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Saturday, August 25, 2012

FDA Questions and Answers Regarding Jerky Pet Treats--UPDATE




This is the actual FDA post with the new portions highlighted:


Product Safety Information - Questions and Answers Regarding Jerky Pet Treats

Questions and Answers Regarding Jerky Pet Treats

Updated August 15, 2012

Why did FDA issue a cautionary update in November 2011?
In 2011, FDA saw an increase in the number of complaints it received of dog illnesses associated with consumption of chicken jerky products imported from China.
FDA previously issued a cautionary warning regarding chicken jerky products to consumers in September 2007 and a Preliminary Animal Health Notification in December of 2008. The number of complaints being received dropped off during the latter part of 2009 and most of 2010. However in 2011, FDA once again started seeing the number of complaints rise to the levels of concern that prompted release of our earlier warnings.
Since the issuance of the CVM Update on November 18, 2011, the agency has received numerous additional complaints regarding chicken jerky products.

Types of Jerky Pet Treat Products

What are the products involved?
The cautionary update issued in November 2011 specifically refers to chicken jerky products that are imported from China. These dried chicken jerky products, intended for dogs, may also be sold as tenders, strips or treats.
Has the agency received reports of illness associated with other types of jerky treats?
Yes. More recently (2012), the product-associated complaints have expanded to other jerky pet treat products such as duck and sweet potato jerky treats. Our investigation now includes these types of jerky treat products.
Are there specific brands we should be concerned about?
No specific products have been recalled because a definitive cause has not been determined. The FDA continues to actively investigate the problem and its origin. If the FDA identifies the cause, the agency will take appropriate action and notify the public.
Why aren’t these products being taken off the market?
There is nothing preventing a company from conducting a voluntary recall. It is important to understand that unless a contaminant is detected and we have evidence that a product is adulterated, we are limited in what regulatory actions we can take. The regulations don't allow for products to be removed based on complaints alone. 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.
Are previously submitted Consumer Complaints regarding jerky pet treat products available to view?
Yes. The following is a list of jerky pet treat product complaints received by FDA's District Consumer Complaint Coordinators (CCC's) between January 1, 2007 - July 2, 2012. These records only comprise complaints received by CCC's and do not include reports received through FDA's electronic Safety Reporting Portal (SRP) system.
The spreadsheet lists a "country of origin" (C.O.O.) column. A few entries list the United States as the C.O.O. This is not correct. The distributor is located in the U.S. but the manufacturer is located in China. In addition, one entry lists, “Afghanistan," as the C.O.O. It should indicate, "China," in the C.O.O. column. Freedom of Information laws require records to be released “as is” regardless of any perceived errors (either manual or human).

Testing of Jerky Pet Treat Products

What is FDA testing for?
Since 2007, FDA has been actively investigating the cause of illness in pets reported in association with the consumption of chicken jerky products. More recently (2012), the product-associated complaints have expanded to other jerky pet treat products such as duck and sweet potato jerky treats. Samples have been tested by FDA laboratories, by the Veterinary Laboratory Response Network (Vet-LRN), and by other animal health diagnostic laboratories in the U.S for multiple chemical and microbiological contaminants.
Product samples were tested for 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. Samples have also been submitted for nutritional composition (which includes glycerol concentrations), vitamin D excess and enterotoxin analysis. Some samples from recent cases (2011-2012) have been submitted for multiple tests and we are awaiting results. More samples are in the process of being collected for testing.
What are the results of testing?
Samples collected from all over the United States have been tested for a wide variety of substances and to date, scientists have not been able to determine a definitive cause for the reported illnesses. For detailed analysis of laboratory samples, please see the following spreadsheet.
Does the above spreadsheet include all of FDA’s laboratory sample results?
No. The test results made public are from testing conducted by FDA's Office of Regulatory Affairs and represent samples analyzed domestically in the field - from consumer complaints, inspections, or assignments. This does not represent all testing that has and is being conducted by FDA. Additional, non-regulatory testing is being conducted at other FDA laboratories or collaborating institutions to try to identify the root cause(s) for the reported illnesses. Several method development initiatives are underway to investigate additional toxic substances for which no standard methods are currently available.
Has there been any indication that metal contamination in chicken jerky products may be the cause of illness in dogs?
FDA’s previous testing of chicken jerky product samples did not show toxic levels of metals. In addition, results from March 2012 toxic metal analyses, which included tests for heavy metals, have again shown samples of chicken jerky products to be negative for toxic metals.
Is FDA contracting with private labs to conduct some of the testing of chicken jerky treats?
Yes, FDA issued a solicitation in March 2012 for private diagnostic labs to submit quotes on conducting analysis of the nutritional composition of 30 chicken jerky treat samples
https://www.fbo.gov/index?s=opportunity&mode=form&id=fd7c441ba86c151bc4e9f0c8f15f1aff&tab=core&tabmode=list&.disclaimer icon
Does this mean that you are no longer testing for other possible contaminants?
No, the FDA is not limiting their testing to one laboratory analysis (nutritional composition). We are submitting samples to multiple laboratories and testing for multiple things including potential toxins.
Is all of the testing of chicken jerky treats being done through contracts with private labs?
No. Testing is being done at FDA laboratories as well.
What type of nutritional analysis is being conducted?
We are testing for fatty acids, crude fiber, glycerol, protein, ash and moisture.
Why are you doing testing of nutritional composition of chicken jerky treats?
We are testing samples, 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 the pet food contamination investigation, 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. In addition, hiring private laboratories to conduct “routine” analyses allows FDA to focus it's efforts on “non-routine” analyses.

Advice to Pet Owners and Consumers

Should I stop feeding chicken jerky treats to my dog?
Chicken jerky products should not be substituted for a balanced diet and are intended to be fed occasionally in small quantities.
FDA is advising consumers who choose to feed their dogs chicken jerky products 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, stop feeding the chicken jerky product. 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).
What are the signs of illness that are being reported?
The signs 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. Owners should consult their veterinarian if signs are severe or persist for more than 24 hours.

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 theFDA 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. 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 sample 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. 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.
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?
The inspections provided valuable information on the 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 the cause of pet illnesses in the United States.
Are the Establishment Inspection Reports (EIRs) available?
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 firms. In particular, one firm falsified receiving documents for glycerin, which is an ingredient in the 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 its products. FDA is further investigating glycerin as a potential source of the illnesses.
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 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?
Yes. FDA has met with many pet food firms in the United States to engage them in assisting with this investigation.

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, any investigations conducted, analyses 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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