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.

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“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:

In 2023, the US Food and Drug Administration (FDA) inspected three Nestlé Purina production facilities. All three manufacturing plants produce Purina ProPlan pet foods in addition to other brands owned by Nestlé Purina.

While the inspections predate the current concerns raised by pet owners regarding Purina ProPlan, the reports shed some light on the manufacturing and quality assurance practices at these locations.

Clinton, Iowa

This facility manufactures extruded dried kibble and extruded treats under several brand names, including: Pro Plan®, Nestlé Purina ONE Beyond®, Nestlé Purina Veterinary Diets®, and Beggin®.

On February 8, 2023, Nestlé Purina announced a recall of Purina Pro Plan Veterinary Diets EL Elemental dry dog food due to “potentially elevated levels of Vitamin D.” The recall covered seven production codes.

Approximately one month later, on March 10, 2023, the company expanded its recall to include two additional production codes.

The recalled products were manufactured in Clinton, Iowa, using a vitamin pre-mix supplied by ADM Nutrition.

ADM is a self-described “… global leader in human and animal nutrition…” with net sales in 2020 of $64 billion.

On February 14, 2023, less than one week after the initial Purina recall announcement, the FDA began a three-day long inspection of the Clinton manufacturing facility.

The investigators reviewed the company’s Hazard Analysis for the recalled product, noting that it identified nutrient (including vitamin D) toxicity and deficiency as hazards likely to occur.

Nestlé chose to apply what is referred to in the inspection report as a “supply chain preventive control” for this hazard. The control consisted of obtaining the vitamin pre-mix from a third-party supplier (ADM Nutrition).

Nestlé did not test either the pre-mix or the finished pet food to ensure that the Vitamin D level was correct.

The conclusion of the FDA investigation team was clear and unequivocal.

The failure to test the inbound pre-mix, the failure to test the finished Purina Pro Plan Veterinary Diets Elemental (PPVD EL) prescription dry dog food, and/or the lack of any other appropriate monitoring or verification steps resulted in your release of the product to the public. These vitamin D levels were up to 77 times (103 IUs/gram versus 1.33 IUs/gram) your expected levels. The consumption of these released lots of product resulted in animals needing veterinary care, and subsequently resulting in your recall of the product.

FDA Establishment Inspection Report (FEI #1924965) for Nestle Purina Pet Care Co., Clinton, IA (February 14-17, 2023)

Although the inspection result ultimately was categorized as “Voluntary Action Indicated,” no formal Inspectional Observations report (Form 483) was issued.

On March 13, 2023, the FDA began a four-day inspection of the ADM Nutrition plant that had supplied the pre-mix to Nestlé.

The investigation team found that ADM’s “prerequisite program” had been inadequate to prevent a wrong ingredient from being added to the pre-mix that was supplied to Nestlé. ADM did not test the pre-mix before supplying it to the Clinton plant.

According to a Warning Letter issued on October 23, 2023, ADM had no preventive controls in place to mitigate the risk of error.

Once again, the FDA’s conclusions were unequivocal.

[T]he findings of elevated levels of vitamin D in several lots of your AA Diet preblend indicate your prerequisite programs were insufficient or you failed to implement them adequately to ensure the inclusion of vitamin D did not result in a nutrient toxicity.

FDA Warning Letter (CMS Case #657846) issued October 23, 2023

Crete, Nebraska

This location manufactures Alpo®, Nestlé Purina ONE®, Pro Plan®, Friskies®, and Nestlé Purina Veterinary Diets® canned dog and cat foods.

On December 2, 2022, the company announced a recall of a “limited amount of Purina Pro Plan Veterinary Diets EN Gastroenteric Low Fat” due to what it described as a labeling error.

On June 27, 2023, the FDA began a three-day inspection of the facility as a follow-up to the recall and to seventeen consumer complaints received by the agency between 2018 and 2023 about foods manufactured at the Crete location.

During the inspection, the FDA investigator learned that the mislabeling of cans was due to a can conveyor motor malfunction. The stoppage of the conveyor line caused sealed cans to accumulate, forcing a diverter gate to open and allowing the comingling of two different products—a cat food and a dog food—prior to the retort (pressure cooking step).

Although the recall notice cited a simple mislabeling, the risk was more serious. According to the inspection report, the “…inadvertent diversion of the product prior to retorting led to the product receiving the incorrect thermal process.”

The consumer complaints included presence of foreign objects, pet illness or injury, and off odor/appearance.

The inspection report notes that the plant did not identify foreign material as a hazard requiring a preventive control, but relied on magnets to detect and remove metal objects from the in-process pet foods.

The investigators also observed problems with the plant’s control of residual chlorine in cooling water.

When cans of food leave the retort, they pass immediately into a water-filled cooling canal. The water is chlorinated to prevent growth of microorganisms, including both bacteria and yeasts.

As the cans cool, a partial vacuum forms inside, which can result in a small amount of cooling water being sucked in.

If the water is not sufficiently chlorinated, live bacteria and yeasts can be carried into the cans. These might be spoilage microbes, or even pathogens.

According to the inspection report, although the cooling water was monitored regularly for chlorine, corrective action was not always taken when the chlorine level fell below the target specified in the company’s food safety plan.

Although these observatons were discussed with management at the close of the inspection, no formal Inspectional Observations report (Form 483) was issued, and the inspection result was classified as “No Action Indicated.”

Edmond, Oklahoma

This location produces extruded dry pet food for dogs, puppies, cats, and kittens under nine brand names: Friskies, Cat Chow, Kit N Kaboodle, Kitten Chow, ONE, Alpo, Beneful, Dog Chow, and Pro Plan.

On April 11, 2023, the FDA conducted a routine inspection of the Edmond location, to review the firms Food Safety practices and discuss a total of six consumer complaints received since the previous inspection in 2019.

Unlike the situation in Clinton and Crete, the inspector found no deviations or deficiencies in the Edmond operations.

The plant uses a supply chain control program that includes pre-requisite approval of all suppliers by the Nestlé Purina corporate office. The plant also submits samples periodically to the corporate lab for nutritional analysis.

The Food Safety Plan uses a single Critical Control Point (“kill step”) for all of its products: extrusion time/temperature. Finished product is tested for Salmonella before being released for distribution.

The inspection was classified as “No Action Indicated.”

Other Nestlé Purina locations

Two other locations—Denver and Flagstaff—also manufacture Purina Pro Plan pet foods.

Flagstaff, Arizona

The Flagstaff production plant was last inspected in 2019. It produces dry, extruded pet food under the following brands: Dog Chow®, Beneful®, Nestlé Purina ONE®, Alpo®, and Pro Plan®.

Although no Form 483 was issued at the completion of the 2019 inspection, four deficiences were discussed with management:

• Inadequate control to minimize the risk of metal foreign object contamination
• Written food safety plan was not revised to reflect significant change in activities
• Large gaps in seals around overhead doors in multiple locations
• Plastic wrap being used as a seal in an air system.

Two of the four issues were corrected and verified before the close of the inspection, and the inspection was classified “No Action Indicated.”

Denver, Colorado

Denver was last inspected in 2018. The location produces pet food under the following brands: Dog Chow®, Cat Chow®, Kit n Kaboodle®, Alpo®, Beneful®, Nestlé Purina ONE Beyond®, Nestlé Purina ONE®, and Pro Plan®.

The 2018 inspection was classified as “No action indicated.” eFoodAlert has requested, but has not yet received, the Establishment Inspection Report for this inspection.

Some take-aways

FDA Form 483. Inspectional Observations

According to the FDA’s Investigations Operations Manual, a Form 483 should be issued “…when in the investigator’s judgement, conditions or practices observed indicate that any food, drug, device, or cosmetic has been adulterated, or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”

This may (and should) include issues such as elevated mycotoxins, presence of pathogens (such as Salmonella), and toxic levels of Vitamin D in pet foods.

It is also arguable that multiple instances of inadequate control of can cooling water should trigger issuance of a Form 483.

Nestlé Purina is not a monolith

In reading the various Establishment Inspection Reports, it becomes clear that while the corporate office provides some direction, each manufacturing location has at least partial autonomy over its operations and food safety decisions.

The Clinton location made no attempt to test either its pre-mix ingredient or its finished products for Vitamin D levels, relying solely on ADM to provide the specified formulation. In contrast, the Edmond plant submitted periodic samples to the corporate lab for nutritional analysis.

Supply-chain preventive control

There are multiple references to supply-chain controls, which boil down to relying blindly upon one’s suppliers to provide a product that meets all specifications.

The Clinton experience with faulty pre-mix supplied by ADM is a glaring example of how dangerous this practice can be. A simple, routine test of each batch of pre-mix would have prevented the release of multiple production lots of toxic pet food.

A Final Word

In January 2024, eFoodAlert reported on an alarming number of consumer complaints about pet illnesses and deaths that appeared to be associated with Purina pet foods.

An FDA investigation into these illness reports is ongoing.

If you or your veterinarian believe that your dog or cat has been injured in any way by a commercial pet food or treat, the FDA wants to hear from you. Visit the FDA web page, How to Report a Pet Food Complaint for a detailed explanation of how to file a complaint.

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The Establishment Inspection Reports issued by the FDA and referenced in this report were obtained in response to Freedom of Information Act requests.

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“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: