(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.
Poultry jerky-type pet treats, generally containing chicken or duck meat, have been associated with clinical illness in dogs and cats for over 10 years. Since 2007, FDA has been sampling and analyzing chicken jerky-type pet treats. These products have primarily originated from China. Over 250 poultry jerky-type pet treats have been analyzed with over 1200 tests to determine potential causes for the renal, gastrointestinal, and other illnesses in dogs.
Trace residues of antibiotics and antivirals were identified in poultry jerky-type treats from China based on investigational analysis by FDA with outside laboratories and FDA regulatory analysis. Antibiotics detected include: sulfaclozine, tilmicosin, trimethoprim, enrofloxacin, and sulfaquinoxaline. Amantadine, an antiviral, has also been detected.
The presence of antibiotics and antivirals in poultry jerky-type pet treats is a concern for the potential safety of the jerky-type treat products for animals. Sulfaclozine, tilmicosin, trimethoprim, and enrofloxacin are not approved for use in poultry. Sulfaquinoxaline, which is approved for use in chickens and turkeys, has a tolerance level of 0.1 ppm, and no finished product should have a residue level above the established tolerance. The antivirals listed below are prohibited for use in poultry including chickens, duck, and turkeys.
***Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO)*** when poultry jerky-type pet treat are found through laboratory analysis to contain the antibiotics and/or antivirals listed below. ***DIO will coordinate a review of all recommendations for addition to DWPE with FDA's Center for Veterinary Medicine (CVM)***.
In order to secure release of an entry that has been detained, the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain the following antibiotics and/or antivirals referenced in the Red List or the level detected is within an established tolerance level (i.e. sulfaquinaxaline).
A sample consists of three subsamples (at least 100 g per subsample). From each subsample, prepare three individual portions using only whole pieces. The target weight for a portion is 30 g. If the individual piece is less than 30 g, whole pieces can be combined to obtain the lowest possible sample weight meeting a minimum of 30 g. If the individual piece is greater than 30 g, use that one piece in its entirety. Grind each portion to a powder and store frozen in a whirl-pak or other suitable container until analysis. All nine portions should be prepared and tested individually.
***Resources for private laboratory testing are available at https://www.fda.gov/media/73540/download ***
***Removal from Detention without Physical Examination (REMOVE FROM RED LIST:
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act.
FDA recommends a firm requesting removal from detention without physical examination provide the following information:
A. Results of the firm's investigation(s) into the product failure.
B. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum:
1) A description of current manufacturing processes which ensure the product is free of non-permitted drug residues; and
2) Verification of the process's adequacy; and
C. For requests to remove products manufactured from one poultry source (i.e., chicken only) from DWPE, a minimum of five (5) consecutive non-violative commercial shipments must have been offered for import to FDA and subsequently released by FDA, based on private laboratory analyses demonstrating the product is free of non-permitted drug residues.
For requests to remove multiple products representing more than one poultry source (i.e., chicken and duck) from DWPE, a minimum of twelve (12) consecutive non-violative commercial shipments must have been offered for import to FDA and subsequently released by FDA, based on private laboratory analyses demonstrating the products are free of non-permitted drug residues.
For additional guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, ***Chapter 9-8, "Detention without Physical Examination (DWPE). ***
***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
via email: Importalerts2@fda.hhs.gov ***
Requests for removal from detention without physical examination will be reviewed by DIO and referred to CVM for additional evaluation.
*** Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at email@example.com
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at firstname.lastname@example.org
Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to Center for Veterinary Medicine (CVM), Division of Compliance,) Animal Food Program Team (HFV-236) at CVMImportRequests@fda.hhs.gov
72B02 Poultry Prod Pet Dog Food
72B99 Pet Dog Food N.E.C.
72F17 Bone, Poultry, Pet Chews (Non-Nutritive)
72F99 Pet Chews (Non-Nutritive), N.E.C.
72G02 Poultry Products, Pet Treats
72G99 Pet Treats, N.E.C
OASIS charge code - VETDRUGRES
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)