Import Alert 69-01

(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 # 69-01
Published Date: 10/16/2023
Type: DWPE

Import Alert Name:

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

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 10/16/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***).

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 originated from Canada. Buffalo District Office has detained at least three other feed entries declaring monensin because FDA testing revealed they did not meet the levels guaranteed by the label.

Monensin is indicated for the prevention of coccidiosis 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 failing to meet label guarantees can pose a threat to the health of animals consuming them.

Guidance:

Divisions may detain, without physical examination, all medicated feed containing monensin manufactured by the firms identified in the Red List of this Import Alert, regardless of intended approved species [i.e., poultry, cattle, swine] or finished form [i.e., mash, pellet, coarse].

Divisions should submit a recommendation for DWPE under this Import Alert when laboratory analysis shows the product contains monensin that was not declared on the product label or does not meet the concentration identified on the product label. DIO will coordinate a review of all recommendations for addition to DWPE with FDA's Center for Veterinary Medicine (CVM).

Any violative finding from a Canadian feed manufacturer, whether monensin or other active ingredient, should be reported to the Canadian Food Inspection Agency (CFIA). Please contact the Center for Veterinary Medicine (CVM), Division of Compliance [HFR-230] with any questions regarding CFIA contacts.

***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 alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence that the monensin in the product meets the concentration declared on the product label. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article.

Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

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 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 the violation, so that the Agency will have confidence that future shipments/entries will be in compliance with the FD&C Act and its implementing regulations.*** For information on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

In addition to the information indicated by the RPM, and in order to fully evaluate whether the conditions that lead
to an appearance of non-compliance have been resolved, FDA recommends that firms provide the following information:

1. Evidence that the firm has determined that the products it is importing are not adulterated or misbranded. Evidence should include:

a. Results of the firm's investigation(s) into the failure to meet label declarations; and,

b. Documentation showing corrective action(s). This should include at a minimum:

1) a description of current manufacturing processes which ensure accurate monensin levels; and

2) verification of the process's adequacy; and

3) labeling, analytical results and supporting records, charts, and/or chromatograms for three production batches.

c. Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses of shipments containing monensin meeting the label declaration. Requests to remove a firm from DWPE under this alert that manufactures various medicated feed products containing monensin should include twelve (12) import entries representative of these products.

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, be sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be evaluated by DIO and CVM.

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 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, Imports Complaint Emergency Recall Team (HFV-231) at (240) 276-9200.
Or
Center for Veterinary Medicine (CVM), Division of Compliance (HFV-230) at CVMImportRequests@fda.hhs.gov

***                                                                                                                                                                       ***

Product Description:

Medicated Feeds

Product Codes:

56L[][]40, 62L[][]06, 67A[][]34, 67C[][]34,
69A[][]34; 69B[][]99; 69C[][]34

Charge:

"The article appears to be 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) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular." [Misbranding, Section 403(a)(1)]


OASIS charge code - FALSE

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CANADA


Great Lakes Nutrition Inc.
Date Published : 09/10/2009
132 Madison Street West , Monkton, CA-ON CANADA
69 A A - 34 Monensin Category I, Medicated Animal Feed, Type B Feed From Type A Med Article
Date Published: 09/10/2009

Notes: Heifer Pre-mix
Problems: MONENSIN;

Macewen Agricentre
Date Published : 09/10/2009
16 Lamoureux St On , St Isidore, ONTARIO CANADA
69 A B - 34 Monensin Category I, Medicated Animal Feed, Type C Feed From Type A Med Article
Date Published: 09/10/2009

Notes: Dairy 22% Medicated Feed for Cattle (Type C Feed)
Problems: MONENSIN;

Meunerie Benjamin Inc.
Date Published : 09/10/2009
226 Rang du Haut-de-la-Riviere N , Saint-Cesaire, Quebec CANADA
69 A - - 34 Monensin Category I, Medicated Animal Feed
Date Published: 09/10/2009

Notes: 16% Super Heifer Rumensin Pellet
Problems: MONENSIN;

Meunerie Hebert Inc
Date Published : 09/10/2009
152 Saint-Georges St , Henryville, Quebec CANADA
69 A B - 34 Monensin Category I, Medicated Animal Feed, Type C Feed From Type A Med Article
Date Published: 09/10/2009

Notes: 19% Dairy feed (category I; type C Medicated Feed)
Problems: MONENSIN;

Meunerie Robitaille
Date Published : 09/10/2009
190 Comeau St , Farnham, Quebec CANADA
69 A - - 34 Monensin Category I, Medicated Animal Feed
Date Published: 09/10/2009

Notes: 16% Super Heifer Rumensin Pellet
Problems: MONENSIN;

Meunerie Sawyerville Inc
Date Published : 01/22/2013
100 Rue De La Meunerie , Cookshire, Quebec CANADA
69 A - - 34 Monensin Category I, Medicated Animal Feed
Date Published: 01/22/2013

Desc: 21.86% Dairy Ration Mash Rum
Problems: MONENSIN;

Moulees Faubert Feeds (1979) Inc.
Date Published : 09/10/2009
5362 Route 138 , Huntingdon, QC CANADA
69 A A - 34 Monensin Category I, Medicated Animal Feed, Type B Feed From Type A Med Article
Date Published: 09/10/2009

Notes: Type B Medicated Feed
Problems: MONENSIN;

RITCHIE FEED & SEED INC.
Date Published : 09/10/2009
1390 Windmill Lane , Gloucester, Ontario CANADA
69 A A - 34 Monensin Category I, Medicated Animal Feed, Type B Feed From Type A Med Article
Date Published: 09/10/2009

Notes: Type B Medicated Feed
Problems: MONENSIN;