FDA Issues Small Entity Compliance Guide for Traceability Rule

FDA issued its Small Entity Compliance Guide for the Requirements for Additional Traceability Records for Certain Foods. "This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in  21 CFR part 1, subpart S. The regulations are binding and have the full force and effect of law."

The compliance date is Jan 20, 2026.

The certain food items are those listed on the FTL (Food Traceability List).

Food Traceability List | FDA

• Cheeses, other than hard cheeses, specifically:  
• Cheese (made from pasteurized milk), fresh soft or soft unripened
• Cheese (made from pasteurized milk), soft ripened or semi-soft
• Cheese (made from unpasteurized milk), other than hard cheese[1]
• Shell eggs Shell egg means the egg of the domesticated chicken.
• Nut butters
• Cucumbers (fresh) Includes all varieties of fresh cucumbers.
• Herbs (fresh) Includes all types of fresh herbs. Examples include, but are not limited to, parsley, cilantro, and basil. Herbs listed in 21 CFR 112.2(a)(1), such as dill, are exempt from the requirements of the rule under 21 CFR 1.1305(e).
• Leafy greens (fresh) Includes all types of fresh leafy greens. 
• Leafy greens (fresh-cut) Includes all types of fresh-cut leafy greens, including single and mixed greens.
• Melons (fresh) Includes all types of fresh melons. 
• Peppers (fresh) Includes all varieties of fresh peppers.
• Sprouts (fresh) Includes all varieties of fresh sprouts (irrespective of seed source), including single and mixed sprouts. 
• Tomatoes (fresh) Includes all varieties of fresh tomatoes.
• Tropical tree fruits (fresh) Includes all types of fresh tropical tree fruit. 
• Fruits (fresh-cut) Includes all types of fresh-cut fruits. 
• Vegetables other than leafy greens (fresh-cut) Includes all types of fresh-cut vegetables other than leafy greens. 
• Finfish (fresh and frozen), specifically:  
• Finfish, histamine-producing species
• Finfish, species potentially contaminated with ciguatoxin
• Finfish, species not associated with histamine or ciguatoxin
• Smoked finfish (refrigerated and frozen) Includes all types of smoked finfish, including cold smoked finfish and hot smoked finfish.[4]
• Crustaceans (fresh and frozen) Includes all crustacean species. 
• Molluscan shellfish, bivalves (fresh and frozen)[5]
• Ready-to-eat deli salads (refrigerated)

There is an entire list of full and partial exemptions and what is required for each.  Each operation will need to determine what actions are required based upon the specific applications.

But for those subject to the Rule, these are the requirements?

What Traceability Plan Must I Have for Foods on the FTL that I Manufacture, Process, Pack, or Hold? (§ 1.1315) If you are subject to the requirements of the Food Traceability Rule, you must establish and maintain a traceability plan containing the following information: 

1. A description of the procedures you use to maintain the records you are required to keep under the Food Traceability Rule, including the format and location of these records; 
2. A description of the procedures you use to identify foods on the FTL that you manufacture, process, pack, or hold; 
3.  A description of how you assign traceability lot codes to foods on the FTL in accordance with § 1.1320, if applicable; 
4.  A statement identifying a point of contact for questions regarding your traceability plan and records; and 
5.  If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods. The farm map must show the location and name of each field or other growing area where you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area. For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the FTL, including geographic coordinates and any other information needed to identify the location of each container

FDA Issues Warning Letter to OH Bakery Operation

FDA issued a Warning Letter to Gary’s Cheesecakes & Fine Desserts, a Cincinnati, Ohio processor of ready-to-eat (RTE) bakery products.  First, there was some significant indicators of rodent and insect activity including presence of rodent poop around ingredient storage and the finding of a dead rat in a trap.  It important to note that similar inspection items were found during a 2020 inspection.

The facility was also not registered with FDA.  Hard to know if the facility had a Food Safety Plan, but one would guess not.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023
Gary’s Cheesecakes & Fine Desserts

Canadian Establishment Recalls Mortadella Deli Meat for Undeclared Tree Nuts - Pistachio

Sofina Foods Inc., a Markham, Ontario, Canada establishment, is recalling approximately 15,165 pounds of ready-to-eat mortadella deli meat products due to misbranding and undeclared allergen, the product may contain pistachio (tree nuts), a known allergen, which is not declared on the product label.
The problem was discovered when the establishment notified FSIS that a customer observed pistachio nut in ready-to-eat regular mortadella deli meat product during slicing.  There have been no confirmed reports of adverse reactions due to consumption of these products.

Pistachio is commonly added to mortadella.

https://www.fsis.usda.gov/recalls-alerts/sofina-foods-inc--recalls-ready-eat-mortadella-deli-meat-products-due-misbranding
Sofina Foods Inc. Recalls Ready-To-Eat Mortadella Deli Meat Products Due to Misbranding and Undeclared Allergen

FSIS Announcement

WASHINGTON, May 19, 2023 - Sofina Foods Inc., a Markham, Ontario, Canada establishment, is recalling approximately 15,165 pounds of ready-to-eat mortadella deli meat products due to misbranding and undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product may contain pistachio (tree nuts), a known allergen, which is not declared on the product label.

Colostrum Product Recalled After Failing to State Contains Milk

Nature’s Energy Children’s Chewable Colostrum is being recalled after it was discovered that the Colostrum containing product was distributed in packaging that did not indicate the presence of milk proteins.  A quick search on the internet revealed that this is not the only product in this category that failed to post a 'Contains' statement for Milk.

Colostrum is milk.   From Healthline -  Bovine colostrum is made from the milky fluid a cow secretes after giving birth. It may help improve immunity, fight germs, and promote gut health. It appears safe for people, but more research is necessary.  Colostrum is a breast fluid produced by humans, cows, and other mammals before breast milk is released.  It’s very nutritious and contains high levels of antibodies, which are proteins that fight infections and bacteria.  Colostrum promotes growth and health in infants and newborn animals, but research shows that taking bovine colostrum supplements may promote immunity, help fight infections, and improve gut health throughout life."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natures-energy-issues-allergy-alert-undeclared-milk-childrens-chewable-colostrum-products
Nature’s Energy Issues Allergy Alert on Undeclared Milk in Children’s Chewable Colostrum Products

Summary

Company Announcement Date:  May 18, 2023

FDA Publish Date: May 18, 2023

Product Type: Food & Beverages

Reason for Announcement: Undeclared milk

Company Name: Nature’s Energy

Brand Name: Nature’s Energy

Product Description: Children’s Chewable Colostrum

Company Announcement

Nature’s Energy of Pleasant Grove, UT is voluntarily recalling Children’s Chewable Colostrum because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Imported Peanut Product Fails to List Peanuts on Label

Werner Gourmet Meat Snacks in Tillamook, OR is voluntarily recalling 14,682 packages of Chile Cacahuates Japones, 5oz Value Size, because it may contain undeclared peanut.  Werner Gourmet Meat Snacks in Tillamook, OR is voluntarily recalling 14,682 packages of Chile Cacahuates Japones, 5oz Value Size, because it may contain undeclared peanut.

Chile Cacahuates Japones are Japanese Spicy Peanuts...but the ingredient statement forgot to mention peanuts as an ingredient.  The product is imported from China, so the importer of this product would be responsible for ensuring proper labeling as part of the FSVP.





https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/werner-gourmet-meat-snacks-issues-allergy-alert-undeclared-peanut-chile-cacahuates-japones
Werner Gourmet Meat Snacks Issues Allergy Alert on Undeclared Peanut in Chile Cacahuates Japones
Summary
Company Announcement Date:  May 18, 2023
FDA Publish Date:  May 18, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanut
Company Name:  Werner Gourmet Meat Snacks
Brand Name:   Werner
Product Description:  Chile Cacahuates Japones

Chocolate Bar Recalled After Incorrect Ingredient Addition Results in Undeclared Allergens

Hu Products announced today a voluntary recall in the United States of a single production lot of Vanilla Crunch Dark Chocolate Bar product (2.1 oz bar) because some packages may potentially contain undeclared hazelnut, cashew, and/or almond that were inadvertently added to the product during manufacturing. 

Appears to be a case of misformulation.  Application of a preventive control at the point of ingredient addition should be considered. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hu-products-issues-voluntary-allergy-alert-undeclared-tree-nuts-hazelnut-cashew-andor-almond-vanilla
Hu Products Issues Voluntary Allergy Alert on Undeclared Tree Nuts (Hazelnut, Cashew, and/or Almond) in Vanilla Crunch Dark Chocolate Bar Product in the U.S.
Summary
Company Announcement Date:  May 18, 2023
FDA Publish Date:  May 18, 2023
Product Type:   Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared tree nuts (hazelnut, cashew, and almond)
Company Name:  Hu Products
Brand Name:  Hu
Product Description:  Vanilla Crunch Dark Chocolate Bar

Pasta Sauce Recalled for Undeclared Anchovy

LiDestri Foods is recalling 24-ounce jars of Wegman’s Italian Classics Diavolo pasta sauce, because it may contain undeclared fish (anchovy).  The recall was initiated after it was discovered via consumer complaint that the Wegman’s Italian Classics Diavolo Pasta Sauce containing anchovies was distributed in packaging that did not reveal the presence of anchovies. Subsequent investigation indicates the problem was caused by a temporary breakdown in LiDestri Foods’ packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lidestri-food-co-issues-allergy-alert-undeclared-fish-anchovy-24-oz-jars-wegmans-italian-classics
LiDestri Food Co. Issues Allergy Alert on Undeclared Fish (Anchovy) In 24-Oz Jars of Wegman’s Italian Classics Diavolo Pasta Sauce
Summary
Company Announcement Date:  May 17, 2023
FDA Publish Date:  May 17, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared fish (Anchovy)
Company Name:  LiDestri Food Co.
Brand Name:  Wegmans
Product Description:  Italian Classics Diavolo Sauce

FDA Updates Investigation of Illnesses Associated with Mushrooms in MT

FDA issued a report on illness that occurred in a Montana restaurant and may be associated with toxic mushrooms.  There have been a total of 50 cases with 3 hospitalizations and 2 deaths.  The last report was issued on May 3, 2023.

• "As of May 15, 2023, the investigation has identified 50 ill people who ate at the restaurant between March 28 and April 17, 2023, of whom 44 people reported eating morel mushrooms. There have been three hospitalizations and two deaths associated with this incident. A sample of leftover mushrooms were collected from the restaurant and laboratory analysis determined that the sampled mushrooms were true morels."
• "Currently, no pathogen, toxin, pesticide, or heavy metal has been identified; however, state and local partners have collected consumer samples from the restaurant and testing and analysis are ongoing. Although epidemiological evidence indicates that morel mushrooms consumed at the restaurant are likely the cause of illnesses, mushroom poisonings can be difficult to diagnose as the exact chemical nature of some toxins found in wild-type mushrooms are currently unknown."
• "Although the mushrooms sampled from the restaurant were found to be true morels, there are varieties of “false morels” that may be mistaken for a true morel due to a similar appearance. “False morels” are toxic and should not be consumed, cooked or uncooked. Gyromitrin is a toxin found in some varieties of false morel mushrooms and it has been linked to several cases of mushroom poisoning and can be fatal even in relatively small amounts. Gyromitrin poisoning can cause symptoms such as headache, vomiting, diarrhea, dizziness, loss of coordination, and in severe cases, seizure, heart failure, liver and kidney damage and death. Gyromitrin toxin can be partially broken down by high temperature; however, even with cooking, toxins may remain and can lead to illness or toxicity."
• "Wild-type mushroom poisonings can cause a variety of symptoms ranging from mild illness to death. Symptoms of wild-type mushroom poisoning depend on the specific toxin, the amount ingested, and the individual. The presence and levels of toxins in any individual species of mushrooms can change over time and by geographic location of where the mushroom was harvested."

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-illnesses-morel-mushrooms-may-2023
Investigation of Illnesses: Morel Mushrooms (May 2023)
Case Counts
Total Illnesses: 50
Hospitalizations: 3
Deaths: 2
Last Illness Onset: April 17, 2023
States with Cases: MT

Recall Notice Reissued for Infant Formula With Potential Cronobacter to Account for Additional Distribution

"On March 17, 2023, the Perrigo Company issued a voluntary recall of certain lots of Gerber® Good Start® SootheProTM Powdered Infant Formula in the U.S., that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility from January 02, 2023 to January 18, 2023. This product was recalled out of an abundance of caution due to the potential presence of Cronobacter sakazakii. Associated Wholesale Grocers, Inc. (AWG) is releasing this additional notice due to one of the recalled products being distributed to its Nashville Division retailers after the initial recall notice was published."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/associated-wholesale-grocers-inc-releasing-notice-due-recalled-infant-formula-being-distributed-its
Associated Wholesale Grocers, Inc. is Releasing this Notice Due to Recalled Infant Formula Being Distributed to its Nashville Division Retailers after the Initial Recall Notice was Published.
Summary
Company Announcement Date: May 13, 2023
FDA Publish Date:  May 14, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Cronobacter sakazakii contamination
Company Name:  Associated Wholesale Grocers, Inc.
Brand Name:  Gerber Good Start
Product Description:  Powdered Infant Formula