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
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Krista J
June 22, 2020 at 4:08 pm
Just before the FDA released their alert about DCM, I had a dog diagnosed with DCM. He was under the care of a cardiologist, taking $600 worth of medications monthly, after an initial $5000 to hospitalize, diagnose and treat. Weeks later he dropped dead in mid stride running through the field at 5 years of age. Heartbreaking! He was on a grain free diet and he was a Doberman (known for developing DCM.) The FDA received reports from top cardiologists that were seeing a trend in breeds not predisposed. Personally, when it comes to health, I appreciate an early warning. Imagine if the FDA didn’t put out a warning and thousands of dogs died-what would people say about the FDA, then. I feel that they are in a “dammed if you” and “dammed if you don’t” position. In the early days, you don’t have the benefit of hindsight and you have to make decisions to protect health based on the data that you currently have which is more often than not very sparse; I think the pandemic is a perfect example of that. Then as the investigation continues, new data supports or doesn’t support the initial position. Another perfect example was the warning that vaping was causing serious lung injury and death. Then as the investigation continued it was determined that it was linked to vitamin E in illicit vaping cannabis products. When an issue first comes to light, you have to make a statement to warn people to potentially save lives and then conduct a more thorough investigation. To reverse that order, would cause a lot more suffering and death to people and animals, alike. Also, legumes and potatoes have still yet to be exonerated when it comes to DCM.
Susan Thixton
June 22, 2020 at 6:03 pm
I’m very sorry you lost a dog to DCM. But we will have to agree to disagree on FDA. When FDA made the first public warning linking DCM to grain free pet foods – the agency had only received 24 complaints over the previous 4 years. Even after their warning, the number of reports they received were well below historical average. While you might have appreciated the warning, especially considering your horrible experience with the disease – I believe FDA has a responsibility to get things right the first time. Or, if they make a mistake, to own that mistake and properly inform pet owners of their mistake. To me, FDA failed us by not investigating properly. Pet owners deserve far better.
Jessica
June 23, 2020 at 1:42 pm
I agree Susan – especially since dobermans are prone to DCM! I looked through the doberman group on facebook, and more people reported DCM on grain-inclusive than grain-free
SPH
June 22, 2020 at 7:22 pm
They protected the US pet food industry from lawsuits.
For producing food that harms pets (stuffed full of fillers, markted as “wholesome and full of fresh meat”).
The industry they are supposed to be “overseeing” for “safety.”
So they also protected themselves and their lousy, $$-driven, krap-human-food-waste recycling-driven, management.
T Allen
June 22, 2020 at 8:10 pm
If this is ever going to stop then small manufacturers of BEG diets will have to come together and file a class action lawsuit. The FDA has to stop being a tool of the PFI.
Jane Eagle
June 23, 2020 at 1:10 pm
Sent to my Congressman: The FDA refuses to enforce its own laws, at least in regard to the multi-billion dollar pet food industry (“expected to reach $30 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 3.36% between 2017 and 2022, according to Zion Market Research.”)
THIS IS FRAUD ON A MASSIVE SCALE. Please make FDA accountable.
https://academic.oup.com/jas/article/98/6/skaa155/5857674
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.
Cindy
June 23, 2020 at 1:18 pm
My dogs have been on grain free food for years.people need to realize that some breeds are prone to certain health issues more than others. Know your breed, know what they are prone to. Do I think the FDA lacked in judgement, absolutely. Did they lack in their investigation, I believe so. Were the dogs that were reported with heart issues or any other health issues prior to being fed grain free? I have 6 dogs at this time, all on grain free and not one has a health issue that is not related to old age.
Janice
June 24, 2020 at 3:31 pm
If you haven’t already, you may want to check out this article about who is behind the article mentioned above: https://thecaninereview.com/2020/06/24/controversy-swirls-around-journals-non-disclosure-conflicts-dcm-article/?fbclid=IwAR0EKFaJQlrhabhIdy8nFEqoL-hQO3z98kKzBMDdzHgKc41Dn_9UjAanXwg Conflicts of interest should be noted.
colton strickland
June 26, 2020 at 3:36 pm
You must be one of those apologists for Big Pet Food Industry. In this present article, potential conflicts of interests may not have been disclosed but their research of over 150 studies that still finds no correlation between grain-free foods and DCM and that is still valid. Compare that to the Big Pet Food Industry shills who came out with the “Opinion” piece a little over a year ago that instantly made the conclusion that grain-free foods were causing DCM and did everything they could to scare the masses into going back to susbstandard products made by Big Pet Food manufacturers. It was all about trying to regain lost market share and they scammed the FDA into carrying their water for them. Now the FDA has been proven wrong by this new analysis and needs to own their mistake and their pandering to the Big Pet Food Industry.
Ms. B Dawson
June 28, 2020 at 5:15 pm
Janice – just read the linked article and think that sauce for the goose is sauce for the gander.
If scientists who are funded by companies that make dog food are unable to reach unbiased analysis of data (as this article asserts), then the industry insiders who sit on AAFCO boards should have their affiliations/industry funding held to the same standard and any decisions they have made scrutinized for bias. For that matter, members of Congress who accept campaign funding from PFI should be charged with conflict of interest, FDA staff should have prior employment publicized so that any favors owed could easily be linked to regulations. Heck, we have had Federal appointees governing the environment who used to work for chemical companies who don’t want to see regulations.
My point is conflict of interest has many depths and analysis of data is different than original research. The assertions made in this study have validity. For instance, if you ask for narrow data – DCM in dogs fed grain-free diets – that leads to a narrow conclusion. In college, my profs drummed ‘bad data is worst than no data at all’ into our heads. Analyzing the percentage of dogs diagnosed with DCM fed grain-free is only valid when compared to dogs diagnosed with DCM in the population at large.
There was a safe guard in place, too. As was stated by the publishers of this article, it was peer reviewed by outside parties. If the conclusions are not defensible, let the FDA step up and show us the flaws. That’s how science is supposed to work.
“I have steadily endeavored to keep my mind free so as to give up any hypothesis, however much beloved (and I cannot resist forming one on every subject) as soon as the facts are shown to be opposed to it.”
~ Charles Darwin
Kathleen
June 29, 2020 at 9:54 am
At a quick glance four of the five individuals who authored the linked paper are from BSM Partners. Zignature is a client of BSM Partners: https://zignature.com/how-its-made/
I have no idea if some of the other named companies consult with BSM partners but there is for certain conflict of interest involved here.