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New Study suggests FDA has some serious explaining to do regarding DCM – Truth about Pet Food

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Did FDA’s Center for Veterinary Medicine unjustifiably alarm millions of pet owners without fully investigating the DCM problem? It appears so.

The FDA first announced to pet owners there is a potential link to canine heart disease with grain-free pet foods in July 2018. In this first announcement from FDA, the agency did not share how many reports of sick pets they had received. But FDA did set off alarms with pet owners and veterinarians stating “Diets in cases reported to the FDA frequently list potatoes or multiple legumes such as peas, lentils, other “pulses” (seeds of legumes), and their protein, starch and fiber derivatives early in the ingredient list, indicating that they are main ingredients.”

From this first FDA announcement regarding canine heart disease, a firestorm of worry erupted. Every news outlet reported on the FDA’s warning of a potential link of canine dilated cardiomyopathy (DCM) to grain-free pet food. The FDA wouldn’t warn pet owners if they hadn’t fully investigated the issue and it wasn’t true…right? Pet owners began to worry.

Six months later, the FDA ups the worry with a second alert telling pet owners the agency is busy investigating this problem, “analyzing cases” and “collaborating” and “consulting“. In this second alert, the FDA repeated their previous warning about grain-free pet foods; “In cases in which dogs ate a single primary diet (i.e., didn’t eat multiple food products, excluding treats), 90 percent reported feeding a grain-free food.” And again, news outlets all across the U.S. shared the FDA warning that grain-free pet foods could cause heart disease in dogs. Pet owners were frightened.

And then six months after the second grain-free pet food FDA warning, the agency takes an unprecedented step in their third DCM announcement. In June 2019, the FDA lists the brand names of pet foods “named most frequently in DCM cases reported to FDA“. Never before had FDA’s Center for Veterinary Medicine (CVM) provided brand names to the public during an investigation. And with this FDA update, the national news headlines became the brand names. Almost everyone was convinced; Grain free pet foods were dangerous…the FDA has warned us 3 times…it’s true, right?

But then the FDA went silent. After 3 VERY public warnings, after their “collaborating” and “consulting“, after taking the unprecedented step of naming brands…the FDA went silent.

A new study might just explain why FDA’s Center for Veterinary Medicine went silent.

Published in the June 2020 Journal of Animal Science is the research paper “Review of canine dilated cardiomyopathy in the wake of diet-associated concerns“. The paper starts off with a dramatic statistic. Based on historical data of DCM diagnosis, “0.5% of the dogs evaluated at U.S. referral-hospitals were diagnosed with DCM. If one considers the estimated total number of dogs in the United States equals 77,000,000 (AVMA, 2019), the published incidence studies (Fioretti and Delli, 1988; Sisson et al., 2000) suggest that a minimum of 308,000 to 1,001,000 dogs in the United States have DCM at any given time.“

But…ignoring historical data, the FDA repeatedly told pet owners there was a concerning rise in DCM cases. The study found something VERY different; “In June 2019, the Food and Drug Administration (FDA) released a public statement that 560 dogs were reported with potential diet-related DCM (FDA, 2019a). If the report was accurate, these 560 cases would represent 0.05% to 0.1% of dogs in the United States with DCM.” In other words, this new paper points out that the cases of DCM reported to the FDA were WELL BELOW what historical data should have told them was an average number of cases.

The paper explains in detail many other potential causes of DCM, something the FDA appears to have NEVER considered before they warned pet owners (3 times) about grain free pet food.

The paper points out that FDA (perhaps intentionally) skewed the data it asked for from veterinarians. “CVM [FDA’s Center for Veterinary Medicine] encourages veterinary professionals to report well-documented cases of DCM in dogs suspected to having a link to diet.” was quoted by the FDA in 2019. This demonstrates how asking for information in a certain way can skew data. Moreover, regardless of what diet the dog is eating, asking the veterinary community and the public for DCM cases in dogs only eating grain-free or exotic protein diets will result in sampling bias.” Had the FDA properly investigated, the agency would have asked for all cases of DCM, not just cases from dogs eating grain free pet food.

And the paper points out that FDA neglected to exclude dogs from their data evaluation that provided poor diet history, and FDA neglected to exclude dogs that had “concurrent medical conditions” that could lead to heart disease including DCM.

Another issue successfully challenged by this paper is the “small manufacturer” issue promoted by FDA but initially started by one of the FDA “consultants” Dr. Lisa Freeman. “Descriptors of pet foods implicated to have a subjective association with DCM are diets with specific characteristics, such as, but not limited to, containing legumes, grain-free, novel protein sources and ingredients, and smaller manufactured brands (Freeman et al., 2018). However, an exhaustive review of the literature provides evidence of conflicting information. For example, boutique diets, defined as produced by a small manufacturer, have been implicated in association with DCM (Freeman et al., 2018; FDA, 2019a). However, when the FDA report is broken down into which pet food manufacturers made the called-out diets (FDA, 2019a), 49% of the brands listed were made by one of the six largest pet food manufacturers in North America (Petfood Industry, 2019). Given that almost half of the brands listed on the FDA report (FDA, 2019a) on June 27, 2019, are not manufactured by boutique pet food companies (Figure 5), it is unlikely that an association can be made to DCM.”

And the paper’s conclusion…(bold added)

“Recently, a correlation between diets with specific characteristics, such as, but not limited to, containing legumes, grain-free, novel protein sources and ingredients, and smaller manufactured brands to DCM has come under scrutiny by academic researchers and the FDA. The use of the acronym “BEG” and its association with DCM are without merit because there is no definitive evidence in the literature. At this time, information distributed to the veterinary community and the general public has been abbreviated synopses of case studies, with multiple variables and treatments, incomplete medical information, and conflicting medical data and opinions from veterinary nutrition influencers. Also, in past literature, sampling bias, overrepresentation of subgroups, and confounding variables in the data weaken this hypothesis. Additionally, based on current literature, the incidence of DCM in the overall dog population is estimated to be between 0.5% and 1.3% in the United States. However, the FDA case numbers (560 dogs) are well below the estimated prevalence. Therefore, it is impossible to draw any definitive conclusions, in these cases, linking specific diets or specific ingredients to DCM.”

Does the FDA’s Center for Veterinary Medicine owe pet owners an explanation?

Opinion: Absolutely.

FDA’s Center for Veterinary Medicine needs to be fully investigated for this incredibly damaging DCM issue. The FDA – with help from their consulting “veterinary nutrition influencers” changed the entire landscape of pet food in the U.S. based on incomplete data and incomplete medical information. Pet owners deserve far better from our tax dollar supported Center for Veterinary Medicine. This failure is inexcusable.

Please email the FDA at AskCVM@fda.hhs.gov asking the agency to issue a public explanation.

Please email the link to the study to your Representatives in Congress asking them to demand a full investigation to why FDA’s Center for Veterinary Medicine was allowed to warn the public 3 times based on a such a poor investigation.

Time will tell what CVM is made of…will they step up and provide pet owners an explanation or will they stick their head in the sand hoping it will all go away?

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
TruthaboutPetFood.com
Association for Truth in Pet Food

Become a member of our pet food consumer Association. Association for Truth in Pet Food is a a stakeholder organization representing the voice of pet food consumers at AAFCO and with FDA. Your membership helps representatives attend meetings and voice consumer concerns with regulatory authorities. Click Here to learn more.

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