Monday, January 30, 2023

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

Wednesday, January 25, 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.
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?

Tuesday, January 24, 2023

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)."