January 9, 2013
On September 14, FDA posted information on its investigation into reports of illnesses associated with the feeding of jerky pet treats. FDA continues to receive reports of illnesses and inquiries from the public and the media. Veterinarians and scientists from FDA’s Center for Veterinary Medicine (CVM) have assembled a report of the cases of illness and FDA’s ongoing investigation. The reports can be accessed at:
Consumer Complaints of Illness to Pets
As FDA investigates consumer complaints and other reported adverse event data from the public concerning jerky pet treats, it is important to remember that these data must be carefully interpreted. In most cases, information from these reports cannot be further confirmed or verified. This information is not data obtained from a controlled clinical trial or as part of an observational epidemiologic study, but rather are a series of reports of events believed by the reporting party to be associated with the consumption of jerky-type products.
Interpreting reports of adverse events
There are several limitations to interpreting passively reported adverse event data, and it is important to note that adverse event data consist of reports or complaints of illness or death and the subjective link with product exposure. The Center is carefully evaluating these reports to try and determine if they should be considered evidence of a causal relationship. The numbers in this report should not be used to calculate incidence rates or estimates of risk, because there is no accurate way to determine overall how many animals were exposed to a product, which is needed as the denominator in calculations of relative risk. It is also inappropriate to make use of adverse event data to compare the relative safety of different products, which may have different usage patterns and/or reporting rates.
It is possible that other food or drug exposures caused the signs and symptoms reported in these reports; thus, there is no certainty that the reported jerky treat caused the adverse event. There may be one or more concomitant diseases, conditions, medications or other foods that can better explain the clinical signs seen. Sometimes a significant amount of time elapses between the date the problem occurred and the date the problem is reported and the reporter does not remember specific details (which can include the brand name or the names of other brands fed at the same time or prior to the report), so the report may contain erroneous information. Reporting bias also may exist in passive reporting systems. For example, increased media attention to specific products may cause increased reporting for those products for some period of time, causing an apparent sudden increase in the number of reports received. CVM Updates were publicly released September 26, 2007, December 19, 2008 and November 18, 2011, and all were followed by increased reporting activity after the update was issued.
However, even with these limitations, CVM strongly believes that the reports, especially the numerous reports documenting Fanconi syndrome, warrant FDA’s continued in-depth investigation of the potential causes of the reported illnesses.
In addition to the summaries of cases of illnesses reported, FDA is also posting the following information regarding two foreign inspections FDA has conducted as part of its investigation:
1. Establishment Inspection Report from Yantai Aska:
The firm is a manufacturer of a variety of chicken jerky, duck jerky, jerky wrapped vegetable and fruit products and other chew type products. An evaluation was conducted of the firm's manufacturing operations including ingredients and raw materials, equipment, the heat treating of products, packaging, quality control, sanitation and product testing. The inspection did not reveal observations with processing and packaging except that the firm falsified Certificates of Analysis (CoA) pertaining to glycerin which is a raw ingredient involved in jerky pet product manufacturing. After further investigations by FDA working in collaboration with the Chinese government’s Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), it was determined that the falsification of documents due to the mislabeling of the glycerin as “industrial grade” was because it was easier, quicker and cheaper to import glycerin into China labeled as industrial use rather than as food or pharmaceutical grade.
As a result of the inspection, AQSIQ informed FDA that it had taken enforcement actions and worked with Yantai Aska to implement corrective actions regarding record-keeping procedures. Accurate and comprehensive record keeping is critical to ensuring that pet foods are not adulterated or misbranded. The actions taken by AQSIQ reflect the critical importance of record-keeping to maintaining a safe food supply for pets and humans. Maintenance of accurate and comprehensive records provides documentation of a firm's efforts to assure the safety of its products. We have been advised that the firm has made the corrective actions required by AQSIQ and is again eligible to export product to the United States.
2. The Establishment Inspection Report from Acidchem International Sdm. Bhd.
The company is a supplier of glycerin and FDA routinely looks at ingredient suppliers during an investigation.
The inspection was a follow up to the Yantai Aska inspection to verify that the firm was using food grade glycerin instead of industrial grade glycerin (as it was labeled) in the production of pet jerky treats. The firm was in full production manufacturing glycerin during the inspection. The condition of the equipment and the storage conditions were observed. Certificates of Analysis (CoA) were reviewed for lots of glycerin that had been identified as being from Acidchem International during the inspection of the jerky pet treat manufacturer in China who had acknowledged falsifying records. All CoAs reviewed at Acidchem International were found to meet minimum USP standards for glycerin. Officials at Acidchem International said some customers in China specified that the shipping marks on the metal drums state "for industrial use only" even though the label states the glycerin is 99.5% minimum. The firm does not manufacture a lower "industrial" grade glycerin. No observations were noted during this inspection.
As this information illustrates FDA is continuing to actively pursue this investigation from a number of different angles including compliance activity and ongoing laboratory and epidemiologic testing and analysis.
FDA continues to devote significant resources to actively investigating the problem and its origin both on its own and in collaboration with outside parties including our international counterparts and federal, state and university laboratories. Based on the results of the testing performed to date, it remains unclear which specific ingredients or finished products may be responsible for causing illnesses in pets. In addition, FDA veterinarians are consulting with other epidemiologists and experts in the veterinary community to engage them in helping look for associated illnesses.
Specifically, FDA is taking the following steps:
- Working with veterinary groups to get the message out to both veterinarians and pet owners about the reports of illness with the consumption of jerky pet treats.
- Continuing to test jerky treats for a number of toxins and ingredients that may cause illness.
- Following up on consumer complaints and where possible testing the treats potentially associated with the reported illness.
- Contacting and working with companies who manufacture jerky pet treats to ensure that they are using appropriate safeguards.
- Continuing our collaborative work with AQSIQ.