Wednesday, January 15, 2025

Nutrition Bars Recalled for Undeclared Milk After 11 Suffer Allergic Reactions

Lifestyle Evolution Inc., based in Oakmont, PA is recalling select lots of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars because they may contain undeclared milk.  This is the same recall announced by customers selling these products, including Amazon, Costco Wegmans, Giant Eagle, on December2, 2024 and not an expansion or different recall.  The recall was initiated after the firm received 11 consumer reports of allergic reaction experienced after consuming the product. As part of the firm’s ongoing investigation, the product was tested and found to contain milk, which is not indicated on the packaging. The firm’s investigation is ongoing

There is a precautionary statement that does include milk, but this of course will not prevent a recall.    Evidently, 11 people with allergies to milk still purchased and ate this product.



https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lifestyle-evolution-voluntarily-recalls-nugo-dark-chocolate-chip-and-nugo-dark-pretzel-due
Lifestyle Evolution Voluntarily Recalls NuGo Dark Chocolate Chip and NuGo Dark Pretzel Due to Undeclared Milk
Summary
Company Announcement Date:  January 10, 2025
FDA Publish Date:  January 10, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Lifestyle Evolution Inc.
Brand Name:  NuGo
Product Description:  NuGo Dark Chocolate Chip Nutrition Bar and NuGo Dark Pretzel Chocolate Nutrition Bar

California Ice Cream Company Recalls Sorbet for Undeclared Egg

The Mochi Ice Cream Company LLC, Vernon, California is recalling 1350 cases of Peach Mango Sorbet, because it may contain undeclared pasteurized cooked egg white.  The recall was initiated after it was discovered that product containing (pasteurized egg white) was distributed in packaging that did not reveal the presence of (the egg white). Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging processes.  

There have been 2 reports of minor allergic response reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mochi-ice-cream-company-llc-issues-allergy-alert-undeclared-egg-peach-mango-sorbet
The Mochi Ice Cream Company LLC Issues Allergy Alert on Undeclared Egg in Peach Mango Sorbet
Summary
Company Announcement Date:  January 09, 2025
FDA Publish Date:  January 10, 2025
Product Type: Food & Beverages
Reason for Announcement:  Undeclared egg
Company Name:  My Mochi Ice Cream Company LLC
Brand Name:  My Mochi
Product Description:  My Mochi Peach Mango Sorbet

Missouri Retail Operations Recalls Mashed Potato Product for Undeclared Wheat

Dierbergs, a retail operations based in Chesterfield, Missouri, is recalling all 16oz Premium Home-Style Mashed Potatoes with a Sell By Date of January 09, 2025. The product carries an undeclared allergen of Wheat.  This is a print-and-apply label and so information was not properly captured / input into the print system.



https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dierbregs-markets-issues-allergy-alert-undeclared-wheat-product
Dierbregs Markets Issues Allergy Alert on Undeclared Wheat in Product
Summary
Company Announcement Date:  January 03, 2025
FDA Publish Date:  January 07, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Dierbergs Markets
Brand Name:  Dierbergs Kitchen
Product Description:  Premium Home-Style Mashed Potatoes

Wednesday, January 8, 2025

Coconut No Longer Considered an Allergen Requiring Labeling and Other Items from Allergen Guidance

In FDA's guidance release, Q&A document - Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) that was released in early January (Link), FDA stated the nut allergens requiring labeling. Coconut is not listed and with that, does not requiring allergen labeling.

We reached out to FDA and they provided this:
• Coconut is no longer considered a major food allergen: Coconut has been removed from the “tree nut list” (see Appendix 1, which is also at the end of this email) and is no longer considered a tree nut for allergen labeling purposes. This determination was made after a scientific evaluation was conducted using the scientific criteria outlined in FDA’s allergen framework guidance 

• Other changes to the tree nut list: [FDA] conducted a scientific review of tree nuts to determine if they are allergens of public health significance. [FDA] clarified that only the tree nuts listed in Appendix 1 are considered major food allergens. Other tree nuts not listed in the table should not be included in the “Contains” statement, even if they are used as ingredient, because the “Contains” statement is reserved for major food allergens. In addition to the removal of coconut, beech nut; butternut; chestnut; chinquapin; cola/kola nut; ginkgo nut; hickory nut; palm nut; pili nut; and shea nut were removed from the “tree nut list.”

• FDA expanded interpretation of "milk” as a major food allergen to include milk from goats, sheep, and other ruminants for food allergen labeling purposes. Milk from ruminant animals other than cows, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “goat milk”. For food allergen labeling purposes, milk and milk ingredient from animals other than cows, should also include the name of the animal source, such as “goat milk” and “whey (goat milk)” in the ingredient list or “Contains goat milk” in a separate Contains statement, or both.

• FDA expanded the definition of eggs to include eggs from ducks, quail and other fowl for food allergen labeling purposes. Eggs from birds other than chickens, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “duck egg”. For food allergen labeling purposes, egg and egg ingredients from birds other than chickens, should also include the name of the bird source, such as “duck egg” and “ovalbumin (duck egg)” in the ingredient list or “Contains duck egg” in a separate Contains statement, or both.
• Additional Information:

o  “Allergen-free” claims should not be accompanied by allergen advisory statements because this would be confusing for consumers, for example, “milk-free” and “may contain milk” should not appear on the same product label and labeling.

o Allergen declaration in an ingredients list or in a “Contains” statement should not also be accompanied by an allergen advisory statement for the same allergen, for example, “Contains milk” and “may contain milk”.

o FDA cannot change the list of major food allergens. Federal law defines “major food allergens,” but the law does not restrict our authority to require labeling for other food allergens by regulation.


Monday, January 6, 2025

USDA-FSIS Issue Health Warning for Foreign Material in Ground Beef Products Produced by Ohio Establishment

USDA-FSIS is issuing a public health alert due to concerns of frozen, raw ground beef products that may be contaminated with foreign material, specifically hard plastic and metal.  The product was produced by Stockyard Packing of Oxford, OH.  The problem was discovered after the firm notified FSIS that it received a consumer complaint reporting that pieces of hard plastic and metal were found in the raw ground beef product.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-frozen-raw-ground-beef-products-due-possible-foreign
FSIS Issues Public Health Alert for Frozen, Raw Ground Beef Products Due to Possible Foreign Matter Contamination

WASHINGTON, Jan. 5, 2025 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns of frozen, raw ground beef products that may be contaminated with foreign material, specifically hard plastic and metal. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.

NJ Specialty Food Company Recalls Cheese After Supplier Notification of Potential Listeria Contamination

Abbey Specialty Foods of Fairfield, NJ is recalling Wicklow Gold Cheddar Nettle & Chive 5.2 oz product and Wicklow Gold Cheddar Tomato & Herb 5.2 oz product because they have the potential to be contaminated with Listeria monocytogenes.  The recall was initiated after our supplier, Wicklow Farmhouse Cheese LTD. notified Abbey Specialty Foods they were recalling these products due to potential Listeria monocytogenes contamination.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbey-specialty-foods-recalls-wicklow-gold-cheddar-nettle-chive-52-oz-and-wicklow-gold-cheddar
Abbey Specialty Foods Recalls Wicklow Gold Cheddar Nettle & Chive 5.2 oz and Wicklow Gold Cheddar Tomato & Herb 5.2 oz Because of Possible Health Risk
Summary
Company Announcement Date:  January 03, 2025
FDA Publish Date:  January 03, 2025
Product Type:  Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Abbey Specialty Foods
Brand Name:  Wicklow Gold
Product Description:  Cheddar style cheeses

NC Firm Recalls Raw Cat Food for Salmonella

Blue Ridge Beef .of Statesville, NC is recalling 1,350 lbs. of their 2 1b log Kitten Mix Lot N25-0716 UPC 8542980013436 due to a contamination of Salmonella. (Lot numbers are stamped in the clips on the end of the chubs/bags).  Due to a customer complaint of animal illness, a sample of the product was collected on 12/12/2024 by the Massachusetts Department of Agriculture Resources and tested by the Massachusetts State Public Health Laboratory. The sampled product tested positive for Salmonella.

This company has had numerous recalls over the past several years (2024, 2024, 2023, 2023)

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-ridge-beef-recalls-blue-ridge-beef-kitten-mix-due-salmonella-contamination
Blue Ridge Beef Recalls Blue Ridge Beef Kitten Mix Due to Salmonella Contamination
Summary
Company Announcement Date: January 03, 2025
FDA Publish Date: January 03, 2025
Product Type:  Animal & Veterinary  Pet Food
Reason for Announcement:  Potential to be contaminated with Salmonella
Company Name:  Blue Ridge Beef
Brand Name:   Blue Ridge Beef
Product Description:  Kitten mix pet food

FDA Release Draft Guidance on Sanitation Programs for Low-Moisture RTE Foods w/ Corrective Actions for Environmental Positives

FDA released a draft guidance on environmental control for manufacturers/processors of low-moisture, ready-to-eat (LMRTE) human foods, including:
  • powdered infant formula (PIF), 
  • peanut butter, 
  • nut butters, 
  • powdered drink mixes, 
  • chocolate, 
  • medical foods in powdered and paste forms, 
  • processed tree nuts, 
  • milk powders, 
  • powdered spices, 
  • snack foods such as chips and crackers, 
  • granola bars, and
  • dry cereal
The guidance is designed to help in "establishing a routine sanitation program for LMRTE foods that can help prevent pathogen contamination events and also sets forth recommendations for corrective actions, including corrective actions for remediation of contamination of food-contact surfaces (FCSs) if prevention fails.
 
Specifically, this guidance discusses:
  • establishing and implementing a sanitation program and routine environmental  monitoring program; 
  • conducting adequate root cause investigations (RCIs) following a pathogen contamination event; 
  • applying a sanitizing7 treatment when remediating a pathogen contamination event; 
  • taking steps to identify affected food; and
  • the limitations of relying solely on a product testing program as verification that pathogen contamination has been eliminated
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-establishing-sanitation-programs-low-moisture-ready-eat-human-foods-and
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event
January 2025

FDA Releases 5th Edition of Q&A on Allergens and Allergen Labeling

FDA released final revision of the allergen Q&A document - Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)

https://www.fda.gov/media/117410/download

This is an important document for reference when food allergen control including labeling requirements.  It covers topics such as labeling bulk materials, spice mixes, and ingredients derived from those containing allergens.

FDA provided the list of tree nuts that must be labeled.  Note that coconut along with other nuts are not on this list, and with that, the allergen labeling does not apply.  Those tree nuts not listed in the table should not be included in the “Contains” statement, even if they are used as ingredient, because the “Contains” statement is reserved for major food allergens. In addition to the removal of coconut, beech nut; butternut; chestnut; chinquapin; cola/kola nut; ginkgo nut; hickory nut; palm nut; pili nut; and shea nut were removed from the “tree nut list.” 

Appendix I (from the updated guidance)

Tree Nuts FDA Considers as Major Food Allergens with their Common or Usual Names and Scientific Names.

Common or usual name

Scientific name

(Family name is identified in parentheses.)

Almond

Prunus dulcis (Mill.) D.A. Webb (Rosaceae)

Black walnut

Juglans nigra L.

(Juglandaceae)

Brazil nut

Bertholletia excelsa Humb. & Bonpl.

(Lecythidaceae)

California walnut

Juglans californica S. Watson

(Juglandaceae)

Cashew

Anacardium occidentale L.

(Anacardiaceae)

Filbert/Hazelnut

Corylus spp.

(Betulaceae)

 

Heartnut/Japanese walnut

Juglans ailantifolia Carriere var. cordiformis

(Makino) Rehder (Juglandaceae)

Macadamia nut/Bush nut

Macadamia spp.

(Proteaceae)

Pecan

Carya illinoinensis (Wangenh.) K. Koch

(Juglandaceae)

Pine nut/Pinon nut

Pinus spp.

(Pineaceae)

Pistachio

Pistacia vera L.

(Anacardiaceae)

Walnut (English, Persian)

Juglans regia L.

(Juglandaceae)

 

FDA also released a guidance document on how additional allergens may be added to the list of allergens.


https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
January 2025


Docket Number:
FDA-2022-D-0099