FDA Issues Draft Guidance on Evaluation Process for Recognition of Additional Regulated Food Allergens

FDA released a draft guidance document on how additional allergens may be added to the group of major food allergens ( milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame).  The document )Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act) provides the approach for evaluating non-listed allergens including:

• The scientific factors that we generally intend to consider when evaluating the public health importance of a non-listed food allergen;
• Other information, relevant to the labeling and production of food containing the food allergen, that we generally intend to consider when evaluating the public health importance of a non-listed food allergen; and
• Our recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.

A concern from a manufacturing perspective is that with the FASTER Act of 2021 which added sesame to the list of regulated food allergens, it opened the door to potential other food allergens being added to the list.  This draft guidance provides the evaluation process for this to occur.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-fda-staff-and-stakeholders-evaluating-public-health-importance-food-allergens-other
Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act

APRIL 2022

TX Establishment Expands Recall of Tortillas for Undeclared Wheat and Milk

The Salsa Texan of Flower Mound, Texas is expanding an earlier recall to include all regular and burrito sized packages of tortillas labeled as Coconut Flour Tortillas and Blended Flour Tortillas because they may contain undeclared wheat and milk. The voluntary recall was initiated after it was discovered that the tortillas were distributed in packaging that did not reveal the presence of wheat or milk.  The initial recall was issued on March 18, 2022.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/salsa-texan-issues-allergy-alert-and-recall-expansion-undeclared-wheat-and-milk-tortillas
The Salsa Texan Issues Allergy Alert and Recall Expansion for Undeclared Wheat and Milk in Tortillas
Summary
Company Announcement Date:  April 15, 2022
FDA Publish Date:  April 15, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat and milk
Company Name:  The Salsa Texan
Brand Name:  The Salsa Texan
Product Description:  Tortillas

EU Salmonella Outbreak in Chocolate Believed to be Due to Bad Buttermilk?

The EFSA (European Food Safety Authority) reports that there have been 150 cases (119 confirmed, 31 probable) of Salmonella Typhimurium infection in 9 different countries.   "Most cases are below 10 years of age and many children have been hospitalised."  As reported in an AP article, "Officials said “the processing step involving buttermilk” was identified by the company as the point of contamination for two products, chocolate eggs that normally have a surprise toy inside and bite-sized praline chocolates. National authorities have previously named the involved company as the Italian chocolate firm Ferrero."

https://www.ecdc.europa.eu/en/news-events/rapid-outbreak-assessment-multi-country-salmonella-outbreak-linked-chocolate-productsEuropean Centre for Disease Prevention and Control
Rapid outbreak assessment: Multi-country Salmonella outbreak linked to chocolate products

On 12 April 2022, ECDC and EFSA published a rapid outbreak assessment on a multi-country outbreak of monophasic Salmonella Typhimurium linked to chocolate products made at a factory in Arlon, Belgium.

The assessment outlines the rapid evolvement of the outbreak. Most cases are children under 10 years of age, with many being hospitalised.

Update - Ferrero Includes Additional Products to Chocolate Recall for Salmonella

Ferrero U.S.A., Inc. of Parsippany, New Jersey updated their recall of Kinder® Happy Moments Chocolate Assortment and Kinder® Mix Chocolate Treats basket due to potential Salmonella contamination.   The initial US recall was issued on April 7, 2022.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferrero-voluntarily-recalls-kinderr-happy-moments-chocolate-assortment-and-kinderr-mix-chocolate
Ferrero Voluntarily Recalls Kinder® Happy Moments Chocolate Assortment and Kinder® Mix Chocolate Treats Basket Because of Possible Health Risk and Advises Consumers to Dispose of Certain Kinder Products Not Intended for U.S. Distribution Due to Recall of Products Made in Belgium
Summary
Company Announcement Date:  April 12, 2022
FDA Publish Date:  April 12, 2022
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Salmonella
Company Name:  Ferrero USA, Inc.
Brand Name:  Kinder
Product Description:  Multiple Products

Organic Popcorn Recalled for Undeclared Milk Allergen After Cross Contact

Snak King is voluntarily recalling 5-ounce packages of “O Organics Sea Salt Organic Popcorn” with “best if used by” dates of 9/24/2022 and 9/25/2022 due to the potential presence of an undeclared milk allergen. This product is being recalled due to cross contamination with a milk allergen.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/snak-king-corporation-issues-recall-and-allergy-alert-undeclared-milk-allergen-o-organics-sea-salt
Snak King Corporation Issues Recall and Allergy Alert on Undeclared Milk Allergen in O Organics Sea Salt Organic Popcorn
Summary
Company Announcement Date:  April 12, 2022
FDA Publish Date:  April 12, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Snak King Corporation
Brand Name:  O Organics
Product Description:  Sea Salt Organic Popcorn

France - E. coli Outbreak Linked to Frozen Pizza

In France, health inspectors have found a link between a brand of frozen pizza and an outbreak of pathogenic E.coli.  There have been 75 E. coli infections with 2 deaths of children (although not all cases have yet been linked).  

As you may remember, in 2007 there was an E.coli outbreak in the US that was associated with frozen pizza.  In this case, it was the pepperoni topping that was an issue.  In that outbreak, 21 were infected.  Another E. coli outbreak linked to frozen foods including frozen pizza occurred in 2013

https://www.rfi.fr/en/france/20220331-frozen-pizza-blamed-for-some-e-coli-infections-sweeping-through-france-children-nestle
Frozen pizza blamed for deadly E coli infections sweeping France
Issued on: 31/03/2022 - 12:44Modified: 31/03/2022

Manufacturer of Raw Pet Food Being Forced to Shut Down

Federal regulators are temporarily shutting down Bravo Packaging of Carney's Point NJ after ongoing issues with the products containing Salmonella and Listeria monocytogenes.  Last year, product from this facility was recalled after FDA testing found Salmonella and Listeria.  This company also recalled product in 2013 and 2014 and 2015

NJ.com
https://www.nj.com/salem/2022/04/nj-pet-food-maker-must-shut-down-correct-health-violations.html
N.J. pet food maker must shut down, correct health violations

Published: Apr. 06, 2022, 11:31 a.m.

By Matt Gray | For NJ.com

A South Jersey pet food company must temporarily shut down its operations and recall products after inspectors repeatedly found food samples contaminated with harmful bacteria, according to federal regulators.

Imported Chocolate Products Recalled That Were Linked to Facility Responsible for European Salmonella Outbreak

Ferrero U.S.A., Inc. of Parsippany, New Jersey is voluntarily recalling its Kinder ® Happy Moments Chocolate Assortment and Kinder ® Mix Chocolate Treats basket, because the product may be contaminated with Salmonella Typhimurium. The products are being recalled because they were manufactured in a facility where Salmonella typhimurium was detected. While there are no reports of illness in the United States to date, Ferrero is voluntarily recalling the products out of an abundance of caution due to reported cases of Salmonella in consumers that consumed products in Europe that were manufactured at the same facility.  In Europe, there has been 125 cases linked to the chocolate egg products from Ferrero.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferrero-voluntarily-recalls-kinderr-happy-moments-chocolate-assortment-and-kinderr-mix-chocolate
Ferrero Voluntarily Recalls Kinder® Happy Moments Chocolate Assortment and Kinder® Mix Chocolate Treats Basket Because of Possible Health Risk
Summary
Company Announcement Date:  April 07, 2022
FDA Publish Date:  April 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Ferrero USA, Inc.
Brand Name:  Kinder
Product Description:  Happy Moments Milk Chocolate and Crispy Wafers Assortment & Mix Chocolate Treats Basket

KY Company Recalls Chocolate Cake in-a-Mug Product After Chocolate Has Undeclared Milk Allergen

Tova Industries; LLC of Louisville, KY is voluntarily recalling Carbquik Mug Cake Double Chocolate Chunk OU-Dairy (Water and Butter Prep), because it contains an undeclared milk. "During an allergen review, our company found that the Chocolate Chips contained in the product had a small percentage (<1%) of a milk allergen, it was determined that the packaging was missing the required Milk Allergen warning, and all product was immediately removed from circulation on February 23, 2022. There is no health risk associated with this product for person who do not have a milk allergy."

Tova Industries; LLC. Issues Allergy Alert on Undeclared Milk in Carbquik Mug Cake Double Chocolate Chunk OU-Dairy | FDA
Tova Industries; LLC. Issues Allergy Alert on Undeclared Milk in Carbquik Mug Cake Double Chocolate Chunk OU-Dairy
Summary
Company Announcement Date:  April 01, 2022
FDA Publish Date:  April 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Tova Industries, LLC
Brand Name:  Carbquik
Product Description:  Double Chocolate Chunk Mug Cake