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 shared: “In late November 2023, the FDA began receiving more frequent adverse event reports of various animal comorbidities (mostly dogs, some cats) that pet owners attributed to pet food.” The FDA states that “initially, the reports were mostly about products made by Nestle Purina Pet Care (Purina)”but the agency has received reports on other brands “as publicity and social media discussion increase”.
This second statement from the FDA seems to indicate that the agency believes that the reports from sick pets ONLY occurred due to ‘publicity and social media discussion’. This seems to rule out the possibility that a pet food issue has occurred.
The FDA says the reported pet illnesses are “Clinical signs (symptoms) described in dogs and cats include gastrointestinal (eg, diarrhea, vomiting), renal (kidney), hepatic (liver), and/or neurological (eg, seizures). weird, the FDA report does not mention bloody diarrhea or bloody vomitingwho was the primary pet owner who reported the symptom from the January 2024 reports previously provided by the FDA through a Freedom of Information Act request. For the FDA to omit this relevant consumer information, gives the appearance that the symptoms reported are less severe.
The FDA’s Summary page states “The FDA received approximately 1,300 adverse event reports for different types of Purina pet food between November 22, 2023, and April 15, 2024.” The total number of adverse event reports as stated in this recent update seems a little lowtaking into account previously provided adverse event reports for January 2024 provided 971 reports for Purina pet foods in just one month. The “FDA”approximately 1,300 adverse event reports” for five months seems suspiciously low, perhaps heavily edited for this public announcement.
The FDA said that of the ‘approximately 1,300 adverse event reports’ received, The agency investigated only “107 reports”..
This means that 1,193 consumer reports to the FDA were ignored; Only 8.2% of all consumer reports about Purina pet foods submitted to the FDA were investigated.
This is the criteria the FDA claims was used to narrow the 1,300 sick/dead pet reports to 107:
- “The owner’s willingness to be contacted for additional information
- Type of symptoms reported (mainly gastrointestinal, hepatic and neurologic cases were selected)
- Time between illness and submission of report (prior to recent illness)
- Availability of veterinary medical records
- Product availability with lot number and best-by date”
The FDA said they collected open samples from pet owners for testing, but did not disclose how many samples were collected/tested, or what specific Purina foods were tested. FDA testing of open samples includes:
- Mycotoxins (aflatoxin, fumonisin, deoxynivalenol)
- Too much vitamin D
- bacteria (Salmonella, E. coli, Listeria, Staphylococcus aureus)
- Pesticides
- Phosphine (a fumigant used to control insects in grain and other commodities)
- Rancid fat
No positive results were found for any of the above contaminants. The FDA “The bacterium Bacillus was identified 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 with ability to produce a toxin known to make humans ill Little is known about B. cereus and how ingestion may affect animals, including pets B. cereus was identified in 7 of the 29 open samples of product provided by pet owners.”
And the FDA tried “20 samples” of Purina products purchased at retail. Similar tests were conducted on unopened products as samples collected from pet owners were all negative.
FDA Inspection of Purina
The FDA made one (and only one) inspection of the manufacturing plant – “at Purina’s manufacturing facility in Clinton, Iowa, the manufacturing site of the products most frequently cited in adverse event reports submitted to the FDA.”
This inspection lasted for 3 days – April 30, 2024 to May 2, 2024.
Of importance – the inspection of the Purina manufacturing plant by the FDA was classified as a “Preventive Controls Surveillance“, not a “for reason” inspection. A ‘for cause’ inspection is typical of inspections when a large number of adverse event reports are received by the agency (as was the case in this instance), a ‘surveillance’ inspection is a routine inspection without distinguished from one produced in a plant with no adverse event reports provided to the FDA.
The Inspection Report states “We have followed up on previous complaints” with this Purina manufacturing plant. There were 24 complaints in total discussed with Purina, 9 of these are consumer complaints from 2007. There was no information in the inspection report indicating that the remaining 15 consumer complaints addressed to Purina were from recent reports of death and illness. And this Purina plant was unaware of all 15 consumer complaints; “Either the company does not have a similar complaint for the lot number or the investigation is inconclusive.”
According to the inspection report, the FDA contacted Purina on “February 6, 2024 regarding complaints and potential new risks.” During the April 30, 2024 FDA inspection of this plant, Purina’s corporate offices were contacted. Mr. Justin Schmidt of Purina corporate told the FDA: Purina “worked 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 are made). Instead, Purina investigates the “potential issue” in their corporate offices.
If we assume (a very safe assumption) the FDA has scheduled an inspection in their February 6, 2024 conversation – this will give Purina 12 weeks to prepare for this inspection.
Of interest, the inspection report revealed that Purina corporate “is reached
at the FDA’s Center for Veterinary Medicine (CVM). on January 19, 2024 about the increase in specific complaints and had a meeting with the CVM.”
Just FOUR DAYS before this Purina meeting with the FDA “about raising specific complaints” – Purina issued a public statement identifying consumer complaints as a “an online rumor.”
And surprisingly, the FDA inspection report said that “No samples were collected.” No samples collected is typical of a standard compliance inspection, it is NOT standard in a ‘for cause’ inspection.
FDA acknowledges 1,300 reports of pet illness with Purina products, FDA admits most reported Purina products were manufactured at this plant…and they did not collect any samples of substances, or swabs for pesticides, or plant-contaminating chemicals.
Check the Timeline:
it’s too late November 2023 – “the FDA began to receive a higher frequency of adverse event reports.”
January 15, 2024 – Purina issued 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 sorry to see the confusion and fear it is causing pet owners.”
January 19, 2024 – Purina corporate “contacted the FDA’s Center for Veterinary Medicine (CVM) regarding the increase in specific complaints and met with the CVM.”
February 6, 2024 – FDA contacted Purina “about complaints and potential new risks.”
April 30, 2024 – The FDA finally inspected a Purina plant, the inspection completed on May 2, 2024. The 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 on their investigation.
Personal opinion: This report is more than smoke and mirrors meant to give the impression that the FDA has actually investigated the number of sick/dead pet reports associated with Purina and other pet foods . Although the FDA tested some Purina pet foods, they did not disclose which foods they tested. While the FDA did conduct an inspection, it was classified as a typical Compliance inspection – not an inspection based on the large number of consumer complaints received. The number of complaints filed was highly redacted, and the FDA investigated only 8.2% of their total redacted.
The FDA report is a shameful representation of how this regulatory agency is ignoring our pets.
Wishing you and your pet(s) the best,
Susan Thixton
Pet Food Safety Advocate
TruthaboutPetFood.com
Association for Truth in Pet Food
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