Import Alert 69-01

"Detention Without Physical Examination of Medicated Feeds Containing Monensin For Failing To Meet Assay Specifications"

In April 2005, Buffalo District Office detained an entry of a Type C medicated feed for cattle containing monensin analyzed as containing 216% of declared concentration and an entry of a Type B medicated feed containing monensin at 72.1% of declared concentration. Both entries were from Canada. Buffalo District Office has detained at least three other feed entries declaring monensin because FDA testing revealed that they did not meet the levels guaranteed by the label.

Monensin is indicated for the prevention of coccidosis in poultry, for increased feed efficiency in cattle, and for the reduction of incidence of liver abscesses in swine caused by a number of bacteria. Monensin is a new animal drug, and feed containing this new animal drug must meet the requirements of the approval, including the levels of drug present in the feed. Feeds containing monensin and falling outside label guarantees can pose a threat to the health of animals consuming them.

Districts may detain without physical examination medicated feeds from the firms identified in the attachmnet to this Import Alert.

Collection and examination of medicated feeds from other feed manufacturers from Canada, or other countries appears to be warranted. Any violative finding from Canadian feed manufacturers, whether it is monensin or other active ingredient, should be reported to the Canadian Food Inspection Agency (CFIA). Please contact CVM, HFV-232 if you have questions regarding contacts within CFIA.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that a firm requesting removal from detention without physical examination provide the following information:

a. Results of the firm's investigation(s) into the problem of monensin not meeting the label declaration.

b. Documentation showing corrective action(s) taken in response to this investigation. This should include at a minimum:

1) a description of the current process used to ensure appropriate monensin levels; and contamination; and

2) verification that the process is adequate; and

3) analytical results and supporting records, charts, and/or chromatograms for three (3) production batches along with their labeling

d. Documentation that a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses that show the shipments contain monensin meeting the label declaration. Requests to remove from the DWPE list multiple products from a manufacturer should include a minimum of twelve (12) import entries representative of products covered by detention without physical examination.

All requests for removal from DWPE should be forwarded to DIOP (HFC-170) which in turn will forward the requests to CVM for evaluation.

Medicated Feeds

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of Section 512 [Adulteration, Section 501(a)(6)]"

OASIS Charge code - FEED & NAD

AND

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears the labeling is false and misleading [Misbranding, Section 403(a)(1)]."

OASIS charge code - FALSE