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.

“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 inspections uncover food safety issues at multiple Purina plants

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.

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

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

Available from all major on-line retailers, including:

Darwin’s to customer: Salmonella-contaminated food “is fine”

In September 2023, an employee of Arrow Reliance, Inc. (doing business as Darwin’s Natural Pet Products) assured a consumer that Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats (Lot 9830, manufactured on Jul 19, 2023), was “fine,” even though the US Food and Drug Administration (FDA) had advised the public the month before that the batch in question was contaminated with Salmonella.

The consumer contacted the company after their cat was diagnosed with a Salmonella infection, according to documents obtained by eFoodAlert in response to a Freedom of Information Act request.

The consumer discarded the unused portions of the cat food and on September 14, 2023, filed a Pet Food Report with the FDA’s Center for Veterinary Medicine.

In response to a separate complaint, filed a few days earlier, the FDA collected an unused portion of Darwin’s Natural Pet Products Natural Selection Chicken Recipe for Cats (Lot code unknown) from the home of a consumer in a different state. The consumer reported that all four of their cats developed gastrointestinal problems after having consumed the product.

The FDA lab found two different Salmonella serotypes (Typhimurium and Hadar) in the sample.

Company aware of contamination

In August 2023, the FDA conducted the latest in a series of investigations into conditions at the Darwin’s Tukwila (Washington State) manufacturing facility.

On August 11, 2023, at the completion of their inspection, FDA investigators presented the company’s owner, Gary Tashjian, with a list of outstanding issues (FDA Form 483, Inspectional Observations). These observations included:

The detection of Salmonella in three different products, manufactured on June 13, June 28, and July 19, 2023.
Use of an unvalidated process as a preventative control for pathogens in the products over a four-month time span.
Lack of documentation that the preventative control process was carried out.

When the company declined to recall the three Salmonella-positive product batches, the FDA issued an Advisory to pet owners, cautioning them to avoid feeding the potentially hazardous batches to their pets.

In a written response to the list of observations, the company asserted (not for the first time) that it was a “…Retail Food Establishment and therefore … not subject to the provisions in the Food Safety Modernization Act which require a food safety plan and preventive controls.”

Notwithstanding this assertion, the company arranged for an independent lab to test retained samples from the implicated products, and reported that their lab found “only trace amounts” of Salmonella in just one of the batches identified by the FDA.

Darwin’s also claimed that the unvalidated process was a “temporary substitution” for its usual, validated process, was initiated as a result of an equipment failure, and that the company had since reverted to the validated process.

Finally, the company reported that it had initiated proper documentation of its preventative control process in response to the FDA’s final observation.

Fraught history

The relationship between Arrow Reliance (Darwin’s) and the FDA has been fraught with discord and disputes almost since the initial inspection of the company’s facilities in 2016. The story is told in some detail in TOXIC: From Factory To Food Bowl, Pet Food Is a Risky Business. More recent chapters in the evolution of Darwin’s relationship with the FDA can be found by entering “Darwin” in the eFoodAlert search box at the top of the page (right hand side).

Do your part to support pet food safety

The FDA relies heavily on reports from consumers and veterinarians to highlight possible pet food safety issues. If you suspect that a pet food or pet treat has caused your furry or feathered companion to become ill, please report your concerns to the FDA.

Pet owners can report suspected illness to FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you work with your veterinarian to submit a pet’s medical records as part of the report. For an explanation of the information and level of detail that would be helpful to include in a complaint to FDA, please see How to Report a Pet Food Complaint.