574 Companion Animals Stricken with DCM. No answers yet

The US Food and Drug Administration (FDA) received a total of 524 reports of companion animals stricken with dilated cardiomyopathy (DCM) between January 1, 2014 and April 22, 2019, according to an update released by the agency today.

Some of the reports involve multiple animals in a single household. In all, DCM was reported in 560 dogs and 14 cats. Five cats and 119 dogs died.

Only seven reports were lodged with FDA during calendar years 2014-2017. The number of incidents spiked to 320 in 2018, and have continued at a steady pace this year, with 197 cases reported between January 1st and April 30th 2019.

FDA has posted a spreadsheet containing all of the individual reports it has received.

BY THE NUMBERS

The ten breeds appearing most often in these reports include: Golden Retriever (95), Mixed (62), Labrador Retriever (47), Great Dane (25), Pit Bull (23), German Shepherd (19), Doberman Pinscher (15), Australian Shepherd (13), Unknown (13) and Boxer (11).

DCM is recognized as a genetic condition in some large or giant breed dogs, including the Doberman Pinscher, the Great Dane, and the Irish Wolfhound, manifesting mainly in male dogs in middle to older age. DCM also is associated with taurine deficiency in Cocker Spaniels.

In contrast, cases of DCM reported to FDA have involved a wide range of dog breeds of all sizes and ages, from 0.4 – 17 years in dogs and 7 – 13 years in cats. More than one half of the cases (58.7% of dogs and 62.5% of cats) involve males.

The vast majority of affected pets (452 of the 524 reports) were fed a dry food diet exclusively. The rest of the animals were fed a diet that included one or more of dry, raw, semi-moist or wet foods. 

More than 90% of the dry dog foods were grain-free. Ninety-three percent of the formulations contained peas and/or lentils. Forty-two percent contained potatoes or sweet potatoes.

The most common animal source proteins were chicken, lamb and fish. Some foods contained exotic meats, such as kangaroo or bison. No one animal protein source predominated in the illness reports.

Dry food brands named most frequently in DCM cases were Acana (67), Zignature (64), Taste of the Wild (53), 4Health (32), Earthborn Holistic (32), Blue Buffalo (31), Nature’s Domain (29), Fromm (24), Merrick (16), California Natural (15), Natural Balance (15), Orijen (12), Nature’s Variety (11), NutriSource (10), Nutro (10) and Rachael Ray Nutrish (10).

THE FDA INVESTIGATION

FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN) has analyzed multiple products for minerals and metals (calcium, magnesium, phosphorus, iron, cobalt, copper, zinc, selenium, iodine) and amino acids including taurine, cysteine, and methionine. No abnormalities were found.

A comparative test of grain-free and grain-containing products for levels of protein, fat, moisture, crude fiber, total dietary fiber, soluble fiber, insoluble fiber, total starch, resistant starch, cystine, methionine and taurine revealed that both types of products contained similar levels of all of these components on a dry matter basis (ie., after removing all moisture content).

Additional tests are in progress

Vet-LIRN has interviewed 95 owners of affected pets, in order to document a complete dietary history and to explore any other possible contributing factors, including environmental factors.

FDA has received results of 19 gross necropsies from dogs with suspected heart disease, and Vet-LIRN is processing tissues from the necropsies for review by a board-certified veterinary pathologist.

Vet-LIRN is collaborating with Chesapeake Veterinary Cardiology Associates (CVCA) to collect medical records, owner interviews, and diagnostic samples from pets diagnosed with DCM. CVCA will be following the medical progress of these pets, including regular collection of diagnostic samples and follow-up echocardiogram. Vet-LIRN is collecting food associated with the pets included in this study for lab analysis.

UNANSWERED QUESTIONS

  1. Why have cases of DCM spiked in recent years? What has changed?
  2. Why are grain-free products so strongly associated with DCM, even though there is little apparent difference in the levels of minerals, amino acids, protein levels, etc. between grain-free and grain-containing products?
  3. Acana (67 DCM reports) and Orijen (12 DCM reports) are both manufactured by the same company. Why is there such a large difference in the number of associated cases between these two brands?
  4. Is there any correlation between brand popularity and number of DCM case reports? Would it be useful to compare the report frequency to the market share of each product?

WHAT CAN PET OWNERS AND VETERINARIANS DO?

  • FDA encourages pet owners and veterinarians to submit reports on any food-associated pet illness. Details for submitting this info can be found on the FDA page “How to Report a Pet Food Complaint.”
  • Pet owners should contact a veterinarian as soon as possible if their dog is showing possible signs of DCM or other heart conditions, including decreased energy, cough, difficulty breathing and episodes of collapse.
  • Veterinarians are urged to report well-documented cases of DCM in dogs suspected of having a link to diet by using the electronic Safety Reporting Portal or calling their state’s FDA Consumer Complaint Coordinators. FDA especially welcomes detailed reports, including information about feeding history, medical records, and diagnostic testing.

AN EDITORIAL NOTE

I have sometimes read complaints from pet owners and at least one blogger that FDA doesn’t care about pet food safety, or about the health of companion animals. 

The agency has spent significant resources and manpower on this investigation for more than a year, and is continuing its efforts to find the root cause for the spike in DCM in dogs. This is a complex, difficult, and wide-reaching investigation with no guarantee of success.

In my opinion, FDA’s commitment to solving the DCM riddle bears witness to its dedication to pet health.

Recalls and Alerts: June 24 – 26, 2019

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.

United States

Food Safety Recall: San Giuseppe Salami Co. by Giacomo recalls SAN GIUSEPPE SALAMI CO. BY GIACOMO ANDOUILLE SAUSAGE (SMOKE FLAVORING ADDED) (Variable weights; Sell by 11/10/2019) due to foreign matter (metal) contamination.

Food Safety Recall: Perrigo Company plc recalls Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron (35 oz/992g; Lot code C26EVFV; Use by February 26, 2021) due to potential presence of metal foreign matter. The recalled product was sold exclusively at Walmart.

Food Safety Recall: Keurig Dr Pepper recalls Peñafiel unflavored mineral spring water products (600mL and 1.5L PET bottles; All date codes; Imported from Mexico) due to the presence of violative levels of arsenic.

Canada

Allergy Alert: Allied Global Sourcing Inc. recalls Emme Foods brand ShangHai Style Deep Fried Turnip Cake (320 g (80 g x 4); All product codes; UPC 6 292640 000265) due to undeclared egg and shrimp.

Allergy Alert: UNFI Canada recalls Certain My/Mo brand bulk mochi ice cream products due to undeclared cashew. Please refer to the recall notice for a complete list of affected products.

Europe

Allergy Alert (Denmark): Dencon Foods A/S recalls certain Chicken wing products due to lack of Danish language allergen labeling. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (Denmark): Mondelez Danmark ApS recalls Oreo Joy Fills Choco Caramel (90g; Best before 22.08.2019) due to lack of Danish language allergen labeling for presence of gluten, milk and soy.

Allergy Alert (Denmark): Animex Foods / Fast Food a la Francaise recalls XXL Grill Sausages (2500g; Best before 24 / 6-2019) due to undeclared cheese.

Allergy Alert (Denmark): Reitan Distribution recalls Rema 1000 Hummus (200g; Best before 27/7-2019; Product of Sweden) and Rema 1000 Aioli (200g; Best before 27/7-2019; Product of Sweden) due to undeclared sesame, mustard and egg.

Allergy Alert (Italy): Lidl Italia SRL recalls Italiamo brand Gelatino alla stracciatella di nocciole / Hazelnut stracciatella ice cream (80g; Best before 16/05/21) due to undeclared almonds.

Allergy Alert (Sweden): Paulig recalls Risenta Buckwheat flakes (250g; Best before 11-06-2020) due to undeclared hazelnut.

Food Safety Recall (France): Industry recalls Ruel brand Filets mignons fumés nature and Bacon cru fumé (All packaging formats and Best before dates) due to Salmonella contamination.

Food Safety Recall (France): Industry recalls Double Dragon brand Mung Bean Vermicelli (Lot 000027640; Best before 31.01.2022) due to elevated lead levels.

Food Safety Recall (France): Industry recalls Meray brand Pistache Premium Quality (Lot 19000438; Best before 06/02/2020) due to elevated aflatoxin levels.

Food Safety Recall (France): Rostain recalls Rostain brand Terrine de Campagne (180g;  Lot #18207011; Best before 23/07/2021) due to foreign matter (glass) contamination.

Food Safety Recall (Italy): SALUMIFICIO ALIPRANDI SPA recalls SALUMIFICIO ALIPRANDI SPA brand SALAMETTO CLASSICO/SALAME MIGNON (~220g; Lot #L190007741) due to Listeria monocytogenes contamination.

Food Safety Recall (Sweden): Siljans Chark recalls various hot dog and sausage products due to Listeria contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Sweden): HKScan recalls Bullens varmkorv / Bullens hot dogs (2.2 kg; Sold on the Ö&B) due to production failure.

Pet Food Safety Recall (Belgium): Tammenga diervoeders
recalls Tammenga diervoeders brand Meatmix fish/turkey/duck raw pet food (5kg and 500g; Lot #041919014024; Best before 08/05/2020) due to Salmonella Typhimurium contamination.

Asia, Africa and the Pacific Islands

Food Safety Recall (Israel): Yesh Maof BaGalil Company Ltd recalls various Yesh Maof brand eggs due to risk of Salmonella Enteritidis contamination. Please refer to the recall notice for a complete list of affected batch codes.

Australia and New Zealand

Food Safety Recall (Australia): Tasman Foods International Pty Ltd recalls Chan’s Yum Cha at Home Vegetarian Shiitake Dumpling, Chan’s Yum Cha at Home Prawn Hargow and Chan’s Yum Cha at Home Sesame Prawn Toast (Products of Vietnam; Use by date of 29/07/2019) due to an incorrect use by date.

FDA reveals name of Hill’s vitamin D premix supplier

DSM Nutritional Products Inc. (DSM) was the supplier of vitamin D premix to Hill’s Pet Nutrition.

DSM is an international corporation that is “…a world leading supplier of vitamins, carotenoids and other nutritional solutions…”, according to the company’s website. Its US headquarters are in Parsippany, New Jersey.

According to the FDA Weekly Enforcement Report released this morning (June 19, 2019), DSM was notified by Hill’s Pet Nutrition (Hill’s) that a dog had become ill after consuming Hills Prescription Diet W/D canned dog food, manufactured using the DSM vitamin premix.

On January 30, 2019, DSM initiated a recall of 2217 Canned Canine PMX Product Code: NP15268025, net weight: 25 Kg per package, package type: Woven polyethylene bag.

The recall encompassed two production lots – 9100058130 and 9100058131 – comprising a total of 2500 Kg (~2.75 tons) of premix.

The premix was produced on August 18, 2018.

DSM notified Hill’s of the recall by telephone. There were no other consignees, and no public recall notice was released.

Hill’s first notified FDA about potentially toxic levels of vitamin D in its canned dog foods on January 31, 2019 and initiated a recall of 25 products manufactured during the months of September 2018 through December 2018.

On March 20, 2019, Hill’s expanded the initial recall to include additional products and lot codes. A second expansion was announced on May 20, 2019.

The recalled products were distributed in the USA and around the world.

FDA initiated an inspection of Hill’s manufacturing facility in February 2019. According to the inspection report, Hill’s blamed a manufacturing error by its premix supplier (DSM) for the toxic levels of vitamin D in its canned dog foods.

Although the Hill’s written procedures called for testing of vitamin D levels in the premix, the company was unable to provide any evidence to FDA inspectors that those tests had been carried out.

Subsequent tests conducted on a retained sample of the premix revealed a level of vitamin D that was roughly 30 times the target range for this ingredient.

As of February 11, 2019, Hill’s acknowledged having received 85 consumer complaints reporting pet deaths.

More than 20 civil lawsuits have been filed against Hill’s Pet Nutrition by grieving pet owners.

FDA offers the following information regarding vitamin D toxicity to pet owners and veterinarians.

  • If your pet is having symptoms of vitamin D toxicity, contact a veterinarian immediately. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.
  • Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them.
  • Consumers can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.
  • The FDA encourages veterinarians treating vitamin D toxicity to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostics. You can submit these reports electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.
  •  Veterinarians should also be aware that vitamin D toxicity may present as hypercalcemia, similar to dogs that have consumed rodenticide. In these cases, FDA suggests that veterinarians confirm diet history to verify whether the dog has been eating any of the recalled products.

For a comprehensive list of Hill’s Pet Nutrition canned pet foods recalled due to excessive Vitamin D, please visit Hill’s Pet Nutrition recalls: Country-by-country breakdown on eFoodAlert