Import Alert 36-01
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(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 # 36-01
Published Date: 02/06/2013
Type: DWPE with Surveillance
Import Alert Name:
"Adulteration of Honey"
Reason for Alert:
NOTE: The revision of this Import Alert dated 8/27/2012 updates the Guidance section by providing additional information about the release of shipments subject to detention without physical examination, the technical reviews of private analytical packages, and the process for removal from detention without physical examination. Changes are noted and bracketed by three asterisks (***).
During the mid 1990s, detentions of imported honey from Brazil, Mexico, and the Soviet Union occurred due to adulteration with corn or cane sugars.
These detentions were based on analytical results received from Geochron Laboratories. This fast analytical technique measures the C-13/C-12 isotope ratio of the sugars in the sample.
FDA laboratories do not have the instrumental capability to analyze honey according to the Official Methods of Analysis of AOAC International, AOAC Official Method 991.41, which requires an isotope ration mass spectrometer.
During the mid 1990s, detentions of imported honey from Brazil, Mexico, and the Soviet Union occurred due to adulteration with corn or cane sugars.
These detentions were based on analytical results received from Geochron Laboratories. This fast analytical technique measures the C-13/C-12 isotope ratio of the sugars in the sample.
FDA laboratories do not have the instrumental capability to analyze honey according to the Official Methods of Analysis of AOAC International, AOAC Official Method 991.41, which requires an isotope ration mass spectrometer.
Guidance:
*** Districts may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert. ***
Surveillance of imported honey from all countries is indicated.
FDA Districts requiring C-13/C-12 isotope ratio analysis should contact one of the following laboratories:
1) Geochron Laboratories
Division of Krueger Enterprises, Inc.
45 Manning Road
Billerica, Massachusetts 01821
*** Tel: (978) 667-7080
Fax: (978) 667-6999***
2) Coastal Science Laboratories, Inc.
6000 Mountain Shadows Drive
Austin, Texas 78735
*** Tel & Fax: (512) 288-5533 ***
3) Center for Applied Isotope Studies
University of Georgia
CAIS Building
120 Riverbend Road
Athens, Georgia 30605
*** Tel: (706) 542-1395
Fax: (706) 542-6106 ***
Arrangements should be made by phone with the laboratory in advance. Approximately two ounces of sample should be shipped within 3 to 10 days.
The findings of partial substitution of cane or corn sweeteners in honey should be routed to CFSAN, *** Food Adulteration Assessment Branch *** before detention is considered. The presence of cane or corn sweetener in the adulteration of honey can be selectively detected by using the internal standard stable carbon radioisotope ratio method. Reference for the appropriate analytical technique is published in the Official Methods of Analysis of AOAC International, AOAC Official Method 991.41, C-4 Plant Sugars in Honey. Both stable carbon isotope ratios for the honey and protein therein (internal standard method) must be obtained.
An appropriate alternate method may be used to determine cane or corn sweetener in honey if the method is adequately documented by a validation study to estimate precision, accuracy, and sensitivity for the specific analyses. Equivalency to the official method must be demonstrated in the submission of analytical data.
For questions or issues concerning science, science policy, sample collections, analysis, preparation, or analytical methodology, contact the Division of Field Science at *** (301) 796-6600. ***
***
In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain added cane or corn sugar.
Included in this Import Alert is a list of laboratories specifically identified for FDA District sample collections. Importers/owners that require analytical testing in order to secure release of an individual shipment are not required to use the identified commercial labs in this Import Alert. The use of these identified labs (by FDA or the importer) does not grant any acceptance or pre-approval of the commercial lab submissions; full analytical packages are required for each sample analysis and each will be reviewed in full, as per standard operating procedures.***
All analytical packages (product subject to DWPE and FDA general surveillance sample collections) will be reviewed by CFSAN, Food Adulteration Assessment Branch (HFS-607).
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 and Policy
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
***
Surveillance of imported honey from all countries is indicated.
FDA Districts requiring C-13/C-12 isotope ratio analysis should contact one of the following laboratories:
1) Geochron Laboratories
Division of Krueger Enterprises, Inc.
45 Manning Road
Billerica, Massachusetts 01821
*** Tel: (978) 667-7080
Fax: (978) 667-6999***
2) Coastal Science Laboratories, Inc.
6000 Mountain Shadows Drive
Austin, Texas 78735
*** Tel & Fax: (512) 288-5533 ***
3) Center for Applied Isotope Studies
University of Georgia
CAIS Building
120 Riverbend Road
Athens, Georgia 30605
*** Tel: (706) 542-1395
Fax: (706) 542-6106 ***
Arrangements should be made by phone with the laboratory in advance. Approximately two ounces of sample should be shipped within 3 to 10 days.
The findings of partial substitution of cane or corn sweeteners in honey should be routed to CFSAN, *** Food Adulteration Assessment Branch *** before detention is considered. The presence of cane or corn sweetener in the adulteration of honey can be selectively detected by using the internal standard stable carbon radioisotope ratio method. Reference for the appropriate analytical technique is published in the Official Methods of Analysis of AOAC International, AOAC Official Method 991.41, C-4 Plant Sugars in Honey. Both stable carbon isotope ratios for the honey and protein therein (internal standard method) must be obtained.
An appropriate alternate method may be used to determine cane or corn sweetener in honey if the method is adequately documented by a validation study to estimate precision, accuracy, and sensitivity for the specific analyses. Equivalency to the official method must be demonstrated in the submission of analytical data.
For questions or issues concerning science, science policy, sample collections, analysis, preparation, or analytical methodology, contact the Division of Field Science at *** (301) 796-6600. ***
***
In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain added cane or corn sugar.
Included in this Import Alert is a list of laboratories specifically identified for FDA District sample collections. Importers/owners that require analytical testing in order to secure release of an individual shipment are not required to use the identified commercial labs in this Import Alert. The use of these identified labs (by FDA or the importer) does not grant any acceptance or pre-approval of the commercial lab submissions; full analytical packages are required for each sample analysis and each will be reviewed in full, as per standard operating procedures.***
All analytical packages (product subject to DWPE and FDA general surveillance sample collections) will be reviewed by CFSAN, Food Adulteration Assessment Branch (HFS-607).
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 and Policy
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
***
Product Description:
Honey
Charge:
The article is subject to refusal under 801(a)(3) in that it appears that corn or cane sugar has been substituted in whole or in part for the product honey [Adulteration, Section 402(b)(2)].
OASIS charge code - SUBSTITUTE
or
The article is subject to refusal under 801(a)(3) in that it appears that damage or inferiority has been concealed� [Adulteration, Section 402(b)(3)].
OASIS charge code - CONCEALED
or
The article is subject to refusal under 801(a)(3) in that it appears that corn or cane sugar has been added to or mixed with the product, honey, so as to increase its bulk or weight, or reduce its strength, or make it appear to be of greater value than it is [Adulteration, Section 402(b)(4).
OASIS charge code - ADDED BULK
OASIS charge code - SUBSTITUTE
or
The article is subject to refusal under 801(a)(3) in that it appears that damage or inferiority has been concealed� [Adulteration, Section 402(b)(3)].
OASIS charge code - CONCEALED
or
The article is subject to refusal under 801(a)(3) in that it appears that corn or cane sugar has been added to or mixed with the product, honey, so as to increase its bulk or weight, or reduce its strength, or make it appear to be of greater value than it is [Adulteration, Section 402(b)(4).
OASIS charge code - ADDED BULK
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(36 C - - --) Honey
Desc:Honey
Notes:economic deception
Notes:economic deception
INDIA
KEJRIWAL BEE CARE PVT LIMITED
Date Published : 07/10/2012
VILLAGE -JAJALPUR , P.O. BANUR , District .: Patiala , RAJPURA Dist.: Patiala, IN-PB INDIA
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 07/10/2012
Desc:Honey
36 C - - 04 Honey
Date Published: 07/10/2012
Desc:Honey
36 C - - 99 Honey, N.E.C.
Date Published: 07/10/2012
Desc:Honey
36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 07/10/2012
Desc:Honey
MALAYSIA
EMINENT FOOD INDUSTRIES SDN BHD
Date Published : 10/02/2012
42 Jalan Bk 1 11 , TAMAN PERINDUSTRI PUCHONG, JALAN PUCHONG , Puchong, Selangor MALAYSIA
36 C - - -- Honey
Date Published: 10/02/2012
Desc:Honey
NEW ZEALAND
Airbourne Honey Ltd
Date Published : 05/21/2012
41 Pennington Street , Leeston, Cantebury NEW ZEALAND
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 05/21/2012
Desc:Honey
36 C - - 04 Honey
Date Published: 05/21/2012
Desc:Honey
36 C - - 99 Honey, N.E.C.
Date Published: 05/21/2012
Desc:Honey
36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 05/21/2012
Desc:Honey
Claridges Organic Ltd
Date Published : 06/12/2012
2 Ivan Jamieson Placeharewood , Christchurchchristchurch, NEW ZEALAND
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 06/12/2012
Desc:Honey
36 C - - 04 Honey
Date Published: 06/12/2012
Desc:Honey
36 C - - 99 Honey, N.E.C.
Date Published: 06/12/2012
Desc:Honey
36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 06/12/2012
Desc:Honey
Claridges Organic Ltd
Date Published : 06/12/2012
P.O 32b Sheffield Crescent , Christchurch, NEW ZEALAND
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 06/12/2012
Desc:Honey
36 C - - 04 Honey
Date Published: 06/12/2012
Desc:Honey
36 C - - 99 Honey, N.E.C.
Date Published: 06/12/2012
Desc:Honey
36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 06/12/2012
Desc:Honey
SAUDI ARABIA
Hamil Al Musk Factory
Date Published : 02/06/2013
Phase 4 Industrial City , Jeddah, SAUDI ARABIA
36 C - - -- Honey
Date Published: 02/06/2013
Desc:All Honey
TURKEY
OMRAT LTD.CO.
Date Published : 10/03/2011
Cumhuriyet Mah. Sanayi Cad. No 108 , Armutlu/ Kemalpasa , IZMIR, TR-35 TURKEY
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 10/03/2011
Desc:Honey
36 C - - 04 Honey
Date Published: 10/03/2011
Desc:Honey
36 C - - 99 Honey, N.E.C.
Date Published: 10/03/2011
Desc:Honey
36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 10/03/2011
Desc:Honey
VIETNAM
TANG MINH IMP. & EXP. TRADING CO.LTD
Date Published : 09/12/2012
Highway 1A BaoHoa Commune, XuanLoc Dist. , DongNai Province , 061, Dong Nai VIETNAM
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 09/12/2012
Desc:Honey
36 C - - 04 Honey
Date Published: 09/12/2012
Desc:Honey
36 C - - 99 Honey, N.E.C.
Date Published: 09/12/2012
Desc:Honey
36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C.
Date Published: 09/12/2012
Desc:Honey
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