7 Months Later, the FDA Finally Gives us Information on Purina

The FDA (7/31/24) released a report titled: “Summary of Purina Pet Food Adverse Event Reports (November 22, 2023 – April 15, 2024), FDA Actions and Findings“. The report gives pet owners some information on what the FDA investigated, and what they did not investigate.

The summary page shares: “In late November 2023, the FDA began to receive an increased frequency of adverse event reports about a variety of companion animal illnesses (largely dogs, a few cats) that pet owners attributed to pet food.” FDA stated that “initially, the reports were mostly about products made by Nestle Purina Pet Care (Purina)”, but the agency received reports on other brands “as publicity and social media discussion increased”.

This second statement from FDA seems to allude that the agency believed reports from sick pets ONLY occurred due to ‘publicity and social media discussion’. It seems to ignore the possibility that a pet food issue was occurring.

FDA stated that the reported pet illnesses were “Clinical signs (symptoms) described in dogs and cats included gastrointestinal (e.g., diarrhea, vomiting), renal (kidney), hepatic (liver), and/or neurological (e.g., seizures) symptoms.” Strangely, the FDA report does not mention bloody diarrhea or bloody vomiting, which was the major pet owner reported symptom from the January 2024 reports previously provided by FDA through a Freedom of Information Act request. For FDA to leave this pertinent consumer information out, gives an appearance the symptoms reported were far less severe.

The FDA Summary page stated “The FDA received approximately 1,300 adverse event reports for a variety of Purina pet foods between November 22, 2023, and April 15, 2024.” This total number of adverse event reports as stated in this recent update seems quite low, considering the previously provided adverse event reports for January 2024 provided 971 reports for Purina pet foods in one month alone. The FDA’s “approximately 1,300 adverse event reports” over five months seems suspiciously low, perhaps severely edited for this public announcement.

The FDA stated that of the ‘approximately 1,300 adverse event reports’ received, the agency only investigated “107 reports”.

This means that 1,193 consumer reports to FDA were ignored; only 8.2% of all consumer reports regarding Purina pet foods submitted to FDA were investigated.

This was the criteria the FDA claimed to use to narrow down 1,300 sick/dead pet reports to 107:

• “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”

The FDA stated they collected opened samples from pet owners for testing, but they did not disclose how many samples were collected/tested, what specific Purina foods were tested. The FDA testing of open samples included:

• Mycotoxins (aflatoxin, fumonisin, deoxynivalenol)
• Excess vitamin D 
• Bacteria (Salmonella, E. coli, Listeria, Staphylococcus aureus)
• Pesticides
• Phosphine (a fumigant used to control insects on grain and other commodities)
• Rancid fat 

No positive results for any of the above contaminants were found. The FDA “did detect the bacterium Bacillus in 17 open product (pet owner-provided) samples. Bacillus is present in the environment and most strains are benign. Bacillus cereus (B. cereus) is a strain capable of producing a toxin known to make people sick. Little is known about B. cereus and how ingestion may affect animals, including pets. B. cereus was detected in 7 out of 29 open product samples provided by pet owners.”

And the FDA tested “20 samples” of Purina products purchased at retail. Similar testing was performed on these unopened products as the samples collected from pet owners, all were negative.

FDA Inspection of Purina

The FDA performed one (and only one) manufacturing plant inspection – “at the Purina manufacturing facility in Clinton, Iowa, the manufacturing site of the most frequently mentioned products in adverse event reports submitted to the FDA.”

This inspection lasted for 3 days – April 30, 2024 through May 2, 2024.

Of significance – the FDA’s Purina manufacturing plant inspection was classified as a “Preventive Controls Surveillance“, not a “for-cause” inspection. A ‘for-cause’ inspection is typical of inspections when a significant number of adverse event reports are received by the agency (as was the case with this instance), a ‘surveillance’ inspection is a standard inspection no different than one done at a plant that had zero adverse event reports provided to FDA.

The Inspection Report stated “We followed up on previous complaints” with this Purina manufacturing plant. There were 24 complaints in total discussed with Purina, 9 of which were consumer complaints from 2007. There was no information in the inspection report that indicated the remaining 15 consumer complaints discussed with Purina were from these recent death and illness reports. And this Purina plant was unaware of all of the 15 consumer complaints; “Either the firm did not have a similar complaint for the lot number or the investigation was undetermined.”

Per the inspection report, FDA contacted Purina on “February 6, 2024 regarding the complaints and potential new hazard.” During an April 30, 2024 FDA inspection of this plant, Purina corporate offices were contacted. Mr. Justin Schmidt of Purina corporate told FDA: Purina “had been working on the potential issue at the corporate level”. In other words, Purina did not investigate the ‘potential issue’ at this manufacturing plant (where many of the reported foods were manufactured). Instead, Purina was investigating the “potential issue” at their corporate offices.

If we assume (a very safe assumption) the FDA scheduled the inspection during their February 6, 2024 conversation – this would have provided Purina 12 weeks to prepare for this inspection.

Of interest, the inspection report disclosed that Purina corporate “had reached
out to the FDA’s Center for Veterinary Medicine (CVM) on January 19, 2024 regarding an increase in specific complaints and had a meeting with CVM.”

Just FOUR DAYS prior to this Purina meeting with FDA “regarding an increase in specific complaints” – Purina issued a public statement that referenced consumer complaints as a “an online rumor.”

And shockingly, the FDA inspection report stated “No samples were collected.” No samples collected is typical of a standard compliance inspection, it is NOT standard in a ‘for-cause’ inspection.

FDA admits to 1,300 pet illness reports with Purina products, the FDA admits most of the reported Purina products were manufactured in this plant…and they did not collect any samples of ingredients, or swab for pesticide, or chemical contaminants in the plant.

Review Timeline:

Late November 2023 – “the FDA began to receive an increased frequency of adverse event reports.”

January 15, 2024 – Purina issues a statement: “Pet parents continue to be understandably scared by an online rumor that there is an issue with Purina pet foods. This rumor is false, and we are saddened to see the confusion and fear that it has caused for pet owners.”

January 19, 2024 – Purina corporate “had reached out to the FDA’s Center for Veterinary Medicine (CVM) regarding an increase in specific complaints and had a meeting with CVM.”

February 6, 2024 – FDA contacted Purina “regarding the complaints and potential new hazard.”

April 30, 2024 – FDA finally inspects one Purina plant, inspection ended May 2, 2024. Inspection was classified as a typical compliance inspection, not a “for-cause” inspection based on adverse event reports.

July 31, 2024 – FDA provides consumers with an update to their investigation.

Personal opinion: This report is little more than smoke and mirrors meant to give an impression the FDA actually investigated the concerning number of sick/dead pet reports linked to Purina and other pet foods. While the FDA did test some Purina pet foods, they do not disclose which foods they tested. While the FDA did perform an inspection, it was classified as a typical Compliance inspection – not an inspection based on a large number of consumer complaints received. The number of complaints provided was highly edited, and the FDA only investigated 8.2% of their edited total.

The FDA report is a shameful representation of how our pets are ignored by this regulatory agency.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
TruthaboutPetFood.com
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