FDA Provides Updated Support Documents for Traceability Rule

FDA provided some updated materials to help companies comply to the Food Traceability Final Rule, that goes into effect on January 20, 2026.  The article in Food Safety Magazine has identified the updated material, but the exact updates are not obvious on the FDA webpage.

This only applies to certain foods that have been judged as having certain risks - Cheeses, shell eggs, nut butters, fresh cucumbers, fresh herbs, fresh and fresh cut leafy greens, fresh melons, fresh peppers, fresh spouts, fresh tomatoes, fresh tropical tree fruits, fresh cut fruits, specific fresh and raw frozen finfish, smoked finfish, fresh and frozen crustaceans and mollusks, RTE deli salads,

One useful addition is the Traceability Plan Example for Restaurants (although it is half example, half explanation, so not really a great example) - https://www.fda.gov/media/174058/download?attachment

https://www.food-safety.com/articles/9065-fda-releases-new-resources-for-food-traceability-final-rule-compliance

FDA Releases New Resources for Food Traceability Final Rule Compliance
By Food Safety Magazine Editorial Team

November 30, 2023

The U.S. Food and Drug Administration (FDA) recently rolled out additional tools and answers to frequently asked questions (FAQs) to inform stakeholders about Section 204 of the Food Safety Modernization Act (FSMA 204), also known as the Food Traceability Final Rule, and help aid entities with compliance.

Additional Recalls for Fruit Products Using Recalled Cantaloupes, CDC Provides Case Update

Updated 12/6/23

A number of food processor / distributors are recalling fruit / cantaloupe products that were derived from cantaloupes that are involved in the recent Malachita cantaloupe recall.  In an updated CDC report, there are now 117 cases with 61 hospitalizations and 2 deaths.

• TGD Cuts, LLC has initiated a voluntary recall of the specific fresh-cut fruit cup, clamshell and tray products
• Pacific Trellis Fruit, LLC is initiating a voluntary recall of 4,872 cases of Malichita brand whole cantaloupe
• Cut Fruit Express Inc. of Inver Grove Heights, MN, is recalling Caribou Coffee Fruit Mix CHPG 6.5oz, and Cut Fruit Express Brand of 6.5oz, 15oz, 16oz, 32oz packages of Fruit Mix contains Cantaloupes and Food service packages of 5lb tray, 10lb bag, 25lb Pail,
• Bix Produce of Little Canada, MN., is issuing a voluntary recall of Grab N’ Go containers of cut cantaloupe and mixed fruit cups 
• GHGA, LLC is voluntarily recalling select fresh-cut products made from whole cantaloupe subject to a previously announced product recall initiated by Sofia Produce, LLC dba Trufresh

FDA Provides Update on Lead Contamination Issue in Apple Cinnamon Sauce Product

In the most recent update on the lead poisoning associated with cinnamon apple pouches, FDA states that there as of Nov 30, there are 57 reported cases (there were 34 reported on Nov 16). To date, confirmed complainants are aged less than 1 to 5 years of age. FDA also identified the supplier of the cinnamon, thought to be the source of the lead in the finished product. The product was produced in Ecuador by Austrofood and was distributed by Wanabana USA, the distributor of WanaBana products.  "The cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador."

"The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. FDA has confirmed that Negasmart does not import cinnamon directly into the U.S."

Adverse Event Overview
Total FDA Adverse Events: 57*
Report Date Ranges: October 17, 2023 – November 28, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2) IA (1), IL (2), KY (3), LA (4), MA (3), MD (4), MI (3), MO (1), NC (5), NE (1), NH (1), NM (1), NY (8), OH (2), PA (1), SC (2), TN (1), TX (3) VA (1), WA (3)
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CFSAN Adverse Event Reporting System (CAERS) reports received by the FDA.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023
Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (November 2023)
Do not eat, sell, or serve multiple brands of recalled apple cinnamon fruit pouches. FDA’s investigation is ongoing.

Current Update
November 30, 2023

FL Company Recalls Protein Bars for Foreign Material - Items from the Trash Can?

Doctors Scientific Organica, of Rivera Beach FL, is recalling their Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Triple Chocolate Almond flavor products due to the potential presence of foreign material, including disposable hairnet, shrink wrap and parchment paper. Foodborne foreign objects that are flexible and not sharp may cause minor injuries such as transient choking or gastrointestinal system injury.

Did someone mistake an ingredient box for a garbage can?  Perhaps.  If so, this is why it is so important to use food containers for only food.  Non-food items must never to into food containers.  It is too easy to use containers for food, whether that be ingredient boxes or pails, for utilitarian purposes in the food plant.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/doctors-scientific-organica-announces-voluntary-recall-limited-quantity-burn-boot-camp-afterburn
Doctors Scientific Organica Announces Voluntary Recall of Limited Quantity of Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Due to Potential Presence of Foreign Material
Summary
Company Announcement Date:November 28, 2023FDA Publish Date:November 29, 2023Product Type:Food & BeveragesReason for Announcement:
Potential presence of foreign materialCompany Name:Doctors Scientific OrganicaBrand Name:
Burn Boot CampProduct Description:
Triple Chocolate Almond Flavored Whey Protein Bars

PA Ag Issues Food Safety Warning for Small Processor's Cheese Potentially Contaminated with Listeria

The Pennsylvania Department of Agriculture warns that consumers should discard "Hilltop Meadow Farm" brand '60 Day Aged Pepper Jack Raw Milk Cheese' with sell by dates of 9/21/2023 or earlier. Testing of this cheese confirmed the presence of Listeria monocytogenes bacteria.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/agriculture-department-warns-consumers-discard-hilltop-meadow-farm-brand-contaminated-60-day-aged
Agriculture Department Warns Consumers To Discard “Hilltop Meadow Farm” Brand Contaminated ‘60 Day Aged Pepper Jack Raw Milk Cheese’
Summary
Company Announcement Date:  November 22, 2023
FDA Publish Date:  November 28, 2023
Product Type:  Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Presence of Listeria monocytogenes
Company Name:  Hilltop Meadow Farm
Brand Name:  Hilltop Meadow Farm
Product Description:  Pepper Jack Raw Milk Cheese

Convenience Store Chain Recalls Fruit Cups Linked to Recalled Cantaloupe With Salmonella Potential

Kwik Trip, Inc. has initiated a voluntary recall of three varieties of fresh-cut fruit cup and tray products listed below because they contain cantaloupe from TruFresh which has the potential to be contaminated with Salmonella.  Products were distributed to Kwik Trip, Kwik Star, Stop-N-Go, Tobacco Outlet Plus Grocery, and Tobacco Outlet Plus convenience stores in the states of Wisconsin, Minnesota, Iowa, Michigan, Illinois, and South Dakota.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kwik-trip-inc-recalls-specific-fruit-cups-and-trays-due-potential-salmonella-contamination
Kwik Trip, Inc. Recalls Specific Fruit Cups and Trays Due to Potential Salmonella Contamination
Summary
Company Announcement Date:  November 27, 2023
FDA Publish Date:  November 28, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Salmonella.
Company Name:  Kwik Trip, Inc.
Brand Name:  Kwik Trip
Product Description:  Fruit cups and trays containing cantaloupe.

Credit Cards Used to Track Customers Exposed to Botulinum Toxin Tainted Sardines in France

In a report on a 2023 botulism outbreak in France that was linked to improperly processed home canned sardines, investigators discuss the importance of credit card information in tracking additional people who may have eaten the food made with the tainted sardines.  The importance of this was that many people who ate at the restaurant had traveled into the city as part of an international event, the Rugby World Cup.   Investigators used credit card information to identify 29 people who may have been exposed.  "Between 11 and 17 September 2023, 15 suspected cases of botulism among 29 exposed individuals were identified from seven countries: UK (n = 4), Canada (n =3), Ireland (n =3), the United States (US) (n =2), France (n =1), Germany (n =1) and Greece (n =1). All cases reported consuming preserved sardines marinated in oil and herbs at Restaurant A. Several cases reported a bad taste or bad smell from this dish."  "Of the 15 cases, .......13 were hospitalised with six requiring invasive mechanical ventilation. All except for the deceased case received heptavalent ABCDEFG botulinum antitoxin [2]."

"In this outbreak investigation, rapid identification of customers exposed to the implicated food was possible through interrogation of credit card payments and retrieval of personal contact information via the credit card companies. Given the severity of botulism, the credit card companies fully cooperated with the health authorities and contacted the identified customers for approval before forwarding the contact details. This enabled contacting and urgently referring three symptomatic British citizens unaware of their illness to an emergency unit for prompt administration of botulism antitoxin."

As for the sardines, "The inspectors did not identify any deviations in food storage but noted incorrect sterilisation techniques in the preparation of canned food."

Eurosurveillance
https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2023.28.47.2300624?
Foodborne botulism outbreak involving different nationalities during the Rugby World Cup: critical role of credit card data and rapid international cooperation, France, September 2023

Turkey Gravy Recalled for Undeclared Soy Due to Mislabeling of Beef Gravy

Seneca Foods Corporation is announcing a voluntary recall of mislabeled Hy-Vee Turkey gravy in glass jars that actually contains beef gravy. This product could potentially contain a soy allergen which is not declared on the label. Seneca is now retrieving improperly labeled Hy-Vee Turkey Gravy from its distribution system. This recall only affects Hy-Vee Turkey Gravy product sold by Hy-Vee. 

Urgent – Food Recall Because of Potential Undeclared Allergen Due to Mislabel
Summary
Company Announcement Date:  November 21, 2023
FDA Publish Date:  November 22, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy
Company Name:  Seneca Foods Corporation
Brand Name:  Hy-Vee
Product Description:  Turkey Gravy

Gift Baskets Recalled for Undeclared Nut Allergens After Discovery of Incorrect Labeling of Hazelnut Cookies

Wine Country Gift Baskets is taking precautionary measures of voluntarily recalling all gift baskets produced with Acorn Baking Company raspberry crème filled cookies. During production, it was discovered that some packages of the raspberry crème filled cookies contained hazelnut crème filled cookies. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-food-recall-raspberry-creme-filled-cookie
Urgent Food Recall— Raspberry Crème Filled Cookie
Summary
Company Announcement Date:  November 24, 2023
FDA Publish Date:  November 24, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Hazelnuts
Company Name:  Wine Country Gift Baskets
Brand Name:  Acorn Baking Company
Product Description:  Raspberry crème filled cookies