FDA releases report on Purina complaints investigation

Between November 22, 2023, and April 15, 2024, the US Food and Drug Administration (FDA) received approximately 1,300 adverse event reports for a variety of Purina pet foods.

Today (July 31, 2024) after more than half a year of follow-up work, including pet owner interviews, lab analyses, and a plant inspection, the agency released the results of its investigation.

Initial triage of complaints

Following an initial review of the ~1300 Adverse Event Reports (ie., complaints), agency veterinarians established a set of criteria to select complaints for more detailed follow-up. The criteria were:

Owner’s willingness to be contacted for additional information
Type of symptoms reported (primarily gastrointestinal, hepatic and neurologic cases were selected)
Time between the illness and submission of report (prioritizing recent illness)
Availability of veterinary medical records
Availability of product with lot number and best-by date

Out of the 1300 complaints received, 107 met all of the established criteria.

The follow-up

The FDA pursued one or more of the following avenues for each of the 107 complaints flagged for follow-up.

Review of veterinary medical records
Interview of pet owners about their pets’ medical and diet histories and other potential exposures
Lab testing of pet food samples still in the pet owners’ possession, including tests for
- Mycotoxins (aflatoxin, fumonisin, deoxynivalenol)
- Excess vitamin D
- Bacteria (including Salmonella, E. coli, Listeria, Staphylococcus aureus)
- Pesticides
- Phosphine (a fumigant used to control insects on grain and other commodities)
- Rancid fat
- Metals

In addition to tests carried out on samples obtained from pet owners, FDA collected 20 sealed product samples from retail settings, representing four brands of Purina pet food. These samples were subjected to the same battery of tests as listed above.

Finally, the FDA conducted a comprehensive Preventive Controls Surveillance Inspection at the Purina manufacturing facility in Clinton, Iowa, the manufacturing site of the most frequently mentioned products in the complaints.

The lab findings

Lab tests did not reveal the presence of mycotoxins, pesticides, phosphine, rancid fat, excess vitamin D, pathogenic bacteria, or excessive heavy metals in any of the samples obtained from pet owners or from retail settings.

Bacillus cereus was found in 17 samples obtained from open packages of pet food collected from pet owners’ homes. Bacillus cereus is a common environmental contaminant, and genetic analysis of the 17 strains showed that they were unrelated to each other. None of the sealed packages of pet food contained Bacillus cereus.

Lab tests were conducted for the following metals and micronutrients: arsenic, cadmium, calcium, chromium, cobalt, copper, iron, lead, magnesium, manganese, mercury, molybdenum, phosphorus, potassium, selenium, sodium, sulfur, thallium and zinc. Findings for metals, including micronutrients, were not of clinical concern, meaning levels were likely too low to trigger animal illness in otherwise healthy pets, according to the FDA report.

The inspection

A team consisting of two FDA investigators and one inspector from the Iowa Department of Agriculture conducted a three-day inspection that began on April 30, 2024.

During the course of the inspection, the team reviewed the firm’s food safety plan, hazard analysis, GMPs, employee training, complaints, pest control, management interviews, and associated records.

The visit did not include a physical inspection of the production plant. No environmental, in-process, or finished product samples were collected during the inspection.

At the end of the inspection, the FDA issued a Form 483, citing the company for not conducting a reanalysis of its food safety plan after having been notified by a representative of the FDA regarding complaints associated with a new potential hazard in pet food.

The plant manager claimed to have been unaware of the complaints/new potential hazard in the pet food they were manufacturing. He explained that complaints were handled at the corporate level. The corporate Director of Quality Assurance acknowledged having been made aware of the complaints. He stated that they had been working on the potential issue at the corporate level with their microbiologists and currently did not see it as a hazard.

The FDA’s conclusion (quoted verbatim)

After thoroughly analyzing pet food adverse event reports, testing opened products from pet owners and sealed products from retail settings, and conducting a facility inspection, the FDA has determined the existing evidence does not identify a public health concern that could explain the symptoms detailed in these adverse event reports about Purina pet foods.

The agency followed standard processes in evaluating the adverse event reports and identifying those most likely to yield additional information. However, this situation did present unique challenges in that there was a large volume of reports describing a wide array of reported symptoms, but relatively few met the criteria for follow up. The agency is aware of various media outlets and bloggers that have reported a high number of adverse events. Unfortunately, the FDA did not receive data to fully evaluate or substantiate most of these cases. As a science-based regulatory and public health agency, the FDA relies on data to be able to analyze adverse events and identify causes of illness.

Throughout its analysis, the FDA had a conscious commitment to notify the public if it uncovered information, such as laboratory results indicating contamination or a specific illness in pets that ate a particular lot, that could translate into actionable advice for veterinarians or pet owners. The agency has previously issued safety advisories in situations when there was a common link between the reports, such as findings of a pathogen, vitamin overdose, or disease agent that connected the food to the illnesses. In the recent situation regarding the adverse event reports mentioning Purina pet food, there was no direct or consistent connection between the wide range of adverse events submitted to the FDA, and evidence does not conclusively link the reported adverse events to Purina pet food.

The FDA continues to monitor and evaluate pet food adverse event reports to identify potential follow-up actions. The agency encourages consumers and veterinarians to submit reports about issues with pet food electronically through the Safety Reporting Portal or by calling an FDA Consumer Complaint Coordinator. For additional support with using the online Safety Reporting Portal, the FDA now offers the SmartHub – Safety Intake Portal, where an electronic assistant helps walk individuals through the process of submitting their report. For an explanation of the information and level of detail that would be helpful to include in a report to the FDA, please see How to Report a Pet Food Complaint.

“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.

“An invaluable resource for busy pet owners” – Food Safety News

Available from all major on-line retailers, including:

FDA remains ‘mum’ on status of Purina complaints investigation

On January 4, 2024, eFoodAlert reported that dozens of dogs and cats who had been fed a Purina ProPlan dry pet food had fallen ill.

A copy of that report was flagged to the US Food and Drug Administration (FDA).

In response to the initial report, a spokesperson for the agency said, “We encourage pet owners or their veterinarians to submit reports of illness or other adverse events associated with pet food directly to FDA by following the instructions on this page: How to Report a Pet Food Complaint.”

Pet owners took the FDA at its word. According to data obtained by Truth About Pet Food in response to a Freedom of Information Act request, the agency received more than 900 complaints during the month of January 2024 alone. More than 90% of those complaints named a Purina product.

Five months later, pet owners who made the effort to report their concerns to the FDA are expressing increasing frustration at the lack of feedback from the federal agency.

Linda’s story

Linda, whose three rescue cats fell very sick after being fed a Purina product, filed two separate complaints with the FDA, and advised the agency that she had retained some of the suspect pet food. She offered to supply the food to the FDA for testing.

The FDA’s Consumer Complaint Coordinator sent this reply. “Good morning. Thank you for contacting the U.S. Food & Drug Administration. Your message has been received. The FDA will not be collecting your consumer sample. If you wish to have your sample tested, please seek a private lab.”

Linda made multiple attempts to contact individuals at the FDA in an effort to learn why the agency was not interested in testing the pet food. None of her calls were returned. No one would take the time to explain to her why the FDA was not interested in testing the pet food she had specifically retained for that purpose.

She then contacted the FDA’s Ombudsman, Erica Katherine, who promised to look into the matter and get back to her within three days.

Three weeks later, she still had not received a response from the Ombudsman.

Finally, Linda contacted the Office of Congresswoman Jahana Hayes, where it now rests.

FDA losing credibility with consumers

In an email to me, Linda wrote, “I do not have any faith in the FDA. Based on my experience with the FDA, I believe they are covering up for Purina. I have been working on this since January and the FDA has done nothing.”

Linda is not alone.

On April 17, 2024, the Association for Truth in Pet Food filed a Citizen Petition, “Requesting that the FDA provide the public with an update(s) to their investigation of this current pet food concern, provide the public with similar information in this current issue as the agency has historically provided the public with past (and other current) issues.”

That petition has now received more than 1,700 comments from pet owners and other interested parties. Following are just a few of those comments.

I have heard several reports of dogs getting sick or dying from Purina foods. Can you tell me what is being done to investigate this problem? There are way too many reports for this to be ignored. Purina is covering vet bills for people but not recalling anything.

Please provide us with details of your investigation into recent pet deaths encompassing many brands of pet food. The FDA has a responsibility to fully investigate.

I am one of those people who had a pet dog sickened by contaminated pet food in Dec 2023 (and believe the contamination started in August 2023). Fortunately I was able to switch my dog to homemade food before he got too sick and he seems to have mostly recovered. I want to know what was in the food that made him and other dogs and cats so sick! The FDA needs to stop dragging their feet on this issue! Use your resources in a timely manner to figure out what is sickening and killing these pets. I support this petition!!

Why has no statement been issued to warn pet owners about the thousands of pets that have been sickened and killed after consuming a variety of different pet foods? We want to know which foods are being investigated! We want to know what tests are being performed on the foods! We want to know how many complaints the FDA has received regarding this matter! We want to know if facilities are being inspected! We want to know how many dogs and cats have died as a result of contaminated food!!! Is there an agenda to kill our pets? Your silence is very suspicious. I have had family members, friends, and fellow rescuers whose cats have died unexpectedly over the last 6 months. The common link is Purina Pro Plan kibble.

FDA: pet owners need to be informed of any wrongdoings, faulty products, imported preservatives and chemicals, allowance for substandard products and foods, heck quality control! Death and illness read everyday on my FB feed is truly concerning. We live in fear to use expensive products already purchased after notification of alerts with possible contamination. Please help…. with your guidance our pets can thrive and we won’t live with fear or heartbreak

How many animals have to die or become really sick from eating food that are supposed to keep them alive and healthy? Please release any and all information to pet owners and the media so we all are in the know of what is causing these pet to become ill or die. What is in the food that is causing this. I refuse to feed processed kibble any longer we must know the truth?!

Step up and do something to hold these big corporations accountable for the unsafe and deadly pet food that is being marketed. Used to be that pet food was safe (all varieties) and a pet parent had the choice as to what they fed their pets. Now, all brands are basically owned by a few giants who do not care about quality nor safety and pets are becoming very ill or dying. I lost one cat and have another who is still struggling months after getting her off of Purina, Blue Buffalo and Royal Canin Prescription food. Please do your job. I know you don’t for human food, so have little hope for pet food, but somebody there has to have a conscious (sic).

Mixed messages

The FDA relies heavily on reports filed by veterinarians and pet owners to provide an early warning of pet food contamination issues.

But the lack of response from the agency—either in the form of a public statement or as an individual response to a complainant’s request for feedback—does nothing to encourage the filing of these reports.

This is the first time in my memory (and I have a very long memory) when the FDA has not issued a public statement on the status of an investigation into a mysterious cluster of pet illnesses.

The melamine adulteration investigation rated a series of public announcements, even before the source of the illnesses was established.
The Beneful investigation was publicized.
The investigation into a suspected link between certain pet food ingredients and an increased incidence of dilated cardiomyopathy (DCM) was publicized in a series of public statements.
Progress in the investigation into illnesses apparently associated with chicken jerky pet treats imported from China also was publicized.

Yet, the agency has not even released a public statement summarizing the number of complaints received. Nor has it been willing to share any information on the progress of its lab investigations into possible toxins or adulterants in the pet food samples submitted by consumers who reported sick and dying pets.

If the FDA wants to retain whatever credibility it has left with consumers, it must offer at least a measure of transparency into the progress of its investigation.

The FDA replies

eFoodAlert reached out to the FDA this week for comment and received the following response from an agency spokesperson:

The FDA takes seriously its responsibility to help ensure that pet food ingredients are safe and nutritious. We review every report of illness we receive, evaluate them and determine if FDA action may be warranted. If/when we identify a human or animal health hazard, we work with firms to recall the product and notify the public.

Although we can’t respond to every adverse event report or test every food sample, please know that the information you provide is very helpful to us. Even if we don’t follow up with you directly, the information you share becomes part of our understanding of the situation. We appreciate the time that pet owners and their veterinarians spend to submit reports of illness or other adverse events associated with pet food directly to the FDA by following the instructions on this page: How to Report a Pet Food Complaint.

“An invaluable resource for busy pet owners” – Food Safety News

Available from all major on-line retailers, including:

Pet food safety advocate petitions FDA to update public on current investigation into pet illnesses

Noted pet food safety advocate, Susan Thixton (Truth About Pet Food), has filed a Citizen Petition with the US Food and Drug Administration (FDA) on behalf of pet owners.

In her petition, dated April 17, 2024, Thixton requested that, “…the Commissioner of Food and Drugs … promptly inform the public to (sic) current pet food investigations in the same manner the agency has updated the public in the past.”

According to the petition, “[b]eginning in approximately December 2023, pet food consumers began reporting serious health issues with their pets (cats and dogs) directly related to pet food. To date of this Petition, more than 2,600 pet owners have reported serious health concerns with their cat or dog. Symptoms reported are very similar; bloody diarrhea, bloody vomiting, in many instances seizures. More than 500 pet deaths have been reported by pet owners. One brand of pet food in particular, pet owners have reported 1,679 cat and dog illnesses, 23% of those reports (390) resulted in the death of the pet.”

The petition requests a release of adverse event reporting data, a summary of the status of the FDA’s investigation, and issuance of a public notice, including an encouragement for pet owners to report any illnesses to the agency.

In support of the request, the petition cites several precedents, including the recent public alert for lead in applesauce products, the investigation into possible links between pet foods and canine heart disease, and the years-long investigation into the link between certain jerky treats and pet illnesses.

Thixton has included a link to the full text of the Citizen Petition in her story, “How Much More Serious Does It Have To Get?”

Individuals who wish to file support for this petition can do so by emailing the FDA’s Center for Veterinary Medicine using this email address and Subject Line:

Email: AskCVM@fda.hhs.gov
Subject Line: Docket ID FDA-2024-P-1916-0001

An editorial note

I was one of the first individuals to make the FDA aware of the spike in pet illnesses/deaths being reported on social media, and the allegations linking those illnesses/deaths to Purina ProPlan foods for dogs and cats.

eFoodAlert posted its first story on this subject on January 4, 2024, and has on a number of occasions requested comments and feedback from FDA media coordinators on the status of the investigation. Unlike the previous investigations referenced in Thixton’s filing, no information has been forthcoming from the agency, either in the form of a public release or advisory, or in the form of a comment for publication.

Earlier today, I contacted the Center for Veterinary Medicine for comment on the filing of the Citizen Petition.

An agency spokesperson replied, “The FDA is reviewing the citizen petition and will respond directly to the petitioner.”

In the information vacuum created by the absence of a public advisory, there has been a range of speculation on social media, including accusations that the FDA is “in the pocket” of Nestlé Purina and other large pet food manufacturers, and that the agency is working with these manufacturers to suppress evidence of a significant problem.

Such speculation can only hurt the credibility of the FDA in its handling of this and other pet food safety investigations.

While it is understandable that the FDA does not want to fuel panic, the agency’s total silence is having the opposite effect.

In the interests of the health and safety of our pets, of transparency, of keeping the public informed, and of FDA’s own credibility, eFoodAlert fully supports the Citizen Petition filed by Susan Thixton of Truth About Pet Food on behalf of pet owners.