RI Firm Recalls RTE Sausage Products After USDA Finds Listeria on Product Contact Surfaces

Daniele International LLC, a Mapleville, R.I., establishment, is recalling approximately 52,914 pounds of ready-to-eat (RTE) sausage products that may be adulterated with Listeria monocytogenes.  The RTE sausage products were produced on various dates from May 23, 2022, through November 25, 2022, and shipped to retail locations nationwide on various dates from December 23, 2022, through January 17, 2023. FSIS discovered the problem during routine inspection activities where Listeria monocytogenes was found on surfaces in which the product came into contact.  There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

The items appear to be sliced meat items, many sold as part of a charcuterie tray.  Brands include FREDERIK’S, Boar’s Head, COLAMECO’S, DEL DUCA, and Gourmet Selection.

https://www.fsis.usda.gov/recalls-alerts/daniele-international-llc-recalls-ready-eat-sausage-products-due-possible-listeria
Daniele International LLC Recalls Ready-to-Eat Sausage Products Due to Possible Listeria Contamination
DANIELE INTERNATIONAL

FSIS Announcement

WASHINGTON, Jan. 29, 2023 – Daniele International LLC, a Mapleville, R.I., establishment, is recalling approximately 52,914 pounds of ready-to-eat (RTE) sausage products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Chicken & Gnocchi Soup Imported from Canada Recalled After Mislabeling Issue Results in Undeclared Egg Allergen

Sovos Brands Intermediate, Inc. (“Sovos”) is voluntarily recalling a limited number of 16-ounce jars of Rao’s Made for Home Slow Simmered Soup, Chicken & Gnocchi, because the affected jars may contain undeclared egg.  The recall was initiated after it was discovered that the egg-containing vegetable minestrone was distributed in packaging that did not reveal the presence of egg because it was mistakenly labeled as Chicken & Gnocchi.  The affected soup is labeled as Chicken & Gnocchi, but will contain vegetable minestrone, which is dark red.  Product is made in Canada.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sovos-brands-intermediate-inc-issues-allergy-alert-undeclared-egg-raos-slow-simmered-soup-labeled

Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone
Summary
Company Announcement Date:  January 27, 2023
FDA Publish Date:  January 28, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Product may contain undeclared egg
Company Name:  Sovos Brands Intermediate, Inc.
Brand Name:  Rao’s
Product Description:  Soup labeled as Chicken & Gnocchi

WA Bakery Recalls Bread for Improper Allergen Labeling

Joy Joy’s Bakery Lakewood, Washington is recalling Ube Spanish Bread, Ube Ensaymada, and Ube Roll because it may contain undeclared wheat.  The recalled products labels declared flour but it does not specify wheat flour. This labeling problem was identified by Oregon Department of Agriculture through the U. S. Food and Drug Administration.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/joy-joys-bakery-issues-allergy-alert-undeclared-wheat-ube-spanish-bread-ube-ensaymada-and-ube-roll
Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
Summary
Company Announcement Date:  January 26, 2023
FDA Publish Date:  January 26, 2023
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Undeclared Wheat
Company Name:  Joy Joy’s Bakery
Brand Name:  Joy Joys Bakery
Product Description:  Ube Spanish Bread, Ube Ensaymada, and Ube Roll

NJ Firm Recalls Rice Cakes for Undeclared Peanut Allergens Resulting From Supplier Issue

Snack Innovations Inc. of Piscataway, NJ is issuing a voluntary recall on several batches of Drizzilicious branded mini rice cake bites, and drizzled popcorn products with the lot numbers listed below due to an undeclared peanut residue.  This voluntary recall was initiated as of the result of a recall that was initiated by one of the ingredient suppliers. The supplier notified the company that they discovered undeclared peanut residue in one of the sub-ingredients used in the process of making the products.

Unfortunately, supplier-related allergen issues has become a more common reason for recalls.  Do you know what suppliers are potential risks regarding undeclared allergens?  How do build that verification of  control into your supplier program?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/snack-innovations-inc-conducts-voluntary-recall-limited-quantity-drizzilicious-mini-rice-cakes-4oz
Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging
Summary
Company Announcement Date:  January 25, 2023
FDA Publish Date:  January 25, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared peanut allergen
Company Name:  Snack Innovations, Inc.
Brand Name:  Drizzilicious
Product Description:  Mini Rice Cake Bites and Popcorn

Recall of Chocolate Cake Sold at Ikea After Metal Piece Detected

Almondy, a brand sold at Ikea stores, is recalling a limited quantity Almondy Chocolate cake with Daim 14.1oz after a metal object has been found in a cake.  (it was probably that part of the Ikea dresser that was missing as you assembled it...just kidding).

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/almondy-initiating-recall-limited-quantity-almondy-chocolate-cake-daim-141oz
Almondy is Initiating a Recall of a Limited Quantity of Almondy Chocolate Cake with Daim 14.1oz
Summary
Company Announcement Date:  January 25, 2023
FDA Publish Date:  January 25, 2023
Product Type:  Food & Beverages  Bakery Product/Mix
Reason for Announcement:  Foreign Object
Company Name:  Almondy
Brand Name:  Almondy
Product Description:  Chocolate Cake with Daim

FDA Rules CBDs Not Allowed as Food Additive, Asks Congress for Regulatory Framework

FDA ruled against a petition seeking to allow CBD to be used in food as a dietary supplement due to safety concerns.  Although we may see products containing CBD (cannabidiol compounds derived from hemp) in the marketplace, they are not allowed.  Companies have continued to produce such products although it was never approved due to the potential safety concerns (CBD Oil - Illegal for Food, Science Largely Unknown).

https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol
FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

For Immediate Release:
January 26, 2023

FDA Issued Warning Letter to CA Food Warehouse and Repack Facility for Rats, Cats, Bats and Bugs

FDA issued a Warning Letter to Gold Coast Distributors of Stockton, CA, an ambient and frozen warehouse and re-packing facility.  FDA determined the food products packaged and/or held in your facility are adulterated.  In short, lots of rats, cats, bats, and bugs.  And throw some mislabeled product on top for good measure.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gold-coast-distributors-inc-dba-shah-distributors-635805-11022022
WARNING LETTER
Gold Coast Distributors Inc. dba Shah Distributors

MARCS-CMS 635805 — NOVEMBER 02, 2022

Recipient:
Mr. Sourabh Roy
CEO
Gold Coast Distributors Inc. dba Shah Distributors
2325 W. Charter Way
Stockton, CA 95206-1135
United States

Issuing Office:
Division of Human and Animal Food Operations West V
United States

WARNING LETTER
WL 635805

Dear Mr. Roy:

The United States Food and Drug Administration (FDA) inspected your ambient and frozen warehouse and re-packing facility, located at 2325 W. Charter Way, Stockton, CA 95206, from May 09-27, 2022. During our inspection of your facility, the FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent, insect, or cat filth present all throughout your facility.

Guidance - Retail Establishments Using Farms and Farmers' Markets Considering 'Approved' Requirement

AFDO (Association of Food and Drug Officials) released guidance for retail establishments who wish to buy food from farmers.  In the Food Code, it states that retail establishments should use a vendor that is an "approved" source.

"The definition of “approved” in the 2017 Food Code 1-201.10(B) says it “means acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.” Paragraph 3-201.11(a) states “food shall be obtained from sources that comply with law”."

So if a restaurant wants to buy produce from a small farmer or a farmers' market, it is permissible, but whether one should may not be an easy question to answer.

The AFDO guidance states:

"Produce (RACs) sourced directly from a farm, from a farmer’s market, or grown by the retail establishment, can be considered an “approved” source at retail unless there are factors that call into question such a conclusion, for example, evidence of contamination, microbial contamination through surveillance testing, or foodborne illness outbreaks."

In the end, the onus is responsibility of the retail establishment,

"Buyers for retail establishments should ensure produce sourced directly from farms or farmer’s market vendors are following safe food handling practices. Current resources can be used to help buyers when selecting their local produce. Due diligence on the buyer’s side is important." 

So while the vendor may not have a GAP inspection, you can still permitted to use produce from them.  One thing you can do is ask if they have attended Produce Safety Growers Training.  You can get to know the farmer....ensure they are following practices, complete your own inspection.

Iowa State has an often referenced checklist for retail purchasing that you can use.

Checklist for Retail Purchasing of Local Produce (iastate.edu)

USDA has a more comprehensive document that was put together for school districts
https://theicn.org/resources/179/produce-safety/105766/verifying-on-farm-food-safety-fact-sheet.pdf

https://www.afdo.org/wp-content/uploads/2022/05/Updated-AFDO-Retail-Produce-Guidance-Formatted.pdf
AFDO Guidance for Interpretation of Approved Source as it relates to Retail Food Establishments and the Produce Safety Rule

With the passage of the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), the FDA has adopted 21 CFR 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (referred to as the Produce Safety Rule). The Produce Safety Rule is complex and has led to many questions from the state and local regulatory food safety jurisdictions as to how it may impact the interpretation of the “approved” source at the retail level. This guidance document will help clarify the issues surrounding fresh produce, which are Raw Agricultural Commodities (RACs) that are locally grown, sourced, and sold in retail food establishments.

Question:
Regulatory authorities ask if produce (RACs) from any source, including farmer’s markets or direct from the farm, is considered an “approved” source for retail?

FDA Issues Draft Guidance on Action Levels of Lead in Food For Babies and Young Children

FDA issued Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry. This document presents "the background and rationale for FDA’s action levels for lead in processed food intended for babies and young children:

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
• 20 ppb for root vegetables (single ingredient); and
• 20 ppb for dry infant cereals

"These action levels reflect levels of lead at which FDA may regard the food as adulterated"

This Draft Guidance comes after a push to establish limits for heavy metals in baby food.

Lead is a challenge with regard to growing and processing food.  From the guidance, 

"Lead is widely present in the environment due to both its natural occurrence and to human activities that have introduced it into the environment. Because lead may be present in environments where food crops used to make food intended for babies and young children are grown, various foods may contain small amounts of lead. Potential sources of lead in food include contaminated soil where crops are grown, contaminated water, atmospheric deposition from industrial activities, and old lead-containing equipment used to process food. As a result of  the first three sources, agricultural crops (e.g., root vegetables) can take up lead from contaminated soil and contaminated soil may be deposited on plant surfaces (e.g., leafy vegetables and cereal grains). Studies suggest that manufacturers may be able to reduce lead levels in food by using practices such as thoroughly peeling root vegetables and thoroughly washing fruits and vegetables, particularly leafy vegetables (Refs. 3, 4, 5, 6). It is possible in some cases for manufacturers who have found elevated lead levels in sources of food intended for babies and young children to choose sources of food or food ingredients with lower lead levels or no detectable lead. Manufacturers could also consider increased testing of ingredients or finished products that are historically known to contain elevated lead levels; this is particularly important for ingredients or finished products intended for babies and young children. Additionally, manufacturers could consider examining their facilities, processes, and equipment to ensure that they are not contributing to lead in their products (Refs. 7, 8)." 

WA Firm Recalls Chocolate-Coated Cashews For Undeclared Peanuts Due to Supplier Issue

SkinnyDipped® of Seattle, WA is voluntarily recalling a limited quantity of SkinnyDipped® Dark Chocolate Cocoa Almond 3.5oz and SkinnyDipped® Dark Chocolate Salted Caramel Cashew 3.5oz due to an undeclared peanut allergen in an ingredient from a raw material supplier.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/skinnydippedr-issues-allergy-alert-undeclared-peanuts-limited-number-skinnydippedr-dark-chocolate
SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products
Summary
Company Announcement Date:  January 20, 2023
FDA Publish Date:  January 23, 2023
Product Type:   Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared peanut allergen
Company Name:  SkinnyDipped
Brand Name:  SkinnyDipped
Product Description:  Dark Chocolate Cocoa Almond & Dark Chocolate Salted Caramel Cashew

USDA Updated Organic Regulations to Help Reduce Fraud

USDA issued a rule for organic food titled, National Organic Program (NOP); Strengthening Organic Enforcement..This rule is designed "to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. The amendments protect integrity in the organic supply chain and build consumer and industry trust in the USDA organic label by strengthening organic control systems, improving farm to market traceability, and providing robust enforcement of the USDA organic regulations."

The reason, as stated in the Executive Summary, "The absence of direct enforcement over some entities in the organic supply chain, in combination with price premiums for organic products, has created the opportunity for organic fraud."  When we think of food fraud, olive oil and honey come to mind.  But the organic food supply chain has offered the greatest opportunities because of these shortcomings.

The rule can be found here - https://www.federalregister.gov/documents/2023/01/19/2023-00702/national-organic-program-nop-strengthening-organic-enforcement

From the Executive Summary:

"This rulemaking strengthens enforcement of the USDA organic regulations through several actions mandated by the Agriculture Improvement Act of 2018:

Health Alert Issued After A Supplier Substitution for Gravy Results in Undeclared Wheat Allergen

U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that the gravy component of ready-to-eat Hy-Vee beef pot roast entrée products may contain wheat, a known allergen, which is not declared on the finished product label. A recall was not requested because the products are no longer available for purchase.

The problem was discovered when the establishment identified that they received a substitute gravy mix from their spice supplier that includes wheat, whereas the normal gravy mix does not. The establishment notified FSIS that the label on the back of the product does not list wheat contained in the substitute gravy mix.

A reminder for the need for the Food Safety Team to review supplier changes / substitutions.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-hy-vee-beef-pot-roast-entree-products-due
FSIS Issues Public Health Alert for Ready-To-Eat Hy-Vee Beef Pot Roast Entrée Products due to Misbranding and an Undeclared Allergen

Federal Agencies Investigate Listeria Outbreak Linked to Enoki Mushrooms - Importers Doing Too Little?

FDA and CDC are conducting an investigation into a Listeria outbreak linked to Enoki Mushrooms distributed by Utopia Foods, Inc. of Glendale, New York.  There are 3 cases, with the three people being hospitalized.

The distributor did issue a recall and then expanded that recall.

There has been plenty of concern about the Listeria risk in enoki mushrooms.  The question has to be asked if these importers are doing enough to ensure that their product is safe.

Case Counts
Total Illnesses: 3
Hospitalizations: 3
Deaths: 0
Last illness onset: October 8, 2022
States with Cases: CA (1), MI (1), NV (1)
Product Distribution: Nationwide


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-enoki-mushrooms-november-2022
Outbreak Investigation of Listeria monocytogenes: Enoki Mushrooms (November 2022)

Alfalfa Spouts Recalled After FDA Testing Finds STEC (Shiga toxin producing E.coli)

Fullei Fresh is voluntarily recalling Alfalfa Sprouts due to the detection of Shiga toxin producing E.coli (STEC.)    It was detected upon sampling of finished product by the FDA.  The company stated that "STEC is a bacterial strain that is not part of our routine microbial testing conducted in compliance with the FDA’s Produce Safety Rule Subpart M on every lot we produce."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fullei-fresh-issues-correction-alfalfa-sprout-recall-because-possible-health-risk
Fullei Fresh Issues Correction on Alfalfa Sprout Recall Because of Possible Health Risk
Summary
Company Announcement Date:  January 17, 2023
FDA Publish Date:   January 17, 2023
Product Type:  Food & Beverages
Reason for Announcement:   Contamination with shiga toxin-producing E. coli
Company Name:  Fullei Fresh
Brand Name:  Fullei Fresh
Product Description:  Alfalfa Sprouts

NJ Firm Recalls Peanut Butter Hot Chocolate for Undeclared Peanuts

Updated on 1/23/23 **A previous version of this press release issued on 1/18/2023. This press release was updated to identify the single unit serving size as “single serve coffee pods”.**

Corim Industries Issues Allergy Alert on Undeclared Peanuts in Peanut Butter Hot Chocolate | FDA

A New Jersey firm is recalling its Peanut Butter Hot Chocolate for undeclared peanuts.

According to the release, "The recall was initiated after it was discovered that a replacement flavoring ingredient from a different supplier may have trace levels of peanut that was not declared on bulk label or finished product label to downstream partners. However, testing conducted by Corim indicated that the levels may be below the limit of detection. The firm’s subsequent investigation identified the root cause as a temporary breakdown in the company's supplier documentation process. The process has been corrected and the company has instituted additional safety checks and corrective actions, including discontinuing the use of this particular flavoring ingredient."

So the peanut butter flavor was provided by a non-peanut-containing ingredient.  However. due to a supplier change, this new flavor ingredient may have contained peanut.  My question is, since the label states peanuts, why not use real peanuts?  This may be due to the firm not wanting to introduce peanut allergens into their operation.  I can't imagine someone who is allergic to peanuts actually taking a chance by consuming this product because peanut allergens are not listed.




https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/corim-industries-issues-allergy-alert-undeclared-peanuts-peanut-butter-hot-chocolate
Corim Industries Issues Allergy Alert on Undeclared Peanuts in Peanut Butter Hot Chocolate
Summary
Company Announcement Date:  January 18, 2023
FDA Publish Date:  January 18, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Peanut Allergen
Company Name:  Corim Industries
Brand Name:  Cocoa de Aroma, Smart Sips and more
Product Description:  Peanut butter hot chocolate products
Company Announcement

NY Distributor of Enoki Mushrooms Expands Recall

Utopia Foods Inc of Glendale, NY, is expanding the recall of its December 2022 recall of enoki mushrooms (because they have the potential to be contaminated with Listeria monocytogenes to include product with Best by dates “Best before 03/02/2023” or “Best before 03.09.23” which were distributed between January 6th to January 13th, 2023.

The potential contamination was initially found through routine sampling conducted in the State of Missouri  that revealed the presence of Listeria monocytogenes in the 200g packages of “Enoki Mushrooms”.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/utopia-foods-expands-recall-enoki-mushrooms-because-possible-health-risk
Utopia Foods Expands Recall on “Enoki Mushrooms” Because of Possible Health Risk
Summary
Company Announcement Date:  January 13, 2023
FDA Publish Date:  January 13, 2023
Product Type:  Food & Beverages  Produce
Reason for Announcement:  Listeria monocytogenes
Company Name:  Utopia Foods Inc.
Brand Name: Utopia Foods Inc
Product Description:  Enoki Mushrooms

USDA Issues Health Alert for Frozen Cooked Swai Fish

USDA is issuing a public health alert because A & S Produce Inc., a Vernon, Calif. establishment conducting business as Greenland Food Company, produced and distributed fully cooked, frozen swai fried fish cutlet products without the benefit of federal inspection. A recall was not requested because the products are no longer available for purchase.  The products involved in this public health alert do not bear the establishment number or a USDA mark of inspection. These items were sold at retail locations in California and through online sales.  FSIS discovered the problem when it was conducting surveillance at an online retailer and found FSIS-regulated products without a USDA mark of inspection.

USDA has regulatory authority for inspection of Siluriformes.  But Siluriformes, as a group, are more than just catfish.  Here is a listing:

TX Firm Recalls Brownies After Mislabeling Issue Yields Undeclared Allergens

Ameripack Foods LLC of Hughes Springs, TX is issuing a recall for 976lbs. of brownies for H-E-B Meal Simple Chocolate Chunk Brownie 13 Oz due to an undeclared – Soy & Egg. The recall was initiated after discovering that trays of brownies were mislabeled on the back as Sopapilla Cheesecake, which does not list egg and soy allergens, on the product ingredient label.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ameripack-foods-llc-announces-allergy-alert-undeclared-soy-and-egg-h-e-b-meal-simple-chocolate-chunk
Ameripack Foods LLC Announces Allergy Alert for Undeclared Soy and Egg in H-E-B Meal Simple Chocolate Chunk Brownie
Summary
Company Announcement Date:  January 11, 2023
FDA Publish Date:  January 11, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy and egg allergens
Company Name:  Ameripack Foods, LLC
Brand Name:  H-E-B Meal Simple
Product Description: Chocolate Chunk Brownie

FDA Issues Final Guidance for FSVP for Imported Foods

FDA issued the Final Guidance for FSVP, the Foreign Supplier Verification Program.  This document "provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling."

When introduced in 2017, this established the requirements for food importers to ensure that significant hazards are identified in foods they import and that the importer was verifying that controls are in place.   However, many food importers are still being found to be out of compliance.  Many of them seem to be unaware that the rule is in place as evidenced by Warning Letters issued by FDA.

The Guidance is lengthy, but should provide answers to most questions posed on the Rule.
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (fda.gov)

https://cacmap.fda.gov/index.php/food/cfsan-constituent-updates/fda-issues-foreign-supplier-verification-programs-importers-food-humans-and-animals-final-guidance
FDA Issues the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Final Guidance
Constituent Update
January 10, 2023

CA Company Recalls Popcorn Snack Products for Undeclared Allergens

Daiso California LLC of La Mirada, CA is recalling the various popcorn snacks, under the brand Tohato and Kashiwado, due of undeclared allergen ingredients.

Daiso had also issued a recall in October of 2022 for cookies that had undeclared almonds and hazelnuts.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-alergy-alert-tohato-and-kashiwado-snacks
Daiso Issues Alergy Alert Tohato and Kashiwado Snacks
Summary
Company Announcement Date:  January 10, 2023
FDA Publish Date:  January 10, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almonds, peanuts, soybeans, milk, and shellfish
Company Name:  Daiso California, LLC
Brand Name:  TOHATO and KASHIWADO
Product Description:  Popcorn and other snacks

FDA Issues Warning Letter to Florida Rice Operation for Heavy Pest Activity

FDA issued a Warning Letter to Florida Gold Foods of Kissimmee FL, a firm that handles dried rice, after FDA inspectors found numerous GMP issues including rodent, insect, and animal activity.  (Animal activity -  investigators observed four (4) or more live cats in the northern end of the building and apparent cat feces and urine throughout the warehouse, and they observed a cat running from building (b)(4) with a rodent in its mouth.  Cats are not pest control for food facilities)

FDA also analyzed several samples for filth.  "Results from the Florida Gold brand 2-lb bags of rice demonstrate that this product was adulterated with various species of insects at larval, pupae and adult stages including multi-stage dead beetles, sawtoothed grain beetles, and red flour beetles. Further, the samples collected from within your facility resulted in numerous filth findings including the presence of rodent excreta pellets of a size implicating a rat, fecal material with internal cat/dog hairs, rat/mouse hairs, two (2) feathers identified as songbird feathers, multi-stage beetles (adult and larvae), and insects including but not limited to, flies and moths."

Of course, there were plenty of GMP issues for cleanliness.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/florida-gold-foods-llc-637153-11222022
WARNING LETTER

Florida Gold Foods LLC
MARCS-CMS 637153 — NOVEMBER 22, 2022

CFP Releases Best Practice Guidance Document for Direct-to-Consumer Delivered Foods

A guidance document was recently released for food delivery business. The regulations covering such operations can be viewed as nebulous since they ship product directly to consumers via a delivery service. This document, written by the Conference for Food Protection (CFP) Direct-to-Consumer Delivery Committee, provides food safety best practices for direct-to-consumer and third-party food delivery services that meet Food Code requirements.

That document can be found at this link: http://www.foodprotect.org/media/guide/guidance-document-for-direct-to-consumer-and-third-party-delivery.pdf

Also included below is the USDA's document, Mail Order Food Safety, which is also a nice reference for those shipping food to consumers.

Food Safety Magazine
https://www.food-safety.com/articles/8233-guidance-on-food-safety-best-practices-for-food-delivery-businesses
Guidance on Food Safety Best Practices for Food Delivery Businesses

The U.S. Food and Drug Administration recently highlighted a voluntary guidance document on food safety best practices for direct-to-consumer and third-party food delivery services.

The guidance features several updates from the original draft, such as recommended practices for transportation directly to a consumer of perishable products, to include proper packaging; temperature control during shipping, receiving, and storage; return of compromised and abused products; and other food safety related topics.

FDA Issues More Warning Letters to Importers for Lack of FSVP - December 2022

In December of 2022, FDA issued close to a dozen food importers, all lacking a FSVP for the products they import.

Ruth Special Food Store LLC. of Belleville, NJ 07109 have not developed FSVPs for any of the foods imported including: Organic shine skin pumpkin kernels, Shine skin pumpkin kernels, and Dry roasted edamame
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ruth-special-food-store-llc-644551-12092022

Bagged Popcorn with Various Allergens Recalled Due to No Allergen Label

Avery’s Savory Popcorn LLC of Dallas, Texas is recalling Gourmet Popcorn, ALL Flavors because it may contain undeclared specific type of allergen. People who have an allergy or severe sensitivity to specific type of allergen (e.g., milk, soy, peanuts, tree nuts {almonds, walnuts, pecans, cashews}, and sulfites) run the risk of serious or life-threatening allergic reaction if they consume these products.

According to the FDA release, "The recall was initiated after it was discovered that product containing (the allergen) was distributed in packaging that did not reveal the presence of the allergen (soy, milk, peanuts, tree nuts). Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes."  From the posted picture, there was either no statement, or someone forgot to stick a label with the allergens on the pre-labeled bag (containing no information about ingredients or nutrition.)

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/averys-savory-popcorn-llc-issues-allergy-alert-undeclared-allergens-gourmet-popcorn
Avery’s Savory Popcorn LLC Issues Allergy Alert on Undeclared Allergens in Gourmet Popcorn
Summary
Company Announcement Date:  December 30, 2022
FDA Publish Date:  January 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk, soy, peanuts, tree nuts, and sulfites
Company Name:  Avery’s Savory Popcorn LLC
Brand Name:  Avery’s
Product Description:  Gourmet Popcorn, All Flavors

FDA Issue Warning Letter to FL Ice Cream Company, Source of July 2022 Listeria Outbreak

FDA issued a Warning Letter to Big Olaf Creamery, an operation that was responsible for a July 2022 Listeria outbreak with 28 cases ("Among 28 ill people with available information, 27 (96%) were hospitalized, and seven illnesses were in pregnant people or their newborns. One death and one fetal loss attributable to listeriosis have been reported.")

In short summary, the company did not have a food safety plan in place, and along with that, apparently no controls for potential hazards.  The company had not identified Listeria as a concern, and testing was only completed after it was the determined that the company as the source of the Listeria outbreak.  

"After the product recall and in response to FDACS’s positive L. monocytogenes environmental and finished product samples and FDACS’s stop sale order ceasing all sale of ice cream products, your firm contracted with a third-party laboratory to conduct environmental swabbing (b)(4). Multiple pieces of equipment used to manufacture RTE ice cream products were reported positive for L. monocytogenes by your contract laboratory, including (b)(4). Additionally, four swabs of finished product ice cream buckets ((b)(4)) were reported positive for L. monocytogenes."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/big-olaf-creamery-llc-dba-big-olaf-642758-12092022
Big Olaf Creamery LLC dba Big Olaf
MARCS-CMS 642758 — DECEMBER 09, 2022

CT Firm Recalls Granola Product After Product Determined to Contain Undeclared Almonds

Garden of Light (dba Bakery On Main) of  East Hartford, Connecticut December is recalling one lot of Organic Oat and Honey Granola for possible Tree nut (Almond)contamination.  The company manufactured 14,304 pounds of product which was distributed by Total Granola in Topco and SEG retail stores throughout the United States. The product recall was voluntarily initiated after it was discovered that product potentially containing Almonds was distributed in packaging that did not reveal the presence of Almonds. No illnesses or injuries have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/garden-light-dba-bakery-main-voluntarily-recalls-oat-honey-organic-granola-due-potential-almond
Garden of Light (dba Bakery On Main) Voluntarily Recalls Oat & Honey Organic Granola Due to Potential Almond Contamination
Summary
Company Announcement Date: December 30, 2022
FDA Publish Date:  December 30, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared almonds
Company Name:  Garden of Light dba Bakery on Main
Brand Name:  Full Circle Market & Naturally Better
Product Description:  Oat & Honey Organic Granola

Imported Potato Ring Snack Recalled for Lack of Milk Allergen Labeling

Daiso California LLC of La Mirada, CA is recalling Tohato Nagewa Snack, an imported crisp potato ring product, because it contains an undeclared milk derivative ingredient. The recall was initiated after it was discovered that the product was distributed in packaging that did not correctly warn for the presence of a milk allergen. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging process.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/daiso-issues-allergy-alert-undeclared-milk-tohato-nagewa-snack
Daiso Issues Allergy Alert on Undeclared Milk in Tohato Nagewa Snack
Summary
Company Announcement Date:  December 30, 2022
FDA Publish Date:  December 30, 2022
Product Type:  Food & Beverages  Snack Food Item 
Reason for Announcement:  Undeclared milk
Company Name:  Daiso California LLC
Brand Name:  Tohato
Product Description:  Nagewa Snack

NJ Firm Recalls Frozen NRTE Pasta After Listeria Positive Sample

Caesar's Pasta, LLC of Blackwood, NJ is recalling 5,610 lbs. of frozen manicotti, because it has the potential to be contaminated with Listeria monocytogenes.  The recall was the result of a routine sampling program, which revealed that the finished products may contain the bacteria. The FDA and the company continue their investigation as to what may have caused the problem.

The product is categorized as "Not-Ready-To-Eat" and cooking instructions on the product label clearly state that product must be cooked to 160 degrees, which would effectively kill the bacteria.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/caesars-pasta-llc-recalls-frozen-manicotti-because-possible-health-risk
Caesar's Pasta, LLC Recalls Frozen Manicotti Because of Possible Health Risk
Summary
Company Announcement Date:  December 29, 2022
FDA Publish Date:  December 29, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Caesar’s Pasta, LLC
Brand Name:  Caesar’s Pasta & Orefresco
Product Description:  Frozen manicotti

Nebraska Firm Recalls Sprouts That May Be Linked to Salmonella Outbreak

SunSprout Enterprises of Fremont, Nebraska is voluntarily recalling four lots (#4211, 5211, 3212, and 4212) of raw alfalfa sprouts in 4-ounce clamshells and 2.5lb packages, with best by dates between 12/10/22 and 1/7/23, due to potential contamination with Salmonella.  The company directly distributed 1406 pounds of product to five foodservice and grocery customers in Nebraska, Kansas, and Iowa between late November and mid December 2022. 

To date, SunSprout has received no complaints or reports of illness due to this recalled product. This voluntary recall is a result of a preliminary investigation by the State of Nebraska in connection with CDC of an outbreak of illness likely associated with alfalfa sprouts.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-sprouts-december-2022

Outbreak Investigation of Salmonella: Sprouts (December 2022)

Do not eat, sell, or serve recalled Sun Sprouts brand Alfalfa Sprouts. FDA's investigation is ongoing.

Case Counts

Total Illnesses: 15

Hospitalizations: 2

Deaths: 0

Last illness onset: 12/13/2022

States with Cases: NE, OK, SD

Oregon Establishment Recalls Frozen Diced Beef After E. coli Positive Test

Morasch Meats Inc., a Portland, Ore. establishment, is recalling approximately 3,930 pounds of raw frozen diced beef products that may be contaminated with E. coli O157:H7.  The problem was discovered by FSIS during review of testing results, which showed the product tested positive for E. coli O157:H7.  These items were shipped to distributor locations in Oregon for further distribution to restaurants and other institutional users.

https://www.fsis.usda.gov/recalls-alerts/morasch-meats-inc--recalls-raw-frozen-diced-beef-products-due-possible-e--coli
Morasch Meats Inc. Recalls Raw Frozen Diced Beef Products Due to Possible E. Coli O157:H7 Contamination

MORASCH MEATS, INC

FSIS Announcement

WASHINGTON, Dec. 22, 2022 – Morasch Meats Inc., a Portland, Ore. establishment, is recalling approximately 3,930 pounds of raw frozen diced beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Imported Pasta Recalled for Undeclared Wheat

World Variety Produce, Inc. is recalling Melissa’s Pasta Para Duros due to undeclared wheat. The product was imported from Mexico.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/world-variety-produce-inc-voluntarily-recalls-melissas-pasta-para-duros-12oz-because-it-contains
World Variety Produce, Inc. Voluntarily Recalls Melissa’s Pasta Para Duros 12oz Because it Contains Undeclared Wheat Allergens
Summary
Company Announcement Date:  December 23, 2022
FDA Publish Date:  December 23, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  World Variety Produce, Inc.
Brand Name:  Melissa’s
Product Description:  Pasta Para Duros

Oat-based Yogurt Alternative Recalled for Almond Allergen Due to Mislabeling Issue

Culture Fresh Foods is issuing a recall for True Goodness by Meijer Oat-Based Plain Yogurt Alternative 24 Oz due to an undeclared - almonds.  The recall was initiated after discovering that tubs labeled as Oat-Based, actually contain Almond-Based product, which is not listed on the product label.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meijer-announces-allergy-alert-undeclared-almonds-true-goodness-oat-based-plain-yogurt-alternative
Meijer Announces Allergy Alert on Undeclared Almonds in True Goodness Oat-Based Plain Yogurt Alternative
Summary
Company Announcement Date:  December 16, 2022
FDA Publish Date:  December 22, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Tree Nuts
Company Name:  Meijer
Brand Name:  True Goodness
Product Description:  Plain Yogurt Alternative

CA Company Recalls Meatless Breakfast Sandwiches and Burritos for Undeclared Milk

Alpha Foods, Glendale, California (December 21, 2022) - Out of an abundance of caution, Miso Brothers, Inc. dba Alpha Foods, is voluntarily recalling its Meatless Breakfast Sandwiches and Burritos due to traces of undeclared milk.  This recall was initiated after it was discovered, that the products containing traces of undeclared milk (Casein - a milk protein) were distributed in retail stores and delivered directly to consumers who purchased our products online. Subsequent investigation indicates that the contamination is likely to have occurred during the production of our products.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alpha-foods-issues-product-recall-due-undeclared-milk-meatless-burritos-breakfast-sandwiches
Alpha Foods Issues a Product Recall Due to Undeclared Milk in Meatless Burritos & Breakfast Sandwiches
Summary
Company Announcement Date:  December 21, 2022
FDA Publish Date:  December 21, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  The Miso Brothers Inc
Brand Name:  Alpha
Product Description:  Frozen Burritos

Imported Baklava Recalled Due to Lack of Allergen Labeling

Falcon Import and Export LLC, of Ashburn, Virginia, is recalling Alsultan Sweets branded Baklava because it may contain undeclared milk and wheat, and Alsultan Sweets branded Betefour because it may contain undeclared cashews, pistachios, and almonds.   The recall was initiated after it was discovered that products containing the allergens were distributed in packaging that did not reveal the presence of the allergens. Distribution of the products has been suspended until the labeling is corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/falcon-import-and-export-llc-issues-allergy-alert-undeclared-milk-wheat-mixed-alsultan-branded
Falcon Import and Export, LLC Issues Allergy Alert on Undeclared Milk & Wheat in Mixed Alsultan Branded Baklava, and Undeclared Cashews, Pistachios, & Almonds in Alsultan Branded Betefour
Summary
Company Announcement Date:  December 20, 2022
FDA Publish Date:  December 20, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk and Tree Nuts
Company Name:  Falcon Import and Export LLC
Brand Name:  Alsultan
Product Description:  Baklava and Betefour

Food Code 2022 Updated from 2017 Version - A Review of Pertinent Changes

FDA released the newest version of the Food Code 2022 - https://www.fda.gov/media/164194/download

"The U. S. Food and Drug Administration (FDA) publishes the Food Code, a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy."

According to the FDA announcement, the biggest changes in this latest update include:

• Adding sesame as a major food allergen to reflect that the Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen;
• Informing consumers, in writing, of major food allergens as ingredients in unpackaged food;
• Adding labeling of major food allergens in bulk food that is available for consumer self-dispensing;
• Creating new requirements for the allowance of pet dogs in outdoor dining spaces; and
• Revising the definition of intact meat, including enhancements to clarify time/temperature cooking requirements

A summary of all the changes can be found here - 

https://www.fda.gov/food/fda-food-code/summary-changes-2022-fda-food-code

Here is a closer look at some of these changes as well as a few others that stand out.  (One item to note is #8 - the lowering of temperature of the water at the handwashing sink to 85F from 100F.  Note: this is not handwashing temperature, but the requirement that the handwashing sink must be capable of delivering running water that is at least 85F)

1. Sesame was added to the list of allergens requiring proper labeling.  Employees must be trained in allergen awareness, and part of this awareness is knowing the signs and symptoms of an allergen reaction, as well as the major allergens are in the food.

2. Definitions were modified for 'intact meat' and 'mechanically tenderized meat'.

“Intact Meat” means a cut of whole muscle(s) MEAT that has not undergone COMMINUTION, MECHANICAL TENDERIZATION, vacuum tumbling with solutions, reconstruction, cubing or pounding.

"Mechanically Tenderized" means manipulating meat by piercing with a set of needles, pins, blades or any mechanical device, which breaks up muscle fiber and tough connective tissue, to increase tenderness. This includes INJECTION, scoring, and processes which may be referred to as “blade tenderizing,” “jaccarding,” “pinning,” or “needling”

This revises the definition of the term “Mechanically Tenderized” to be consistent with the USDA FSIS description of “mechanically tenderized” in the 2015 final rule titled Descriptive Designation of Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Product (80 FR 28153). The rule established labeling requirements for raw or partially cooked mechanically tenderized beef products and clarified that products injected with a marinade or solution are considered mechanically tenderized.

3. Amended §1-201.10 (B) to revise the definition of the term “Ready-to-Eat Food” to indicate what Ready-to-eat Food does not include.  [This was to make it clear that just because it is manufactured by a food company, it does not make it ready-to-eat....see #6 below]

"Ready-to-eat food" does not include:
(a) Commercially pACKAGED FOOD that bears a manufacturer’s cooking instructions; and
(b) FOOD for which the manufacturer has provided information that it has not been processed to control pathogens

4.  Added additional duties to Person in charge, specifically those to ensure temperature control during thawing.  (2-103.11)

• Amended to add new paragraph (J) to address additional duty requirement for the Person in Charge to ensure food employees are properly maintaining the temperatures of time/temperature control for safety foods during thawing and redesignated paragraphs (J) – (P) as new paragraphs (K) –(Q).

(J) FOOD EMPLOYEES are properly maintaining the temperature of TIME/TEMPERATURE CONTROL FOR SAFETY FOODS during thawing through daily oversight of the FOOD EMPLOYEE’S routine monitoring of FOOD temperatures; P

5.  Added a section on food donations...basically the Food Code applies when donating food.

• Added new Subpart 3-204 on food donation under Part 3-2 Sources, Specifications, and Original Containers and Record
• Added a new § 3-204.10 titled Food Donation, to indicate when food may be offered for donation.

3-204.10 Food Donation.

FOOD stored, prepared, PACKAGED, displayed, and labeled in accordance to LAW and this Code may be offered for donation

6.  Addressing manufacturing cooking instruction (3-401.15).  Basically if a food has to be cooked per manufacturing instructions, it cannot be considered RTE.  The biggest issue may be associated with frozen vegetables that have cooking instructions that may be served. raw.

• Amended to add a new § 3-401.15 addressing manufactured food cooking instructions.

3-401.15 Manufacturer Cooking Instructions.

(A) Commercially PACKAGED FOOD that bears a manufacturer’s cooking instructions shall be cooked according to those instructions before use in READY-TO-EAT FOODS or offered in unPACKAGED form for human consumption, unless the manufacturer’s instructions specify that the FOOD may be consumed without cooking. P

(B) FOOD for which the manufacturer has provided information that it has not been processed to control pathogens, when used in READY-TO-EAT FOODS or offered for human consumption, shall be cooked according to a time and temperature appropriate for the FOOD.

7.  Amended allergen labeling for bulk foods

• Amended sub¶ 3-602.11(C)(2) to add a cross reference to sub¶ 3-602.11(B)(5) to address major food allergen labeling in bulk food available for consumer self dispensing.

(C) Bulk FOOD that is available for CONSUMER self-dispensing shall be prominently labeled with the following information in plain view of the CONSUMER:

(1) The manufacturer's or processor's label that was provided with the FOOD; or

(2) A card, sign, or other method of notification that includes the information specified under Subparagraphs (B)(1), (2), (5) and (6) of this section.

(D) Bulk, unPACKAGED FOODS such as bakery products and unPACKAGED FOODS

that are portioned to CONSUMER specification need not be labeled if:

(1) A health, nutrient content, or other claim is not made;

(2) There are no state or local LAWS requiring labeling; and

(3) The FOOD is manufactured or prepared on the PREMISES of the FOOD ESTABLISHMENT or at another FOOD ESTABLISHMENT or a FOOD PROCESSING PLANT that is owned by the same PERSON and is regulated by the FOOD regulatory agency that has jurisdiction.

8.  Lowered the water temperature requirements for hand sinks from 100F to 85F.  (5-202.12) 

• Amend ¶ 5-202.12(A) to revise the hot water temperature at the hand sink from at least 38°C (100°F) to at least 29.4°C (85°F).

5-202.12 Handwashing Sink, Installation.

(A) A HANDWASHING SINK shall be equipped to provide water at a temperature of at least 29.4oC (85oF) through a mixing valve or combination faucet. Pf

9.  Dogs MAY be allowed to be in outdoor dining areas - 6-501.115  [No mention of cats]

• Amended § 6-501.115 Prohibiting Animals to add a new exception paragraph (D) to allow for pet dogs in outdoor dining areas, where approved.

(D) If approved by the regulatory authority, food establishments may allow pet dogs in outdoor dining areas