Import Alert 72-07

(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 # 72-07
Published Date: 08/14/2020
Type: DWPE

Import Alert Name:

"DETENTION WITHOUT PHYSICAL EXAMINATION OF POULTRY JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)"

Reason for Alert:

NOTE: Revision to this Import Alert dated October 27, 2016 is to update the removal from DWPE language. Changes are noted and bracketed by three asterisks (***).

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.

Guidance:

Divisions may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert.

***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).

Antibiotics

- Sulfaclozine

- Tilmicosin

- Trimethoprim

- Enrofloxacin

- Sulfaquinoxaline

Antivirals

- Amantadine

- Rimantadine

- Memantine

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 firmís 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 firmís 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 processís 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 FDAís 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

Or

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 oraoismdssimpcomplsysbr@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation,
or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

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, Human and Animal Food Investigation Team (HFV-232) at (240) 276-9200 instead of Imports Complaint Emergency Recall Team (HFV-231).
Or
Center for Veterinary Medicine (CVM), Division of Compliance (HFV-230) at CVMImportRequests@fda.hhs.gov ***

Product Description:

PRODUCTS: Poultry Jerky-Type Pet Treats

PRODUCT CODES:
72B[][]02 Poultry Prod Pet Dog Food
72B[][]99 Pet Dog Food N.E.C.
72F[][]17 Bone, Poultry, Pet Chews (Non-Nutritive)
72F[][]99 Pet Chews (Non-Nutritive), N.E.C.
72G[][]02 Poultry Products, Pet Treats
72G[][]99 Pet Treats, N.E.C

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains.[ADULTERATION, 402(a)(2)(C)(ii)]

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)


CHINA


Qingdao Myjian Foodstuff Co., Ltd.
Date Published : 03/15/2016
Zhangjialou Zhiju , Xiaonan , Qingdao, Shandong CHINA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Notes: Problem; Amantadine

72 G - - 02 Poultry Products, Pet Treats
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Notes: Problem; Amantadine

TIANJIN SHENGFA FOODSTUFFS CO., LTD.
Date Published : 06/16/2014
Gaozhuang, Yangjiabai, Hangu District , Tianjin, China , Tianjin, Tianlushi CHINA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 10/05/2016

Desc: Chicken Jerky Pet Treats
Notes: Problem;Amantadine

72 G - - 02 Poultry Products, Pet Treats
Date Published: 10/05/2016

Desc: Chicken Jerky Pet Treats
Notes: Problem; Amantadine

Weifang Sinogen Group Co.,Ltd.
Date Published : 10/26/2015
D, Weifang, Shandong , No. 667 Weizhou Road , Weifang, Shandong CHINA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Problems: ENROFLOXACIN;

72 G - - 02 Poultry Products, Pet Treats
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Problems: ENROFLOXACIN;

Yantai Yummy Pet Food
Date Published : 01/08/2016
North Of Huwang Village , Xinzhuang Town , Zhaoyuan, Shandong CHINA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Notes: Problem; Amantadine

72 B - - 05 Comb Prod Pet Dog Food
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Notes: Problem; Amantadine

72 G - - 02 Poultry Products, Pet Treats
Date Published: 10/05/2016

Desc: Duck Jerky Pet Treats
Notes: Problem; Amantadine

Zibo Dagongyuan Industrial & Trade Co., Ltd
Date Published : 06/27/2016
Fushan Industry Park, Weigu , Zibo; Town, New , Zibo, Shandong CHINA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 06/27/2016

Desc: Chicken Breast Jerky
Notes: Problem: Amantadine

72 B - - 05 Comb Prod Pet Dog Food
Date Published: 06/27/2016

Desc: Chicken Breast Jerky
Notes: Problem: Amantadine

72 G - - 02 Poultry Products, Pet Treats
Date Published: 10/05/2016

Desc: Chicken Jerky Pet Treats
Notes: Problem; Amantadine ;