Import Alert 72-06
(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 # 72-06
Published Date: 07/20/2021
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF CAT FOOD PRODUCTS DUE TO THE PRESENCE OF PROPYLENE GLYCOL
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 07/20/2021 updates the guidance, agency contacts, charge code language, and PAC. Changes to the import alert are bracketed by asterisks (***).
Propylene glycol is considered by FDA to be generally recognized as safe (GRAS) in animal food for only some uses and under some conditions.
FDA, however, has determined that it has not been shown to be safe for use when used in or on cat food, and has prohibited this use unless it is covered by a food additive regulation, new animal drug approval, or notice of claimed investigational exemption for a food additive or new animal drug (See 21 CFR 589.1001). There currently are no food additive regulations, approved new animal drug applications, or notices of claimed investigational exemption that provide for the use of propylene glycol in or on cat food.
Based on the results of tests conducted on samples collected by FDA, the products listed in the Red List of this Import Alert have been found to be cat food products bearing or containing propylene glycol. These products are considered to bear an unapproved food additive that is unsafe under section 409(a) of the Federal Food Drug and Cosmetic Act (FFD&CA), and therefore appear to be adulterated under section 402(a)(2)(C)(i) of the FFD&CA.
Propylene glycol is considered by FDA to be generally recognized as safe (GRAS) in animal food for only some uses and under some conditions.
FDA, however, has determined that it has not been shown to be safe for use when used in or on cat food, and has prohibited this use unless it is covered by a food additive regulation, new animal drug approval, or notice of claimed investigational exemption for a food additive or new animal drug (See 21 CFR 589.1001). There currently are no food additive regulations, approved new animal drug applications, or notices of claimed investigational exemption that provide for the use of propylene glycol in or on cat food.
Based on the results of tests conducted on samples collected by FDA, the products listed in the Red List of this Import Alert have been found to be cat food products bearing or containing propylene glycol. These products are considered to bear an unapproved food additive that is unsafe under section 409(a) of the Federal Food Drug and Cosmetic Act (FFD&CA), and therefore appear to be adulterated under section 402(a)(2)(C)(i) of the FFD&CA.
Guidance:
Divisions may detain, without physical examination, the indicated products from the firms identified on the Red List of this import alert.
A recommendation for detention without physical examination should be forwarded to the Division of Import Operations (DIO) when Divisions encounter cat food products which are found, through laboratory analysis, to contain propylene glycol. DIO and the Center for Veterinary Medicine (CVM) will evaluate regulatory packages on a case-by-case basis.
***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:***
In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. This evidence, in the form of a private lab analysis, may verify compliance of the article in that the product does not contain propylene glycol.
***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. For 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 under this Import Alert, all relevant information supporting the request should be forwarded to 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 then referred to CVM for additional evaluation.
***Questions or issues involving import operations should be addressed to ORA/DIO at (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 with regard to pet food or treats on policy, sample collection recommendations, or any additional questions, should be addressed to CVM/Division of Compliance at CVMImportRequests@fda.hhs.gov***
A recommendation for detention without physical examination should be forwarded to the Division of Import Operations (DIO) when Divisions encounter cat food products which are found, through laboratory analysis, to contain propylene glycol. DIO and the Center for Veterinary Medicine (CVM) will evaluate regulatory packages on a case-by-case basis.
***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:***
In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. This evidence, in the form of a private lab analysis, may verify compliance of the article in that the product does not contain propylene glycol.
***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. For 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 under this Import Alert, all relevant information supporting the request should be forwarded to 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 then referred to CVM for additional evaluation.
***Questions or issues involving import operations should be addressed to ORA/DIO at (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 with regard to pet food or treats on policy, sample collection recommendations, or any additional questions, should be addressed to CVM/Division of Compliance at CVMImportRequests@fda.hhs.gov***
Product Description:
Cat Food
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of Section 409. [Adulteration, Section 402(a)(2)(C)(i)]. ***
OASIS charge code: UNSAFE ADD
and/or
*** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)] ***
OASIS charge code: POISONOUS
OASIS charge code: UNSAFE ADD
and/or
*** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)] ***
OASIS charge code: POISONOUS
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
SHANDONG EVERGREEN INDUSTRIAL AND TRADING CO., LTD.
Date Published : 10/17/2012
Building Room 1 # 2904 , 2 Jiahe Xinxing
, Qingdao,
Shandong CHINA
72 A - - 05 Comb Prod Pet Cat Food
Date Published: 10/17/2012
Desc: Vitakitty Treats (Chicken Breast with Flaxseed & Vitamins)
Problems:
PROPYLENE GLYCOL ALGINATE CFR-172.858 (EMU/STA);