FDA Issues Warning Letter to Foreign Firm, a Manufacturer of RTE Mouth Fresheners

FDA issued a Warning Letter to STC India Private Limited, an Indian manufacturer of RTE mouth fresheners called Mukhwas.  In the report, FDA cited Preventive Control issues, specifically around the control of pathogens in a RTE food, and GMP issues, including pest control and cleaning issues.

According to Wikipedia,  "Mukhwas is a colorful Indian Ayurvedic[1] after-meal snack or digestive aid widely used as a breath freshener, especially after meals." They "can be made of various seeds and nuts, often fennel, anise, coconut, coriander, and sesame. They are sweet in flavor and highly aromatic due to added sugar and the addition of various essential oils, including peppermint oil. The seeds can be savory or sweet—coated in sugar and brightly colored."

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stc-india-private-limited-661775-07212023
STC India Private Limited
MARCS-CMS 661775 — JULY 21, 2023

Infection from Cat Bite from Previously Unknown Bacterial Species....What Else Do Cats Have in Their Arsenal?

In the UK, a man's hand was bitten [furiously] by a feral cat which resulted in a severe infection. After struggling to get the infection under control, investigators discovered by DNA analysis that this was a novel strain of bacteria in the genius Globicatella.

"Globicatella are streptococcus‐like organisms that have been rarely isolated from clinical specimens."  "The genus Globicatella was first described in 1992 when several unidentified streptococcus‐like clinical isolates were characterised in the USA.17 The isolates were isolated from blood cultures of patients with bacteraemia, urine of patients with urinary tract infections, and cerebrospinal fluid of a patient with meningitis, but the clinical details were not described."  (Lau, etal 2006) 

Who knows what else is lurking in cats' mouths.  Perhaps some cat-owning evil microbiology genius is weaponizing cats with these 'new' bacterial species in order to take over the world?

https://wwwnc.cdc.gov/eid/article/29/8/22-1770_article#r5
CDC - Emerging Infectous Disease
Volume 29, Number 8—August 2023
Research Letter
Soft Tissue Infection of Immunocompetent Man with Cat-Derived Globicatella Species

Nick K. JonesComments to Author , Juliana Coelho, Julie M.J. Logan, Karen Broughton, Katie L. Hopkins, Bruno Pichon, Isabelle Potterill, Yu Wan, Alex W.N. Reid, and Theodore Gouliouris

Author affiliations: Cambridge University Hospitals, Cambridge, UK (N.K. Jones, A.W.N. Reid, T. Gouliouris); University of Cambridge, Cambridge (N.K. Jones, T. Gouliouris); United Kingdom Health Security Agency Antimicrobial Resistance and Healthcare Associated Infections Reference Unit, Colindale, UK (J. Coelho, J.M.J. Logan, K. Broughton, K.L. Hopkins, B. Pichon, I. Potterill, Y. Wan); Imperial College London, London, UK (K.L. Hopkins, B. Pichon, Y. Wan)

Abstract

We report a novel Globicatella species causing extensive soft tissue infection in a man bitten by a stray domestic cat in the United Kingdom. We identified this bacterium by 16S rRNA gene sequencing, whole-genome sequencing, and biochemical profiling and determined antimicrobial drug susceptibility.

PA Firm Recalls Two Lots of Popcorn for Undeclared Allergens After Mis-Bagging

Bickel’s Snack Foods, Inc. of York, PA is voluntarily recalling two lots of 8 oz. Butter Flavored Popcorn due to the undeclared presence of milk.  The error occurred when Cheddar Flavored Popcorn was inadvertently placed into bags labeled as Butter Flavored Popcorn. The error was identified by a store employee who alerted the manufacturer.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bickels-snack-foods-inc-issues-allergy-alert-undeclared-milk-specific-lots-butter-flavored-popcorn
Bickel’s Snack Foods, Inc. Issues Allergy Alert on Undeclared Milk in Specific Lots of Butter Flavored Popcorn
Summary
Company Announcement Date:  August 08, 2023
FDA Publish Date:  August 08, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Bickel’s Snack Foods, Inc.
Brand Name:  Bickel’s Snack Foods, Inc.
Product Description:  Butter Flavored Popcorn

Kiwi Fruit Recalled After State Lab Sampling Detects Listeria

David Oppenheimer and Company I LLC is voluntarily recalling from the market all one-pound clamshells of organic green kiwifruit described below because they have the potential to be contaminated with Listeria monocytogenes.   The recalled organic green kiwifruit is grown in New Zealand, exported to North America and repacked locally for sale in one-pound clear plastic clamshells. The recall was the result of a routine sampling by the Kentucky Department for Public Health on July 7, 2023. Since being notified on August 3, David Oppenheimer and Company I LLC has worked with Zespri to trace the product through the supply chain to two grower lots, and immediately ceased the distribution of organic green kiwifruit from the related grower lots as it continues its investigation in cooperation with the U.S. Food and Drug Administration.

So what is the risk?  In one study "Mangoes, a mix of diced kiwi, cantaloupe and pineapple as well as a mix of diced pineapple, mango, grapefruit, kiwi and pomegranate did not support a growth potential that exceeded 0.5 log CFU/g over six days (Ziegler etal. 2018)  However, another study showed that Listeria could survive on the outside of a kiwi for 30 days.  . Yuan and Wang (2018) found that the "three pathogens [E. coli O157:H7, Salmonella spp., and L. monocytogenes] survived for up to 30 days on whole kiwifruit when stored at the room temperature, regardless of the inoculation levels and the kiwifruit variety. The survival of pathogens on fruit surfaces had been shown by other studies."

So from a retail sampling perspective, finding Listeria on a fruit that will not support growth is an issue for recalls.  One can not overlook control of Listeria in the processing environment for products that will not support growth or have not historically had Listeria issues.  One must consider that testing and finding Listeria on such products can result in a recall situation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/david-oppenheimer-and-company-i-llc-voluntarily-recalls-organic-green-kiwifruit-due-possible-health
David Oppenheimer and Company I, LLC Voluntarily Recalls Organic Green Kiwifruit Due to Possible Health Risk
Summary
Company Announcement Date:  August 08, 2023
FDA Publish Date:  August 08, 2023
Product Type:  Food & Beverages  Fruit/Fruit Product
Reason for Announcement:  Possible Listeria monocytogenes contamination
Company Name:  David Oppenheimer and Company I LLC
Brand Name:  Zespri
Product Description:  Organic green kiwifruit

Exporting Food to EU - Limits on What You Can Call Cheese Products

An article in the Wall Street Journal, "The U.S. Has a Beef With Europe—Over Cheese" discusses the push by Europe to prevent US manufacturers who export cheese from using terms like Feta, Gorgonzola and Parmesan. The EU states that these cheeses must be made in certain countries to be sold under those names in the EU. There is concern by US producers that this trend will extend to other products like cured meats. "EU officials said these protected products, known as “geographical indications,” represent intellectual property and command a premium because consumers associate these products with the regions responsible for their high reputation.  EU officials say their system doesn’t prevent U.S. producers from selling their wares abroad—it only limits how they can label certain items in the EU and other countries where these protections are part of trade agreements. "

https://www.wsj.com/articles/the-u-s-has-a-beef-with-europeover-cheese-2880b63e
The U.S. Has a Beef With Europe—Over Cheese
Feta, Gorgonzola and Parmesan must be made in certain countries to be sold under those names in the EU

WASHINGTON—Klondike Cheese sells its crumbly, Wisconsin-made cheese as feta throughout the U.S. 

In Europe, the company would have to label it white-brined cheese, or some variation that doesn’t mention the word feta. The company doesn’t even bother exporting it there.

Not being able to call the cheese feta “effectively closes off that entire market for me,” said Luke Buholzer, vice president of sales at Klondike, which makes Odyssey-brand feta cheese. 

Klondike is among the U.S. companies bristling as the European Union expands its list of foods, wines and spirits whose names are reserved for use by traditional local producers. There are now more than 3,500 of these protected items, up almost 28% since 2010, according to data from AND International, an independent food industry research firm.

Continues (subscription maybe needed) - https://www.wsj.com/articles/the-u-s-has-a-beef-with-europeover-cheese-2880b63e

CA Establishment Recall RTE Chicken Potstickers Due to Undeclared Allergens

Day-Lee Foods Inc., a Santa Fe Springs, Calif., establishment, is recalling approximately 10,511 pounds of frozen ready-to-eat (RTE) chicken potsticker products due to misbranding and undeclared allergens.  The product labeled as chicken potstickers may actually contain mandarin orange chicken, which contain milk and eggs, known allergens, that are not declared on the product label.  The problem was discovered when the establishment notified FSIS that it received a customer complaint indicating they purchased a box of Chicken Potstickers but found it actually contained Mandarin Orange Chicken instead. The Mandarin Orange Chicken product contains milk and eggs, known allergens that are not declared on the Chicken Potsticker label.

https://www.fsis.usda.gov/recalls-alerts/day-lee-foods-inc--recalls-frozen-ready-eat-poultry-products-due-misbranding-and
Day-Lee Foods Inc. Recalls Frozen Ready-To-Eat Poultry Products Due to Misbranding and Undeclared Allergens

DAY-LEE FOODS INC.

FSIS Announcement

WASHINGTON, Aug. 5, 2023 – Day-Lee Foods Inc., a Santa Fe Springs, Calif., establishment, is recalling approximately 10,511 pounds of frozen ready-to-eat (RTE) chicken potsticker products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product labeled as chicken potstickers may actually contain mandarin orange chicken, which contain milk and eggs, known allergens, that are not declared on the product label.

MO Establishment Recalls Raw Beef Product for Foreign Material, Specifically Soft Clear Plastic

USDA issued a Public Health Alert for raw beef product produced by Cargill Meat Solutions' Marshall, MO, for foreign matter, specifically soft, clear plastic.  The problem was discovered when the establishment notified FSIS that it received a complaint from a retail store that soft, clear plastic was noticed in the product.  A recall was not requested because the product is no longer available for purchase, but USDA is concerned about product that may be stored frozen.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-raw-beef-product-due-possible-foreign-matter
FSIS Issues Public Health Alert for Raw Beef Product Due to Possible Foreign Matter Contamination
CARGILL MEAT SOLUTIONS

FSIS Announcement

WASHINGTON, Aug. 4, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns of a raw beef product that may be contaminated with extraneous material, specifically soft, clear plastic. FSIS is issuing this public health alert to ensure that consumers are aware that this product should not be consumed. A recall was not requested because the product is no longer available for purchase.

Retailer Issues Two Recalls Soup for Insects and Falafel for Rocks

Trader Joes issued two food product recalls this week - broccoli cheddar soup that may contain insects and ready-to-eat falafel that may contain rocks.  "Both affected products have since been removed from Trader Joe's shelves and destroyed. No adverse health effects have been reported to date in relation to the broccoli cheddar soup recall, and no information was provided about any potential injuries or health events due to the recalled falafel."

https://www.health.com/trader-joes-falafel-soup-recall-7567745#
Trader Joe's Recall: Certain Falafel and Soup Products May Contain Rocks, Insects
By Julia Landwehr
Updated on July 31, 2023
Fact checked by Sarah Scott

Trader Joe's has issued recalls for two popular products due to the potential presence of insects and rocks, the company said in two separate press releases.

FDA Issues Warning Letter to Small NJ Italian Foods Co

FDA issued a Warning Letter to a pretty small NJ Italian Food company who did not have a Food Safety Plan.  There continues to be issues involving small food companies that have yet to address FSMA regulations.   Many may feel that they are flying under the radar.  This is such a case where this small Italian food company did not have a food safety plan, and along with that, did not have documented controls in place for allergens among other potential hazards.

Here is a pic taken from a Google search of the address.  Looks to be a retail operation that is doing distribution.  If FDA can find this place located in a neighborhood in Trenton.......

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/porfirios-italian-foods-inc-656454-06212023
Porfirios Italian Foods, Inc.
MARCS-CMS 656454 — JUNE 21, 2023
Recipient:
Mr. Robert Calabro
Owner
Porfirios Italian Foods, Inc.
320 Anderson Street
Trenton, NJ 08611
United States

Nacho Cheese Flavored Chips Recalled After Incorrect Chips Packaged Resulting in Undeclared Allergens

Frito-Lay has issued a voluntary recall of a limited number – less than 7,000 bags – of 14.5 oz and 1 oz Doritos Nacho Cheese Flavored Tortilla Chips that may contain undeclared soy and wheat ingredients from spicy sweet chili tortilla chips.  The products covered by this recall were distributed at retail stores only in Pennsylvania and other outlets.

So it seems that sweet chili tortilla chips, with their soy and wheat ingredients, were filled into bags of nacho cheese flavored chips.  This created an issue for undeclared allergens.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frito-lay-issues-allergy-alert-undeclared-soy-and-wheat-doritos-nacho-cheese-flavored-tortilla-chips
Frito-Lay Issues Allergy Alert on Undeclared Soy and Wheat in Doritos Nacho Cheese Flavored Tortilla Chips Distributed in Pennsylvania
Summary
Company Announcement Date:  August 01, 2023
FDA Publish Date:  August 01, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared Soy and Wheat Allergen
Company Name:  Frito-Lay
Brand Name:  Doritos
Product Description:  Doritos Nacho Cheese Tortilla Chips

CDC Report on Persistent Strain of Salmonella Linked to Multiple Outbreaks

CDC issued a report on A strain of Salmonella infantis labeled REPJFX01 that has been responsible for multiple outbreaks in the US and abroad.  First identified in 2012, information from more than 2,900 cases have been reported to PulseNet as of December, 2022.  The source of food identified in two of 7 outbreak was raw chicken meat.

"This strain of Salmonella Infantis is relatively diverse genetically. Bacteria in the strain are within 82 allele differences of one another by core genome multilocus sequence typing (cgMLST). This is more genetically diverse than typical multistate foodborne outbreaks, in which bacteria generally fall within 10 allele differences of one another."

What is a persistent strain?

CDC uses “persistent” to describe some strains of bacteria that have caused illness for years. The strains continue to cause illness, even though the number of illnesses they cause might vary over time. The strains are sometimes linked to more than one source, making them harder to control.

Fast Facts
Bacteria Salmonella enterica  Serotype Infantis
Antimicrobial Resistance Profile Multidrug resistant (details below)
Persistent Strain REPJFX01
First Detection June 2012
Illnesses Reported in PulseNet 2,900
Outbreaks Investigated 7
Identified outbreak sources*  

• Raw chicken products (confirmed): 1 outbreak
• Mechanically separated chicken (suspected): 1 outbreak

*Confirmed sources were implicated by epidemiologic plus traceback or laboratory data. Suspected sources were implicated by epidemiologic data only. More info

https://www.cdc.gov/ncezid/dfwed/outbreak-response/rep-strains/repjfx01.html
Persistent Strain of Salmonella Infantis (REPJFX01) Linked to Chicken
Posted July 21, 2023

REPJFX01

REPJFX01 is a persistent, multidrug-resistant strain of Salmonella Infantis bacteria that has caused illnesses and outbreaks in the United States and globally.

Europe- Salmonella Outbreak Possibly Linked to Cherry Tomatoes

In Europe, from August 2022 to July 2023, there have been 92 cases of Salmonella Senftenberg reported with cases in Austria (5), Belgium (4), Czechia (4), Estonia (1), Finland (12), France (16), Germany (26), Ireland (1), the Netherlands (5), Norway (1), Sweden (11), the United Kingdom (4), and the United States (2).    Investigators believe cherry tomatoes as the source, but this has not been confirmed.

From the EFSA report, "The outbreak strain was detected in France from a mixed salad dish, containing cherry tomatoes and green leafy vegetables, prepared on 17 August 2022 but not served. Tomatoes from the salad in France and tomatoes in Austria were suspected as the vehicle of infections by national authorities and were traced back to wholesalers in Germany, the Netherlands and Spain, and to growers in the Netherlands, Spain and Morocco. In the absence of microbiological evidence from the tomatoes, the source of the infections could not be established."

https://www.efsa.europa.eu/en/supporting/pub/en-8211
Multi-country outbreak of Salmonella Senftenberg ST14 infections possibly linked to cherry like tomatoes
Published: 27 July 2023
Adopted: 27 July 2023

NY Establishment Recalls Products Produced in "Back Room" (Not-USDA-Inspected) Areas

Kingsland Food Processing Corp., a Maspeth, N.Y. establishment, is recalling an undetermined amount of various frozen meat and poultry products that were produced without the benefit of federal inspection (USDA).  The problem was discovered when FSIS inspection personnel observed various meat and poultry products being produced in rooms that are not within the official premises of the establishment and, therefore, were not inspected.


https://www.fsis.usda.gov/recalls-alerts/kingsland-food-processing-corp--recalls-various-frozen-meat-and-poultry-products
Kingsland Food Processing Corp. Recalls Various Frozen Meat and Poultry Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, July 27, 2023 – Kingsland Food Processing Corp., a Maspeth, N.Y. establishment, is recalling an undetermined amount of various frozen meat and poultry products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Recall of Imported Canned Pork and Beef Stew Products Produced by Ineligible Brazilian Food Company

 E B Express Provisions, a distributor and importer of record located in Newark, N.J. is recalling approximately 622 pounds of the pork and beef bean stew products that were imported from an establishment in Brazil that is not eligible to export meat products to the United States.   The problem was discovered when FSIS conducted recall effectiveness checks for Recall 027-2023 and identified ineligible pork and beef bean stew products from Brazil imported by E B Express Provisions.

https://www.fsis.usda.gov/recalls-alerts/e-b-express-provisions-recalls-ineligible-canned-pork-and-beef-bean-stew-products
E B Express Provisions Recalls Ineligible Canned Pork and Beef Bean Stew Products Imported From Brazil

FSIS Announcement

WASHINGTON, July 26, 2023 – E B Express Provisions, a distributor and importer of record located in Newark, N.J. is recalling approximately 622 pounds of the pork and beef bean stew products that were imported from an establishment in Brazil that is not eligible to export meat products to the United States, U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

NY Firm Recalls Mozzarella Sticks for Undeclared Allergens After Ingredient Addition Error

Rich Products of Buffalo, NY is recalling 15 cases of Member’s Mark Breaded Mozzarella Sticks because they may contain undeclared egg and soy.  The recall was initiated after Rich’s discovered that an incorrect raw material was used during the manufacturing process that introduced egg and soy to the product. Egg and soy do not appear in the ingredient listing on the package.

While there is a focus on labeling with regard to Allergen Preventive Controls, this is an example where an argument can be made for instituting an Allergen Preventive Control at the point of formulation.  In this case, you would have monitoring and verification of ingredient addition.  Verified monitoring is an important addition provided by making a processing step a preventive control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rich-products-issues-allergy-alert-undeclared-egg-and-soy-members-marktm-breaded-mozzarella-sticks
Rich Products Issues Allergy Alert on Undeclared Egg and Soy in Member’s Mark™ Breaded Mozzarella Sticks
Summary
Company Announcement Date:  July 25, 2023
FDA Publish Date:  July 25, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg and soy
Company Name:  Rich Products
Brand Name:  Member’s Mark
Product Description:  Member’s Mark Breaded Mozzarella Sticks

Texas Establishment Recalls Pulled Pork Product Due to Undeclared Soy Associated with Use of Soy Lecithin

Nuevo Garcia Foods, LLC, a San Antonio, Texas establishment, is recalling approximately 4,784 pounds of pulled pork product due to misbranding and an undeclared allergen.  The product may contain soy lecithin, a known allergen, which is not declared on the product label.  FSIS inspection personnel discovered the problem during routine label verification review and determined that soy lecithin was not listed on the pulled pork product label when it was used prior to the cooking process.

https://www.fsis.usda.gov/recalls-alerts/nuevo-garcia-foods-llc-recalls-fully-cooked-pulled-pork-product-due-misbranding-and
Nuevo Garcia Foods, LLC Recalls Fully Cooked Pulled Pork Product Due to Misbranding and Undeclared Allergen

FSIS Announcement

WASHINGTON, July 21, 2023 – Nuevo Garcia Foods, LLC, a San Antonio, Texas establishment, is recalling approximately 4,784 pounds of pulled pork product due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product may contain soy lecithin, a known allergen, which is not declared on the product label.

NY Cheese Produce Recalls Product After Listeria Positive Environmental Test Results

Cooperstown Cheese Company of Milford, NY, is recalling 1400 pounds of cheese purchased, sold or distributed from June 21, 2023 to July 10, 2023 because it has the potential to be contaminated with Listeria monocytogenes. Product was distributed in New York State and reached customers through farmers markets, restaurants and retail stores.  The listeria was found through routine environmental testing by the firm and during an FDA inspection.  The company has ceased production as they and FDA continue to investigate the problem.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cooperstown-cheese-company-recalls-products-because-possible-health-risk
Cooperstown Cheese Company Recalls Products Because of Possible Health Risk
Summary  
Company Announcement Date:  July 21, 2023
FDA Publish Date:  July 21, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Cooperstown Cheese Company LLC
Brand Name:  Cooperstown Cheese Company
Product Description:  Cheese Products

Article - 2022 Canadian E.coli (STEC) Outbreak Associated with Kimchi

An article in Epidemiology and Infection, a 2021/2022 outbreak of E. coli in kimchi is discussed.  While we would think that the fermented kimchi product would not have issues with enteric pathogens, this case proves otherwise.   The E.coli (STEC) was thought to come in on the Napa cabbage which was grown in Washington state.  The second issue was that E.coli was acid tolerant, allowing it to survive in product down to pH of 4.1.  Generally, low pH and contribution of lactic acid bacterial growth (Lee, 2021) would eventually eliminate pathogens, but in this case, the product was consumed closer to the manufacturing date.

From the article, "Given that kimchi is acidic in nature, typically with a pH less than 4.5 [Reference Kim, Jang, Kim, Lee, Kim, Ryu and Rhee14], it is often assumed to be an unlikely source for foodborne outbreaks. However, the present outbreak, and those noted above from East Asia, have called this assumption into question. Interestingly, pH testing in this outbreak revealed that pH decreased over time throughout the product’s shelf life. With decreased pH thought to reduce pathogenic load, it is notable that cases in this outbreak had consumption dates closer to the beginning of the product’s shelf life, when pH was likely higher, and the product was less acidic. It is also notable that a positive result for STEC O157 in this outbreak was found in a product with a pH result of 4.1, indicating that this strain of STEC O157 may have also been acid-tolerant, surviving exposure to this pH. Research is ongoing to determine if this may have been the case. This outbreak serves as a reminder that kimchi is a potential source of foodborne outbreaks, and that mitigating measures to prevent pathogen introduction and growth should be considered in the manufacturing process."


Epidemiology and Infection
https://www.cambridge.org/core/journals/epidemiology-and-infection/article/fermenting-a-place-in-history-the-first-outbreak-of-escherichia-coli-o157-associated-with-kimchi-in-canada/B8EC9B59037C9506D1EAE19DDD4E9AAC
Fermenting a place in history: The first outbreak of Escherichia coli O157 associated with kimchi in Canada

CA Distributor Recalls Imported Black Melon Seed Due to Undeclared Soy and Wheat

Richin Trading Inc. of Alhambra, CA is recalling its 6 ounce and 12 ounce packages of Tim Heung Yuen brand black melon seed because they may contain undeclared soy and wheat.  The recall was initiated after it was discovered that the soy and wheat containing product was distributed in packaging that did not state the presence of soy and wheat.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/richin-trading-inc-issues-allergy-alert-undeclared-soy-and-wheat-black-melon-seed
Richin Trading Inc. Issues Allergy Alert on Undeclared Soy and Wheat in Black Melon Seed
Summary
Company Announcement Date:  July 19, 2023
FDA Publish Date:  July 19, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy and wheat allergens
Company Name:  Richin Trading Inc.
Brand Name:  Tim Heung Yuen
Product Description:  Black Melon Seed

CA Company Recalls Muffin Mix After Copacker Formulation Error Leads to Undeclared Milk

ONO LLC of San Diego, CA, issuing a voluntary recall of its 2.75 ounce packages of ONO Vegan Blueberry Muffin Protein Overnight Oats, with lot number 11923, because it may contain undeclared milk.  The recall was initiated immediately after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by an accidental ingredient mix up by the copacking facility.

Note that milk is included in the "Produced in a facility that uses peanuts, wheat, and milk products", but that does not comply with allergen labeling regulations.

From brand owners perspective, ensuring the co-packer facility has well developed and implemented Allergen Preventive Controls is critical.  In this case, control at the point of formulation / ingredient addition is needed.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ono-llc-issues-allergy-alert-undeclared-milk-vegan-blueberry-muffin-lot-number-11923
ONO LLC Issues Allergy Alert on Undeclared Milk in Vegan Blueberry Muffin with Lot Number 11923
Summary
Company Announcement Date:  July 18, 2023
FDA Publish Date:  July 19, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  ONO LLC
Brand Name:  ONO
Product Description:  Vegan Blueberry Muffin Protein Overnight Oats

CDC MMWR - 2022 E.coli (STEC) Outbreak Among Farm Camp Participants at Goat Farm

In CDC MMWR, a report on a 2022 E.coli (STEC) outbreak linked to a farming camp in Tennessee where children got to interact with baby goats.  There were 12 ill camp attendees.  "TDH concluded that this outbreak was associated with STEC O157:H7-infected kids and involved secondary transmission. Hand-to-mouth contact has been observed to occur almost three times per hour among children aged 6–10 years,** supporting the potential for STEC ingestion from contaminated environmental surfaces."

https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a6.htm
Notes from the Field: An Outbreak of Shiga Toxin–Producing Escherichia coli O157:H7 Associated with a Farming Camp — Tennessee, 2022
Weekly / July 21, 2023 / 72(29);805–806
Lindsey Ferraro, MPH1; D. J. Irving, MPH1; Jack Marr, MPH1; Kelly Orejuela, MPH1; Erin Murray1; Mugdha Golwalkar, MPH1; Lisa M. Durso, PhD2; Julie Viruez, MLS3; Robin Rasnic, MT3; Katie Garman, MPH1; John Dunn, DVM, PhD1 (VIEW AUTHOR AFFILIATIONS)

FDA Updates Ongoing Investigation into Hepatitis A Associated with Frozen Strawberries

FDA provided an update of the Hepatitis A outbreak that was linked to frozen strawberries. As of July 18, 2023, there are now ten cases of Hepatitis A linked to frozen strawberries with 4 of those hospitalized. All cases are on the West Coast of the US. The last reported case was on June 4, 2023.

FDA last reported on this outbreak in mid-June. At the time, there was one less case than was reported now.  The problem is of course, with frozen product, people may still have these frozen strawberries in their freezer.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-hepatitis-virus-infections-frozen-strawberries-february-2023
Outbreak Investigation of Hepatitis A Virus Infections: Frozen Strawberries (February 2023)
Do not eat recalled Frozen Strawberries. FDA’s investigation is ongoing.

Current Update
July 20, 2023

Case Counts
Total Illnesses: 10
Hospitalizations: 4
Deaths: 0
Last Illness Onset: June 4, 2023
States with Cases: CA (2), HI (1), OR (1), WA (6)

Product Distribution: Nationwide

As of July 18, 2023, a total of 10 outbreak-associated cases of hepatitis A have been reported from four states. Based on epidemiological data collected by CDC, 10/10 (100%) people who provided information about what they ate before becoming ill reported eating frozen organic strawberries.

FDA Completes Investigation into Illness Outbreak Related to Mushrooms in MT (May 2023)

FDA announced that the investigation of illness related to mushrooms sold by MT restaurant.

"Morel mushrooms are a type of edible mushroom that are commonly foraged from the wild and are sometimes cultivated for commercial sale. Morel mushrooms are generally considered safe to eat, but they may contain some toxins that can cause health problems. The toxins in morel mushrooms that may cause illness are not fully understood; however, using proper preparation procedures, such as cooking can help to reduce toxin levels."

"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."

Case Counts
Total Illnesses: 51
Hospitalizations: 3
Deaths: 2
Last Illness Onset: April 21, 2023
States with Cases: MT

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-illnesses-morel-mushrooms-may-2023
Investigation of Illnesses: Morel Mushrooms (May 2023)

FDA assisted Montana state partners with an investigation of multiple illnesses at a single restaurant. FDA’s investigation is complete.

Recall of Beef Jerky Product Sold Online By Non-inspected TN Firm

 Suya Slice, LLC, a Memphis, Tenn. establishment, is recalling approximately 445 pounds of ready-to-eat beef products that were produced without the benefit of federal inspection.  Products were sold online as well as at retail.  The problem was discovered when FSIS followed up on a referral from the Illinois Department of Agriculture and observed beef products that did not have the USDA mark of inspection at a retail location. Upon further investigation, FSIS determined that the products were not produced in an FSIS-inspected establishment.

https://www.fsis.usda.gov/recalls-alerts/suya-slice-llc-recalls-ready-eat-beef-products-produced-without-benefit-inspection
Suya Slice LLC, Recalls Ready-to-Eat Beef Products Produced Without Benefit of Inspection
FSIS Announcement

WASHINGTON, July 14, 2023 – Suya Slice, LLC, a Memphis, Tenn. establishment, is recalling approximately 445 pounds of ready-to-eat beef products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

MD Facility Recalls Pork Dumplings Not Produced Under USDA Inspection

Mulan Dumpling, LLC, a Hyattsville, Md. establishment, is recalling approximately 1,560 pounds of frozen meat and poultry dumpling products that were produced without the benefit of federal inspection
Although the products subject to recall bear the USDA mark of inspection, they were produced in an establishment without a federal grant of inspection. These items were shipped to retail grocery store locations in Maryland, Virginia, and Washington, D.C.  The problem was discovered when FSIS received a referral from the Maryland Department of Health and observed that the meat and poultry dumpling products were produced and sold by an establishment that was not inspected by FSIS.

https://www.fsis.usda.gov/recalls-alerts/mulan-dumpling-llc-recalls-frozen-meat-and-poultry-dumpling-products-produced
Mulan Dumpling, LLC, Recalls Frozen Meat and Poultry Dumpling Products Produced Without Benefit of Inspection
FSIS Announcement

WASHINGTON, July 15, 2023 – Mulan Dumpling, LLC, a Hyattsville, Md. establishment, is recalling approximately 1,560 pounds of frozen meat and poultry dumpling products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Lunch Kits Recalled After Supplied Ingredient Was Subject to Cross Contact with Allergen

"The USDA FSIS is issuing a public health alert for Never Any! brand ready-to-eat (RTE) ham and cheese lunch kits containing chocolate chip cookies that may contain peanut, a known allergen, which is not declared on the finished product label. A recall was not requested because the products are believed to no longer be available for purchase.  The problem was discovered when the producing establishment was notified by their chocolate chip cookie supplier that the chocolate chip cookies may contain peanut residue, a known allergen, which is not declared on the label. "  The product was made in Canada by Maple Leaf Foods and was distributed by Aldi retail chain. 

This is an issue which is getting more attention - an ingredient supplier's allergen control program. In this case, the supplier of the chocolate chip cookie item allowed allergen cross contact with peanuts. While this is a USDA product, the FDA covers this as part of the Preventive Control regulation under Supply Chain Preventive Control.  In the upcoming update to the FSPCA training curriculum that covers this regulation, there will be added attention to this issue.

 

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-never-any-brand-ready-eat-ham-and-cheese-lunch-kits
FSIS Issues Public Health Alert for Never Any! Brand Ready-To-Eat Ham and Cheese Lunch Kits Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, July 19, 2023 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for Never Any! brand ready-to-eat (RTE) ham and cheese lunch kits containing chocolate chip cookies that may contain peanut, a known allergen, which is not declared on the finished product label. FSIS is issuing this public health alert to ensure that consumers with an allergy to peanut are aware that this product should not be consumed. A recall was not requested because the products are believed to no longer be available for purchase.

March '23 Explosion at PA Chocolate Plant Result of Discontinued, But Leaking Gas Line

The National Transportation Safety Board (NTSB) has found evidence of two natural gas leaks that may have caused the March 24, 2023, explosion and fire at the R.M. Palmer Co. chocolate plant in West Reading, Pa., that killed seven people, injured 11 and destroyed Building 2 of the facility.  The NTSB investigation indicates that natural gas was leaking from a DuPont Aldyl A service tee that was installed by the natural gas service provider in 1982 and later determined to be susceptible to performance failures by pipeline industry guidance.  They replaced this service tee in 2021 with a new service line, however, the old 1982 tee remained connected to the natural gas supply.

Food Processing
https://www.foodprocessing.com/workforce/worker-safety/news/33008440/ntsb-crack-in-retired-gas-service-tee-may-have-led-to-rm-palmer-chocolate-plant-explosion
NTSB: Crack in Retired Gas Service Tee May Have Led to R.M. Palmer Chocolate Plant Explosion
National Transportation Safety Board (NTSB) investigation reveals crack in service tee retired from service in 2021, but not disconnected from the natural gas supply.
Andy Hanacek
July 19, 2023

PA Ag Issues Warning for Raw Goat Milk After Campylobacter Detected

The Pennsylvania Department of Agriculture warns that consumers should immediately discard raw goat milk sold from Dove Song Dairy doe to possible contamination with Campylobacter. Three people who consumed this product and became ill with campylobacteriosis were reported by the Pennsylvania Department of Health. Raw milk samples tested by the Pennsylvania Department of Agriculture are presumptively positive for Campylobacter.

People with Campylobacter infection usually have diarrhea (often bloody), fever, and stomach cramps. Nausea and vomiting may accompany the diarrhea. Symptoms usually begin two to five days after infection and last about one week

Daily Review
https://www.thedailyreview.com/news/consumers-should-discard-dove-song-dairy-brand-raw-goat-milk-due-to-possible-contamination-pa/article_fb94a95c-dc8b-5de3-8449-ad2ac629785d.html
Consumers should discard Dove Song Dairy brand raw goat milk due to possible contamination: Pa. Ag. Dept.

For The Review Pennsylvania Department of Agriculture Jul 19, 2023

FDA Acknowledges There Is Alignment of 3rd Party Audit Standards with FSMA Regulations

FDA released results of their evaluation of 3rd party audit standards to assess whether those standards are in alignment with FDA FSMA regulations.  FDA finding of alignment indicates that the relevant technical components of the PC Human Food or Produce Safety rules have been addressed.  

Why is this important?  "Under FSMA, the PC Human Food rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule – allow for third-party audits to be used as supplier verification activities."  As is common industry practice, "Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. "  So, "a finding of third-party audit standards alignment with the FSMA regulations could help give importers and receiving facilities confidence that the standards used to audit their suppliers adequately address applicable FDA food safety requirements. This information, along with results of a firm’s audits, also could help inform the FDA in determining risk prioritization and resource allocation."

So these audit standards were found to be in alignment:

Preventive Controls for Human Foods (PCHF)

• BRC Global Standard Food Safety plus the Global Standard Food Safety, Issue 9, Interpretation Guideline
• FSSC 22000 Scheme 5.1 for Food Manufacturing plus the FSSC 22000 Version 3 FSMA PCHF Report Addendum
• SQF Food Safety Code: Food Manufacturing, Edition 9 plus the SQF Addendum for the Preventive Controls for Human Food

Produce Safety Rule (PSR)

• GLOBALG.A.P. Integrated Farm Assurance – All Farm Base-Crops Base – Fruit and Vegetables Checklist. Version 5.4-1-GFS plus the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-on Module Version 1.3

https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-alignment-findings-voluntary-pilot-program-evaluate-third-party-food-safety-standards
The FDA Announces Alignment Findings from Voluntary Pilot Program to Evaluate Third-Party Food Safety Standards

Constituent Update

July 17, 2023

Today, the U.S. Food and Drug Administration (FDA) is announcing the findings from the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.

Frozen Fruit Bars Recalled for Undeclared Allergens

Dreyer’s Grand Ice Cream, Inc. is voluntarily recalling a limited number of its Outshine No Sugar Added Strawberry Fruit Bars that may contain an undeclared milk allergen.   The company is recalling this product because it may contain trace amounts of milk. Although the investigation is ongoing, they believe a faulty valve allowed trace levels of milk to be introduced into the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dreyers-grand-ice-cream-inc-issues-allergy-alert-undeclared-milk-outshine-no-sugar-added-strawberry
Dreyer’s Grand Ice Cream, Inc. Issues Allergy Alert on Undeclared Milk in Outshine No Sugar Added Strawberry Fruit Bars in 6 Count Pack
Summary
Company Announcement Date:  July 17, 2023
FDA Publish Date:  July 18, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  Dreyer’s Grand Ice Cream, Inc.
Brand Name:  Outshine
Product Description:  No Sugar Added Strawberry Fruit Bars

DC Establishment Recalls Tubs of Spicy Hummus for Undeclared Sesame After Incorrect Lid Applied

Cava Foods, Inc., a subsidiary of Cava Group, Inc. in Washington D.C., is issuing a voluntary recall of one lot of its packaged CAVA Spicy Hummus due to the potential for the product to contain undeclared sesame, which is a food allergen.   CAVA voluntarily initiated the recall after a single retail store notified the company that packaging lids for CAVA Spicy Labneh (which do not declare sesame as an ingredient) were applied to containers of Spicy Hummus, which contains sesame, a common allergen. The wrong lid was applied to a limited number of Spicy Hummus containers by a third-party supplier.

Here is another recall related to mislabeling where a lid label is applied to the wrong product.  Seems like an easy enough issue to prevent through development and implementation of a good Allergen Preventive Control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cava-foods-inc-subsidiary-cava-group-inc-issues-allergy-alert-undeclared-sesame-cava-spicy-hummus
Cava Foods, Inc., a Subsidiary of Cava Group, Inc. Issues Allergy Alert for Undeclared Sesame in Cava Spicy Hummus
Summary
Company Announcement Date:  July 17, 2023
FDA Publish Date:  July 18, 2023
Product Type:  Food & Beverages Prepared Food  
Reason for Announcement:  Undeclared sesame allergen
Company Name:  Cava Foods, Inc.
Brand Name:  CAVA
Product Description:  Spicy Hummus, 8 oz tub

Ohio Firm Recalls Cashew Butter After Product Found to Contain Peanuts or Almonds

Heinen’s of Warrensville Heights, OH is voluntarily recalling Heinen’s Fresh Ground Cashew Butter, due to the possibility that it may contain undeclared Peanuts or Almonds.  The recall was initiated after it was discovered that product containing Peanuts or Almonds was distributed in Fresh Ground Cashew Butter Containers that did not reveal the presence of additional allergens. Subsequent investigation indicates that this was isolated to a single distributed Sell By Date of 8/27/23

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heinens-issues-allergy-alert-undeclared-peanuts-and-almonds-heinens-fresh-ground-cashew-butter
Heinen’s Issues Allergy Alert on Undeclared Peanuts and Almonds in Heinen’s Fresh Ground Cashew Butter
Summary
Company Announcement Date:  July 13, 2023
FDA Publish Date:  July 17, 2023
Product Type:  Food & Beverages  Butter/Butter Product
Reason for Announcement:  Undeclared peanut and almond allergens
Company Name:  Heinen’s
Brand Name:  Heinen’s
Product Description:  Fresh Ground Cashew Butter

Ingredient Supplier of Batter Recalls 6 Million Pounds of Product Due to Salmonella Potential

Newly Wed Foods, an ingredient supplier is recalling 6 million pounds of batters/breaders due to Salmonella. This recall will not be listed on the normal recall page because it is not product that is sold to the consumer. Rather, it is posted on the Enforcement Report page - Enforcement Report (fda.gov). Batter and breader are used in breading applications for foods that will be cooked, generally fried.

California Recall of Asian Chopped Salad Due to Undeclared Allergens Packed With Wrong Condiment Pack

In California, Braga Fresh is recalling a single production run of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit 12oz bag purchased from Whole Foods Markets stores.  The product is being recalled because it contains incorrect condiment ingredients resulting in undeclared milk and egg that was not listed on the product label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/braga-fresh-issues-precautionary-recall-365-whole-foods-market-brand-organic-asian-inspired-chopped
Braga Fresh Issues Precautionary Recall of 365 By Whole Foods Market Brand Organic Asian Inspired Chopped Salad Kit 12oz Bag Due to Potential Presence of Undeclared Allergens
Summary
Company Announcement Date:  July 11, 2023
FDA Publish Date:  July 12, 2023
Product Type:  Food & Beverages  Prepared Food  
Reason for Announcement:  Undeclared milk and egg allergens
Company Name:  Braga Fresh
Brand Name:  365 By Whole Foods Market
Product Description:  Potential or Undeclared Allergen - milk and egg

Thinking of Taking a Cruise - Norovirus Cases from 1st Half of 2023 On Course for Most Cases in over a Decade

The Vessel Sanitation Program (VSP) requires cruise ships to log and report the number of passengers and crew who say they have symptoms of gastrointestinal illness. Learn more about illnesses and outbreaks reported to VSP and find information about outbreaks of gastrointestinal illness on cruise ships.

In the first half of 2023, there were 13 reports of ships with Norovirus cases where roughly 3 to 5% of passengers and 1 to 2% of staff became infected.  In 2022, there were 4 cases and in 2021, there was only one case.  We would have to go back to 2012 where there were more cases for the entire year (16) to be more than seen in the first half of this year.

OR Food Establishment's Use of Outdated Packaging Leads to Unlabeled Sesame Issue

Betty Lou’s Inc., McMinnville, OR is recalling 1.5oz (42g) packages of Betty Lou’s Brand Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds, BB 08MAY24 1283, due to undeclared sesame allergen. The recall was initiated after it was discovered by a regular Betty Lou’s Inc. internal review, an old version roll of packaging was used during production, and product containing sesame was distributed in packaging that did not reveal the presence of sesame.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/betty-lous-inc-issues-allergy-alert-undeclared-sesame-paleo-java-nuts-about-energy-balls-cacao
Betty Lou’s Inc. Issues Allergy Alert on Undeclared (Sesame) in Paleo Java Nuts About Energy Balls With Cacao, Coffee & Pumpkin Seeds
Summary
Company Announcement Date:  July 10, 2023
FDA Publish Date:  July 11, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared sesame allergen
Company Name:  Betty Lou’s Inc.
Brand Name:  Betty Lou’s
Product Description:  Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds

FDA Releases List of Chemicals Not Allowed in Foods and Chemicals Under Review

The FDA released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review.
 

This week, FDA issued Warning Letters to a number of companies that were selling products with Delta-8 Tetrahydrocannabinol (Delta-8 THC), an isomer of Delta-9 THC, the intoxicating component found in marijuana. many of these products look like snacks or candies and can be an issue for children mistakenly eating. 

This is a good reference for chemicals in question.

Post-market Determinations that the Use of a Substance is Not GRAS

• 4-androstenedione
• Arimistane
• Betel nut (Areca catechu)
• Caffeinated alcoholic beverages (CABs)
• Cannabidiol (CBD)
• Delta-8-tetrahydrocannabinol  (THC)
• 1,3-dimethylamylamine  (1,3-DMAA)
• Ginkgo biloba
• Kava
• Melatonin
• Picamilon

List of Select Food Ingredients and Food Contact Substances Currently Under FDA Review

• Authorized PFAS: Certain Short-Chain Per- and Polyfluoroalkyl Substances (PFAS) Food Contact Substance
• Authorized PFAS: Uses of other Per- and Polyfluoroalkyl Substances (PFAS) in food contact applications Food Contact Substance
• Brominated-Vegetable-Oil (BVO)  - Food Additive
• Irgafos 168 - Food Contact
• Partially Hydrogenated Oil (PHO) - food additive
• Phthalates - Food contact
• Red Dye No. 3 - Color Additive
• Titanium Dioxide - Color Additive

List of Select Contaminants Currently Under FDA Review

• Arsenic - Environmental Contaminant
• Cadmium - Environmental Contaminant
• Lead - Environmental Contaminant
• 4-MEI Methylimidazole CAS Number 822-36-6 - Process contaminant in some caramel colors and flavors, and in some foods and beverages during the normal cooking process
• Mercury - Environmental Contaminant
• 3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE)  - Process contaminants that can occur in refined edible oils, such as vegetable oils, and foods made with these oils, including infant formula
• Per- and Polyfluoroalkyl Substances (PFAS) - Environmental Contaminant
• Thallium - Environmental Contaminant

https://www.fda.gov/food/cfsan-constituent-updates/fda-update-post-market-assessment-certain-food-ingredients
FDA Update on Post-market Assessment of Certain Food Ingredients

Constituent Update

July 12, 2023

Today, the U.S. Food and Drug Administration (FDA) released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review. The FDA also released a Conversations with experts about the agency’s work to enhance the assessment of ingredients in foods on the market. These resources are intended to provide more insight on the FDA’s post-market assessments.

The New Food Safety Concern for Summer - Cyclospora

Cases of Cyclosporiasis (infection from the parasite Cyclospora) have been increasing in the US, and we have seen an increase coming from domestically grown produce, while imported produce has been historically the primary issue.  Last month, CDC reported a large outbreak of Cyclospora where imported broccoli may have been the source.

Currently, there is an ongoing outbreak in the Houston, TX area.  A source has not yet been identified, although one would expect it to be related to the consumption of fresh produce, especially those items that cannot be vigorously washed....items such as .fresh cilantro, pre-packaged salad mix, raspberries, basil, snow peas, and mesclun lettuce.

In CDC MMWR article released this week, an Florida outbreak of Cyclospora linked to bagged salad is covered with a discussion how cases have been increasing over the past year.

The symptoms They usually begin about 1 week after exposure. If the infection is not treated, symptoms can last for several weeks to a month or more. Symptoms may include the following:

• Frequent bouts of watery diarrhea (the most 
• common symptom)
• Loss of appetite and weight
• Cramping, bloating, and/or increased gas
• Nausea (vomiting is less common)
• Fatigue
• Low-grade fever

https://publichealth.harriscountytx.gov/Portals/27/Documents/News/Cyclosporiasis_SM.pdf
Harris County Public Health
FOR IMMEDIATE RELEASE
July 7, 2023
Cyclospora Cases on the Rise in Harris County
HCPH urges residents to take protective measures to prevent gastrointestinal illness
HOUSTON — Harris County Public Health (HCPH), the Houston Health Department and Fort Bend
County Health & Human Services, have received reports of an increased number of Cyclospora
infections within their jurisdictions and urge people to use caution this summer while cooking and
spending time outdoors.

Imported Soup Base Recalled for Undeclared Milk

Ziyad Brothers Importing of Cicero, IL, is recalling its 35.2 fluid ounce packages of Ziyad Brand Jameed Soup Starter because it does not declare milk.  The recall was initiated after it was discovered during a routine internal company review that the product was distributed in packaging that disclosed the presence of “lactic casein powder” in the ingredient list but it did not further clarify that this ingredient is derived from “milk.”

The product itself is made with a sheep yogurt base, which is not dairy.  However the lactic casein powder was derived from milk.  Product was imported from Jordan.  The importer in this case, needs to conduct a hazard analysis as part of the FSVP - Foreign Supplier Verification Program, and should have determined this ingredient as an allergen as part of that analysis.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ziyad-brothers-importing-issues-allergy-alert-undeclared-milk-jameed-soup-starter
Ziyad Brothers Importing Issues Allergy Alert on Undeclared Milk in Jameed Soup Starter
Summary
Company Announcement Date:  July 07, 2023
FDA Publish Date:  July 07, 2023
Product Type:  Food & Beverages  Soup
Reason for Announcement:  Undeclared milk
Company Name:  Ziyad Brothers Importing
Brand Name:  Ziyad
Product Description:  Jameed Soup Starter

NY Firm Recalls Mispackaged Blintzes Resulting in Undeclared Milk

MilMar Food Group LLC, of Goshen, NY is recalling 1200 units of Spring Valley Potato Blintzes, because it may contain undeclared milk.  A voluntary recall was initiated after it was discovered through a consumer complaint that product containing milk was potentially packed into packaging that did not reveal the presence of milk. Subsequent investigation revealed that the potential problem was caused by a temporary breakdown in the company’s packing processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/milmar-food-group-llc-issues-allergy-alert-undeclared-milk-spring-valley-potato-blintzes?utm_medium=email&utm_source=govdelivery
Milmar Food Group LLC Issues Allergy Alert on Undeclared Milk in Spring Valley Potato Blintzes
Summary
Company Announcement Date:  July 06, 2023
FDA Publish Date:  July 06, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  MilMar Food Group LLC
Brand Name:  Spring Valley
Product Description:  Potato Blintzes

Imported Sheep Milk Cheese Recalled Due to Potential Listeria Contamination

Estancia Holdings of Cumming, GA is recalling one Lot of Tome Corse Sheep Ottavi due to a potential contamination of Listeria monocytogenes. Estancia Holdings was notified by the French supplier that a wheel they received may be contaminated with Listeria Monocytogenes.

Tomme Corse Ottavi is is a raw sheep's milk with a natural, taupe-colored rind that takes on a light white or orange-colored bloom from natural bacteria which flourish in the aging caves, where the cheese matures from 6 to 8 months. Product is from Ghisonaccia, a coastal region of Eastern Corsica.
Adapted from Source - https://chefshop.com/Tomme-Corse-Ottavi-Cheese-P7154.aspx

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/estancia-holdings-recalls-tome-corse-sheep-ottavi-due-potential-listeria-monocytogenes-contamination
Estancia Holdings Recalls Tome Corse Sheep Ottavi Due to Potential Listeria monocytogenes Contamination
Summary
Company Announcement Date:July 05, 2023

FDA Publish Date:July 05, 2023

Product Type:Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential Foodborne illness

Company Name: Estancia Holdings

Brand Name:  Fromager Affineur

Product Description:  Tome De Brebis Sheep Milk Cheese

Gluten Free Waffles Recalled After Mislabeling Issue with Gluten Containing Product

Van’s International Foods (“Van’s” or “the Company”) is voluntarily recalling certain packages of Van’s Gluten Free Original Waffles, because they may contain undeclared wheat.  The recall was initiated after it was discovered that wheat-containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates that the problem was caused by the inclusion of a limited number of cartons for Van’s Gluten Free Original Waffles with a pallet of cartons intended for wheat containing products. Immediate steps were taken to prevent recurrence.

As part of  being in compliance with the Preventive Controls regulations, the company would have an allergen preventive control for labeling.  A difficulty here is that someone improperly stored pre-labeled cartons on the wrong pallet, perhaps these cartons were from a previous production run, and at the end of that production run, the remaining unused cartons were returned back to the label storage area and improperly placed on the pallet of gluten-containing cartons.  It is easy to see how a box or two of cartons on the pallet could have been missed, even if there were some checks in place at the point of labeling.  The allergen preventive control at the point of labeling needs to address this type of situation.  This could include an entire pallet check, a control component for the return of unused labels, and/or an inline bar code reader.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-food-recall-vans-gluten-free-original-waffles-due-potential-presence-undeclared-wheat
Urgent Food Recall of Van’s Gluten Free Original Waffles Due to Potential Presence of Undeclared Wheat Allergen
Summary
Company Announcement Date:  July 03, 2023
FDA Publish Date:  July 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  Van’s International Foods
Brand Name:  Van’s
Product Description:  Gluten Free Original Waffles

Breakfast Sandwich Cookies Recalled for Undeclared Peanuts

Mondelēz Global LLC announced today a voluntary recall of two varieties of belVita Breakfast Sandwich products [cookies], manufactured in the United States and sold nationwide, due to the possibility that the products may contain undeclared peanut resulting from cross-contact on a single manufacturing line. The company "became aware of this issue during an internal manufacturing inspection, when [they] found the potential presence of peanut protein residue on the line used to make these products. There have been three unconfirmed reports of possible allergic reaction to date related to these products."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mondelez-global-llc-conducts-voluntary-recall-two-varieties-belvita-breakfast-sandwich-products-sold
Mondelēz Global LLC Conducts Voluntary Recall of Two Varieties of belVita Breakfast Sandwich Products Sold in the United States Due to Undeclared Peanut Allergen
Summary
Company Announcement Date:  July 03, 2023
FDA Publish Date:  July 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Mondelez Global LLC
Brand Name:  belVita
Product Description:  Breakfast sandwich products

Change in Nut Mix Ingredient Leads to Recall of Party Mix Due to Undeclared Walnuts

Fry Daddy’s Brand of Walker, Michigan is voluntarily recalling its Party Mix in all flavors and sizes due to undeclared walnuts.  "This occurred due to a change to the deluxe mixed nuts removing hazelnuts and pistachios and adding walnuts to the party mix. The recall was initiated after it was discovered that the product containing walnuts was distributed in packaging that did not reveal the presence of walnuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fry-daddys-brand-issues-allergy-alert-undeclared-walnut-all-party-mix-products
Fry Daddy’s Brand Issues Allergy Alert on Undeclared Walnut in all Party Mix Products
Summary
Company Announcement Date:  June 30, 2023
FDA Publish Date:  July 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared walnuts
Company Name:  Fry Daddy’s Brand
Brand Name:  Fry Daddy
Product Description:  Party Mix

FDA Issues Warning Letter to OH Bakery

FDA issued a Warning Letter to an Ohio Bakery for the following issues:

Lack of Allergen Preventive Control for Sesame

• The "facility’s written hazard analysis for the buns did not consider allergen cross-contact at all steps where your sesame seed buns and non-sesame seed buns are made on shared equipment (e.g., “(b)(4),” “Baking,” “Depanning,” “Cooling,” and “(b)(4)”). Your facility manufactures at least 21 bun products that contain allergens (such as wheat, soy, and sesame); products containing different allergen profiles (i.e., with or without sesame seeds) are processed on shared equipment and using shared utensils on the same production day."
• The facility did "not adequately controlling the hazard of allergen cross-contact during our inspection. FDA investigators observed apparent sesame residue on the “(b)(4) conveyor” after sanitation had been completed for the changeover from a sesame seed bun batch to a non-sesame seed bun batch produced on shared equipment. Our investigators observed sesame seeds immediately after the buns were depanned, which you consider to be part of the bun cooler. When this was pointed out by the investigators, the non-sesame seed bun was already traveling along the conveyor with sesame seed residue still present even though an employee was trying to clean it."

Lack of Sanitation Preventive Control in Post-Process Environment

• "Did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE bun products, as required by 21 CFR 117.130(a)(1). Your facility’s written hazard analysis considered biological contamination from the environment at certain post-baking steps but did not identify it as requiring a preventive control at processing steps such as “Depanning,” “Cooling,” “(b)(4), and Packaging.” Your RTE buns are exposed to the environment prior to packaging where they could be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes." 
• The "investigators observed several instances where you did not record sanitation activities at the post-baking steps in your process and did not take corrective actions when sanitation was not performed. Our review of your “Master Sanitation Schedule” records from June 3, 2022, through January 6, 2023, found that you did not record sanitation activities at the frequency for which they should occur. When asked by our investigators about the missing sanitation records, your Senior Engineer stated if there was no record then sanitation did not happen."

Lack of Corrective Action to Environmental Samples

• During the investigators’ review of your environmental monitoring records, it was noted that you have had at least four instances in the not ready-to-eat areas in your facility where you had either a suspected positive or confirmed positive for Listeria with no further action taken.

Pest Control

• At least one live mouse was observed between pallets of (b)(4) bags of (b)(4) brand Pure Granulated Sugar in the warehousing area. Eight incidents of rodent activity were documented in the shipping area, tray washing room, boiler room, and break room by your pest control operator between the period of May 18, 2022, to January 18, 2023, including rodent activity on January 4 and January 18, 2023, in the warehousing area where FDA investigators observed a live rodent during the inspection.
• Apparent rodent excreta pellets (AREPs) were observed on pallets and flooring in the warehousing areas"

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/schwebel-baking-company-653005-06092023

FDA Warning Letter
Schwebel Baking Company

MARCS-CMS 653005 — JUNE 09, 2023

MI Establishment Recalls Beef Wieners Containing Smoked Sausage Product

Perdue Premium Meat Company, Inc., doing business as Alexander & Hornung, a Saint Clair Shores, Mich., establishment, is recalling approximately 3,204 pounds of fully cooked beef wiener products due to misbranding and undeclared allergens.  The product may actually contain smoked sausage, which contains milk, a known allergen, which is not declared on the wiener product label.  The problem was discovered when the establishment notified FSIS that one of their customers reported receiving product labeled as beef wieners in cartons labeled as hot smoked sausage. The vacuum-sealed packages labeled as beef wieners were then found to contain the smoked sausages.

https://www.fsis.usda.gov/recalls-alerts/perdue-premium-meat-company-inc--dba-alexander-hornung-recalls-brookside-brand-fully
Perdue Premium Meat Company, Inc., DBA Alexander & Hornung Recalls Brookside Brand Fully Cooked Beef Wiener Products Due to Misbranding and an Undeclared Allergen

PERDUE PREMIUM MEAT COMPANY, INC.

FSIS Announcement

WASHINGTON, July 1, 2023 – Perdue Premium Meat Company, Inc., doing business as Alexander & Hornung, a Saint Clair Shores, Mich., establishment, is recalling approximately 3,204 pounds of fully cooked beef wiener products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product may actually contain smoked sausage, which contains milk, a known allergen, which is not declared on the wiener product label.