon

Both recalls are the result of an analysis conducted by the New York State Department of Agriculture and Markets (NYSAGM) that revealed the product contained elevated levels of lead. The companies have ceased the production and distribution of the product as the FDA and the companies continue their investigation as to what caused the problem.

NY Distributor is Recalling Cinnamon Powder After Testing Finds Elevated Lead Levels

ALB-USA Enterprises, Inc. of Bronx, NY is recalling ALB Flavor brand Cinnamon Powder, because it potentially contaminated with elevated levels of lead. The recall was the result of an analysis conducted by the Connecticut Agricultural Experiment Station (CAES) that revealed the product contained elevated levels of lead.

The company has ceased the importing and distribution of the product as the FDA and the company continue their investigation as to what caused the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alb-usa-enterprises-recalls-alb-flavor-ground-cinnamon-because-possible-health-risk
ALB-USA Enterprises Recalls ALB Flavor Ground Cinnamon Because of Possible Health Risk
Summary
Company Announcement Date:  July 26, 2024
FDA Publish Date:  July 26, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Metal Contaminant - Lead
Company Name:  ALB-USA ENTERPRISES
Brand Name:  ALB Flavor
Product Description:  Ground Cinnamon Powder

Additional Recall Notices Issued Due to Purchasing of Recalled Produce with Potential Listeria

In light of the the Listeria-related recall associated with product from Ohio-based Weirs Farms, other food companies and distributors are issuing recalls.

• Supreme Service Solutions LLC. (dba Supreme Produce) is assisting in a Kroger Store recall for items purchased from Weirs Farm Inc. (purchased from Kroger Stores)
• ALDI Inc., (“ALDI”) is recalling Freshire Farms jalapenos, green peppers and green beans
• JFE Franchising, Inc. of Houston, TX, is recalling a limited number of products because they may be contaminated with Listeria monocytogenes.

Announcements for each are listed below.

Case Count Update on Recalled Mushroom-Infused Snack Items

FDA provided an update on the number of illnesses linked to the mushroom infused product. FDA and CDC issued the first health warning last month linked to these bioactive-mushroom-infused snack products.  A month later and there are 74 reported cases with 38 hospitalizations and potentially 2 linked deaths. 

The Diamond Shruumz-brand products have been recalled and should no longer be available for sale. These products were available online and in person at a variety of retail locations nationwide including smoke/vape shops, and at retailers that sell hemp-derived products such as cannabidiol (CBD) or delta-8 tetrahydrocannabinol (delta-8 THC).

Case Counts

Total Illnesses: 74

Hospitalizations: 38

Potentially associated deaths: 2 (under investigation)

Last illness onset: July 20, 2024

States with Cases: AL (4), AZ (6), CA (1), CO (1), FL (1), GA (7), IN (6), IA (5), KY (5), MD (1), MN (2), MO (1), MT (1), NV (1), NJ (2), NY (1), NC (3), ND (2), OH (2), OK (1), OR (1), PA (2), SC (5), SD (1), TN (4), TX (1), VA (4), WA (2), Unknown State (1)

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-illnesses-diamond-shruumz-brand-chocolate-bars-cones-gummies-june-2024
Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies (June 2024)

FDA Releases Report on Sampling of Fresh Herbs for Pathogens

The FDA released their report for the "Microbiological Surveillance Sampling: FY17-21 Fresh Herbs (Cilantro, Basil & Parsley) Assignment". In this project, FDA completed its collection and testing in September 2021, having obtained 1,383 samples in all.  "The samples collected were tested for Cyclospora cayetanensis, Salmonella spp., and Shiga toxin-producing Escherichia coli (STEC). The assignment aimed to estimate the prevalence of these pathogens in the three types of fresh herbs and to take follow-up actions in the case of pathogen findings, as warranted. The agency also sought to identify common factors, such as origin, among the pathogens’ findings."

 The results can be found here - https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling-fy17-21-fresh-herbs-cilantro-basil-parsley-assignment

Cyclospora cayetanensis Findings

• C. cayetanensis in 11 of the 120 basil samples, 7 of the 553 cilantro samples, and none of the 139 parsley samples, an estimated prevalence of 9.2% for basil, 1.3% for cilantro, and 0% for parsley.
• The agency detected C. cayetanensis in 18 samples out of 812 domestic and imported samples collected and tested

Salmonella spp. Findings

• Salmonella spp. in 7 of the 248 basil samples, 8 of the 849 cilantro samples, and 2 of the 261 parsley samples, an estimated prevalence of 2.8% for basil, 0.9% for cilantro, and 0.8% for parsley.
• The FDA detected Salmonella spp. in 17 samples out of 1,358 domestic and imported samples collected and tested.

STEC Findings

• The FDA detected STEC in none of the 242 basil samples, 1 in 849 cilantro samples, and none of the 259 parsley samples, an estimated prevalence of 0% for basil, 0.1% for cilantro, 0% for parsley.
• The agency detected STEC in one (1) domestic sample out of 1,350 samples collected and tested.

Actions Taken

• As to the domestic samples that tested positive for a target pathogen, the agency worked with each firm that owned or distributed the adulterated herbs to effect four voluntary product recalls.
• With respect to the import samples that tested positive for a target pathogen, the FDA refused to admit 20 shipments associated with positive findings into the U.S. and placed the responsible firms and product on Import Alert 99-23 and/or Import Alert 99-35, thereby requiring additional controls for future entries.

https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-summary-report-fresh-herbs-sampling-assignment
FDA Releases Summary Report on Fresh Herbs Sampling Assignment
Constituent Update
July 26, 2024

FDA Release Webpage on Microplastics and Nanoplastics in Foods

There has been increasing news on microplastics and nanoplastics in our food supply.  FDA published a webpage to share their current thinking on the topic. 

Here are some of the items of note:

• Plastics "originate when then break down from weathering in the environment over time into small particles called microplastics and nanoplastics."
• Environment a more important source than migration from food packaging - "Microplastics and nanoplastics may be present in food, primarily from environmental contamination where foods are grown or raised. There is not sufficient scientific evidence to show that microplastics and nanoplastics from plastic food packaging migrate into foods and beverages."
• No demonstrated impact on health  - "While many studies have reported the presence of microplastics in several foods, including salt, seafood, sugar, beer, bottled water, honey, milk, and tea, current scientific evidence does not demonstrate that the levels of microplastics or nanoplastics detected in foods pose a risk to human health".
• More research is needed - "While there are many studies on microplastics in food, the current state of science is limited in its ability to inform regulatory risk assessment. This is due to several factors, including a continued lack of standardized definitions, reference materials, sample collection and preparation procedures, and appropriate quality controls, to name a few. There have been fewer studies on nanoplastics because available scientific measurement methods are not very reliable at detecting polymer particles with such small sizes."

https://www.fda.gov/food/environmental-contaminants-food/microplastics-and-nanoplastics-foods
Microplastics and Nanoplastics in Foods

Key Points:

• Some evidence suggests that microplastics and nanoplastics are entering the food supply, primarily through the environment.
• Current scientific evidence does not demonstrate that levels of microplastics or nanoplastics detected in foods pose a risk to human health.
• The FDA continues to monitor the research on microplastics and nanoplastics in foods and is taking steps to advance the science and ensure our food remains safe.

Virginia Establishment Recalls Deli Meat After Found Positive for Listeria

Boar's Head Provisions Co., Inc., a Jarratt, Va., establishment, is recalling all liverwurst product produced by the establishment that is currently available in commerce because it may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The company is also recalling additional deli meat products that were produced on the same line and on the same day as the liverwurst and, therefore, may be adulterated with L. monocytogenes. The company is recalling approximately 207,528 pounds of products.

The problem was discovered when FSIS was notified that a sample collected by the Maryland Department of Health tested positive for L. monocytogenes. The Maryland Department of Health, in collaboration with the Baltimore City Health Department, collected an unopened liverwurst product from a retail store for testing as part of an outbreak investigation of L. monocytogenes infections. Further testing is ongoing to determine if the product sample is related to the outbreak.

This is part of a investigation into a multistate outbreak of L. monocytogenes infections linked to meats sliced at delis. As of July 25, 2024, 34 sick people have been identified in 13 states, including 33 hospitalizations and two deaths.


https://www.fsis.usda.gov/recalls-alerts/boars-head-provisions-co--recalls-ready-eat-liverwurst-and-other-deli-meat-products
Boar's Head Provisions Co. Recalls Ready-To-Eat Liverwurst And Other Deli Meat Products Due to Possible Listeria Contamination

WASHINGTON, July 26, 2024 – Boar's Head Provisions Co., Inc., a Jarratt, Va., establishment, is recalling all liverwurst product produced by the establishment that is currently available in commerce because it may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The company is also recalling additional deli meat products that were produced on the same line and on the same day as the liverwurst and, therefore, may be adulterated with L. monocytogenes. The company is recalling approximately 207,528 pounds of products.

KY Cheese Processor Recalls Cheese After State Testing Finds Listeria in One Lot

Kenny’s Farmhouse Cheese of Austin, Ky is recalling St. Jerome cheese, batch 231129, because it has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing by the Kentucky Department of Public Health revealed the presence of Listeria monocytogenes in a package of St. Jerome batch 231129.   No illnesses have been reported to date in connection with this recalled lot.

In cases such as this, we can expect that an investigation will be conducted to determine the source of contamination and the level of control within the facility.  In many cases, these recalls are expanded beyond the one lot initially recalled when  it is determined that sufficient controls were not in place.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kennys-farmhouse-cheese-recalls-st-jerome-cheese-lot-231129-because-possible-health-risk
Kenny’s Farmhouse Cheese Recalls St. Jerome Cheese Lot: 231129 Because of Possible Health Risk
Summary
Company Announcement Date:  July 24, 2024
FDA Publish Date:  July 24, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness - Listeria monocytogenes
Company Name:  Kenny’s Farmhouse Cheese
Brand Name:  Kenny’s Farmhouse Cheese
Product Description:  St. Jerome cheese

Ohio Distributor Expands Recall of Produce Items for Listeria

Wiers Farm Inc. of Willard, OH, is expanding its July 12, 2024, recall to include additional produce because it may be contaminated with Listeria monocytogenes. Wiers Farm Inc., in cooperation with the Ohio Department of Agriculture (ODA), began its investigation in response to original findings reported by the Michigan Department of Agriculture (MDARD). This expansion is in response to that investigation. Products involved in this expanded recall were packed between July 5-12 (2024).

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-expands-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination
Wiers Farm, Inc Expands Voluntary Recall on Whole and Salad Cucumbers Due to Possible Contamination with Listeria
Summary
Company Announcement Date:  July 22, 2024
FDA Publish Date:  July 23, 2024
Product Type:  Food & Beverages  Vegetable Products
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Wiers Farm, Inc.
Brand Name:  Wiers Farm, Freshire Farms
Product Description:  Vegetables and Bagged Salads
Company Announcement  

CA Company Recalls Walnuts After Testing Finds Listeria

Stutz Packing Company of Indio, CA is voluntarily recalling it’s 1-pound packages of Shelled Walnuts, because it has the potential to be contaminated with Listeria monocytogenes.  The recall was the result of routine sampling which revealed that the finished products contained the bacteria.

These Walnuts were distributed to food bank warehouses in Texas and Arizona which further distribute to other distribution centers that can go to consumers, or smaller foods banks, school lunch programs, shelters, or prison food systems.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stutz-packing-co-recalls-walnut-product-because-possible-health-risk
Stutz Packing Co. Recalls Walnut Product Because of Possible Health Risk
Summary
Company Announcement Date:  July 19, 2024
FDA Publish Date:  July 22, 2024
Product Type:  Food & Beverages  Tree Nuts  
Reason for Announcement:  Potential Foodborne Illness - Listeria monocytogenes
Company Name:  Stutz Packing Company
Brand Name:  Stutz Packing Company
Product Description:  Shelled Walnuts

FDA Issues Warning Letter to SC Processor for Continued Listeria Presence

FDA issued a Warning Letter to Discover Fresh Foods, LLC of Greenville, SC, a manufacturer of refrigerated ready-to-eat (RTE) dips and spreads.  This issue is that the company had a ongoing contamination issue of the same Listeria strain.

According to the report, FDA laboratory analysis of environmental sample #1242488 collected on December 13, 2023, found that three (3) out of the 99 total environmental swabs were positive for L. monocytogenes. The positive swabs were recovered from non-food-contact surfaces in Production Room (b)(4), and (b)(4)) during the production of Taste of the South Fried Pickle Dip, and the underside of the top level of the red cart in (b)(4). FDA laboratory analysis of sample #1242488 also found three (3) out of the 99 swabs were positive for Listeria innocua (L. innocua). These swabs were obtained from the (b)(4) transfer pump bottom frame, trash bin wheel, and bottom of sanitation squeegee.

The same organism had been found in the 

• three (3) L. monocytogenes isolates obtained from FDA environmental sample 124288 in 2023;
• four (4) L. monocytogenes isolates obtained from USDA FSIS environmental samples in 2023;
• one (1) L. monocytogenes isolate obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2023;
• two (2) L. monocytogenes isolates obtained from USDA FSIS environmental samples in 2018;
• one (1) L. monocytogenes isolates obtained from Buffalo Style Chicken Dip collected by USDA FSIS in 2018; and
• one (1) L. monocytogenes isolate obtained from Chipotle Chicken Salad collected by FDACS in 2017.

Based on these results of the WGS analysis, the twelve (12) isolates represent a single strain of L. monocytogenes. The presence of the same strain of L. monocytogenes over multiple years indicates that there has been a resident pathogen in the facility since at least November 2017. 

Then in 2024, additional sampling by USDA found Listeria.  "USDA FSIS notified FDA L. monocytogenes was detected in two (2) additional environmental swabs collected from non-food-contact surfaces (e.g., cart wheels) at [the] facility".  The company got rid of a chopper that they felt was the source, however, is the issue resolved?   When contamination becomes then endemic within a facility, it can now be very wide spread, locating in numerous niches.

It is surprising that USDA was not more aggressive, and for that matter, the company was not more aggressive in solving this issue.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/discover-fresh-foods-llc-677021-06262024
Discover Fresh Foods, LLC
MARCS-CMS 677021 — JUNE 26, 2024

KY Establishment Recalls Hot Dog Products Produced Without USDA Inspection

AW Farms, an Argillite, Ky., establishment, is recalling approximately 6,900 pounds of hot dog products that were produced without the benefit of federal inspection,  The problem was discovered when FSIS was notified by a state public health partner about these products. FSIS investigated and determined that the hot dog products were produced and distributed without the benefit of federal inspection.

https://www.fsis.usda.gov/recalls-alerts/aw-farms-recalls-ready-eat-hot-dog-products-produced-without-benefit-inspection
AW Farms Recalls Ready-To-Eat Hot Dog Products Produced Without Benefit of Inspection

WASHINGTON, July 15, 2024 – AW Farms, an Argillite, Ky., establishment, is recalling approximately 6,900 pounds of hot dog products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Oregon Firm Recalls Sausage Products Due to Undeclared Soy

Taylor's Sausage, Inc., a Cave Junction, Ore., establishment, is recalling approximately 74 pounds of ready-to-eat Landjaeger sausage products due to misbranding and undeclared allergens.  The product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered during routine FSIS in-plant verification activities when FSIS personnel observed that soy, a known allergen, was being used as an ingredient and was not declared on the finished product label.

https://www.fsis.usda.gov/recalls-alerts/taylors-sausage-inc--recalls-ready-eat-landjaeger-sausage-products-due-misbranding
Taylor's Sausage, Inc. Recalls Ready-To-Eat Landjaeger Sausage Products Due to Misbranding and Undeclared Allergens

WASHINGTON, July 13, 2024 - Taylor's Sausage, Inc., a Cave Junction, Ore., establishment, is recalling approximately 74 pounds of ready-to-eat Landjaeger sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, which is not declared on the product label.

Ohio Distributor Recalls Cucumbers After State Testing Finds Listeria

Wiers Farm Inc. of Willard, OH, is voluntarily recalling a limited number of whole cucumbers with a pack date of June 5, 2024 and bagged salad cucumbers with a pack date of June 5, 2024 and June 6, 2024 due to possible contamination with Listeria monocytogenes. This product was not grown or harvested by Wiers Farm. It was sourced from out of state, then handled and distributed by Wiers Farm. Wiers Farm Inc. is coordinating closely with regulatory officials in connection with the recall.  The potential contamination was discovered by the Michigan Department of Agriculture and Rural Development (MDARD) through routine sampling.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria
Wiers Farm, Inc Issues a Voluntary Recall on Whole and Salad Cucumbers Due to Possible Contamination with Listeria
Summary
Company Announcement Date:  July 12, 2024
FDA Publish Date:  July 16, 2024
Product Type:  Food & Beverages  Vegetable Products
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Wiers Farm, Inc.
Brand Name:  Wiers Farm
Product Description:  whole cucumbers and bagged salad

RTE Granola Facility Issued Warning Letter in Wake of Salmonella-related Recall

FDA issued a Warning Letter to PepsiCo for their Quaker Oats  manufacturing facility located in Danville, IL, a facility that manufactures RTE granola bars and RTE cereals.  This facility issued a recall of product for Salmonella in December of 2023.  In April of 2024, the facility was closed.

Noted in the report was timing, which is interesting.

• On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023.
• The positive sample was later confirmed on December 11, 2023, following an investigation of a suspected (but not confirmed) laboratory error concerning the initial results. 
• On December 12, 2023, your corporate Research & Development laboratory in Plano, TX, confirmed the finished product sample as positive for Salmonella Cubana and that the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4) on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. 
• On December 14, you notified FDA of your decision to recall specific granola bars and granola cereals due to the potential of being contaminated with Salmonella and filed an RFR report.
• On December 19, 2023, FDA collected samples (environmental swabs) of your production environment. FDA analysis of sample INV 1234817 confirmed one swab was positive for Salmonella spp. The swab was collected in a crack on the floor in the (b)(4); the investigator noted that apparent food residue was observed at the sampling location. Whole genome sequencing (WGS) was conducted on the Salmonella isolate obtained from the FDA environmental swabs. The WGS analysis confirmed the isolate to be Salmonella Cubana and the isolate did not match other food, environmental, or clinical isolates in the database. 
• January 3, 2024 - We advised you of the WGS results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020.
• On January 11, 2024, your laboratory analysis identified that Salmonella Cubana that originated in the (b)(4) Room and contaminated the granola line had spread to (b)(4) areas of the extruded RTE cereal line, (b)(4). This included areas where extruded material is exposed to the environment without an additional kill-step. That same day you expanded your recall to cover all RTE cereals, bars, and snacks within shelf-life manufactured at the Danville facility or manufactured with ingredients manufactured at the Danville facility.

Items to note:

• A long delay from presumptive positive to confirmed...about two weeks.
• Had found previous environmental positives from the RTE area - "the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4) on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. But the organism had been in the facility since 2020.

Issues

• One of the biggest issues was lack of proper corrective action.  "records of corrective actions included cleaning/sanitizing the affected area and additional (b)(4) swabbing,  but they did not include corrective actions that that would have reduced the likelihood that the problem would recur. For example, your “Pathogen Environmental Monitoring (PEM)” investigation worksheet dated September 15, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways on the floor under the (b)(4) and at the “sandwich point” (b)(4) in the (b)(4) Room on the (b)(4) floor (zone (b)(4) areas) but did not consider other areas as potential sources of contamination.

{[FDA}  recommend the company consider incorporating WGS as a tool to investigate pathogen isolates obtained in the environmental monitoring program and/or  finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE food products would provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.

• GMPs were also an issue - plant equipment and utensils used in manufacturing and processing were not designed and of such material and workmanship as to be adequately cleanable, or adequately maintained to protect against contamination

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pepsico-inc-679972-06122024
WARNING LETTER
PepsiCo, Inc.

MARCS-CMS 679972 — JUNE 12, 2024

Jarred Tahini Recalled After Testing Finds Salmonella

AB World Foods US, Inc. of Oakbrook Terrace, Illinois, is voluntarily recalling Al’Fez Natural Tahini in 5.6oz glass jars because it has the potential to be contaminated with Salmonella.  To date, AB World Foods US, Inc. has received no reports of illness related to the recalled product from consumers in the United States.  The potential for contamination was noted after testing by the company revealed the presence of Salmonella. The company has ceased distribution of the product as the company continues their investigation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ab-world-foods-us-inc-recalls-alfez-natural-tahini-because-possible-health-risk
AB World Foods US, Inc. Recalls Al’Fez Natural Tahini Because of Possible Health Risk
Summary
Company Announcement Date:  July 12, 2024
FDA Publish Date:  July 12, 2024
Product Type:  Food & Beverages 
Reason for Announcement: Potential to be contaminated with Salmonella
Company Name:  AB World Foods US, Inc.
Brand Name:  Al’Fez
Product Description:  Tahini

Overseas Operations Using Potentially Contaminated Cooking Oil

A Chinese state media investigation found "tank trucks were delivering chemicals and edible oil interchangeably without cleaning."  "The furor follows a bombshell investigation published on July 2 by the state media outlet Beijing News, which found multiple cases of tank trucks transporting edible cooking oil immediately after delivering chemicals used for coal-to-liquid processing."

It appears that this is a widespread issue done primarily for cost savings.

In HACCP or Preventive Controls training, we discuss the need to reevaluate your plan when new information becomes available.  This would be the type of issue that when you learn about, you check to see whether this issue impacts your own operation.  Perhaps you are buying imported oil roasted nuts or frozen pre-fried breaded chicken nuggets.   Does this issue affect those items?

https://www.msn.com/en-us/news/world/china-is-freaking-out-over-an-open-secret-that-its-cooking-oil-was-ferried-for-years-in-chemical-tanks-that-weren-t-cleaned/ar-BB1pE693
China is freaking out over an 'open secret' that its cooking oil was ferried for years in chemical tanks that weren't cleaned
Story by mloh@businessinsider.com (Matthew Loh) • 15h

China has been hit by another major food scandal, this time involving cooking oil in chemical tanks.

Oregon Firm Recalls Potato Salad Due to Foreign Material - Hard Plastic

Reser’s Fine Foods Beaverton, OR is voluntarily recalling Hill Country Fare Mustard Potato Salad 48oz (3LB) with a Use By Date of JUL/26/24 due to the possibility of pieces of hard plastic foreign material in the package. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-hill-country-fare-mustard-potato-salad-use-date-jul2624
Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad With a Use By Date of JUL/26/24
Summary
Company Announcement Date:  July 02, 2024
FDA Publish Date:  July 09, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Hard Plastic Foreign Material
Company Name:  Reser’s Fine Foods
Brand Name:  Hill Country Fare
Product Description:  Mustard Potato Salad

Owner of NY Cheese Operation Sentenced for 2016/2107 Listeria Outbreak

The owner of a NY cheese company was sentenced this week for his company's failure to protect product from Listeria contamination which resulted in an Listeria outbreak in 2016 thru 2017.  This outbreak resulted in the death of two people and hospitalization of two others.

Vulto Creamery of Walton, NY has been shut down.  The recall was initiated in March of 2017 and then expanded to include all raw milk cheese a few weeks later.  FDA issued a report of the investigation of the facility in April of 2017.  A summary of the FDA findings includes:

• LM was all over the plant, on food contact equipment, and on product.
• While the plant did testing and found Listeria species, they did NOTHING beyond re-clean the area. They did not do follow-up testing nor did they try to determine where the Listeria was coming from, whether is was LM, or whether it impacted product.
• They followed poor sanitary practices including not properly washing hands
• Poor cleaning of facility and equipment
• Poor design and maintenance of the facility

Johannes Vulto, founder and owner of Vulto Creamery LLC based in Walton, was sentenced to three years probation and ordered to pay a $100,000 fine, along with 240 hours of mandated community services.

Binghamtonhomepage.com
https://www.binghamtonhomepage.com/delaware-county/vulto-creamery-founder-sentenced-for-deadly-cheese/
Vulto Creamery founder sentenced for deadly cheese
by: Spencer Gustafson
Posted: Jul 9, 2024 / 04:23 PM EDT
Updated: Jul 9, 2024 / 05:20 PM EDT

Canadian Establishment Recalls RTE Chicken Products After USDA Detects Listeria

Al-Safa US LLC, the importer of record located in Mississauga, Ontario, Canada, is recalling approximately 2,010 pounds of imported frozen ready-to-eat chicken products that may be adulterated with Listeria monocytogenes.  The problem was discovered after FSIS performed routine product testing and the results indicated the product may be contaminated with Listeria monocytogenes.

https://www.fsis.usda.gov/recalls-alerts/al-safa-us-llc-recalls-frozen-ready-eat-chicken-products-due-possible-listeria
Al-Safa US LLC Recalls Frozen Ready-To-Eat Chicken Products Due to Possible Listeria Contamination

WASHINGTON, July 5, 2024 – Al-Safa US LLC, the importer of record located in Mississauga, Ontario, Canada, is recalling approximately 2,010 pounds of imported frozen ready-to-eat chicken products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Oregon Facility Recalls Various Non-alcoholic Mixes Due to Non-compliance Issues

Urban River Spirits is issuing a voluntary recall of various non-alcoholic mixers and spritzes to additional shelf stability testing requirements from the Oregon Department of Agriculture.  Urban Spirits is issuing a voluntary recall of these Urban Spirits non-alcoholic drink mixes due to being produced in an unlicensed and uninspected facility. The product safety is undetermined due to potential under-processing. The product is packaged in 750 mL glass bottles.

Hopefully the pH is sufficiently low and the product amply heated to eliminate vegetative pathogens and spoilage organisms, including yeast.  But who knows...certainly not the State inspection folks.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urban-spirits-issues-voluntary-recall-urban-spirits-non-alcoholic-drink-mixes-due-potential-under
Urban Spirits Issues Voluntary Recall of Urban Spirits Non-Alcoholic Drink Mixes Due to Potential Under-Processing
Summary
Company Announcement Date:  July 02, 2024
FDA Publish Date:  July 03, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential for under-processing
Company Name: Urban River Spirits
Brand Name:  Urban River Spirits
Product Description:  Nonalcoholic drink mixes

Delta Flight to Europe Diverted Back to NY After Crew and Passengers Served Moldy Food

A Delta flight to Amsterdam from NY was diverted back to NY after it was discovered that chicken served on the flight was moldy.

"We were probably halfway to Amsterdam, around Nova Scotia and starting to cross ocean when the pilot came on and said there was some type of food issue,' Kirchoff recalled."

There were no apparent ill effects according to this report.

"There were 24 aided cases upon landing, including 10 members of the flight crew and 14 passengers, all of whom declined to receive medical attention,' a Port Authority spokesperson told DailyMail.com."

In the end, it was better that precautionary actions were taken.  If the product had mold indicating potential temperature abuse, no telling what else could have been present, including the risk of Staphylococcus growth and toxin formation.

But this is not a good compliance to food safety procedures for the Delta foodservices.

Daily Mail.com
https://www.dailymail.co.uk/news/article-13597279/Delta-flight-ill-served-moldy-chicken-pilots.html
I was on the Delta flight where 24 people fell ill including both pilots… after they served moldy chicken
By NATASHA ANDERSON FOR DAILYMAIL.COM

PUBLISHED: 11:46 EDT, 3 July 2024 | UPDATED: 13:18 EDT, 3 July 2024

'They said they saw some mold on the chicken,' she added. 'I asked if anyone had gotten sick and they told us no one had been affected, but the pilots both ate the chicken.'

Salmonella Outbreak Linked to Cucumbers - Outbreak Strain Found in Grower's Canal Water

Bedner Growers, Inc. in Florida has been identified as the source of Salmonella contaminated cucumbers that have caused 449 reported cases of illness.  FDA found the outbreak Salmonella strains in the canal water.

"FDA collected samples at the grower in Florida and identified Salmonella Braenderup in untreated canal water. WGS determined that the Salmonella found in the water is the same strain of Salmonella Braenderup that made people in this outbreak sick. Additional soil and water samples collected at Bedner Growers, Inc. were positive for other strains of Salmonella. CDC and FDA are looking to see if these strains have caused illness in people."

Of the 449 reported cases, 125 people have been hospitalized.

"As of July 2, a total of 449 people infected with one of the outbreak strains of Salmonella Africana and Salmonella Braenderup have been reported from 31 states and the District of Columbia (see map). Of these illnesses, 215 people were infected with the newly added Salmonella Braenderup strain. Illnesses started on dates ranging from March 11, 2024, to June 4, 2024 (see timeline). Of 360 people with information available, 125 have been hospitalized and no deaths have been reported."

CDC
https://www.cdc.gov/salmonella/africana-06-24/index.html
Salmonella Outbreak Linked to Cucumbers
Posted July 2, 2024

Fast Facts
Illnesses: 449 (38 new Africana, 215 Braenderup new)
Hospitalizations: 125 (11 new Africana, 50 Braenderup new)
Deaths: 0
States: 31 states and the District of Columbia (1 new Africana, 26 Braenderup)
Recall: Yes
Investigation status: Active (first posted on June 5, 2024)

Outbreak Investigation Summary
Epidemiologic, traceback, and laboratory data show that cucumbers were contaminated with Salmonella and made people sick. Testing identified the Salmonella Braenderup strain in untreated canal water used by a grower in Florida. Cucumbers from this grower are no longer in season and any sold previously are no longer on shelves.

NC Facility Recalls Raw Pet Food After Inspection Samples Positive for Listeria

Viva Raw LLC, Hillsborough, NC is voluntarily recalling dog and cat foods, including the Viva Turkey for Dogs Ground, Viva Turkey for Dogs Chunked, Viva Turkey for Cats, Viva Pure Turkey, and Viva Beef & Turkey for Puppies all manufactured under Lot 21244 because this lot, which includes these five products are contaminated with Listeria monocytogenes and is a potential health risk to people and pets.

The issue was discovered during a facility inspection conducted by the U.S. Food and Drug Administration (FDA) and The North Carolina Department of Agriculture (NCDA). The FDA tested samples of Viva Turkey for Dogs and found samples from Lot 21244 were positive for Listeria monocytogenes. All products produced in Lot 21244 were slated for destruction. However, we have since learned some of the product from this lot was inadvertently released from the warehouse.

No illnesses related to this lot have been reported to date.

A few items to point out....1) If one lot is positive for Listeria, it is likely other lots are positive for Listeria unless tight controls were in place for those other lots and not this lot, and 2) Allowing suspect product to be shipped indicates a lack of tight food safety related SOPs

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viva-raw-issues-voluntary-recall-dog-and-cat-food-including-select-viva-turkey-recipes-lot-21244-due
Viva Raw Issues Voluntary Recall of Dog and Cat Food Including Select Viva Turkey Recipes (Lot 21244) Due to Potential Listeria Monocytogenes Health Risk to People and Pets
Summary
Company Announcement Date:  July 01, 2024
FDA Publish Date:  July 01, 2024
Product Type:  Animal & Veterinary  Food & Beverages  Animal Feed
Reason for Announcement:  Listeria monocytogenes
Company Name:  Viva Raw, LLC
Brand Name:  Viva
Product Description:  Raw dog and cat food

Ongoing Salmonella Outbreak Associated with Backyard Chickens

CDC is reporting on an ongoing Salmonella outbreak associated with backyard chickens.  "As of June 20, 2024, 195 people infected with one of the outbreak strains of Salmonella have been reported from 38 states (see map). Illnesses started on dates ranging from February 18, 2024, to May 30, 2024 (see timeline). Of 136 people with information available, 50 (37%) have been hospitalized. No deaths have been reported."

"Of 45 people with information available, 36 (80%) reported purchasing or obtaining poultry before their illness started. People reported purchasing poultry from multiple retail stores or directly from a hatchery. Multiple hatcheries supplied birds to the retail stores. A common poultry supplier has not been identified across all outbreaks."

Investigators in Minnesota, Ohio, and Utah collected samples from inside the boxes used to ship poultry from hatcheries to retail stores, including the box liner and bedding. WGS showed that the Salmonella Altona, Cerro, and Mbandaka found in these samples are the same strains as the ones found in sick people.

https://www.cdc.gov/salmonella/backyardpoultry-05-24/index.html
Salmonella Outbreaks Linked to Backyard Poultry
Posted June 27, 2024

Fast Facts
Illnesses: 195 (86 new)
Hospitalizations: 50 (17 new)
Deaths: 0
States: 38 (9 new)
Investigation status: Active (first posted on May 23, 2024)

Lancaster Country (PA) Bakery Issued Warning Letter

FDA issued a Warning Letter to McClure’s Lancaster Old Fashioned, LLC, a processor of ready-to-eat (RTE) bakery products located in Bowmansville, PA, 17507.  McClure's is a self-described Amish bakery.  (Located in the heart of Amish Country, McClures Bakery has been bringing delicious Amish baked goods to our customers for more than 50 years. The bakers at our family-owned and operated bakery specialize in making shoofly pies, cakes, bread, and other traditional recipes using the finest ingredients.)

• Did not have a hazard analysis completed for all products.
• Did not identify Salmonella as a hazard requiring a preventive control.
• Did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) as a known or reasonably foreseeable hazard
• did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control
• Duct tape is not a sanitary fix - Investigator observed production of Country Maid Creme Filled Doughnuts with Lot Code: 263 and noted duct tape at the joints of the grey PVC pipe which appeared uncleanable and was located directly above exposed creme inside the doughnut filler-hopper.
• Added allergen to Contains statement although not used in formulation - "labeling is false or misleading because “peanut” is declared in the “Contains” statements; however, “peanut” is not an ingredient in the formulations of these products. You stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to the CGMP and PC rule. Instead, firms must comply with the applicable CGMP and PC requirements to address allergen cross-contact."
• A number of labeling-related issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mcclures-lancaster-old-fashioned-llc-670611-05162024
McClure’s Lancaster Old Fashioned, LLC
MARCS-CMS 670611 — MAY 16, 2024

Recipient:
Mr. Thomas Keenan
Owner & President
McClure’s Lancaster Old Fashioned, LLC
1212 Reading Road
Bowmansville, PA 17507
United States

FDA Issue Warning Letter to Dollar Tree for Failure to Remove Lead-contaminated Apple Sauce from Shelves

FDA issued a Warning Letter to Dollar Tree retailer for failing to stop selling the lead-contaminated cinnamon apple sauce after the recall was announced by WanaBana.  As you may recall, this was the imported apple sauce that used cinnamon adulterated with lead chromate.

From the Warning Letter, "On October 29, 2023, Wanabana USA initiated a voluntary recall of all WanaBana Apple Cinnamon Fruit Puree pouches. As a consignee of the recalled products, Dollar Tree Inc. (Dollar Tree or you) was notified in writing, on October 29, 2023, of Wanabana USA’s voluntary recall of Apple Cinnamon Fruit Puree pouches. Subsequent recall audit checks of your Dollar Tree and Family Dollar/Dollar Tree combination stores (collectively referred to as your “Dollar Tree stores”) revealed that you continued to offer the recalled WanaBana Apple Cinnamon Fruit Puree pouches on store shelves well after the recall was initiated, despite FDA’s numerous attempts to bring this serious issue to your attention."

Basically, lead-contaminated product was left available to be sold for more than a month.  Here is a management team that needs to be held responsible.  Guess what, this Dollar Tree also owns Family Dollar....that same one with the rat infestation issue.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dollar-tree-inc-674301-06112024
WARNING LETTER
Dollar Tree Inc.
MARCS-CMS 674301 — JUNE 11, 2024

FDA Issue Warning Letter to Bakery for Bad Labeling Decisions

FDA issued a Warning Letter to a PA bakery operation.  The primary issue was putting allergens in the Contains statement, but not including those items in it the formulation.

The "bread loaf products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations. The Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product is misbranded for a similar reason; the product label includes walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements; however, these nuts are not ingredients in the formulation of the product. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls."

The company also tried to say brown sugar was a natural flavor.  "Flavor were not declared on the label, and you stated that the Brown Sugar Powder and the (b)(4) ingredients meet the definition of “Natural Flavors” and are considered to be included as that on the label. According to 21 CFR § 101.22(a)(3), the term “natural flavor” means “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR §§ 182.10, 182.20, 182.40, and 182.50 and Part 184, and the substances listed in 21 CFR § 172.510. If these ingredients do not meet the definition of natural flavor contained in 21 CFR § 101.22(a)(3), they may not be declared as such on the label."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bimbo-bakeries-usa-inc-672140-06172024
WARNING LETTER

Bimbo Bakeries USA, Inc.
MARCS-CMS 672140 — JUNE 17, 2024

FDA Study Confirms Milk Pasteurization Will Inactivate Highly Pathogenic H5N1 Avian Influenza

FDA along with USDA announced that they completed a study that confirms pasteurization is effective at inactivating Highly Pathogenic H5N1 Avian Influenza (H5N1 HPAI) virus in fluid milk and other dairy products made from pasteurized milk.  "The study – the only one to date designed to simulate commercial milk processing – found that the most commonly used pasteurization time and temperature requirements were effective at inactivating the H5N1 HPAI virus in milk. These results complement the FDA’s initial retail sampling study in which all 297 samples of dairy products collected at retail locations were found to be negative for viable H5N1 HPAI virus."

https://www.fda.gov/food/alerts-advisories-safety-information/updates-highly-pathogenic-avian-influenza-hpai
Updates on Highly Pathogenic Avian Influenza (HPAI)

June 28, 2024

The FDA, along with our federal partners at the U.S. Department of Agriculture, is announcing results from a first-of-its-kind study using the process typically used by commercial milk processors. The intention of this study was to further confirm that pasteurization is effective at inactivating Highly Pathogenic H5N1 Avian Influenza (H5N1 HPAI) virus in fluid milk and other dairy products made from pasteurized milk.

Minnesota Establishment Recalls Egg Products for Undeclared Milk Due to Mis-packaging Issue

M.G. Waldbaum dba Michael Foods Inc., a Gaylord, Minn. establishment, is recalling approximately 4,620 pounds of liquid egg products due to misbranding and undeclared allergens...the product contains dairy (milk) which is not declared on the label.  The problem was discovered during a routine carton inventory evaluation. The establishment notified FSIS when it discovered that a limited amount of Whole Egg with Citric Acid cartons was unaccounted for, and there was a corresponding excess of Breakfast Blend Scrambled Egg carton in inventory. The establishment investigated and determined that the unaccounted Whole Egg with Citric Acid cartons were inadvertently utilized during a single short Breakfast Blend Scrambled Egg production run. The Breakfast Blend formulation contains an allergen, a dairy ingredient (milk), which is not declared on the Whole Egg with Citric Acid label.

USDA does not have the same allergen preventive control requirements as FDA, however, this is an example where those types of controls could prevent this type of issue.  However, it was an inventory check that informed the company that something was wrong.

https://www.fsis.usda.gov/recalls-alerts/michael-foods-inc--recalls-fair-meadow-foundations-liquid-egg-products-due
Michael Foods Inc. Recalls Fair Meadow Foundations Liquid Egg Products Due to Misbranding and Undeclared Allergens

WASHINGTON, June 30, 2024 – M.G. Waldbaum dba Michael Foods Inc., a Gaylord, Minn. establishment, is recalling approximately 4,620 pounds of liquid egg products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains dairy (milk), a known allergen, which is not declared on the product label.

CA Company Recalls Products with Mushroom Bioactive Compounds

Prophet Premium Blends of Santa Ana, California is recalling Diamond Shruumz Infused Cones, Chocolate Bars, and Gummies (Micro- and Mega/Extreme-Dose), because such products contain Muscimol, a chemical found in mushrooms of the genus Amanita; Muscimol could be a potential cause of symptoms consistent with those observed in persons who became ill after eating Diamond Shruumz products. Reported symptoms have included those linked to seizures, agitation, involuntary muscle contractions, loss of consciousness, confusion, sleepiness, nausea and vomiting, abnormal heart rates, and hyper/hypotension.

At this time, there are 39 illnesses that have been reported to date. States with cases include: AL, AZ, CA, CO, GA, IN, IA, KY, MD, MN, MO, MT NV, NJ, NY, NC, OH, PA, SC, TN. Reported symptoms have included those linked to central nervous system excitation (e.g., seizures, agitation, and involuntary muscle contractions), central nervous system depression (e.g., loss of consciousness, confusion, and sleepiness), gastrointestinal symptoms (e.g., nausea and vomiting), and cardiovascular involvement (e.g., abnormal heart rates and hyper/hypotension).

As posted earlier this month, FDA issued a health warning on this product.  The recall was not initally issued.  As stated in this posting, "To date, Prophet Premium Blends received two (2) complaints (on May 27, 2024), regarding consumers becoming ill after consuming the entire chocolate bar. Upon receiving the complaints, we reviewed the products’ Certificates of Analysis (COAs) which showed higher than normal amounts of Muscimol. Prophet Premium Blends initiated this Recall and has ceased the production and distribution of the Diamond Shruumz product line as the FDA and Prophet Premium Blends continues their investigation as to what is the cause of the serious adverse effects."

On Muscimol from Wikipedia, "Muscimol, a psychoactive compound derived from the ibotenic acid found in certain mushrooms, particularly Amanita muscaria, has garnered significant interest due to its unique effects on the nervous system. Muscimol binds to GABA receptors in the brain, resulting in its sedative and hallucinogenic properties.[39] Muscimol-based products are currently being investigated for their potential therapeutic applications, especially in the treatment of anxiety, insomnia, and other neurological disorders.[40][41] The psychoactive nature of muscimol necessitates stringent regulation and cautious usage to ensure safety.[42] However, ongoing research aims to harness its medicinal benefits in a controlled context, highlighting the broader scientific interest in natural compounds as potential sources for novel medical treatments.[43][44]"

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prophet-premium-blends-recalls-diamond-shruumz-products-because-possible-health-risk
Prophet Premium Blends Recalls Diamond Shruumz Products Because of Possible Health Risk
Summary
Company Announcement Date:  June 27, 2024
FDA Publish Date:  June 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Toxic levels of muscimol
Company Name:  Prophet Premium Blends
Brand Name:  Diamond Shruumz
Product Description:  Infused Cones, Chocolate Bars, and Gummies

NY Firm Recalls Raw Macadamia Nuts After Lab Test Finds Salmonella

Sunco and Frenchie LLC of Pine Brook, New Jersey is recalling Terrafina brand Macadamia in the Raw packed in 6 oz plastic containers, because it has the potential to be contaminated with Salmonella.  The potential contamination of Salmonella was discovered through the State of New York Department of Agriculture and Markets Food Laboratory through routine testing. The company is recalling this product as FDA and Sunco and Frenchie LLC continue their investigation.  The raw macadamia nuts were manufactured by SolCaribe, S.A., Costa Rica.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunco-frenchie-llc-recalls-terrafina-brand-macadamia-raw-because-possible-health-risk
Sunco & Frenchie LLC. Recalls Terrafina Brand Macadamia in the Raw Because of Possible Health Risk
Summary
Company Announcement Date:  June 28, 2024
FDA Publish Date:  June 28, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Salmonella contamination
Company Name:  Sunco and Frenchie LLC
Brand Name:  terrafina
Product Description:  Macadamia in the Raw

NY Firm Recalls Salad Items for Listeria After Positive NY State Lab Test

Solata Foods LLC. of Newburgh, NY, is recalling its “Fresh Spinach” listed below because they may be contaminated with Listeria monocytogenes.   The contamination was discovered after sampling by New York State Department of Agriculture and Market Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of L. monocytogenes in a 9-ounce package of Bogopa “Fresh Spinach.” Production of the product has been suspended

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/solata-foods-recalls-fresh-spinach-and-spinach-products-due-possible-health-risk
Solata Foods Recalls Fresh Spinach and Spinach Products Due to Possible Health Risk
Summary
Company Announcement Date:  June 21, 2024
FDA Publish Date:  June 27, 2024
Product Type:  Food & Beverages  Vegetable Products
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Solata Foods LLC
Brand Name:  Solata, Gaia Organic, Full Circle Organic, Farmer Direct, Uncle Vinny’s, Bogopa
Product Description:  Spinach and salad mixes

Canadian Bakery's Mislabeling Issue Results in Recall for Undeclared Walnut Allergen

FGF Brands Inc of Toronto, Ontario is recalling 11830 cases of ALDI - Bakeshop Chocolate Chip Muffin 4 count, because it may contain undeclared Walnut.   The recall was initiated after it was discovered that the walnut-containing product was distributed in packaging that did not reveal the presence of walnut. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fgf-issues-allergy-alert-undeclared-walnuts-aldi-bakeshop-chocolate-chip-muffin-4-count
FGF Issues Allergy Alert on Undeclared Walnuts in “Aldi - Bakeshop Chocolate Chip Muffin 4 Count"
Summary
Company Announcement Date:  June 26, 2024
FDA Publish Date:  June 26, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Walnut allergen
Company Name:  FGF Brands Inc.
Brand Name:  Aldi Bake Shop Bakery
Product Description:  Chocolate Chip Muffin 4 count

CA Chocolate Company Recalls Chocolate Product for Undeclared Hazelnuts

Feve Artisan Chocolatier and Dandelion Chocolate of San Francisco, CA are voluntarily recalling a single lot code of Feve Artisan Chocolatier x Dandelion Chocolate Chocolate-Covered Cocoa Nibs because the product may contain undeclared hazelnuts.  The recall was initiated after it was discovered that product containing hazelnuts was distributed in Chocolate-Covered Cocoa Nibs packaging that did not reveal the presence of this allergen. This issue was isolated to a single lot.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/feve-artisan-chocolatier-and-dandelion-chocolate-issue-allergy-alert-undeclared-hazelnuts-chocolate
Feve Artisan Chocolatier and Dandelion Chocolate Issue Allergy Alert on Undeclared Hazelnuts in Chocolate-Covered Cocoa Nibs
Summary
Company Announcement Date:  June 24, 2024
FDA Publish Date: June 25, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared hazelnut allergen
Company Name:  Feve Artisan Chocolatier and Dandelion Chocolate
Brand Name:  Feve Artisan Chocolatier x Dandelion Chocolate
Product Description:  Chocolate-covered cocoa nibs, 4 oz

Imported Smoked Salmon Slices Recalled for Listeria Contamination

Foppen Seafood, of Harderwijk, The Netherlands is recalling Smoked Norwegian Salmon Slices – Toast sized, 8.1 oz, identified by lot number 412, sold in Kroger and Payless Supermarkets across 15 states in the USA.  The recall was issued after routine testing has revealed the presence of Listeria monocytogenes.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/foppen-seafood-issues-recall-smoked-norwegian-salmon-slices-81oz-toast-sized-sold-kroger-and-payless
Foppen Seafood Issues a Recall of Smoked Norwegian Salmon Slices 8.1oz Toast Sized Sold at Kroger and Payless Supermarket Stores Due to Listeria Contamination
Summary
Company Announcement Date:  June 25, 2024
FDA Publish Date:  June 25, 2024
Product Type:  Food & Beverages Fish
Reason for Announcement:  Listeria monocytogenes contamination
Company Name:  Foppen Paling En Zalm B.V.
Brand Name:  Foppen
Product Description:  Smoked Norwegian Salmon Slices – Toast sized, 8.1 oz
Company Announcement  Reason for Recall

Nut Packer Recalls Nut Mix for Undeclared Peanut

DSD Merchandisers LLC of Livermore, CA is voluntarily recalling UPC 6-51433-99651-6 Deluxe Roasted & Salted Mixed Nuts, Sell by: 10/09/24, due to the presence of undeclared peanut.  
The recall was initiated after a consumer contacted DSD merchandisers, LLC through the company website to report they purchased product and upon consuming, noticed that the product contained peanut, which they then noted the label did not declare Peanut on the Ingredient Statement nor the Allergen Statement portion of the label. The label just contained a packed on same equipment as product containing peanut statement. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's formulation change processes and packaging label change process.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dsd-merchandisers-llc-announces-voluntary-recall-deluxe-roasted-salted-mixed-nuts-due-undeclared
DSD Merchandisers, LLC Announces Voluntary Recall of Deluxe Roasted & Salted Mixed Nuts Due to Undeclared Peanut
Summary
Company Announcement Date:  June 24, 2024
FDA Publish Date:  June 24, 2024
Product Type: Food & Beverages  Nuts & Nut Products  
Reason for Announcement:  Undeclared Peanut
Company Name:  DSD Merchandisers, LLC
Brand Name:  DSD Merchandisers, Inc.
Product Description:  Deluxe Roasted & Salted Mixed Nuts

Washington State Company Recalls Dried Orzo and Dried Campanelle Due to Potential Molding

Wildly Beloved Foods of Clinton, Washington is recalling approximately 30 packages of Orzo (vegan) Dried and 30 packages of Campanelle (vegan) Dried, 10 oz, due to potential mold growth contamination.  The recall was initiated after determining the product was under-dried and finding three packages within the company's retail marketplace that had the beginning signs of mold.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wildly-beloved-foods-recalling-orzo-vegan-dried-and-campbell-vegan-dried-due-potential-mold
Wildly Beloved Foods is Recalling Orzo (Vegan) Dried and Campbell (Vegan) Dried Due to Potential Mold
Summary
Company Announcement Date:  June 24, 2024
FDA Publish Date:  June 24, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with mold
 Company Name:  Wildly Beloved Foods
Brand Name:  Wildly Beloved Food
Product Description:  Dried Orzo and Dried Campanelle

Maryland Ice Cream Company Recalls Product After FDA Finds Listeria

Totally Cool, Inc. of Owings Mills, Maryland is recalling multiple brands of ice cream products, because they have the potential to be contaminated with Listeria monocytogenes.  Totally Cool, Inc. has ceased the production and distribution of the affected products due to FDA sampling which discovered the presence of Listeria monocytogenes. The company continues its investigation and is taking preventive actions. No other products produced by Totally Cool, Inc. are impacted by this recall.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/totally-cool-inc-recalls-all-ice-cream-products-because-possible-health-risk
Totally Cool, Inc., Recalls All Ice Cream Products Because of Possible Health Risk
Summary
Company Announcement Date:  June 24, 2024
FDA Publish Date:  June 24, 2024
Product Type:  Food & Beverages  Ice Cream/Frozen Dairy
Reason for Announcement:  Listeria monocytogenes
Company Name:  Totally Cool, Inc.
Brand Name:  Multiple brand names
Product Description:  Ice Cream Products

Ohio Company Recalls Hedgehog Feed After State Lab Finds Salmonella

Vitakraft Sun Seed Inc. of Weston, OH is recalling Sun Seed Vita Prima Hedgehog Food and Vitakraft Vita Smart Hedgehog Food because it has the potential to be contaminated with Salmonella.  The initial recall was issued on June 21, and then expanded by the company on June 28, 2024.  

Products from the recalled lot were distributed to the following states: AZ, CA, FL, GA, IL, IN, KY, MA, MI, MN, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, AND WI.

Vitakraft Sun Seed was notified on June 18, 2024, by the Minnesota Department of Agriculture that Salmonella was detected in an inspection sample of product from Lot Number 417429. The tests which identified the bacteria were part of random testing performed by the State of Minnesota on consumer products, and not prompted by any consumer concerns. To date, there have been no reports of illness.






https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vitakraft-sun-seed-recall-sun-seed-vita-prima-hedgehog-food-due-possible-salmonella-health-risk-0
Vitakraft Sun Seed Recall of Sun Seed Vita Prima Hedgehog Food Due to Possible Salmonella Health Risk
Summary
Company Announcement Date:  June 28, 2024
FDA Publish Date:  July 01, 2024
Product Type:  Animal & Veterinary  Food & Beverages  Animal Feed
Reason for Announcement:  Due to potential Salmonella contamination
Company Name:  Vitakraft Sun Seed Inc.
Brand Name:  Sunseed Vita Prima
Product Description:  Hedgehog Food

Imported Dog Treats Sold Online Recalled for Potential Metal Contamination

TDBBS LLC, of Richmond, VA is voluntarily recalling 3,551 bags of Green Tripe dog treats due to the potential presence of foreign metal objects in the dog treat.  The recalled product was distributed between February to May 2024, and sold nationwide in retail stores and through online mail orders.  Product is imported from Turkey.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tdbbs-llc-recalls-green-tripe-dog-treats-due-potential-foreign-metal-object-contamination
TDBBS LLC Recalls Green Tripe Dog Treats Due to Potential Foreign Metal Object Contamination
Summary
Company Announcement Date:  June 20, 2024
FDA Publish Date:  June 21, 2024
Product Type:  Animal & Veterinary
Reason for Announcement:  May Contain Metal Objects
Company Name:  TDBBS LLC
Brand Name:  BARKWORTHIES and BEST BULLY STICKS
Product Description:  Green Tripe Dog Treats

Canned Coffee Recalled for Failing to Meet Regulatory Requirements That Address Clostridium botulinum

Snapchill LLC (Snapchill) of Green Bay, WI is voluntarily recalling all canned coffee products manufactured by the company, within expiration date, because their current process could lead to the growth and production of the deadly toxin, botulinum toxin, in low acid canned foods.  The problem was identified when the U.S. Food and Drug Administration (FDA) notified Snapchill that the low acid canned foods process for manufacturing the recalled products was not filed with FDA, as is required by regulation. No illnesses have been reported to-date, and Snapchill is not aware of any instances in which the company’s products contained botulin toxin. 

The issue with this situation is that by regulation, canned coffee meets the definition of a low acid food unless it is acidified to the lower pH.  If not acidified, the pH can be greater than 4.6 (pH of coffee ranges widely).  With that, the processor of liquid canned coffee must file the process with FDA as part of the Low Acid Canned Food regulations (LACF).  These regulations primarily focus on prevention of Clostridium botulinum (the causative agent of botulism poisoning) in canned foods.

There is not substantial publicly available research on the growth of Clostridium botulinum in coffee.  While anyone who has left their coffee in their thermal cup over the weekend knows that not much grows in it...but that is not good enough.  And what happens when we add cream, sugar, of flavors?  Clearly, more publicly available research is needed.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/snapchill-llc-recalls-canned-coffee-products-due-potential-clostridium-botulinum
Snapchill LLC Recalls Canned Coffee Products Due to Potential Clostridium botulinum
Summary
Company Announcement Date:  June 17, 2024
FDA Publish Date:  June 20, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Clostridium botulinum
Company Name:  Snapchill LLC
Brand Name:  Snapchill
Product Description:  Coffee Products

NY Sauce Processor Recalls Tomato Basil Sauce Due to Potential Under-Processing

Hudson Harvest of Germantown, NY, is voluntarily recalling Hudson Harvest Tomato Basil Sauce because of reported swelling, leaking, or bursting jars. There is a possibility that the product has been under processed, which could lead to the potential for spoilage organisms or pathogens.

This would be considered an acid food which would hot filled (and perhaps run through a hot water bath or shower afterwards).  While there is the possibility that the pH was higher then it should be (above 4.6), there could be an issue when the pH approaches 4.6 from spoilage organisms.  More likely was the the required hot fill temperature was not maintained during processing.  Exploding glass jars is often the sign of yeast contamination, and this would occur when processing fill temperatures drop too low.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hudson-harvest-issues-voluntary-recall-tomato-basil-sauce-due-potential-under-processing
Hudson Harvest Issues Voluntary Recall of Tomato Basil Sauce Due to Potential Under-Processing
Summary
Company Announcement Date:  June 18, 2024
FDA Publish Date:  June 19, 2024
Product Type: Food & Beverages
Reason for Announcement:  Potentially under processed, which could lead to the potential for spoilage organisms or pathogens
Company Name:  Hudson Harvest
Brand Name:  Hudson Harvest
Product Description:  Tomato Basil Sauce