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

US Experiencing Increase in Norovirus Outbreaks

CDC data indicates there is a higher than normal number of Norovirus outbreaks.  "Data from the CDC's National Respiratory and Enteric Virus Surveillance System show that 22% of norovirus tests were positive for the week ending December 21, which is also higher than seen during the same time period in recent years."

Cruise ships also have been having their issues. "Data released earlier this week by the CDC show that 16 cruise ship norovirus outbreaks were reported in 2024, including 5 in December that sickened 890 passengers and crew members."

https://www.cidrap.umn.edu/norovirus/us-norovirus-outbreaks-are-cdc-data-show
US norovirus outbreaks are up, CDC data show
News brief January 2, 2025
Chris Dall, MA

Avian Influenza in Cats Linked to Raw Pet Food

In Oregon, the "Oregon Department of Agriculture (ODA) yesterday reported that a house cat has died from H5N1 avian flu after eating raw frozen pet food, which has prompted the voluntary recall of raw pet food that was sold nationwide through distributors in 12 states as well as in British Columbia."

"In a statement, the ODA said the house cat that tested positive for H5N1 died after eating raw food. Tests confirmed a genetic match between a sample from the cat and the virus from Northwest Naturals raw and frozen pet food."

In California, the "LADPH [Los Angeles Dept of  Health] said H5 avian flu from product samples of Monarch Raw Pet Food has been found in an investigation into an illness involving a house cat with a lab-confirmed infection after consuming the product. Four other cats from the same household have presumed H5 infections after eating the same food."  "Officials said an investigation is still under way into fatal illnesses of four cats from a separate household that had drunk raw milk."

"According to Monarch Raw Pet Food's website, the food was sold at farmer's markets in Laguna Niguel, Orange, San Jacinto, and Fountain Valley. The company said its raw meat pet food is made from raw ground chicken composed of muscle, organ meat, skin, fat, and bone and that it is sourced from human-grade free-range poultry raised in the San Joaquin Valley."


https://www.cidrap.umn.edu/avian-influenza-bird-flu/california-probe-ties-cats-avian-flu-illness-raw-pet-food
California probe ties cat's avian flu illness to raw pet food
Lisa Schnirring January 2, 2025
Avian Influenza (Bird Flu)

California Produce Company Recalls Broccoli Florets After State Testing Finds Listeria

 Braga Fresh of Soledad, Calif. is voluntarily issuing a precautionary advisory of a single production lot of washed and ready-to-eat 12oz Marketside Broccoli Florets with best if used by date Dec 10, 2024.  This advisory is being initiated due to possibility of contamination with Listeria monocytogenes. The potential for contamination was discovered during random sampling by Texas Health & Human Services from a Texas store location where one of multiple samples yielded a positive test result.  This product is past its best if used by date and is no longer in stores, but consumers may have frozen the item for later use.

Just to point out that this recall is for one lot of product due to Listeria being detected in that product.  As we have seen with other recalls involving Listeria, recalls can be expanded if it is determined that the facility did not have control of Listeria as determined from that company's internal controls.  Records of testing and cleaning as well as observation of practices may indicate issues, or may be viewed as suspect for not being sufficiently robust.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/braga-fresh-issues-voluntary-and-precautionary-advisory-due-possible-health-risk
Braga Fresh Issues Voluntary and Precautionary Advisory Due to Possible Health Risk
Summary
Company Announcement Date:  December 27, 2024
FDA Publish Date:  December 31, 2024
Product Type:  Food & Beverages  Produce
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Braga Fresh
Brand Name:  Marketside
Product Description:  Broccoli Florets

PA Candy Company Recalls Meltaway Bars After Mispackaging Issue With Cashew Containing Product

Gardners Candies of Tyrone, PA is recalling its 1.25 ounce packages of Gardners Candies brand Cappuccino Meltaway® Bars because they may contain undeclared tree nuts (cashews).   The recall was initiated after it was discovered that the tree nut-containing product was distributed in packaging that did not reveal the presence of tree nuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.  Production of the product has been suspended until the company is certain that the problem has been corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gardners-candies-issues-allergy-alert-undeclared-tree-nuts-cappuccino-meltawayr-bars-and-gardners
Gardners Candies Issues Allergy Alert on Undeclared Tree Nuts in Cappuccino Meltaway® Bars and Gardners Meltaway Treat Boxes Containing Cappuccino Meltaway Bars
Summary
Company Announcement Date:  December 27, 2024
FDA Publish Date:  December 27, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Tree Nuts (Cashews)
Company Name:  Gardners Candies, Inc.
Brand Name:  Gardners Candies
Product Description:  Chocolate Candy Bars

USDA-FSIS Announces Stronger Measures for Listeria Verification in RTE Facilities

In the aftermath of the Listeria outbreak associated with deli meat from Boar's Head Virginia facility, UDSA-FSIS announced increased measures to help ensure that companies producing RTE meat and poultry items are controlling Listeria.

Testing for Listeria species for a broader look at Listeria control - Effective January 2025, FSIS will add broader Listeria species testing to all samples of ready-to-eat product, environmental and food contact surfaces. FSIS laboratories currently test these samples for Listeria monocytogenes, which is the specific type of Listeria species that causes illness. However, adding additional species testing to the agency’s regulatory framework will help provide more information about the effectiveness of a facility’s sanitation program and can signal to FSIS if follow up is needed (for example, a Food Safety Assessment, intensified sampling, or enforcement actions).

Improved instruction to inspectors - FSIS will update its instructions and training for food safety inspectors to better equip the workforce to recognize and highlight systemic problems in a standardized way. Agency inspectors will receive updated instructions and training, and FSIS field supervisors will routinely review these instructions with inspectors to ensure full understanding and appropriate application. Inspectors will also receive supplemental Listeria monocytogenes control training designed to help strengthen inspectors’ understanding of the regulatory requirements in FSIS’ Listeria Rule and how to verify establishments have designed and implemented food safety systems that comply with those requirements.

Full Inspections (FSAs) for RTE facilities - FSIS will conduct Food Safety Assessments (in-depth food safety reviews) at ready-to-eat meat and poultry facilities. In FY 2025, FSIS is prioritizing completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria. These reviews will provide information about the plants individually and collectively and could inform future policy or process changes to target this microorganism.

Supervisor follow-up to these inspections (FSAs) - FSIS field supervisors will conduct in-person, follow-up visits when systemic issues are identified during a Food Safety Assessment. Follow-up visits by FSIS field supervisors will bolster oversight from more senior inspection staff to ensure a facility fully addresses issues identified during a Food Safety Assessment and could inform enforcement action by FSIS. Field supervisors will work with inspectors to ensure the facility stays in compliance.

Verifying risk factors for Listeria in facilities - FSIS inspectors will verify specific Listeria monocytogenes-related risk factors at ready-to-eat facilities weekly. These risk factors include changes in physical plant modifications, such as new construction; indicators of sanitation problems, such as condensation, roof leaks, damaged equipment, or cracked floors; and Listeria species or Listeria monocytogenes positive test results from company testing. FSIS district offices, agency field supervisors and inspectors will review, analyze and consider the weekly data from each facility to determine if there are systemic issues that warrant further action, such as a Food Safety Assessment, intensified sampling, or enforcement steps.

Work better with state inspected facilities - FSIS will clarify state and Federal requirements for consistent oversight of Talmadge-Aiken (TA) programs through updated cooperative agreements and instructions. 

Revise triggers that warrant action - FSIS will revise establishment-review alert triggers. One significant criterion used to guide a district office’s decision to conduct a Public Health Risk Evaluation (PHRE), which typically precedes a Food Safety Assessment, is a monthly list of facilities with higher rates of noncompliance related to public health that is generated using an algorithm

https://www.fsis.usda.gov/news-events/news-press-releases/fsis-announces-stronger-measures-protect-public-listeria
FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes

WASHINGTON, December 17, 2024 – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced several new steps to strengthen the agency’s oversight of food processing facilities it regulates (meat, poultry and egg products) and ensure safe food. These steps reflect the agency’s continual effort to protect public health through science-based regulation, strong enforcement, and advancement of its prevention-first approach to eliminating foodborne illness.

Ohio Firm Recalls Salsa Product for Undeclared Yellow 5 and 6.

Jose Madrid Salsa of Zanesville, OH is announcing a voluntary recall of our Chipotle Con Queso Salsa. The salsa is being recalled because it contains Yellow 5 and Yellow 6, which were not listed on the ingredient label. Individuals who are allergic or sensitive to Yellow 5 or Yellow 6 run the risk of minor to serious or life-threatening allergic reactions if they consume this product.  

The problem was discovered during a routine inspection of the production facility by the Ohio Department of Agriculture acting on behalf of the FDA. 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/recall-jose-madrid-salsa-chipotle-con-queso
Recall of Jose Madrid Salsa Chipotle Con Queso
Summary
Company Announcement Date:  December 20, 2024
FDA Publish Date:  December 20, 2024
Product Type:  Food & Beverages  Gravy/Sauces
Reason for Announcement:  Undeclared Yellow 5 and Yellow 6
Company Name:  Jose Madrid Salsa
Brand Name:  Jose Madrid
Product Description:  Chipotle Con Queso Salsa

Retailer Recalls Imported Buttered Vegetables For Not Declaring Milk

 Lidl US is recalling all lots of their Taste of Deutschland Buttered Vegetables 10.5 oz box UPC 4 056489 122876 due to undeclared milk allergen. The recall was issued due to undeclared milk in the products.  The recall was initiated after it was discovered by the FDA during an inspection that the labels did not list the allergen milk in the ingredient statement.  

Butter is listed on the label, but milk is not declared.  Product is imported from Germany.  This falls on the FSVP importer, in this case probably the retailer, to ensure that the product meets US regulatory standards.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lidl-recalls-taste-deutschland-buttered-vegetables-due-undeclared-milk-allergens
Lidl Recalls Taste of Deutschland Buttered Vegetables Due to Undeclared Milk Allergens
Summary
Company Announcement Date:  December 20, 2024
FDA Publish Date:  December 20, 2024
Product Type:  Food & Beverages
Vegetable Products  Allergens
Reason for Announcement:  Undeclared milk
Company Name:  Lidl US
Brand Name:  Taste of Deutschland
Product Description:  Frozen Buttered Vegetables, Carrots, Peas, Cauliflower, & Corn

California Company Recalls Protein Powder After Allergic Reaction to Peanut

Orgain of Irvine, California is voluntarily recalling a single batch of its 30g Protein Organic Plant Based Powder - Chocolate 2.01lb because it may contain undeclared peanut residue.  The recall is limited to a single batch of 30g Protein Organic Plant Based Powder - Chocolate 2.01lb and was distributed nationwide both in retail stores and online.  Orgain has conducted a complete review of the production process for this batch and found no discrepancies. This voluntary recall was initiated out of an abundance of caution following a report of an allergic reaction from one consumer. No other illnesses have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/orgain-issues-voluntary-allergy-alert-possible-undeclared-peanut-residue-single-batch-30g-protein
Orgain Issues Voluntary Allergy Alert on Possible Undeclared Peanut Residue in a Single Batch of 30G Protein Organic Plant Based Powder – Chocolate 2.01lb
Summary
Company Announcement Date:  December 19, 2024
FDA Publish Date:  December 19, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Product may contain undeclared peanut
Company Name: Orgain
Brand Name:  Orgain
Product Description:  30g Plant Protein Complete Protein Powder – Chocolate