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: 06/16/2014
Import Alert Name:
, "DETENTION WITHOUT PHYSICAL EXAMINATION OF CHICKEN JERKY-TYPE PET TREATS DUE TO THE PRESENCE OF ANTIBIOTIC AND/OR ANTIVIRAL RESIDUE(S)"
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. Reason for Alert: Chicken jerky-type pet treats 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 chicken 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 chicken 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 chicken 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: Districts may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert. Districts should submit a recommendation for addition to the Red List when jerky-type pet treat are found through laboratory analysis to contain the antibiotics and/or antivirals listed below. Recommendations for detention without physical examination should be forwarded to the Division of Import Operations (DIO). DIO and FDA’s Center for Veterinary Medicine (CVM) will evaluate regulatory packages on a case-by-case basis. 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 is within an established tolerance level (i.e. sulfaquinaxaline). Antibiotics - Sulfaclozine - Tilmicosin - Trimethoprim - Enrofloxacin - Sulfaquinoxaline Antivirals - Amantadine - Ramatidine - Mematadine A firm wishing to be removed from detention without physical examination should provide information to FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance with applicable regulations. 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. Documentation showing that a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses demonstrating the product is free of non-permitted drug residues. Requests to remove a firm that manufactures various jerky-type pet treat products from DWPE under this alert should include twelve (12) import entries representative of these products. For additional guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, Section 9-6, "Detention Without Physical Examination (DWPE)." A firm, shipper, or importer wishing to request removal from detention without physical examination should forward information supporting its request to FDA at the following address: Food and Drug Administration Division of Import Operations and Policy 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. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at (301) 796-6600. For questions or issues involving import operations, contact DIO’s Import Operations and Maintenance Branch at (301) 796-0356. For questions or issues involving OASIS or PREDICT screening, contact DCS’s Import Compliance Systems Branch at ORAHQOEIODCSIMPCOMPLSYSBR@fda.hhs.gov . Other questions may be directed to CVM, Division of Compliance, Imports Complaint Emergency Recall Team (HFV-230) at (240) 276-9200.
Product: Chicken Jerky-Type Pet Treats Product Codes: 72B02 (Poultry Prod Pet Dog Food) 72B99 (Pet Dog Food N.E.C.)
“This article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be an animal food that bears or contains a new animal drug that is unsafe within the meaning of Section 512.” [Adulteration, Section 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)
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: 06/16/2014
Desc:Chicken Breast Strips