Statement in Response to FDA Findings

On June 27, 2019, the Federal Drug Administration (FDA) issued its third status report on its investigation into any potential connection between certain diets and Dilated Cardiomyopathy (DCM), a type of heart disease, in dogs.  While DCM impacts less than one percent of U.S. dogs, with .0007% being supposedly related to diet, we recognize that these studies are of critical importance to those families whose beloved dogs have been afflicted by this heart diseases.   

As you review the FDA’s most recent report, it’s important to understand the following:

·      The American Veterinary Medical Association estimates that there are 77 million pet dogs in the United States. Most dogs in the U.S. have been eating pet food without apparently developing DCM. 

·      The FDA continues to believe that the potential association between diet and DCM in dogs is a complex scientific issue that may involve multiple factors and that the actual cause has still yet to be determined.

·      Among all the cases from all brands that were reported to the FDA, the overwhelming majority of impacted dogs belonged to breeds genetically predisposed to DCM, a disease that was first discovered in the 1980’s well before the grain-free diets were available for pets. 

·      The DCM cases reported to the FDA included dogs who ate both grain and grain-free diets.

·      The FDA states that chicken is the number one protein of affected dogs, as you know, Zignature does not use chicken.  The FDA also stated that no one animal protein was predominant, refuting the earlier claim that this issue is caused by exotic proteins.

·      The FDA issued the June 27th update, even though it has no definitive answers yet, to solicit additional reports from pet owners and veterinarians to help further it’s investigation.

To further efforts to fully understand these cardiac issues we have created a dedicated customer care line.  We encourage our customers or their veterinarians to call  (888) – 897-72-07 6:30 am – 3:00 pm PST. This company was founded out of a passion and commitment to pet health and we care deeply about animals. We continue to invest in our own research to ensure we continue to make the safest and highest quality pet food on the market today.

FAQ

 What is Canine DCM?

 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). DCM is prevalent in certain breeds, especially larger dogs. 

How do I know if my dog has DCM?

Please contact your veterinarian to determine if diagnostic tools such as echocardiograms are deemed prudent for your dog. If your dog is showing possible signs of DCM or other heart conditions, including decreased energy, cough, difficulty breathing and episodes of collapse, you should contact your veterinarian immediately.

Is this an issue only for boutique brands of dog food?

No.  The pet food advocacy website, the truthaboutpetfood.com, has taken a close look at the data that the FDA has released and found that the FDA received a significant number of DCM reports from the largest pet food producers.

Is there a link between exotic proteins and DCM?

Based on the most recent data released by the FDA, and contrary to previous speculation, that does not seem to be the case.  Most of the cases (more than 50%) reported to the FDA were for foods containing chicken, lamb and salmon.

How does Zignature formulate its food?

Our meticulously designed diets have been formulated by a thought-leading team of veterinarians, PhD animal nutritionists and veterinary research scientists to deliver the safest pet products on the market that exceed the industry’s AAFCO guide for balanced and thorough nutrition.

Has Zignature been contacted by the FDA? Are you cooperating with the agency?

We want to do all we can to help the scientific community determine if there is any tie between a dog’s diet and dilated cardiomyopathy.  We intend to share any data we collect through our customer care line with the FDA to help further their investigation.

Why are you continuing to use legumes in your diets?

Millions of dogs that suffer from severe allergies from gluten are able to live healthy lives because of grain free solutions like Zignature. As no one has been able to determine if or what the association may be between a dog’s diet and this rare cardiac condition, we believe it’s important that we continue to serve the millions of dogs that thrive on our diets.  

We remain confident that the pet products created by Zignature’s expert formulation team of veterinarians, PhD animal nutritionists and veterinary research scientists deliver the safest and most nutritious dietary standards available today. Our diets have always included taurine through meats and fish in all our products, which is important given that taurine is a meaningful nutrient dogs are sometimes unable to synthesize naturally. While taurine has always been included in our diets, new studies have shown that extra taurine is important for dogs cardiovascular health. Zignature further supplements all of its diets with extra taurine and L-Carnitine, providing some of the highest level of taurine available in the industry.

Zignature Statement in Response to FDA Findings

June 27, 2019

Our company was founded by pet parents who have a passion and commitment to pet health. Our meticulously designed diets have been formulated by a thought-leading team of veterinarians, PhD animal nutritionists and veterinary research scientists to deliver the safest pet products on the market that exceed the industry’s AAFCO guide for balanced and thorough nutrition. 

While the vast majority of our customers thrive with our high quality, grain-free pet formula, we are taking the FDA’s recent announcement very seriously. 

As such, we have created a dedicated customer care line (888-897-7207 6:30am – 3:00pm PST ) so we can understand more to further ensure the safety of all pets. As the FDA said in it’s release, it still does not have enough information to fully understand these cardiac issues. 

Any pet owners or veterinarians who have information on this matter are strongly encouraged to contact our dedicated customer care line backed by our team of veterinary experts and nutritionists. Ensuring the health of all our pet customers continues to be our top priority.

 

Communication on the DCM concern and the current facts

June 7, 2019

We are committed to pets being their happiest and healthiest

Zignature was created 8 years ago by pet parents with a passion and commitment to make the highest quality, most nutritious and safest pet food on the planet. Our goal and devotion is to continue to formulate the world’s safest pet food products that are nutritionally strong and provide a path for pets to be their happiest and healthiest. 

Meticulously designed diets by a team of veterinary research scientists and nutritional experts 

Interest in dilated cardiomyopathy (DCM) in dogs and the ongoing FDA investigation into the long-standing pattern generated questions for us at Zignature and our valued pet parents. Our desire is to communicate our thoughts on the ongoing FDA investigation and share with pet parents, like you, the immense confidence we have in our meticulously designed diets formulated by Zignature’s thought leading team of veterinarians, PhD animal nutritionists and veterinary research scientists. Since the founding of our company in 2010, our products are exactingly formulated by this team to deliver you and your pets the safest, most nutritious pet products on the market and meet standards far above the industry’s AAFCO guide for balanced and thorough nutrition.  

Taurine levels in Zignature products are some of the highest in the industry

We remain confident that the pet products created by Zignature’s expert formulation team of veterinarians, PhD animal nutritionists and veterinary research scientists deliver the safest and most nutritious dietary standards available today. Our diets have always included taurine through meats and fish in all our products, which is important given that taurine is a meaningful nutrient dogs are sometimes unable to synthesize naturally. While taurine has always been included in our diets, new studies have shown that extra taurine is important for dogs cardiovascular health. Zignature further supplements all of its diets with extra taurine, providing some of the highest level of taurine available in the industry. 

The FDA is not advising any dietary changes 

The FDA’s most recent position is that DCM is scientifically complex and likely involves many components. The majority of factors talked about include long-standing genetic predisposition (largely in golden retrievers), appropriate diet of essential nutrients, and the ability for nutrients to be synthesized by a dog’s physiology.  In the most recent FDA update on 2/19/19, it said “The reports include dogs that have eaten grain-free and grain containing foods, and also include vegetarian or vegan formulations. They also include all forms of diets: kibble, canned, raw and home-cooked. This is why we do not think these cases can be explained simply by whether or not they contain grains, or by brand or manufacturer.”* The FDA also said, “At this time, we are not advising dietary changes based solely on the information we have gathered so far.”

Thus, the FDA is not advising dietary changes based on the data it has gathered. From our own internal studies and the conclusion of many experts in the industry it appears that the real cause for the increase in DCM in dogs could take years to be discovered. 

Zignature internal studies reveal no correlation to DCM 

In parallel with the FDA investigation, our own third party internal studies found no link between our high quality pet food products and any of the other physical characteristics that correlate to DCM.

DCM was discovered 18 years ago in 2001 before 21st Century grain free diets 

DCM is not a new problem with dogs. The connection between diet and DCM in dogs was first discovered in a paper published in the Journal of the American Veterinary Medical Association in 2001.12 cases of DCM described in the paper were collected between 1997 and 2001, years before grain-free dog food became available and popular on the market this century.

We have great confidence in our naturally sourced grain-free diets

As we continue to have great confidence in our naturally sourced diets that meet the needs of dogs who suffer from allergies and grain intolerances, we are providing an exclusive line designed by our expert formulation team that is nutritionally sound and grain-inclusive. We feel as a partner to pet parents, it is important for us to listen to and understand our valued extended family, and offer a variety of pet food that most aligns with the needs of your pet family.

We will continue to do whatever it takes to keep your pet safe

We are committed to doing whatever it takes to keep your pet safe. If you have any concerns about DCM or other health issues, we encourage you to reach out to us directly at contact@pets-global.com so we can connect you with one of our resident expert pet nutritionists or veterinary research scientists to discuss together.