In response to multiple requests for data through the Freedom of Information Act, FDA is providing documents related to consumer complaints received by the agency’s Center for Veterinary Medicine (CVM) associated with Nestle Purina Beneful dry dog food and the center’s subsequent activities to investigate and identify a potential cause for these illnesses.

During 2012, CVM received approximately three consumer complaints per month associated with Nestle Purina Beneful dry dog food. In January 2013, CVM received a surge of consumer complaints that occurred after a media report implicated Beneful dry dog food as a potentially harmful dog food product (FDA frequently sees an increase in reporting following media coverage).

Most of the complaints for Beneful came from pet owners and not from veterinarians. Such adverse event reports have limitations in that they often do not contain complete medical information, nor do they identify the percentage of consumers using the product who have filed a complaint. Additionally, such adverse event reports do not take into account other factors, such as existing disease, exposure to chemicals or contaminants, foods, or other medications, that may have triggered or contributed to the cause of the event.

In order to learn more about a potential link between the cases and Beneful dry dog food, FDA collected and performed microbial, mycotoxin and toxicological analyses of samples related to six consumer complaints that involved 7 dogs (6 illnesses, 1 death) in CA, IL, MA, VA and NJ. Product associated with an additional case of illness was unavailable for testing.

The testing did not identify a cause for the illnesses. However, given the increasing number of consumer complaints, FDA further analyzed all Beneful-related consumer complaints received from March 2011 through February 2013, and initiated an investigation at three Nestle Purina manufacturing facilities. Laboratory analyses of samples collected during the field investigations revealed certain violations in labeling and elevated levels of cyanuric acid and ammelide in six other samples. These substances were present at levels that would be unlikely to cause a health hazard. Further testing by a third party using a different analytical method indicated that these analogs were not present in a split sample.

At the conclusion of this investigation, FDA did not find sufficient evidence to support Beneful dry dog food as the source of the reported gastrointestinal illnesses. FDA is continuing to closely monitor and evaluate complaints for Beneful to determine any potential follow-up actions, and encourages consumers or veterinarians with complaints about a specific pet food product to submit a report to the Safety Reporting Portal.

For more information:

• Incident Summary Final Report
• Nestle Purina Establishment Inspection Reports
  • Flagstaff, AZ
  • Edmund, OK
  • Mechanicsburg, PA
• Consumer Complaints