Import Alert 72-06

DETENTION WITHOUT PHYSICAL EXAMINATION OF CAT FOOD PRODUCTS DUE TO
THE PRESENCE OF PROPYLENE GLYCOL

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.

Districts 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 Districts encounter cat food products which are found, through laboratory analysis, to contain propylene glycol. DIO and CVM will evaluate regulatory packages on a case-by-case basis.

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.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer 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.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request 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 then referred to CVM for additional evaluation.

For questions or issues concerning import operations, contact DIO Import Operations and Maintenance Branch at (301) 796-0356.

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.

Other questions may be directed to CVM, Division of Compliance, Imports Complaint Emergency Recall Team (HFV-231) at (240) 276-9200.

Import Alert Language last updated: October, 2012

Cat Food

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a food additive which is unsafe within the meaning of Section 409. Contains propylene glycol [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 it injurious to health [Adulteration, section 402(a)(1)].

OASIS charge code - POISONOUS