Recalls and Alerts: March 9-10, 2023

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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United States

Pet Food Safety Recall: Nestlé Purina PetCare Company recalls Purina Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food (8 lb and 20 lb bags; Lots 2213 1082 & 2214 1082, respectively; UPC 38100 19190 & 38100 19192, respectively) due to potentially elevated levels of vitamin D. The recalled products were distributed throughout the United States by prescription only through veterinary clinics, Purina Vet Direct, Purina for Professionals, and other select retailers with the ability to validate a prescription.

Pet Dietary Supplement Recall: Stratford Care USA, Inc recalls multiple brands of Omega-3 Supplements for cats and dogs (60 soft gels per bottle; Lot 31133 & 30837; Expiry 04/13/23 & 10/26/22, respectively) due to potentially elevated levels of Vitamin A. Please refer to the recall notice for a complete list of affected products, which were distributed throughout the United States in Veterinary Clinics, Distribution Centers, Retail Stores, and Online Market Places such as Amazon and Chewy.

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Canada

Allergy Alert: Da Zhan Ltd. recalls four Da Zhan Ltd. brand fish products due to undeclared egg and soy. Please refer to the recall notice for a complete list of affected products, which were sold in British Columbia.

Food Safety Recall: Salaison Limoges Extra inc. (Terrebonne, QC) recalls MAQUEREAU FUME / Smoked mackerel (Sold up to 8 March 2023) due to incorrect storage temperature instructions on the package label.

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Europe

OUTBREAK INVESTIGATION UPDATE (Sweden): Sweden’s Public Health Agency has received reports of 79 confirmed cases of Salmonella Enteritidis infections linked to consumption of eggs. The outbreak strain was found in the production environment of an egg producer at the turn of the year.

Allergy Alert (France): Industry recalls Alpina Bebida de avena / Oat drink (250 ml & 1 L; Lot L97A & L17B; Various Use by dates between 08/05/2023 and 27/05/2023) due to undeclared milk.

Allergy Alert (France): RACINES recalls Racines Bio brand Sucre de fleur de coco / Organic coconut blossom sugar (480g; Lot F00401CS PA; Best before 03/07/2023) due to undeclared sulphites.

Allergy Alert (France): SOCIETE LESAGE & FILS recalls Chili con carne (Lot 30665128; Use by 18/03/2023) due to undeclared barley and anchovies.

Allergy Alert (Spain): INDUSTRIA CONFITERA COLMENAR, SL warns of undeclared milk in PETISÚ MALTITOL and VANILLA MALTITOL PASTRY (2 kg trays and individual bags; Lots 19230103, 20230103, 23230104; Best before 03-19-2023, 03-20-2023, 03-23-2023).

Food Safety Recall (France): HDC PRODUCTION SAVEURS DES MAUGES recalls Saveurs des mauges brand Mini rillauds / marinated pork (150g & 200g; Lot 3061; Use by 28/03/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): UNIVERDIS SA LECLERC recalls CREPINETTE SAVOYARDE / Savoyard raw pork patty (Date produced 25/02/2023) due to Salmonella contamination.

Food Safety Recall (France): BEXIANIS recalls Chipolatas de jeune bovin femelle sous-vide / Veal chipolatas (Lot 1502M627; Use by 04/03/2023) due to Salmonella contamination.

Food Safety Recall (France): LURE DISTRIBUTION E.LECLERC recalls ANDRE BAZIN brand SAUCISSE DE MONTBELIARD IGP / Sausages (Lot 642422; Use by 07/05/2023) due to Salmonella contamination.

Food Safety Recall (France): CARREFOUR recalls Reflets de France brand Jambon de Savoie 9 mois – 6 tranches / Savoie ham, aged 9 months – 6 slices (90g; Lot 210158622; Use by 03/06/2023) due to possible Listeria monocytogenes contamination.

Food Safety Recall (Italy): Cooperativa Produttori Latte e Fontina recalls Fontina DOP Pascoli Italiani cheese (250g; Lot C037105286; Use by 10/04/2023) due to shigatoxin-producing E. coli contamination.

Food Safety Recall (Italy): Coppiello Giovanni srl recalls Sfilaccio di equino / Horse stew (100g; Lot 2301002; Use by 02/06/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (Spain): Friber, S.A. recalls Cecina loncheada en aceite de oliva / Sliced cecina (jerky) in olive oil (100g; Expiry 11/07/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (Sweden): DAVA FOODS SVERIGE AB recalls Familjens Val M 24p HP eggs (24/pkg; Best before 2023-03-13) and Frukostägg L 12p Kart/HP / Breakfast eggs, Large (12/pkg; 2023-03-12) due to possible Salmonella contamination.

Asia, Africa and the Pacific Islands

Allergy Alert (Israel): Bee Lider Ltd recalls Batunchik Creamo brand Chocolate candy with whole hazelnuts with nut cream filling (29g; Expiration date 08.05.2023) due to undeclared milk.

Australia and New Zealand

Allergy Alert (Australia): Stone & Wood Brewing Co. recalls Counter Culture Eirinn Irish Cream Stout (All Best Before Dates Up to and including 16/08/23) due to undeclared milk.

Food Safety Recall (Australia): Y&J Connect Pty Ltd recalls K-mama Enoki Mushrooms (300g; Best before 03.06.2023; Product of South Korea) due to Listeria monocytogenes contamination.

Food Safety Recall (New Zealand): She Universe Ltd recalls GoodFor brand Sugar Free Spheres (12g; Purchased instore between 4 August 2022 and 10 March 2023) and She Universe brand Sesame & Cashew Butter Batons (100g; Best before 30/03/2023, 12/04/2023, 27/04/2023, 01/06/2023, 22,06,2023, 23/08/2023) due to possible Salmonella contamination.

Food Safety Recall (New Zealand): Forty Thieves Ltd recalls Forty Thieves brand Organic Tahini Hulled (500g glass jar; Date markings BB 10102023, BB 05122023, BB 17012024 and BB 22022024; Product of Turkey) due to possible Salmonella contamination.

Food Safety Recall (New Zealand): Bin Inn Retail Group Ltd recalls Bin Inn brand Organic Hulled Tahini and Bin Inn brand Organic Unhulled Tahini (500g & 1 kg; All batches; All dates; Product of Turkey) due to possible Salmonella contamination.

Food Safety Recall (New Zealand): GoodFor Ltd recalls GoodFor brand Silky Ta-hini (420g glass jar; Best before 12/02/2024; Product of Turkey) due to possible Salmonella contamination.

Food Safety Recall (New Zealand): Ceres Enterprises Ltd recalls multiple organic tahini products due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

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FDA warns Darwin’s in follow-up to sick cat complaint

The US Food and Drug Administration (FDA) has issued a stern warning to Arrow Reliance Inc. (doing business as Darwin’s Natural Pet Products), following what the agency referred to as an “inadequate” response to violations of the Food Drug and Cosmetics Act (FD&C Act) documented during an August-September 2022 inspection.

The inspection was carried out in response to a consumer complaint received by the FDA, in which the consumer reported that a Darwin’s cat food had caused illness in three kittens. The consumer provided documentation that a stool sample from one of the kittens tested positive for Salmonella.

Background

On July 8, 2022, the FDA was contacted by a consumer who complained that Darwin’s cat food had made her three kittens ill.

The FDA collected unopened packages of the suspect food from the consumer and found Salmonella in two samples.

With the Salmonella-positive results in hand, the FDA urged Darwin’s to initiate a recall of the contaminated products.

The company refused, and the FDA advised Darwin’s that the agency would issue a public caution.

On July 29, 2022, Darwin’s filed a request in federal court for a temporary restraining order to prevent the FDA from releasing information about the contaminated products to the public.

The court rejected the company’s request, and on August 5, 2022, the FDA finally was able to issue a caution to pet owners, advising them not to feed certain Darwin’s cat foods to their pets due to Salmonella contamination.

On August 23, 2022, the FDA began an inspection of Darwin’s manufacturing facility and, on September 30, 2022, handed a completed list of Inspectional Observations (FDA Form 483) to the company.

The company’s Director of Quality replied to the list of observations on October 14th.

What Darwin’s claims

Darwin’s claims that its Salmonella-contaminated raw pet foods are not adulterated, because (a) the microbe is not an “added substance,” and (b) it is up to the FDA to demonstrate that the Salmonella is present at a level that makes it “ordinarily injurious” to the intended consumer.

In its filing for the temporary restraining order, the company made reference to USDA enforcement policies for Salmonella and questioned why it should be acceptable for the pathogen to be present in raw poultry, beef and other meats for human consumption, but not in pet food.

Unresolved issues

1. Adulterated Animal Food

The FDA collected and analyzed unopened samples from the complainant.

One of the samples contained Salmonella Typhimurium, a serotype well known to cause both human and animal illness.

A second sample contained both Salmonella Typhimurium and Salmonella Kentucky, another serotype known to cause disease.

A third sample collected during the inspection of Darwin’s manufacturing facility also yielded Salmonella Typhimurium.

Because Salmonella can cause serious–sometimes fatal–illness in humans and in animals, the FDA considers the presence of the microbe at any level to be hazardous if the food is meant to be consumed without cooking.

Therefore, the three lots of Salmonella-contaminated cat food were adulterated within the meaning of the FD&C Act, according to the Warning Letter.

2. Use of an Unapproved Food Additive

In 2021, the FDA expressed its concern to Darwin’s regarding the company’s use of peroxyacetic acid (PAA) as an additive to control pathogens in its raw pet foods, as the chemical was not “generally recognized as safe” (GRAS) for the intended use.

During the 2022 inspection, the FDA observed that PAA was still being added to the pet foods, and that the company had increased the level of PAA to a concentration significantly higher than the recognized maximum safe level for its use in any food.

The FDA was unable to find any scientific data to indicate that the concentration of PAA incorporated into Darwin’s pet foods was safe for dogs or cats to consume.

The agency also reviewed documentation of a third-party lab study, undertaken on Darwin’s behalf, to validate the ability of PAA to control pathogens in the company’s raw pet foods. The FDA concluded that the level of pathogen control demonstrated during the study was inadequate to ensure a pathogen-free state in the company’s finished products.

3. Food Facility Registration

Under the FD&C Act, Darwin’s is required to register with the FDA as a “food facility.”

The company has long insisted that it supplies its products directly to customers and, as a “retail food establishment,” is exempt from this mandate.

However, Darwin’s ships the majority of its products to customers through third-party warehouses rather than directly from its manufacturing facility. Therefore, the company does not meet the definition of “retail food establishment” under the FD&C Act.

What happens next?

The company was given fifteen (15) working days to respond to the issues raised in the Warning Letter.

In the absence of a satisfactory response, the FDA may undertake legal action, including the possibility of seizure of products and/or seeking an injunction against the company.

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Sunday Supplement: Proposed new FDA food structure leaves pet food out to dry

IN MY OPINION

The proposed new US Food and Drug Administration (FDA) organization structure leaves the Center for Veterinary Medicine (CVM) sucking on a hind teat.

Never a major player in the FDA heirarchy, the CVM has been formally excluded from the Human Foods Program, with only a dotted line connecting it to the Office of the Deputy Commissioner.

Although the CVM will report directly to the Office of the Commissioner of Food and Drugs, its relatively small budget and political profile will leave this essential element of food safety and nutrition with little voice or influence at the table.

Why does this matter?

The CVM is responsible for oversight of animal feed, pet foods and veterinary medicines.

If animal feeds are not properly regulated and supervised, animal nutrition–and ultimately human nutrition–suffers.

If veterinary medicines are not properly regulated and supervised, the health of livestock and the safety of the human diet suffers.

If pet foods are not properly regulated and supervised, the health of companion animals suffers.

Pet health matters

Pets play an important role in the mental and physical health of their human companions.

Those of us who have lost a dog, cat, or other pet to illness, accidents, or simply old age, understand the grief that this loss entails.

In addition, if an animal develops a gastrointestinal illness such as salmonellosis as a result of contaminated pet food, this illness can be passed along to people in the same household.

This is not speculation.

Kibble, raw pet foods, and pet treats contaminated with Salmonella have caused several outbreaks of human illness large enough to attract the attention of the US Centers for Disease Control and Prevention (CDC).

Without a strong voice at the budget table, the CVM will not have the resources to oversee the pet food industry.

We have seen what has happened in the past when a pet food manufacturer has been allowed to operate on a “voluntary compliance” basis. More often than is healthy, the emphasis is on voluntary, and compliance falls by the wayside.

Can this be fixed?

I realize that the CVM has elements both of food and of pharmaceuticals in its regulatory portfolio.

Nevertheless, every component of the CVM’s mandate–animal feed, animal medications, pet food–indirectly supports the safety and nutriton of human or animal food.

I would propose that the scope of the proposed new directorate be expanded to include the CVM, and that the word “Human” be dropped from the title of the new Deputy Commissioner.

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Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen