Raw pet food company sues to block FDA public health alert

Arrow Reliance Inc. (d.b.a. Darwin’s Natural Pet Products) has filed suit in US federal court in an attempt to prevent the US Food and Drug Administration (FDA) from issuing a Public Health Alert about possible Salmonella contamination in a cat food product.

Darwin’s, which is based in Tukwila, Washington, filed the their request for a temporary restraining order on July 29, 2022, in the US District Court, Western District of Washington (Case 2:22-cv-01057).

Screen Shot 2022-08-01 at 1.58.32 PMThe lawsuit contends that the FDA “wrongfully” threatened to issue the Public Health Alert if the company refused to issue a recall of its adult cat food.

The FDA’s request for a product recall apparently arose after kittens tested positive for Salmonella.

When contacted by eFoodAlert, a spokesperson for the FDA stated that the agency does not comment on pending litigation.

The background

logo-Darwins-pet-foodDarwin’s is the producer and distributor of a range of raw food products for dogs and cats.

The company was founded in 2002 by Gary Tashjian, who began producing frozen raw pet foods in his own kitchen.

In time, Tashjian moved his manufacturing operations into a facility in Tukwila, WA, just outside of Seattle.

In June 2016, the FDA received a consumer complaint about foreign objects in the company’s products. In response, the FDA and representatives from the Washington State Department of Agriculture (WSDA) paid a visit to the Tukwila facility.

During the course of their visit, the FDA and state investigators noted several objectionable conditions in the production plant. They also reviewed the company’s consumer complaint log, including four complaints that mentioned Salmonella.

As part of their follow-up, WSDA inspectors sampled two of the finished raw pet food products for lab analysis. One of those samples was found to contained Salmonella.

In response, the company destroyed its inventory of the contaminated production lot. As none of the product had been shipped, there was no need for a recall.

In December 2017, following a spate of product recalls due variously to Listeria monocytogenes, Salmonella, and/or E. coli O28 in multiple product samples, the FDA returned to Darwin’s plant to conduct an intensive investigation that lasted until late January 2018.

During the course of its investigation, the FDA became aware of at least six customer complaints about sick pets, including one dead kitten.

On April 2, 2018, the FDA issued a formal Warning Letter, notifying the company of its findings and giving the company fifteen business days in which to respond with a written description of corrective actions.

The company was reinspected in 2018/19, during which time Darwin’s management refused to supply the FDA investigation team with records pertaining to the production, sanitation, environmental testing and distribution of finished product lots using the same protein ingredients as two samples that were identified positive for the presence of Salmonella.

FDA inspected Darwin’s again in June 2021. This time, the company cooperated fully with the inspectors, who noted a few observations of concern. These were corrected by company management before the inspection was completed, and no formal list of Inspectional Observations was issued.

The current situation

At the moment, there is no information available beyond what has been included in the company’s request for a temporary restraining order.

If the request is not granted, the FDA will be free to release additional details, including a Public Health Alert, if it chooses to do so.

In the interim, any consumer who suspects that a Darwin’s product may have caused his dog or cat to become ill should file a formal complaint with the FDA, using the agency’s pet food complaint portal.

For additional information on safety issues surrounding the feeding of raw pet food to companion animals, check out the FDA website


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Recalls and Alerts: July 11-13, 2022

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Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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Chapter 6. Birth of a Pathogen

United States

OUTBREAK INVESTIGATION: CDC reports 23 Listeria monocytogenes illnesses in 10 states. Twenty-two people have been hospitalized and one person has died. In addition, one pregnant woman lost her unborn baby due to the illness. The outbreak has been linked to Big Olaf ice cream products. The company recently announced a product recall (see below).

Allergy Alert: FSIS issues public health alert for TRADER JOE’S CAESAR SALAD WITH WHITE CHICKEN MEAT and Creamy Caesar Dressing (9 oz. plastic clamshell containers; Lot code GHNW 186-06; Best by 07/11/22 and 07/12/22) due to undeclared egg.

Allergy Alert: Tovala recalls Gochujang-Glazed Pork Chop Bowl and Gochujang-Glazed Salmon Bowl (Enjoy By dates between 7/11/22 through 7/14/22) due to undeclared peanuts.

Food Safety Recall: Belfonte Dairy recalls “Chocolate to Die For” Premium Ice Cream (1.5 quarts; Plant code 25-050; Use by 05/18/24) due to undeclared peanuts.

Food Safety Recall: Big Olaf Creamery recalls Big Olaf brand ice cream products (All flavors, lots, codes, and all expiration dates through 6/30/2022) due to potential Listeria monocytogenes contamination. The product was sold at Big Olaf retailers in Florida as well as to consumers in restaurants and senior homes, and one location in Fredericksburg, Ohio.

Food Safety Recall: Enjoy Life Natural Brands LLC recalls multiple baked snack products due to foreign material contamination (hard plastic pieces). Please refer to the recall notice for a complete list of affected products.

Pet Treat Safety Recall: Stormberg Foods recalls Beg & Barker Chicken Breast Strips Dog Treat, Billo’s Best Friend Chicken Breast Strips Dog Treat, and Green Coast Pets Chicken Crisps Dog Treat products (Various sizes; All batch codes; Expiry dates from 06/06/23 to 06/23/23) due to potential Salmonella contamination.

Canada

OUTBREAK INVESTIGATION: The Public Health Agency of Canada is investigating a non-travel related outbreak of Cyclospora in British Columbia (1 case), Ontario (75 cases) and Quebec (8 cases). Four people have been hospitalized. The source of the outbreak is undetermined at this time.

Allergy Alert: UNFI Canada Inc. recalls That’s It. brand Dark Chocolate Fig Truffles (100g; Batch code 12 14 23; UPC 8 50013 71693 7) due to undeclared milk.

Food Safety Recall: Covic International Trading Inc. recalls Enoki Mushrooms (200g; Batch code AF009D; Date code 25 07 2022; UPC 8 807076 001496) due to Listeria monocytogenes contamination.

Europe

Allergy Alert (Belgium): Jumbo Supermarkten recalls Jumbo Aardappelsalade met ei / Potato salad with egg (400g; Lot 712722; Best before  27/07/2022) due to undeclared mustard.

Allergy Alert (France): Barilla France SAS recalls Barilla brand LASAGNE n.189 COLLEZIONE / Lasagna dry pasta (500g; Lots I12414282 & I12414292; Best before 20/09/2023 & 21/09/2023, respectively) due to undeclared egg.

Allergy Alert (France): BOLTON FOOD recalls Saupiquet brand Les Saladières – Taboulé – Salade végétarienne / Vegetarian taboula salad (220g; Lot L-21-063-E; Best before 04/03/2024) due to undeclared fish.

Allergy Alert (Ireland): FSAI warns consumers that Dunnes Stores White Sub Rolls (290g; Best before 17/07/2022) contains undeclared milk and eggs.

Allergy Alert (Italy): REVOLUTION S.r.l. recalls REVOLUTION brand GRISSONCELLI ALL’ OLIO (12 pieces; Lot 190522; Best before 19/11/22) due to undeclared peanuts.

Allergy Alert (Italy): REVOLUTION S.r.l. recalls REVOLUTION brand RUSTICHELLI (12 pieces; Lot 130522; Best before 13/11/22) due to undeclared peanuts.

Allergy Alert (Italy): REVOLUTION S.r.l. recalls REVOLUTION brand MIX SFOGLIA / Bulk mix (12500g bag; Lots 050422 & 270422; Best before 05/04/23 & 27/04/23) due to undeclared peanuts.

Allergy Alert (Netherlands): Jumbo recalls Jumbo Aardappelsalade met ei / Potato salad with egg (400g; Lot 712722; Best before  27/07/2022) due to undeclared mustard.

Food Safety Recall (Belgium): Delhaize recalls Delhaize brand COQARDENNE Chipolata de poulet / chicken sausage (Lots 485394, 485862 & 485598; Expiration dates 12/07/2022, 13/07/2022 & 14/07/2022, respectively) due to Salmonella contamination.

Food Safety Recall (Belgium): Albert Heijn recalls AH houdbare halfvolle melk / Shelf-stable, part-skimmed milk (6x200ml; Lot 513867 E; Best before 27-11-2022) due to Bacillus cereus contamination.

Food Safety Recall (France): METRO FRANCE recalls METRO CHEF brand Gnocchi de pommes de terre / Potato gnocchi (1 kg; Lot 1442; Use by 23/07/2022) due to possible Bacillus cereus contamination.

Food Safety Recall (France): AUCHAN recalls STEAK HACHE DE BOEUF / Ground beef steak (Sold between 01/07/2022 and 13/07/2022) due to Salmonella contamination.

Food Safety Recall (France): FRANSAL recalls CRAYON CHORIZO / Mini dry sausages (500g; Lot 0640202191; Best before dates between 11/09/2022 and 13/10/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): SILVE INTERMARCHE recalls ADELIE COLOSSE FACON GRANOLA / Ice cream on a stick, with granola (4-pack; Lots 040 22, 104 22 & 167 22; Best before 07/08/2024, 10/10/2024 & 12/12/2024, respectively) due to potential foreign matter contamination (wood splinters).

Food Safety Recall (France): SOCIETE NOUVELLE GAST recalls Gast brand TETE ROULEE PISTACHEE / Head cheese with pistachios (2 slices/pkg; Lot 22178; Multiple Use-by dates) due to Listeria monocytogenes contamination.

Food Safety Recall (France) Aldi recalls PAYS GOURMAND brand VIANDE HACHEE PUR BOEUF, 5% / Pure ground beef, 5% fat (300g; Lots 22333351 & 22333366; Use by 21/06/2022) due to possible shigatoxin-producing E. coli contamination.

Food Safety Recall (Germany): EDEKA ZENTRALE Stiftung & Co. KG recalls EDEKA Bio MY VEGGIE Salatmayonnaise / Organic salad mayonnaise (250 ml; Best before 14.11.2022) due to possible foreign matter contamination (pieces of glass).

Food Safety Recall (Germany): Kaadan Alshalati, Ahmad Feras recalls Sesame Tahini Algota (800g; Lot 1066; Best before 01/2023) due to Salmonella spp. and Salmonella Mbankada contamination.

Food Safety Recall (Iceland): Lagsmaður ehf / Fiska.is recalls TRS Hot Madras Curry (100g; Product of India) due to possible Salmonella contamination.

Food Safety Recall (Romania): Mega Image recalls H VAN WIJNEN SOMON CARPACCIO / Salmon Carpaccio (120g; Lot 86BK/221405; Expiration dates 07.06.2022 & 10.06.20220) due to Listeria monocytogenes contamination.

Asia, Africa and the Pacific Islands

Allergy Alert (Israel): AG Gilro recalls Waffle Crunch filled with walnut flavored cream (150g; Expiration date 05.07.2023) due to undeclared walnut traces.

Allergy Alert (Israel): A. Biscotti Ltd. recalls Chocolate Cookies (240g; Use by 06/08/2022) due to undeclared walnut.

Recalls and Alerts: February 17-18, 2022

 

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Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations? Click on the TAINTED menu at the top of the page to read a short excerpt, then follow the buy links to add a digital or print copy to your personal library.

United States

OUTBREAK INVESTIGATION: FDA reports three cases of Cronobacter sakazakii infections and one case of Salmonella Newport infection in infants who were fed powdered infant formula manufactured by Abbott Nutrition (Sturgis, MI). The infections were reported in Minnesota (1), Ohio (1) and Texas (2). All four infants were hospitalized and one has died. The manufacturer has initiated a voluntary recall (see notice below).

OUTBREAK ALERT: The Massachusetts Department of Public Health (MDPH) is investigating an outbreak of three cases of Salmonella infections in individuals who handled Dog Gone Dog Treats. All three outbreak victims are residents of Essex County, MA. Two of the victims are adults in their 70s and the third is a child. The MDPH lab has recovered Salmonella from opened and unopened packages of the dog treats.

Allergy Alert: Lehi Valley Trading Company recalls three brands of Yogurt Raisins due to undeclared peanut. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Family Dollar, Inc. recalls certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the present due to the presence of rodents and rodent activity at Family Dollar Distribution Center 202. Products covered by this retail level recall include all: (i) drugs; (ii) medical devices; (iii) cosmetics; (iv) dietary supplements; and (v) human and animal (pet) food products. Please refer to the recall notice for additional information, including a list of affected stores.

Food Safety Recall: Corfu Foods, Inc. recalls PACIFIC DYNASTY SWAI FILLETS (15-lb bulk corrugated box packages; Lot code VN 461 VI 354; Product of Vietnam) because the product was not presented for import reinspection into the United States.

POWDERED INFANT FORMULA SAFETY RECALL: Abbott recalls certain production lots of Similac, Alimentum and EleCare powdered infant formulas after four illnesses were associated with consumption of these products (see FDA Outbreak Investigation notice). The recalled products were distributed nationwide in the USA and also exported to Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

Canada

POWDERED INFANT FORMULA SAFETY RECALL: Abbott recalls multiple Abbott brand (Similac) powdered infant formula products from the marketplace due to possible Cronobacter sakazakii and Salmonella contamination. These products were distributed across Canada. Please refer to the recall notice for a complete list of affected products. There have been reported illnesses associated with consumption of these products in the USA, but no illnesses have been reported in Canada.

Allergy Alert: Frobisher International Enterprises Ltd. recalls 3Fish brand Sauerkraut Fish (Szechuan Style) (400g; UPC 8 74718 00529 5; All codes that do not declare milk on the label) and Tilapia Soup with Pickled Vegetables (400g; UPC 8 74718 00534 9; All codes that do not declare milk on the label) due to undeclared milk.

Food Safety Recall: Las Olas Traiteur (Longueuil, QC) recalls Las Olas traiteur BŒUF BOURGUIGNON (380g; Sold from 17 January 2022 to 21 January 2022), because the product was prepared and packed in a manner that may render it unsafe to consume.

Europe

POWDERED INFANT FORMULA SAFETY RECALL: Abbott recalls certain production lots of Similac, Alimentum and EleCare powdered infant formulas after four illnesses were associated with consumption of these products (see FDA Outbreak Investigation notice). The recalled products were distributed nationwide in the USA and also exported to the United Kingdom.

Allergy Alert (Belgium): AFSCA orders recall of Sau Tao Bean Strip noodles (All Best before dates for 2022) due to undeclared soy.

Allergy Alert (Belgium): Brasserie de Silenrieux recalls Cuvée des Lacs de l’eau d’Heure beer (Lot 229A; Best before end of 2022) due to undeclared gluten.

Allergy Alert (Denmark): Lidl Danmark recalls Pistachio Mix (200g) due to undeclared wheat flour and eggs.

Allergy Alert (Netherlands): Liroy B.V. recalls Sau Tao Amoy Bean Strip (250g; (All Best before dates for 2022) due to undeclared soy.

Allergy Alert (Spain): Food Safety Authority reports that SANAVI brand Harifen Vanilla Cookies (200g; Lot 35L & 29J; Expiration dates 04.30.2023 & 02.28.2023, respectively) contain undeclared soy.

Allergy Alert (UK): Liroy B.V. recalls Sau Tao (Sun Shun Fuk) ST Amoy Bean Strip (250g; All dates) due to undeclared soy.

Food Safety Recall (Belgium): LT Foods recalls Golden Sun brand Riz Basmati / Basmati rice (1 kg; Best before 06/10/2023) due to aflatoxin contamination.

Food Safety Recall (Belgium): Jumbo recalls Jumbo biologische kipdijlapjes / Organic chicken thighs (220g; Best before 19-02-2022 and 21-02-2022) due to possible Salmonella contamination.

Food Safety Recall (Belgium): Albert Heijn recalls Albert Heijn brand Basmati rijst Aromatisch / Aromatic basmati rice (400g; Best before 10/08/2023) due to ochratoxin contamination.

Food Safety Recall (Belgium): AFSCA orders recall of Matias brand Farinha de Milho Amarela / Yellow corn flour (500g; Lot 070621D2; Best before 01/04/2022) due to fumonisin contamination.

Food Safety Recall (France): GAEC LA BAROTIERE recalls several varieties of GAEC LA BAROTIERE brand FROMAGE DE CHEVRE FERMIERS / Farmer’s goat cheese due to possible Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (France): CARREFOUR ANTIBES recalls SALADE DE MUSEAUX VINAIGRETTE (Sold from 6 February 2022 to 7 February 2022 at the Charcuterie stand of CARREFOUR ANTIBES) due to Listeria monocytogenes contamination.

Food Safety Recall (France): Fromagerie Le Pic recalls Le Pic brand SAPIC BLANC LS cheese (Lot 15012224; Best before 23/02/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): LSP Sporternährung GmbH recalls Oat King Haferriegel “Milk & Honey” / Oat bar (95g; Lot 777; Best before 20.09.2022) due to possible Salmonella contamination.

Food Safety Recall (Germany): Dirk Rossmann GmbH recalls enerBio Pistaziencreme / Pistachio cream (200g; Best before 08.03.2023) due to Salmonella contamination.

Food Safety Recall (Iceland): Fiskvinnslan Hrefna recalls Ísfirðingur brand Smoked Salmon (Expiry dates 14.1.02022, 14.02.2022 and 08.03.2022) and Ísfirðingur brand Smoked Rainbow (Expiry date 08.03.2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Luxembourg): Food Safety Authority orders recall of Oat King Haferriegel “Milk & Honey” / Oat bar (95g; Lot 777; Best before 20.09.2022) due to possible Salmonella contamination.

Food Safety Recall (Netherlands): Jumbo recalls Jumbo biologische kipdijlapjes / Organic chicken thighs (220g; Best before 19-02-2022 and 21-02-2022) due to possible Salmonella contamination.

Food Safety Recall (Netherlands): Bio+ recalls Bio+ kipdijfilet / Organic chicken thighs, deboned (220g; Best before 21-02-2022) due to possible Salmonella contamination.

Food Safety Recall (Netherlands): Odin Groothandel BV recalls multiple products containing chicken due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Romania): SC MONTANA POPA SRL recalls Salam Picantella / Salami (Lot L155627012022; Expiry date 27.04.2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Romania): SC La Meseni SRL recalls Salam Verona / Raw, dried salami (300g; Lot 13; Expiry date 01.05.2022) due to Listeria monocytogenes contamination.

Pet Food Safety Recall (UK): Dogs Choice UK recalls Frozen Chicken and Beef, Frozen Chicken and Beef Ready Meal, and Frozen Chicken Liver raw dog foods (500g; Batch code 080222+2; Best before 08 August 2022) due to Salmonella contamination.

Asia, Africa and the Pacific Islands

POWDERED INFANT FORMULA SAFETY RECALL: Abbott recalls certain production lots of Similac, Alimentum and EleCare powdered infant formulas after four illnesses were associated with consumption of these products (see FDA Outbreak Investigation notice). The recalled products were distributed nationwide in the USA and also exported to Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

Australia and New Zealand

POWDERED INFANT FORMULA SAFETY RECALL: Abbott recalls certain production lots of Similac, Alimentum and EleCare powdered infant formulas after four illnesses were associated with consumption of these products (see FDA Outbreak Investigation notice). The recalled products were distributed nationwide in the USA and also exported to Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

Allergy Alert (New Zealand): Functional Whole Foods New Zealand Ltd recalls specific batches and dates of its Waihi Bush Organic Farm brand Flax Fibre – Original, Waihi Bush Organic Farm brand Flax Fibre Balancing Greens, Waihi Bush Organic Farm brand Flax Fibre Detoxalin, and Waihi Bush Organic Farm brand Women’s Support due to undeclared gluten. Please refer to the recall notice for complete details for the affected products.

Latin America and the Caribbean

POWDERED INFANT FORMULA SAFETY RECALL: Abbott recalls certain production lots of Similac, Alimentum and EleCare powdered infant formulas after four illnesses were associated with consumption of these products (see FDA Outbreak Investigation notice). The recalled products were distributed nationwide in the USA and also exported to Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.