Import Alert 36-01

(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 # 36-01
Published Date: 10/18/2017
Type: DWPE with Surveillance

Import Alert Name:

"Adulteration of Honey"

Reason for Alert:

This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer rights for or on any person, and does not operate to bind FDA or the public.

NOTE: The revision of this Import Alert dated 10/17/2017 removes the non-FDA laboratory and surveillance information and updates the “Guidance” section by providing additional information.

Previous revisions of this Import Alert dated 7/8/2013 added sampling and laboratory information for non-FDA laboratory testing and dated 8/28/2012 updated the “Guidance” section by providing additional information.

*** Honey is a commodity that is known to potentially be subject to economic adulteration through addition of cane or corn sweeteners.

Guidance:

Divisions may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert.
*** ***



Recommendations for addition to Detention Without Physical Examination:
Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food Safety and Applied Nutrition (CFSAN), when necessary, 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 other responsible party to the shipment should provide results of a third-party laboratory analysis, which verifies the product does not contain added cane or corn sugar according to AOAC Official Method 991.41.

All analytical packages will be reviewed by CFSAN, Dietary Supplement and Labeling Assessment Branch.

Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

For guidance on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof wishes 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.

Questions or issues involving import operations should be addressed to ORA/DIO/Import Operations and Maintenance Branch at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSCS/Import Compliance Systems Branch at orahqoeiodcsimpcomplsysbr@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at (301) 796-6600 or orahqorsmanagement@fda.hhs.gov.

Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement at CFSANEnforcement@fda.hhs.gov. ***

Product Description:

PRODUCT: Honey

PRODUCT CODE: 36C[][][]

Charge:

“The article is subject to refusal under 801(a)(3) in that it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.” [Adulteration, Section 402(b)(2)]

OASIS charge code - SUBSTITUTE

or

“The article is subject to refusal under 801(a)(3) in that it appears to be food which has damage or inferiority concealed in any manner.” [Adulteration, Section 402(b)(3)]

OASIS charge code - CONCEALED


or

“The article is subject to refusal under 801(a)(3) in that the food appears to have a substance added to, mixed or packed with it so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or 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

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


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


MEXICO


Apiexport SA de CV
Date Published : 09/08/2016
Calle Silvestre Revueltas 19 , Alvaro Obregon, Col. GUADALUPE INN , Mexico, Distrito Federal MEXICO
36 C - - 04 Honey
Date Published: 09/08/2016

Desc:Honey

36 C - - 99 Honey, N.E.C.
Date Published: 09/08/2016

Desc:Honey


NEW ZEALAND


Claridges Organic Limited
Date Published : 06/12/2012
2 Ivan Jamieson Place , Christchurch Airport , Christchurch, Canterbury 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
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


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

demtat
Date Published : 03/30/2013
fevzi cakmak mh 10442 sokak no 18 , Konya, Konya TURKEY
36 C - - -- Honey
Date Published: 03/30/2013

Desc:All 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