FDA statement and the Acana Letter

RETAILER TOOLKIT – KANSAS STATE UNIVERSITY SPONSORED MEETING (“COLLOQUIUM”) ON DCM November 5, 2020

LINK TO CHAMPION PET FOODS ONLINE DCM REFERENCE

Champion has created an online resource with information about DCM that retail partners can post on their websites with or without a formal message. Currently, Champion has funded paid search through the end of November to drive consumers searching for information about DCM to this portion of our website. Here is the link to the landing page, as well as a snapshot of the top of the page.

https://championpetfoods.com/en/dilated-cardiomyopathy.html

KEY MESSAGES:

MUCH NEEDED CLARITY FROM FDA ON DILATED CARDIOMYOPATHY (DCM) IN DOGS:

• DCM is a rare and scientifically complex disease that impacts approximately 1% of dogs in the U.S. On November 3 Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, provided an important update and much-needed clarity on the causes of Dilated Cardiomyopathy (DMC) in dogs. We are pleased that the conclusions he drew about DCM, are very much in line with those we have drawn at Champion Petfoods and the research we have conducted and shared with the pet food industry.

Namely, Solomon underscored:

• DCM is a complex medical condition about far more than diet: “Historically, DCM has been primarily linked to genetic predisposition in certain breeds, but in the context of these atypical cases, emerging science indicates that non-hereditary DCM is a complex medical condition that may be affected by the interplay of multiple factors such as genetics, underlying medical conditions and diet,” Solomon wrote.

• No pet food has been declared unsafe or linked to DCM: “FDA has not taken regulatory action against or declared any specific pet food products unsafe or definitively linked to DCM,” Solomon wrote. “The scientific community engaged on DCM continues to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM.”

Dr. Solomon’s latest update can be found via this link.  Proceedings from the scientific forum were published by Kansas State at the end of October and can also be found here:

https://www.fda.gov/animal-veterinary/cvm-updates/interdisciplinary-scientific-cooperation-will-lead-way-understanding-non-hereditary-dcm

• Solomon’s important update follows a virtual scientific forum that took place on September 29 at Kansas State University. Champion Petfoods, along with other researchers, academics, veterinarians, and other pet food manufacturers presented research on the cause of DCM. Members of the U.S. Food and Drug Administration (FDA) provided a scientific update on an investigation that it launched in July 2018.

• More than 20 people presented and provided a variety of research and perspectives focused on genetics, nutrition and overall pet health and condition. Champion was one of only two manufacturers selected to present at the meeting. 

• Champion’s in-house animal nutrition experts, and other industry-leading nutritionists, cardiologists, geneticists and researchers, presented a broad range of differing scientific perspectives on potential causes linked to the disease. Presentations highlighted the scientific complexity of DCM and reiterated that multiple factors can contribute, alone or in combination, to the development of the disease including breed, genetics, biology, pre-existing health conditions, digestive issues, obesity, nutrition and processing of key nutrients, as well as activity level.

WHAT CHAMPION PRESENTED: 

• Champion’s in-house animal nutrition experts shared their analysis of FDA data, their theory on factors related to DCM and the results of our research and reinforced that:

• Grain-free foods are not hazardous to a dog’s health and are not inherently dangerous. If they were unsafe, the FDA would have taken regulatory action. It has not done so.
• DCM is a rare and complex disease in dogs, the development of which may be determined by the interplay of multiple factors.
• We have seen no scientific evidence that the absence of grains in a dog’s diet causes DCM or that the presence of grains in a dog’s diet protects against DCM.
• Implication of grain-free foods in the development of DCM is an over-generalization that is unsupported by robust scientific evidence.

FINAL TAKEAWAYS:

• In addition to the research Champion presented, information presented at the scientific forum reinforced that millions of dogs have been eating grain-free diets for years and thrived. This provided important perspective – that DCM affects less than 1% of the 77 million pet dogs in the U.S. compared with cancer that will affect 1 in 4 dogs and obesity that will impact 1 in 3 dogs.  Sound nutrition must address the overall health of the dog.

• Champion is passionate about the premium quality of the grain-free food we make and how our recipes provide the nutrition that contributes positively to a healthy pet. We know that our grain-free foods are safe, nutritionally complete, and designed for optimal health. This industry should continue to represent grain-free foods with confidence and feel good about the nourishment grain-free foods provide pets.

ABOUT CHAMPION:

• Founded in a small town in Alberta, Canada, Champion Petfoods is committed to pet health and sound nutrition guides all we do.  At Champion, we have been pioneers in crafting premium food for dogs and cats since 1985. 

• We specialize in making foods that are Biologically Appropriate to nourish as nature intended. That means we include high amounts of the finest whole prey ingredients from both fresh and raw animal sources.  Our ingredients have been selected from carefully curated suppliers whom we know and trust. 

Our foods are crafted by passionate nutrition and health experts in world class kitchens, and as Pet Lovers ourselves, we guarantee the highest quality and safety in every ORIJEN and ACANA product we make.  Champion sells products in nearly 100 countries worldwide.

Association of American Feed Control Officials (AAFCO) Nutritional Standards: At Champion Petfoods, all of our food is formulated by our in-house team of qualified animal nutritionists and veterinary experts to meet standards established by the Association of American Feed Control Officials (AAFCO).  AAFCO is a non-profit organization that enforces regulations established by the FDA Center for Veterinary Medicine and provides nutritional standards for complete and balanced pet foods.  Overall, our industry-leading and award-winning quality assurance far exceeds AAFCO standards.  

World Small Animal Veterinary Association (WSAVA) Global Nutritional Recommendations: World Small Animal Veterinary Association (WSAVA) is an association of companion animal veterinary associations with the goal of advancing the health and welfare of animals through raising standards of veterinary care around the world.  At Champion Petfoods, we test our foods throughout the manufacturing process for nutritional accuracy, digestibility and palatability, answering the key questions outlined by WSAVA to help pet lovers and veterinary experts select quality dog food.

FAQ

1. What did the FDA recently communicate about the causes of DCM in dogs?

On November 3, Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, provided an important update and much-needed clarity on the causes of Dilated Cardiomyopathy (DMC) in dogs. We are pleased that the conclusions he drew about DCM, are very much in line with those we have drawn at Champion Petfoods and the research we have conducted and shared with the pet food industry. Namely, Solomon underscored:

• DCM is a complex medical condition about far more than diet: “Historically, DCM has been primarily linked to genetic predisposition in certain breeds, but in the context of these atypical cases, emerging science indicates that non-hereditary DCM is a complex medical condition that may be affected by the interplay of multiple factors such as genetics, underlying medical conditions and diet,” Solomon wrote.

• No pet food has been declared unsafe or linked to DCM: “FDA has not taken regulatory action against or declared any specific pet food products unsafe or definitively linked to DCM,” Solomon wrote. “The scientific community engaged on DCM continues to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM.”

Based on the scientific evidence presented at the meeting and the outcomes shared by Dr. Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, we continue to believe grain-free foods are safe and nutritionally complete. 

2. What is DCM?

Dilated cardiomyopathy (DCM) in canines is a disease that 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 exceedingly rare - while there are 77 million pet dogs in the U.S., less than 1% may develop DCM.  Based on the available scientific evidence, we know many factors may cause a dog to develop the disease including breed, genetics, biology, pre-existing health conditions, digestive issues, obesity, nutrition and processing of key nutrients, as well as activity level.

3. Solomon indicated that continued research is needed for a “fuller understanding of non-hereditary DCM”. What does this mean? Will the FDA find out what the true cause of DCM is?

According to Dr. Solomon’s recent remarks the FDA views the research into DCM as a an “ongoing, collaborative, multidisciplinary scientific venture” and that the scientific community engaged on DCM will need to continue “to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM.”  Dr. Solomon emphasized that the FDA has just one piece of the venture, as the regulator of animal food and reviewer of adverse event reports.  On this basis, we do not believe the FDA will be serving in a sole capacity to find the solution for hereditary DCM. Rather, they will provide additional updates if and when substantive scientific information comes to light.

4. Who attended and shared data at the research for (“colloquium”)?

Champion Petfoods, along with over 120 other researchers, academics, veterinarians, members of the FDA and other pet food manufacturers, convened virtually on September 29. Over 20 individuals presented a variety research and perspectives with presentations focused on genetics, nutrition and overall pet health and condition. Champion was one of only two manufacturers selected to present its research at the meeting.

Presentations provided a balanced and broad range of scientific perspectives on potential causes linked to the disease, highlighting the scientific complexity of DCM and its many contributing factors.

5. What data did Champion present at the Colloquium?

Champion’s in-house animal nutrition experts shared their analysis of FDA data and their research on factors related to DCM.  Champion's research shows there are many causal factors that may lead to DCM, including breed, genetics, biology, pre-existing health conditions, digestive issues, obesity, nutrition, activity level, and ability to process key nutrients – all of which help to define the unique nutritional needs of the individual dog.  Champion's research also examined the digestibility of grain-free foods and concluded that grain-free foods are nutritionally sound.

6. What information does Champion provide the FDA on the safety of its products?

We are committed to frequent and open communication with the FDA to provide the latest data, research and science on the safety and quality of our products. While the FDA has reiterated that the issue is not a regulatory one, as a matter of science we are able to help clarify with agency representatives the nutritional benefits of grain-free diets and further the understanding of the multiple factors contributing to DCM.  We know the FDA has appreciated this transparency.

7. Does this change FDA’s previous position on grain-free foods? Are they safe for all dogs now?

It continues to be our perspective that grain-free foods are safe and nutritionally complete.  The outcome shared by Dr. Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, underscores two main points about DCM:

• DCM is a complex medical condition about far more than diet: “Historically, DCM has been primarily linked to genetic predisposition in certain breeds, but in the context of these atypical cases, emerging science indicates that non-hereditary DCM is a complex medical condition that may be affected by the interplay of multiple factors such as genetics, underlying medical conditions and diet,” Solomon wrote.

• No pet food has been declared unsafe or linked to DCM: “FDA has not taken regulatory action against or declared any specific pet food products unsafe or definitively linked to DCM,” Solomon wrote. “The scientific community engaged on DCM continues to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM.” 

8. While DCM may be multifactorial, are any factors more likely than others?

Why some dogs develop DCM is a complex issue that has been studied by scientists for decades. From published research and data presented at the Colloquium we know many factors may cause a dog to develop DCM including breed, genetics, biology, pre-existing health conditions, digestive issues, obesity, nutrition and processing of key nutrients, as well as activity level. We believe the best diet for your dog depends on the unique nutritional needs of your pet.

9. What if my dog demonstrates risk factors for DCM? How should that impact my diet selection?

We believe the best diet for your dog depends on the unique nutritional needs of your pet. If a health assessment of your pet determines that they are a part of the small number of dogs at risk for DCM, due to breed, genetics, biology, pre-existing health conditions, digestive issues or obesity, you may have particular considerations when choosing the best diet. This could include specific protein content, the origin of the protein, considerations for taurine levels, vitamin or nutritional supplements. However, grain-free foods are known as a safe and nutritious option for dogs, and have helped millions of dogs thrive.   

10. What additional industry or Champion research is underway about grain-free and DCM?

Champion is actively working internally and with other leading researchers to advance research and provide accurate information about nutrition and pet health based on sound science.  Most recently, our studies have included:

• We wanted to know whether the absorption of an amino acid called taurine, which contributes to eye health, reproduction, fat digestion and a healthy heart, was impacted by the consumption of grain-free foods. Through a 26-week AAFCO feeding trial in a cohort of 8 Labs, we found that taurine status actually improved when dogs were switched from a grain-based to a grain-free food. This is important because there is a hypothesis that inadequate levels of taurine is a factor associated with the development of DCM in dogs.
• Another common misconception is that grain free foods are less digestible than grain-based foods due to their legume content. A recent study of digestibility and bioavailability of amino acids in different diets showed that their legume content did not negatively impact digestibility or bioavailability of amino acids such as taurine, methionine and cystine.
• We have completed studies on starch, fiber, and amino acids, including taurine, in all our ACANA and ORIJEN diets. We compared across other industry diets that are both grain-based and grain-free. We concluded that our ORIJEN and ACANA diets are nutritionally complete and sound. 

11. You say research says grain-free foods are safe, but other dog food manufacturers say research says they’re not safe. Who should people believe?

There is no question that grain-free foods are safe and nutritionally complete.  Champion has been making premium grain-free foods for 15 years, and dogs thrive on our products.  

On November 3, Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, provided an important update and much-needed clarity on the causes of Dilated Cardiomyopathy (DMC) in dogs. We are pleased that the conclusions he drew about DCM, are very much in line with those we have drawn at Champion Petfoods and the research we have conducted and shared with the pet food industry. Namely, Solomon underscored:

• DCM is a complex medical condition about far more than diet: “Historically, DCM has been primarily linked to genetic predisposition in certain breeds, but in the context of these atypical cases, emerging science indicates that non-hereditary DCM is a complex medical condition that may be affected by the interplay of multiple factors such as genetics, underlying medical conditions and diet,” Solomon wrote.

• No pet food has been declared unsafe or linked to DCM: “FDA has not taken regulatory action against or declared any specific pet food products unsafe or definitively linked to DCM,” Solomon wrote. “The scientific community engaged on DCM continues to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM.”

We are passionate about the premium quality of the grain-free food we make and are committed to optimizing pet health through sound nutrition. Grain-free foods are safe and nutritionally complete – our history and the science proves it. This industry should continue to represent grain-free foods with confidence and feel good about the value grain-free foods provide pets.

12. What about the ongoing claims that diet is a factor and potential cause of DCM?

From the scientific evidence presented at the Colloquium, to the recent remarks delivered by Dr. Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, we know that pointing to grain-free foods as a potential cause of DCM is not supported by robust scientific evidence and actually distracts from identifying the real causal factors.

We also know that good nutrition is always a factor in good health.  That is as true in dogs as in people. Here is what makes Champion’s products the right choice to ensure optimal health:    

• More than 35 years of experience in making pet food
• State-of-the-art manufacturing facilities in which we make all our products
• We analyze every formula according to the most rigorous industry standards to validate the nutritional adequacy of every diet, both at the time of development and routinely from commercial production
• We substantiate the nutritional adequacy of our diets with AAFCO Feeding Trials;
• We have an internal team of qualified nutritionists, scientists, and a veterinarian who guides our formulation, validation, food safety, and research programs
• We have research partnerships globally, and we do peer-reviewed published research
• This level of commitment ensures we remain on the cutting edge of science and sound pet nutrition

13. What do you have to say now to people who claim their dogs died from eating your grain-free food?  

As pet lovers ourselves, we know the heartache that comes from losing a pet, and our hearts go out to anyone that has experienced that loss. We know pet lovers are looking for answers, and we are committed to ensuring our foods are safe and continuing research on important topics, like the impact of nutrition on the development of DCM. 

Based on available scientific evidence, grain-free foods are not dangerous or unsafe.  The FDA has reiterated that DCM is a scientifically complex disease that is caused by many factors. Those factors include breed, genetics, biology, pre-existing health conditions, digestive issues, obesity, activity level, and the dog's ability to process key nutrients. Pointing to a grain-free diet as the cause of DCM is unsupported by the scientific evidence and does not advance our understanding of the disease. 

If grain-free products were the cause of a fatal disease, FDA would be required to take regulatory action, which it has reiterated it does not plan to do.

14. I’ve heard about DCM linked to grain free foods with legumes. How much legume content do your foods have? Why do you still use legumes?

Currently, researchers attribute many factors as possible causes for DCM in dogs, including genetics, breeding and lifestyle. The FDA has stated that: “…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.”

Legumes are not a significant feature in Champion's recipes, and never have been. We know how important animal protein is in a dog's diet.  Our high meat inclusions provide our dogs' diets with all the essential amino acids, such as methionine and cystine (the precursors to the synthesis of taurine), as well as many essential vitamins and minerals. We also choose to use a blend of fruits and vegetables for their nutritional benefits. Our legume ingredients provide a great source of fiber, and essential vitamins and minerals, such as zinc, folate and copper.

15. I’ve heard a lack of taurine can contribute to DCM. What does Champion do to monitor taurine in its products?

Champion has set minimum standards for the amount of taurine we require in our foods. While high levels of taurine naturally occur in many of the ingredients in our foods, including fish, meat and poultry, if our minimum standard is not met, we add more taurine to our recipes to ensure dogs who eat our foods are getting the complete nutrition they need.

We have also conducted a 26-week AAFCO feeding trial in a cohort of 8 Labs that found that taurine status was not negatively affected and improved when dogs were switched from a grain-based to a grain-free food. From studies presented at the Colloquium, it is clear that data are currently inconclusive and do not show a causal relationship between low taurine levels in dog food and DCM. Overall, more research on this topic is required. 

FDA Provides Much-Needed Clarity on DCM in Dogs

• On November 3 Steven Solomon, DVM and Director of the FDA’s Center for Veterinary Medicine, provided an important update and much-needed clarity on the causes of Dilated Cardiomyopathy (DMC) in dogs. Namely, Solomon underscored:

• DCM is a Complex medical condition about far more than diet: “Historically, DCM has been primarily linked to genetic predisposition in certain breeds, but in the context of these atypical cases, emerging science indicates that non-hereditary DCM is a complex medical condition that may be affected by the interplay of multiple factors such as genetics, underlying medical conditions and diet,” Solomon wrote. 

• No pet food has been declared unsafe or linked to DCM: “FDA has not taken regulatory action against or declared any specific pet food products unsafe or definitively linked to DCM,” Solomon wrote. “The scientific community engaged on DCM continues to assess the available information and fill data gaps to determine what factors may contribute to the development of non-hereditary DCM.”

• Solomon’s important update follows a virtual scientific forum that took place on September 29 at Kansas State University. Researchers, academics, veterinarians, members of the U.S. Food and Drug Administration (FDA), and other pet food manufacturers presented research on the cause of DCM.

The Bottom Line   

• The implication of grain-free foods in the development of DCM is an over generalization and oversimplification not supported by the robust scientific evidence. A misplaced focus on grain-free foods distracts from identifying the multiple potential factors that cause DCM. 
• Research demonstrates that a dog with a genetic predisposition to developing DCM and/or has other conditions, such as diabetes, digestive issues, or obesity, play a role in how the dog accesses essential nutrients in the food and may contribute to the possibility of developing DCM.
• Millions of dogs have been eating grain-free diets for years and have thrived. This provided important perspective – DCM affects less than 1% of the 77 million pet dogs in the U.S. compared with cancer that will affect 1 in 4 dogs and obesity that will impact 1 in 3 dogs.  Sound nutrition must address the overall health of the dog.
• Grain-free foods are safe, nutritionally complete and designed for optimal health.

We value the relationship we have with all of you who frequent our store(s) and our website  seeking recommendations and information from us.  If you have questions about DCM we hope the latest information helpful.  As a trusted resource in providing information about pet health, we’ll keep you updated with the latest information on this important issue.  Thank you!

 LINK TO CHAMPION PETFOODS ONLINE DCM REFERENCE

 Champion has created an online resource with information about DCM that retail partners can post on their websites with or without a formal message. 

 Currently, Champion has funded paid search through the end of November to drive consumers searching for information about DCM to this portion of our website. Here is the link to the landing page, as well as a snapshot of the top of the page.

https://championpetfoods.com/en/dilated-cardiomyopathy.html