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