FDA’s curious ‘inflection point’ on DCM (not an update!)

After near silence on the DCM and grain-free pet food investigation and no real updates for a year, FDA has issued statements that raise more questions.

If projections are correct, pet food could weather 2020 in decent shape. | (Sergey Nivens | Shutterstock.com)
If projections are correct, pet food could weather 2020 in decent shape. | (Sergey Nivens | Shutterstock.com)

When it comes to the U.S. Food and Drug Administration’s (FDA) investigation into canine dilated cardiomyopathy (DCM) and a tenuous link to grain-free pet food, it keeps getting curiouser and curiouser, to quote that sage explorer Alice in Wonderland.

Perhaps nothing illustrates the situation better than this recent statement from Steven M. Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine (CVM): “I want to emphasize that this is not an investigative update; it’s an inflection point that provides FDA with an opportunity to clarify and emphasize the following points.”

The statement was part of an overall communication released by FDA/CVM on November 3, 2020, along with an even curiouser Q&A list. Neither document explained what Solomon meant by “inflection point.” The Merriam-Webster dictionary defines the term as “a moment when significant change occurs or may occur: turning point.” If that’s what Solomon meant, it could be a positive sign of the investigation and situation truly progressing. I confess to having doubts.

Stealth forum on DCM: first communication in eight months

The FDA statements came out a little more than a month after the agency organized and hosted a rather under-the-radar virtual scientific forum at Kansas State University (KSU) that featured presentations by Solomon and other CVM representatives, as well as a few industry and other experts. Apparently, Solomon’s presentation comprised an overview of the points he referred to in the statement quoted above. Those included emphasizing that CVM does not consider this a regulatory situation and that pet owners should consult their veterinarians about their pets’ specific health and diet status. The money statement, if you will, was this:

“Historically, DCM has been primarily linked to genetic predisposition in certain breeds, but in the context of these atypical cases, emerging science appears to indicate 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.”

In fewer words, it’s complex and involves many factors, not just diet (if diet is indeed involved). Ryan Yamka, Ph.D., founder and independent nutritionist with Luna Science and Nutrition, provided perspectives and insights on that and other CVM statements and presentations in a recent blog post. I believe many, if not most, people in the pet food industry would agree with his thoughts.

That includes me, but the forum and subsequent CVM statements raise so many other questions. To start, why is this the first we’re hearing from the agency on the DCM situation since late January 2020, when Dave Edwards, Ph.D., of CVM gave what was essentially a non-update (though billed as one) at the 13th Annual Pet Food Conference organized by the American Feed Industry Association?

Obviously, like every other entity around the world, the agency has been dealing with a global pandemic and trying to operate within constraints imposed by that, so it makes sense that their attention has been focused elsewhere. But, in turning their attention back to DCM, why be so quiet, almost stealth, in organizing the virtual forum at KSU?

Puzzling steps and timelines, low confidence

Dana Brooks, president and CEO of the Pet Food Institute (PFI), also presented at the forum and explained to me recently that, from her understanding, FDA/CVM and KSU wanted to keep the focus on science and research to date, rather than having a public forum. She also commented that, because the DCM situation has been so fraught with emotion, from so many sides, she thought CVM wanted to avoid that and instead have just science-based discussions. (Brooks and PFI issued their own statement shortly after CVM’s came out.)

Again, that makes some sense, yet another participant alluded to me that the way presenters and participants were selected for the forum was puzzling; for example, the pet food industry did not seem well represented. This person also said that, though the agency had stressed the “attendee only” aspect of the forum, they then contacted the presenters shortly afterward to ask to share their presentations.

The recent FDA statements present another puzzle: Why did it take over a month for them to be issued? And actually, my contact who participated in the forum shared that during the event, CVM said there would be no forthcoming communiques on the DCM issue. Yet here we have these latest releases.

The end result is that FDA/CVM seems to be figuring this out as they go along, rather than having a proactive strategy and plan. That does not inspire much confidence in their approach.

No strategy or direction on DCM?

Truly, the bottom line to the entire DCM investigation and situation is that FDA/CVM has no answers – which is not necessarily a surprise and, in fact, is as it should be, because there is still so little known and much research yet to do. That’s exactly what many in the pet food industry have been saying since the agency launched its investigation more than two years ago, in July 2018; it’s confounding that it took CVM so long to finally arrive at the same place. More importantly, it raises the question, again, of why they started the investigation at all, announced it very publicly and kept making public announcements (including naming brands in June 2019) until going almost silent this year.

Perhaps more concerning is that CVM doesn’t seem to know where they’re going with this, or if they do, they’re not communicating it well. Solomon stressed that research is ongoing, as I know it is within the industry itself (which Brooks confirmed). Yet based on the recent releases from CVM, it seems they’re still fixated on diet, despite their overall stated position that “non-hereditary” DCM is complex and multifactorial and that the main release is titled, “Interdisciplinary Scientific Cooperation Will Lead the Way to Understanding of Non-Hereditary DCM.”

To wit: In both that release and in the answers to two of the questions in the Q&A, Solomon/CVM said that they have asked pet food manufacturers for their formulations because those could “substantially benefit our understanding of the role of diet.” This is an issue that CVM has been emphasizing all along; Solomon spent several minutes discussing it during an update he gave a little over a year ago at the 2019 Feed and Pet Food Joint Conference, hosted by PFI and the National Grain and Feed Association. Which is a non-starter, for several reasons.

First, after CVM so publicly named brands mid-2019, why would any manufacturer trust the agency with its proprietary formulations? Sure, FDA promises to keep the information confidential, but there’s a lack of trust; and even if they can assuage those concerns, information can always leak or be compromised.

In addition, the focus on formulations epitomizes FDA’s focus on diet in these cases of DCM; as Brooks pointed out, a formulation is only one piece of information that should be considered and researched. FDA’s near obsession with that seems to take us back to square one.

The final indicator that this investigation and CVM’s approach lacks direction or strategy: The agency dodged answering one of its own questions in the Q&A it published! The question was, “How long will it take to pinpoint the cause(s) of non-hereditary DCM?” Of course, it’s difficult to provide a timeframe, considering all the unknowns and number of research areas still to explore. So why not just answer it that way – or, instead of giving a non-answer, why post the question at all?




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