The U.S. Food and Drug Administration’s (FDA) public updates on its ongoing investigation into canine dilated cardiomyopathy (DCM) and possible recent links to grain-free pet food have left many pet owners, veterinarians and pet retailers anxious and confused. As for the pet food industry: let’s just say the DCM investigation and FDA updates have strained the bonds of an essential professional working relationship between an industry and its regulators.

Steven M. Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine (CVM), acknowledged as much during his presentation to industry representatives attending the 2019 Feed and Pet Food Joint Conference, hosted by the Pet Food Institute (PFI) and National Grain and Feed Association in Kansas City, September 30-October 2. “I understand that many of you in this room are probably not happy with the information we’ve released in our three updates,” he remarked, in what may have been the understatement of the year.

And, if anyone needed confirmation of the effect on the pet food brands named in FDA’s third update in late June, new data just released from Nielsen showed declining sales for the 16 brands featured most prominently in the alert. (It certainly didn’t help that FDA seemed to highlight those brands, despite its list including dozens more, which led many mainstream media to key on only those 16 featured ones. Nor did FDA provide any context or corroborating information.)

Affected dogs’ entire diet, health overlooked?

Solomon’s presentation, plus his answers to follow-up audience questions about the DCM investigation, caused a lot of head-scratching and concern. For example, he referred several times to CVM’s collection of data on the DCM cases. “We followed the evidence, which led to a potential link to grain-free pet food,” he said. “This isn’t just anecdotal; it’s also corroborated by pet owners and veterinarians,” in terms of their reporting of what the dogs were fed.

But do the investigators really know the levels of those ingredients used in each food, how they may have interacted with other ingredients – and did they have complete health histories for the affected dogs or a thorough list of everything they had been eating? “In almost all cases, the consumer has been over-feeding other edibles (treats, chews, dental bones, bones, rawhide, broths, toppers, supplements, on and on),” wrote George Collings, Ph.D., president and general manager of Nutrition Solutions, on LinkedIn.

Collings and his team have been digging into FDA’s data, along with past peer-reviewed research on DCM and other factors that may be associated with it. “In multiple consumer focus groups, it is difficult to find consumers that feed only one ‘complete and balanced’ food,” he wrote in a document posted on LinkedIn. “By our estimates in dealing with hundreds of consumers, it is likely that 90+% feed other edibles with their pet food and do not consider these extras as part of a daily food regimen.”

In a private conversation with me, Collings reiterated that feeding of such extras contributes to an imbalanced diet, leading to not only rising pet obesity but also, possibly, other diseases. What owners are feeding could be triggering or exacerbating a genetic problem. “Genetic disorders can be made far worse with food regimens that are incomplete and imbalanced,” he wrote on LinkedIn.

Overfeeding and imbalanced pet diets would also explain why another of Solomon’s comments during his presentation suggests CVM is only scratching the surface in its investigation. “In many of these cases, symptoms of DCM are reversed with change in diet and supplementation of taurine, and that’s usually not the case with DCM,” Solomon said. Thus, the agency is focusing its investigation on the pet foods reported by owners of affected dogs, he added.

I wondered about that focus as soon as I heard Solomon’s comments, and Collings seemed to agree it came off as short-sighted. “Changing a DCM patient to a new food simply forces the consumer off the imbalanced food regimen because the new food regimen is now ‘complete and balanced,’” he wrote on LinkedIn, presuming the change also steered the patient away from all the other edible extras it had been eating. Or, as he expressed to me separately: “That's the case with addressing any disease or condition that has a nutritional link; if you change the diet to a complete and balanced one with no excesses, the pet will usually get better.”

Genetic predisposition is key

FDA’s hyper-focus on diet seems to be contributing to the most glaring oversight of all: genetic predisposition. At least two audience members at the 2019 Joint Conference asked Solomon whether CVM was including this in its investigation; he merely doubled down on his previous comments about how they were focusing on the grain-free dietary link.

Yet several people in the industry have written, or expressed privately, that this is a significant area needing further study. On LinkedIn, Collings posted documents referencing peer-reviewed research going back to 1993 documenting DCM as a heritable disease in dogs and especially in purebred dogs; in fact, it’s been documented in 55 different breeds, with 25 breeds being shown as high risk.

Collings and other experts have also pointed out that just documenting the number of times legumes and similar ingredients have appeared in the pet foods being fed to dogs with DCM is a very simplistic way to suggest a link between the disease and grain-free pet foods. Every legume ingredient differs significantly from the others in terms of the types and levels of starches, proteins and fibers present; Collings also delved into this on LinkedIn.

Yet he brought even that aspect back to the genetics. “This report documents how widespread DCM really is, and in fact, in the late 1980s and early 1990s, DCM was reported to be in 0.5% to 1.1% of all dogs. Funny thing, no legumes were fed then.”

FDA’s approach has served no one

In what may be the biggest head-scratcher from CVM, they seem to have had no comprehension of the impact their alerts would have. “They admitted they were taken off guard by the huge reaction among consumers, retailers, veterinarians and on social media,” Dana Brooks, president and CEO of PFI, told me. “They even told ingredient suppliers [of peas, lentils, potatoes and similar ingredients implicated] that pet food companies would never stop using those ingredients! I think they were quite naïve.”

Yes, definitely naïve, and shortsighted in their investigation to the point of maybe even bordering on irresponsible. Worse, their approach doesn’t do service to anyone: not the agency, not the pet food industry, not veterinarians and certainly not the consumers Solomon referred to several times in using the agency’s “public health responsibility” to justify the three narrow DCM updates issued so far.

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dphillips@wattglobal.com