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Questions & Answers: FDA’s Work on Potential Causes of Non-Hereditary DCM in Dogs

In September 2020, FDA joined scientific experts from academia, industry, and veterinary medicine in a scientific forum hosted by Kansas State University to examine the potential causes of non-hereditary dilated cardiomyopathy (DCM) in dogs. The event was a forum where scientists with research into DCM could share information, collaborate, and discuss many different – and even conflicting – theories on the condition. FDA; the veterinary community, especially veterinary nutritionists and veterinary cardiologists and other specialists; industry and academia, continue to examine this issue to help determine what factors may be contributing to the heart conditions observed and reported to FDA.

Because every dog is unique and has their own nutritional needs, your veterinarian is in the best position to advise you on how to best feed your dog. Please consult your veterinarian to discuss before making a change in your dog’s diet. We encourage veterinarians to review the KSU proceedings. We recognize that you may have questions. Below we have compiled answers to address some of the frequently asked questions raised by pet owners and veterinarians. These may be updated as we learn more. 

1. What is canine dilated cardiomyopathy (DCM) and how does non-hereditary DCM differ from the genetic form?
DCM is a disease of a dog’s heart muscle and results in an enlarged heart. As the heart and its chambers become dilated, it becomes harder for the heart to pump, and heart valves may leak, which can lead to a buildup of fluids in the chest and abdomen (congestive heart failure). Historically, DCM has been primarily linked to a genetic predisposition in certain breeds, but emerging science appears to indicate that non-hereditary forms of DCM occur in dogs as a complex medical condition that may be affected by the interplay of multiple factors such as genetics, underlying medical conditions, and diet. Aspects of diet that may interact with genetics and underlying medical conditions may include nutritional makeup of the ingredients and how dogs digest them, ingredient sourcing, processing, formulation, and/or feeding practices.

Reports from veterinary cardiologists demonstrate some good results in improving heart function in non-hereditary DCM cases, unlike genetic forms of DCM, with appropriate veterinary treatment and dietary modification, when caught early in the progression of the disease.

2. Why is FDA focused on potential dietary causes of non-hereditary DCM?
While non-hereditary DCM appears to be caused by a confluence of multiple factors, FDA is a regulatory agency and has regulatory authority over animal food, including pet food, thus the reason for the agency’s focus on diet as a potential contributor. There is no public health agency that tracks animal health in the same way that the Centers for Disease Control and Prevention tracks human health, therefore FDA has called on the veterinary and academic communities, as well as industry, to contribute research on various aspects of non-hereditary DCM. Many representatives from these sectors participated in the recent KSU scientific forum and several agreed to publicly share their abstracts and/or presentations.

3. What is FDA doing to better understand non-hereditary DCM cases? 
Our veterinarians, animal nutritionists, epidemiologists and pathologists have been working with veterinary cardiologists and nutritionists from academia, industry and private practice to better understand the clinical presentation of the cases and potential ties to diet, such as bioavailability of critical nutrients and how well a dog digests these nutrients. FDA scientists also presentedExternal Link Disclaimer at the KSU symposium on a subset of dogs that had fully or partially recovered from DCM with diet change and veterinary care.

4. What additional information would help further understanding of non-hereditary DCM?
FDA is encouraged by the response of veterinary cardiologists, veterinary nutritionists, academia and industry in delving into this issue and we encourage other scientists to take part. As we look further into the role that diet may play in these cases, we hope to explore additional avenues of inquiry such as formulation, nutrient bioavailability, ingredient sourcing, and diet processing to determine if there are any common factors. We have asked pet food manufacturers to share diet formulation information, which could substantially benefit our understanding of the role of diet in the development of non-hereditary DCM. Formulation data shared with the FDA will be kept confidential.

5. How many cases have been reported to the FDA?
Between January 1, 2014 and July 31, 2020, the FDA received more than 1100 case reports of diagnosed dilated cardiomyopathy in dogs. The majority of these cases were reported immediately after FDA provided public updates. Some of these cases involved more than one animal from the same household. In the reported cases, more than 280 of those dogs were reported to have died.  Of the approximately 20 cat reports, there were approximately 13 cat deaths. The agency received additional reports of other types of cardiac disease in dogs, however, these reports did not meet our case definition requirement of a confirmed DCM diagnosis.

6. Do the diets associated with cases of non-hereditary DCM appear to have any commonalities?
Most of the diets associated with the reports of non-hereditary DCM have legume seed ingredients, also called “pulses” (e.g., peas, lentils, etc.), high in their ingredient lists (although soy is a legume, we did not see a signal associated with this ingredient). These include both “grain-free” and grain-containing formulations. Legumes, including pulse ingredients, have been used in pet foods for many years, with no evidence to indicate they are inherently dangerous, but analysis of data reported to CVM indicates that pulse ingredients are used in many “grain-free” diets in greater proportion than in most grain-containing formulas. FDA has asked pet food manufacturers to provide diet formulations so we can further understand the proportions of ingredients in commercially-available diets and possible relationships with non-hereditary DCM.

The FDA does not know the specific connection between these diets and cases of non-hereditary DCM and is continuing to explore the role of genetics, underlying medical conditions, and/or other factors. 

7. Is FDA planning to continue naming the brands most associated with cases?
No, we are not planning to update the commonly reported brands, as we are aware that several pet food companies have adjusted diet formulations since our initial announcements about DCM. We have asked pet food manufacturers to share diet formulation information, which could substantially benefit our understanding of the role of diet in these cases. We continue to encourage pet owners to discuss their animals' diets with their veterinarians.

8. Is this an issue with only grain-free diets or diets containing legumes or pulses?
No. FDA has received reports of non-hereditary DCM associated with both grain-free and grain-containing diets. Most of the diets associated with reports of non-hereditary DCM have non-soy legumes and pulses (e.g., peas, lentils, etc.) high in their ingredient lists. However, it is important to note that legumes and pulses have been used in pet foods for many years, with no evidence to indicate they are inherently dangerous. CVM’s data show that pulse ingredients are likely used in many “grain-free” diets in greater proportion than in most grain-containing formulas.

9. As a regulatory agency, has FDA requested any recalls of pet foods associated with non-hereditary DCM?
FDA has no definitive information indicating that the diets are inherently unsafe and need to be removed from the market, but we are continuing to work with stakeholders in assessing how the diets may interact with other factors that may be impacting non-hereditary DCM. We encourage pet owners to work with their veterinarians, who may consult with a board-certified veterinary nutritionist, prior to making diet changes. We also encourage veterinarians to review the proceedings of the KSU symposium in order to learn more about non-hereditary DCM. FDA continues to pursue scientific understanding of non-hereditary DCM and welcomes additional contributions from other scientists.

10. How long will it take to pinpoint the cause(s) of non-hereditary DCM?
We see this as an ongoing, collaborative scientific venture, of which FDA has just one piece as the regulator of animal food and reviewer of adverse event reports received as part of the pet food early warning and surveillance system. The scientific community continues to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM. We look forward to continuing to engage with scientists as opportunities arise. We will also provide additional updates to notify the public if or when substantive scientific information comes to light.




FDA continues investigation into dog heart damage linked to diet

Since the first warnings about canine heart failure possibly associated with grain-free pet foods, scientists are still trying to figure out the cause.

It was only by chance that veterinarians discovered that Martha Martin’s beloved black Lab, Sophie, had developed a potentially fatal heart disease. The dog was being treated for a snake bite when the veterinarian detected an abnormal heart rhythm and ordered up an echocardiogram. “I’ll never forget when the vet turned to me and asked if Sophie was being fed a grain-free dog food,” Martin remembers. “I felt like someone sucker punched me". The 7-year-old dog had been consuming the same brand of grain-free canine food since she was a puppy — as had Martin’s other dog, Bailey. An echocardiogram showed that 9-year-old Bailey also had the beginnings of dilated cardiomyopathy, or DCM.

Martin switched both dogs to a different food, one that contained grain, hoping that might help heal their hearts.

In the more than two years since the Food and Drug Administration first warned dog owners about heart failure in their animals that may be associated with grain-free pet foods, more than 200 dogs have reportedly died from the condition and scientists are still trying to figure out why.

Research has suggested that ingredients used in place of grains in dog food might be involved in the development of DCM, a disease in which the heart gets larger, leaving it weaker. Some breeds of large dogs are genetically susceptible to DCM, including Great Danes, German shepherds and Doberman pinschers, according to VCA Animal Hospitals.

“Most of the diets associated with the reports of non-hereditary DCM have legume seed ingredients, also called “pulses”— peas and lentils, for example — high in their ingredient lists,” FDA spokesperson Monique Richards said. “Although soy is a legume, we did not see a signal associated with this ingredient.”

The issue may be the quantity of ingredients used in nontraditional dog foods.

“Legumes, including pulse ingredients, have been used in pet foods for many years, with no evidence to indicate they are inherently dangerous, but analysis of data reported to [the FDA] indicates that pulse ingredients are used in many “grain-free” diets in greater proportion than in most grain-containing formulas,” Richards said in an email to NBC News. “FDA has asked pet food manufacturers to provide diet formulations so we can further understand the proportions of ingredients in commercially-available diets and possible relationships with non-hereditary DCM.”

However, it’s not clear whether it’s simply the amount of these ingredients in the foods, said Dr. Bruce Kornreich, a veterinary cardiologist in the department of clinical sciences at the Cornell University College of Veterinary Medicine.

“It may not just be what is in the diet,” he said. “It could be where it’s sourced from or how it’s processed.”

A recent study showed that dogs with DCM that were consuming nontraditional dog foods were more likely to show improvements in the condition and to live longer if, along with their heart medications, they were switched to a traditional dog food.

“Our study was a retrospective look at 75 dogs with DCM over a period of time that was just under five years,” said the study's co-author, Dr. Lisa Freeman, a veterinary nutritionist and a professor at the Cummings School of Veterinary Medicine at Tufts University. “One of the new findings in our study was that we had a significant increase over time in the number of dogs with DCM. That increase began even before the first FDA alert.”

To date, the FDA hasn’t recommended a recall of any grain-free products or declared any specific pet food products unsafe. To submit a safety report to the FDA, go to the Safety Reporting Portal.

The Pet Food Institute responded in a statement to NBC News, “PFI member nutritionists, veterinarians and product safety specialists have been closely studying dilated cardiomyopathy (DCM) to better understand whether there is a relationship between DCM and diet in dogs not genetically predisposed to the disease. Drawing on our review of both historic and recent scientific analyses and published papers, PFI members are devoting thousands of hours to improving our understanding of DCM and its causes, all with the goal of advancing pet well-being.”

Millions of dogs in the U.S. regularly consume grain-free foods without reported problems, Dana Brooks, CEO and president of the Pet Food Institute, said via email.

“Current research suggests that a variety of factors may influence the development of DCM in dogs,” she wrote. “The number of submitted DCM reports suggest that, if diet is a factor, it may be among several elements involved such as individual dog physiology.”

Normally in pets with DCM, the heart gets bigger and its contractions get weaker as time goes by, Freeman of Tufts University said. But the hearts of dogs switched to a traditional dog food showed improvements.

“They lived significantly longer than those with no diet change,” she said.

The experience of Martin’s dogs echoes that. She switched Sophie and Bailey over to a grain-containing food. Bailey immediately started to improve and soon had normal ECGs. But Sophie wasn’t as lucky. “Every visit with the cardiologist showed her getting worse,” Martin said. “The cardiologist told me she didn’t think she’d be able to recover. I was crushed.”

Martin had noticed that Sophie seemed to be having digestive issues, too, and on a hunch switched her pet to a food made by the same manufacturer that was geared toward dogs with gut issues.

“She thrived on it,” Martin said. “Several months later, we went to the cardiologist expecting to hear more bad news. Lo and behold, she had turned around and was going the other way. Our vet was ecstatic.”

The number of DCM cases reported to the FDA have been on the rise since it issued its warnings in 2018. By July 31, 2020, the agency had received more than 1,100 reports of DCM in dogs, with 280 dying from the condition. There have also been DCM reports in cats. Of the 20 cases in cats, approximately 13 died.

The FDA, along with experts from academia, industry and veterinary medicine, met virtually in September in a scientific forum hosted by Kansas State University to explore the potential causes of nonhereditary DCM in dogs.

In November, Dr. Steven Solomon, director of the FDA's Center for Veterinary Medicine, reflected on the Kansas State forum on the FDA's website.

“The best thing you as a pet owner can do is to talk to your veterinarian about your dog’s dietary needs based on their health and medical history," he wrote.

Kornreich of Cornell University has sympathy for owners' whose pets are suffering from DCM.

“It’s sad,” he said. “You have to tell people that the decision they made in the management of their baby affected their health. They were trying to do the right thing.”




The U.S. Food and Drug Administration has identified more than a dozen brands of pet food it says are most frequently connected to a spike in reported cases of heart disease in dogs.

The FDA is continuing to investigate more than 500 reports of dilated cardiomyopathy, or DCM, in dogs eating certain types of pet food. A form of canine heart disease, DCM can cause congestive heart failure in dogs. "We know it can be devastating to suddenly learn that your previously healthy pet has a potentially life-threatening disease like DCM," Steven Solomon, director of the FDA's Center for Veterinary Medicine, said Thursday in a statement. Because the FDA has "not yet determined the nature of this potential link, we continue to encourage consumers to work closely with their veterinarians."

Dog Food Brands Named Most Frequently in DCM Cases Reported to FDA. Graph shows the dog food brands most frequently named in reports of DCM submitted to FDA. 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; Rachael Ray Nutrish 10

DCM Cases: Ingredients or Characteristics of Reported Diets (%)

Dog Food Formulations in DCM Reports to FDA

DCM Reports to FDA - Most frequently reported dog breeds. Graph shows number of DCM reports for the most frequently reported dog breeds. Golden Retriever 95; Mixed 62; Labrador Retriever 47; Great Dane 25; Pit Bull 23; German Shepherd Dog 19; Doberman Pinscher 15; Australian Shepherd 13; Unknown 13; Boxer 11; Mastiff 8; German Short-haired Pointer 7; Shetland Sheepdog 7; Weimaraner 7; American Bulldog 6; American Cocker Spaniel 6; Standard Poodle 6; Bulldog 5; Shih Tzu 5

The FDA initially alerted the public to the cases plaguing dogs last July but did not specify food brands. The agency instead pointed to pet food labeled as "grain-free" and containing peas, lentils and other legume seeds and/or potatoes as their primary ingredients.

A new report from the Food and Drug Administration makes navigating the pet food aisle more complicated for dog owners. As The New York Times reports, the FDA has linked 16 popular dog food brands to canine heart disease—many of which bill themselves as healthier options.

The FDA traced adverse cardiovascular symptoms in dogs to many grain-free pet foods that replace ingredients like wheat and corn with peas, lentils, legume seeds, or potatoes. The brands included in the study—listed in descending order of most related heart disease cases—included Acana, Zignature, Taste of the Wild, 4Health, Earthborn Holistic, Blue Buffalo, Nature’s Domain, Fromm, Merrick, California Natural, Natural Balance, Orijen, Nature’s Variety, NutriSource, Nutro and Rachael Ray Nutrish.

Products from these brands are often marketed as "wholesome," "high-protein," and "all-natural" alternatives to conventional dog food. But the new report from the FDA shows that a grain-free diet can be potentially harmful to a dog's health. Between January 1, 2014 and April 30, 2019, the FDA received 560 reports of canine dilated cardiomyopathy, a condition that's typically seen in larger dog breeds and can lead to heart failure. Of those cases, 119 of them were fatal. Canine dilated cardiomyopathy is believed to be partly genetic, but according to the administration, many of the dogs they studied were not genetically predisposed towards the condition. The likely culprit behind their diagnoses was diet.

"We understand the concern that pet owners have about these reports: the illnesses can be severe, even fatal, and many cases report eating 'grain-free' labeled pet food," the FDA stated in the report. "The FDA is using a range of science-based investigative tools as it strives to learn more about this emergence of DCM [dilated cardiomyopathy] and its potential link to certain diets or ingredients."

Makers of grain-free pet food claim that kibble made from corn and wheat doesn't reflect the diet of dogs' wild ancestors, and is therefore bad for them. Canine heath experts say this is a myth: Wild canids like wolves ingest grains in the stomachs of the herbivores they hunt. What's more, grains contain vitamins, minerals, and fiber that dogs can benefit from.

Regardless of a dog's diet, pet owners should be aware of the symptoms of canine dilated cardiomyopathy. A dog that exhibits decreased energy, coughing, difficulty breathing, and episodes of collapse should be taken to the vet as soon as possible.

For more detailed information, please visit https://www.fda.gov/animal-veterinary/news-events/fda-investigation-potential-link-between-certain-diets-and-canine-dilated-cardiomyopathy