By Helen Santoro 100journalists
In 2018, the U.S. Food and Drug Administration, acting on feedback from a group of veterinary researchers, began investigating whether the growing popularity of grain-free dog foods had led to a sudden increase in disease. life-threatening heart disease in dogs, dilated cardiomyopathy.
Four years later, the FDA has found no strong link between diet and dilated cardiomyopathy. He also did not reject such a link, and the search continues. However, the publicity surrounding this problem has reduced the once-promising market for grain-free dog food.
Additionally, a tangled web of funding and industry interests appears to have influenced the origin, data collection, and conduct of the FDA study, according to internal FDA records.
A six-month investigation by 100Reporters found that veterinarians who induced the FDA to consider a diet have financial and other ties to major sellers of grain-containing pet foods. Additionally, agency records show that for the initial study, some veterinarians were instructed to submit only cases of dilated cardiomyopathy (DCM) involving grain-free, “exotic,” or “boutique” pet foods. “. Suppliers of ingredients used in grain-free dog food have also lobbied the FDA to protect their market.
As a result, the conversation around DCM and grain-free foods is deeply divided, with each side claiming that the other prioritizes industry relations over scientific integrity and the lives of pets.
“It’s become such an emotional issue,” said Dana Brooks, CEO of the Pet Food Institute, whose members produce most of the pet food in the United States. “We’re scrambling to try to figure out what’s going on.”
cause for concern
Grain-free pet diets became popular in the early 2000s, relying heavily on legumes — seeds of legumes including peas, beans, and lentils. In 2019, grain-free kibble accounted for 43% of dry pet food sold.
Until 2017, the FDA saw one to three reports of DCM per year. But between January 1 and July 10, 2018, she received 25 cases. Seven reports came from a single source, animal nutritionist Lisa Freeman of Tufts University’s Cummings School of Veterinary Medicine, an FDA spokesperson said. However, FDA records obtained under the Freedom of Information Act indicate that these reports may not have been entirely representative of cases seen at the Tufts Clinic.
In a June 2018 email to FDA veterinarian Jennifer Jones, Freeman attached a document asking veterinarians to report cases to the FDA: ingredient, or grain-free diet (BEG).
Asked if this could be seen as select data that would shape the investigation, Freeman said through Tufts Media Relations: “The protocol for this email was developed and intended to assist veterinary cardiologists in the early stages of investigating potential associations. between diet and dilated cardiomyopathy.
“I have shared the protocol with the FDA to inform them of our clinical recommendations for patients at this time,” Freeman wrote, noting that they “continue to study” any diets containing DCM-related ingredients. “regardless of the manufacturer”.
In an email, an FDA spokesperson wrote, “FDA has never requested that DCM cases reported to the agency be restricted to certain types of diets. We welcome all DCM reports with a suspected link to food, regardless of diet type.
According to PubMed.gov, Freeman has received funding from major grain-based food vendors, including Nestle Purina Petcare, Hill’s Pet Nutrition, and Mars Petcare, since 2002. His recent conflict of interest disclosures state, “During the Over the past 3 years, Dr. Freeman has received research funding, given sponsored talks and/or provided professional services to Aratana Therapeutics, Elanco, Hill’s Pet Nutrition, Nestlé Purina PetCare, P&G Pet Care (now Mars) and Royal Canin.
Industry funding is common in animal nutrition science. Freeman said she was supportive of his research and had “transparently disclosed the sources of funding for the work I am doing on this topic.”
Two veterinary cardiologists – Darcy Adin of the University of Florida College of Veterinary Medicine and Joshua Stern of the University of California, Davis School of Veterinary Medicine – have also worked with the FDA.
Emails from a public records request indicate that in April 2018, Jones spoke with Freeman, Stern and Adin about grain-free dog food and DCM and requested spreadsheets of their clinical case data.
Adin has been involved in studies that have received funding from Purina since 2018 and since 2017 from the Morris Animal Foundation, a non-profit animal health charity founded by Mark Morris Sr., which created the first line company-produced dog food. become Hill’s Pet Nutrition.
University of Florida public relations said neither Adin nor the university received direct corporate financial support for these studies.
Stern has authored studies funded by the Morris Animal Foundation since 2011 and currently receives funding from the foundation.
“I fully understand the conflict of interest issues with people funded by the pet food industry,” Stern said. “It’s hard to find a veterinary nutritionist who hasn’t done research for pet food companies.”
Purina, Hill’s and Mars did not respond to multiple requests for comment.
In July 2018, the FDA announced its investigation, noting that many of the 25 dogs diagnosed did not have a genetic predisposition to DCM. The common thread, he says, seems to be a grain-free diet.
A year later, the FDA took the unusual step of naming 16 dog foods, almost all grain-free, that appeared most frequently in their DCM case reports. “We’ve never seen anything like this before without knowing the cause,” Brooks said.
Joseph Bartges, professor of animal nutrition at the University of Georgia, was not surprised, noting that the FDA flagged grain-free foods early on. “When you only look for what you want to see, you only see what you look for,” Bartges said. In July 2020, reports of DCM numbered 1,100 — likely resulting from the FDA encouraging people to report the disease,” Brooks said.
Suppliers of ingredients for grain-free foods have, in turn, mobilized their forces to protect their market share.
In its 2019 annual report, the USA Dry Pea & Lentil Council said it “convinced the FDA to clarify its language on its concerns and minimize harm to the industry.”
In a 2019 letter to FDA officials, Senator Jon Tester of Montana — a major pulse-growing region — complained that the agency’s “unsubstantiated warning” had hurt pulse growers. The following year, seven senators signed another letter to the FDA pointing out a “bias on the causation of this disease”.
The FDA has continually stated that DCM involves several factors. Shortly after that letter, Steven Solomon, director of the FDA’s Center for Veterinary Medicine (CVM), emphasized this point, describing DCM as “a scientifically complex and multifaceted problem”, adding that “we . . . do not consider not this as a regulatory issue at this time.
An FDA spokesperson wrote that when meeting with stakeholders, “Ultimately, all FDA decisions and work are guided by science, data, and our public health mission.” .
Regardless of the survey’s final findings, sales of grain-free dry dog food have fallen since June 2018 and decreased by $60 million between 2021 and 2022. Meanwhile, sales including grain increased in 2019. and increased by $700 million between 2020 and 2021.
Getting an answer on DCM will be difficult because of the complexity of science and industry influence, said Marion Nestle, author of Pet Food Politics. “They’re all trying to protect their market share.”