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Wednesday, May 28, 2014

FDA Questions and Answers Regarding Jerky Pet Treats


Updated May 16, 2014

What is the issue?

FDA continues to investigate ongoing illnesses, predominantly in dogs whose owners report exposure to jerky pet treats from China.
Since 2007, FDA has become aware of an increasing number of illnesses in pets associated with the consumption of jerky pet treats. As of May 1, 2014, FDA has received approximately 4,800 reports of pet illnesses which may be related to consumption of the jerky treats (These include 1800 complaints received since FDA’s last update in October 2013). Most of the reports involve jerky products sourced from China. The majority of the complaints involve dogs, but cats also have been affected. The reports involve more than 5,600 dogs, 24 cats, three people and include more than 1,000 canine deaths. There does not appear to be a geographic pattern to the case reports.
FDA has received adverse event reports for many sizes and ages of dogs, and for multiple breeds. About 60 percent of the reports are for gastrointestinal illness (with or without elevated liver enzymes) and about 30 percent relate to kidney or urinary signs. The remaining 10 percent of cases involve a variety of other signs, including convulsions, tremors, hives, and skin irritation.
FDA continues to investigate these illnesses in conjunction with Vet-LIRN laboratories and State partners. FDA has also worked with colleagues in academia and industry, and met with the Chinese regulatory agency responsible for pet food to ensure that they are aware of U.S. requirements for pet food safety and to develop collaboration on sharing information to support FDA’s investigation. FDA has also hosted Chinese scientists at our veterinary research facility to further our scientific cooperation.
Can you characterize the approximately 1,800 complaints received since the Oct. 22, 2013 update?

It is typical for FDA to receive a sharp increase in reports immediately after releasing an update. The October 2013 was our most comprehensive update yet, and included a novel approach: reaching out directly to veterinarians through the American Veterinary Medical Association. We intentionally designed this outreach in order to receive information about new or ongoing cases currently under veterinary care.
About 25 percent of the reports were what we refer to as “historic” cases: illnesses that occurred several months or even years previously. The remaining cases were more recent, but may or may not have received veterinary attention. 
 How have you followed up on these reports?
Out of the new cases, we identified about 150 well-documented cases for further investigation. We continue to correspond with the owners and veterinarians of these pets to track their progress and to obtain and test samples of blood, urine, feces and tissue.
Through this testing, we have been able to identify 72 more dogs that tested positive for Fanconi or Fanconi-like syndrome, a rare kidney disease normally seen primarily in certain breeds as a genetic disease.
We also had the opportunity to complete necropsies (post-mortem examinations) on 26 dogs, through the consent of their owners. Additional necropsies are still in progress.

What were the findings of the 26 necropsies that were performed?
We are exceptionally grateful to the owners who consented to allow FDA to perform post-mortem examinations of their beloved pets. We understand this is a difficult decision to make and appreciate the opportunity to learn more about the potential cause of death. In half of the cases, we found evidence of several diseases, including widespread cancer, Cushing’s disease, mushroom toxicity, abscess, or internal bleeding secondary to trauma. We do not believe that these deaths are related to consumption of jerky pet treats.
In the remaining 13 dogs, a relationship to jerky pet treats could not be ruled out, although we are still not able to identify an exact cause-and-effect nature of that relationship. Of these 13 dogs, 11 had indications of kidney disease and two had gastrointestinal disease.
We still have necropsy cases pending and will provide updates in future reports.
What is the goal of FDA’s joint study with CDC?
Because the Centers for Disease Control and Prevention (CDC) is involved with public health issues that affect both human and animal health, FDA requested their expertise in collaborating on a study comparing cases of sick dogs with “controls” (dogs who have not been ill). The goal of the study is to compare the foods eaten by the sick dogs (cases) to those eaten by the dogs that did not get sick (controls), in order to determine whether sick dogs are eating more jerky pet treats than in healthy dogs are.
Investigators first identified about 100 cases of kidney illnesses in dogs reported to FDA since July 1, 2013, regardless of jerky pet treat exposure. The cases included dogs diagnosed with Fanconi or Fanconi-like illness, or dogs that were 5 years of age or younger and had kidney failure. Cases were selected solely on this case definition and not on what food they consumed. Investigators then identified approximately three control (not ill) dogs within a 100-mile radius of each case by “cold-calling.” It took more than 12,000 phone calls to identify less than 300 controls. We interviewed the owners of both the case and control dogs using a detailed questionnaire that included in-depth questions about the types of foods the dogs ate, as well as other factors that could lead to renal disease.
The data collected during this investigation will allow federal investigators to better understand what is making pets sick. The study is still ongoing, and we will share results when they are completed, hopefully before the end of 2014. 


Types of Jerky Pet Treat Products

What are the products involved?
The majority of complaints involve chicken jerky (treats, tenders, and strips), but others include duck, sweet potato, and treats where chicken or duck jerky is wrapped around dried fruits, sweet potatoes, or yams.
Are there specific brands we should be concerned about?
The illnesses have been linked to many brands of jerky treats. The one common factor the cases share is consumption of a chicken or duck jerky treat or jerky-wrapped treat, mostly imported from China. Pet owners should be aware that manufacturers do not need to list the country of origin for each ingredient used in their products, so packages that do not state on the label that they are made in another country may still contain ingredients sourced from China or other countries that export to the U.S.
Why aren’t these products being taken off the market?
There is nothing preventing a company from conducting a voluntary recall. This is an ongoing investigation and FDA will notify the public if a recall is initiated. Currently, FDA continues to urge pet owners to use caution with regard to jerky pet treat products.
Some of these products were removed from the market in January 2013, after the New York State Department of Agriculture and Marketing (NYSDAM) Food Laboratory identified six unapproved antibiotic drugs in certain jerky pet treats manufactured in China. Subsequently, complaints of illnesses associated with jerky pet treats dropped significantly. The decline in reports is likely due to the lack of availability of the jerky treats that make up the bulk of the market. However, some products did remain on the market and we did continue to receive reports associated with the jerky pet treat products that were still available.

FDA received a flurry of new case reports immediately after our last update in October 2013, which fits the pattern we have come to expect. Reports dropped off again around January 1, 2014. 
 
Where can I see the complaints associated with jerky pet treats?
Complaints come into the FDA through two pathways: through regional consumer complaint coordinators in each of FDA’s district offices and through the Safety Reporting Portal.

Where is the spreadsheet for the complaints received since October 2013?Because our primary goal for our Dear Veterinarian letter was to obtain data about current or recent cases under veterinary care, we focused first on identifying the best cases for timely follow up. FDA is still in the process of compiling all of the raw reports received since October 2013 into a new spreadsheet and will post it as soon as it is complete.
 

Testing of Jerky Pet Treat Products

What is FDA testing for?
FDA’s ongoing scientific investigation includes testing samples of products for multiple chemical and microbiological contaminants. These tests have been conducted by FDA laboratories, by the Veterinary Laboratory Response Network (Vet-LIRN), and by other animal health diagnostic laboratories in the United States.
To date, product samples have been tested for contaminants known to cause the symptoms and illnesses reported in pets including Salmonella, metals, furans, pesticides, antibiotics, mycotoxins, rodenticides, nephrotoxins (such as aristolochic acid, maleic acid, paraquat, ethylene glycol, diethylene glycol, toxic hydrocarbons, melamine, and related triazines) and were screened for other chemicals and poisonous compounds. DNA verification was conducted on these samples to confirm the presence of poultry in the treats. The FDA’s testing of jerky treat product samples for toxic metals including tests for heavy metals have been negative.
Samples were also submitted for nutritional composition, including fatty acids, crude fiber, glycerol, protein, ash and moisture and other excess nutrients. The purpose of nutritional composition testing is to verify the presence of ingredients listed on the label.
Since October 2013, FDA has added testing for antiviral drugs to its testing portfolio, after some older products tested positive for the antiviral drug amantadine. 

To view an overview of FDA’s jerky pet treat testing program, please see Jerky Pet Treat Investigational Rationale and Results.
What is amantadine and why would it be in chicken?
Amantadine is an antiviral drug that is FDA-approved for use in people and has also been used in an extra-labelfashion dogs for pain control. FDA prohibited its use in poultry in 2006.

Amantadine was first approved by FDA in 1966, and the approved uses include treatment of Parkinson’s disease, and prevention or treatment of influenza A. The Centers for Disease Control and prevention no longer recommend amantadine for treatment of flu because some strains are resistant to it.

FDA does not believe that amantadine contributed to the illnesses because the known side effects or adverse events associated with amantadine do not seem to correlate with the symptoms seen in the jerky pet treat-related cases. However, it should not be present at all in jerky pet treats, and we have notified the Chinese authorities that we consider the presence of amantadine in these products to be an adulterant. Chinese authorities have also assured us that they will perform additional screening and will follow up with jerky pet treat manufacturers. We have also notified the U.S. companies that market jerky pet treats found positive for amantadine of this finding.

Is FDA currently testing imported jerky pet treats for amantadine?
FDA is in the process of conducting a survey assignment of both domestic and imported jerky pet treats for amantadine, as well as other antivirals. Of the 13 samples analyzed thus far, none have tested positive for antivirals. 
 
Has there been any indication that metal contamination in jerky pet treats may be the cause of illness in dogs?
FDA’s testing of jerky pet treat samples to date has not revealed toxic levels of metals. In addition, results from March 2012 toxic metal analyses, which included tests for heavy metals, have again shown samples of jerky pet treats to be negative for toxic metals.
Is FDA contracting with private labs to conduct some of the testing of jerky pet treats?
Yes, FDA issued a solicitation in March 2012 for private diagnostic laboratories to submit quotes on conducting analyses of the nutritional composition of 30 chicken jerky pet treat samples. That document is available atAnalysis of Nutritional Composition of 30 Animal Food Products (Chicken Jerky Treats). Additionally, FDA works in conjunction with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN) to investigate and test jerky pet treats for several different contaminants.
Testing may include one or more of the following analyses:
  • Salmonella
  • Metals/Elements (such as arsenic, cadmium and lead, etc.)
  • Markers of irradiation level (such as acyclobutanones).
  • Pesticides
  • Antibiotics (including both approved and unapproved sulfanomides and tetracyclines)
  • Antivirals (including amantadine, rimantadine, oseltamivir and others)
  • Mold and mycotoxins (toxins from mold)
  • Rodenticides
  • Nephrotoxins (such as aristolochic acid, maleic acid, paraquat, ethylene glycol, diethylene glycol, toxic hydrocarbons, melamine, and related triazines)
  • other chemicals and poisonous compounds (such as endotoxins)
Hiring private laboratories to conduct these analyses allows FDA to focus its efforts on other aspects of the investigation.
Why is FDA testing the nutritional composition of jerky pet treats?
We are testing jerky pet treat samples for their nutritional composition, in part, to determine the concentration of glycerin in the various products. Moisture content is needed to calculate concentration on a dry weight basis. FDA is evaluating the ratios of the various components in the sample treats.
What some might describe as “routine” analysis can often provide FDA with important leads. It is important to understand the composition of a product and its ingredients to determine where there might be a potential for problems to occur. For example, during a prior investigation involving contaminated pet food, FDA looked carefully at all the ingredients and it was later discovered that melamine was being used to raise the level of the protein in the products. Without a clear understanding of all the ingredients in a product, FDA cannot conduct a thorough analysis or investigation.

Advice to Pet Owners and Consumers

Should I stop feeding jerky pet treats to my dog?
Jerky pet treats should not be substituted for a balanced diet and are intended to be fed only occasionally and in small quantities.
FDA is advising consumers who choose to feed their dogs jerky pet treats to watch their dogs closely for any or all of the following signs that may occur within hours to days of feeding the products:
  • decreased appetite;
  • decreased activity;
  • vomiting;
  • diarrhea, sometimes with blood;
  • increased water consumption; and/or
  • increased urination.
If the dog shows any of these signs, consumer should immediately stop feeding the jerky pet treat. In addition, owners should consult their veterinarian if signs are severe or persist for more than 24 hours. Blood tests may indicate kidney failure (increased urea nitrogen and creatinine).Urine tests may indicate Fanconi-like syndrome (increased glucose in spite of normal blood glucose).
What are the signs of illness that are being reported?
The signs of illness that may be associated with jerky pet treat products include decreased appetite; decreased activity; vomiting; diarrhea, sometimes with blood; increased water consumption and/or increased urination. These signs may occur within hours to days of feeding the products.
Laboratory tests may indicate kidney problems, including Fanconi-like syndrome. Although many dogs appear to recover, some reports to the FDA have involved dogs that have died.
FDA continues to investigate the problem and its origin. Some of the illnesses reported may be the result of causes other than eating jerky pet treat products.
What should I do if my dog shows signs of illness after eating pet jerky treat products?
If your dog shows any of the signs listed above, stop feeding the jerky pet treat product and consider contacting your veterinarian. FDA also asks that owners save the pet treat product for possible testing later on. When possible, this should be done by placing the jerky pet treat product, including its original packaging or container, in a larger sealable bag.

Submitting Complaints

How can I submit a complaint associated with jerky pet treat products?
Veterinarians and consumers alike should report cases of animal illness associated with pet foods to the FDA Consumer Complaint Coordinator in their state, or electronically through the Safety Reporting Portal.
More information regarding How to Report a Pet Food Complaint can be found athttp://www.fda.gov/petfoodcomplaints.
What should I do with the remainder of the jerky pet treat product that may have made my dog sick?
If your pet has experienced signs of illness, please retain the opened package and remaining pieces of the jerky pet treat product that are in the original packaging. When possible, you should place the jerky pet treat product, including its original packaging or container, in a larger sealable bag both to preserve the contents and ensure that no further contamination takes place. It is possible that your samples will be collected for testing. If your product samples are collected, please be sure to provide the FDA official with all of the samples that you have. The extensive testing that is being conducted may require multiple pieces from the package. It is also possible that a toxicant may be present in some of the samples in the package, but not all, since it is not unusual for bags of jerky treats to contain strips from several different birds. We may be able to get better or more accurate testing results with a larger sample size.
After you have reported the problem to FDA, we will determine what type of follow-up is necessary and whether your particular sample will be collected for analysis.
I’ve already submitted a complaint to FDA, when will I get a response?
Every report is important to FDA. In each case, the information the consumer furnishes is evaluated to determine how serious the problem is and what follow-up is needed.
Once a consumer has filed a report with their local FDA Consumer Complaint Coordinator, or electronically through our safety reporting portal, FDA will determine whether there is a need to conduct a follow-up phone call or obtain a sample of the jerky pet treat product in question. While FDA does not necessarily respond to every individual complaint submitted, each report becomes part of the body of knowledge that helps to inform FDA on the situation or incident.
Additional information on what happens when a problem is reported can be found at the following link:http://www.fda.gov/Safety/ReportaProblem/QuestionsandAnswersProblemReporting/ucm056069.htm.
I reported a complaint to the FDA, but my sample of jerky pet treat was never tested - could I get my sample tested by a private lab?
Even though your particular sample may not be tested, your report to FDA is important. While in some cases, a sample of the product may be collected directly from the consumer, in many cases, product samples from the same lot and code will be collected from retailers, wholesalers or the manufacturer for laboratory analysis.
FDA is working with various animal health diagnostic laboratories across the U.S. to determine why these products are associated with illness in dogs. You may have your treat tested by a private laboratory if you wish; however, it may be costly to have numerous tests conducted on your sample. Please be assured that FDA continues to devote time, energy and resources at multiple levels of the agency to determine the root cause of the reported illnesses. We are hopeful that our diligent investigation and scientific collaboration will help us understand the source of the pet illnesses.

Inspections

Has FDA conducted any inspections of facilities in China?
Yes. During April 2012, FDA conducted inspections of several facilities in China that manufacture jerky pet treats for export to the U.S.
How did FDA determine which facilities to inspect in China?
FDA selected these firms for inspection because the jerky products they manufacture have been associated with some of the highest numbers of pet illness reports in the U.S.
What did the FDA learn from the inspections?
FDA’s inspections of several facilities in China provided valuable information on these firms’ jerky pet treat manufacturing operations, including ingredients and raw materials used in manufacturing, manufacturing equipment, the heat treating of products, packaging, quality control, sanitation, and product testing. Although these inspections helped to identify additional areas that we may investigate, FDA found no evidence indicating that these firms’ jerky pet treats are associated with pet illnesses in the United States.
Are the Establishment Inspection Reports (EIRs) available?
Yes, the EIRs relating to FDA’s inspection of the Chinese manufacturing facilities are publicly available. Please see the Compliance & Enforcement box athttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Additional information on EIR conclusions and decisions can be found at:http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM320617.doc. 
Were there any concerns with the recordkeeping practices of the firms?
Yes. The FDA identified concerns about the record keeping practices of several of the inspected Chinese firms. In particular, one firm falsified receiving documents for glycerin, which is a common ingredient in jerky pet treats.
As a result of the inspection, the Chinese authority, the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), informed FDA that it had seized products at that firm and suspended exports of the firm’s products to the U.S. FDA is further investigating glycerin as a potential source of the reported illnesses in pets.
What is FDA doing in addition to inspecting Chinese manufacturing facilities?
In follow-up to these inspections, FDA sent a delegation to China in April 2012 to express to AQSIQ our concerns about the complaints we continue to receive concerning jerky pet treat products imported from that country. As a result, FDA and AQSIQ agreed to expand the investigation of jerky pet treats. In addition to sharing our epidemiological findings with AQSIQ, we initiated a scientific collaboration, and we have taken other steps to attempt to identify the root cause of the illness complaints. FDA and AQSIQ are meeting regularly to share findings and discuss further investigational approaches.
Has FDA reached out to any U.S. pet food firms?
FDA has also reached out to U.S. pet food firms to enlist their help in this public health investigation and is seeking further collaboration on scientific issues and data sharing.

Additional Information

Have there been reports similar to this in other countries?
We have reached out to relevant competent authorities in other countries to request intelligence on increased reports of illness in dogs associated with consumption of chicken jerky treats in those countries, any investigations or analyses they may have conducted on suspect products, etc. We have received some feedback regarding our questions and some suggested collaboration and sharing of information.
Where can I go to get more information?


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