Import Alert 36-04

(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 # 36-04
Published Date: 12/04/2019
Type: DWPE

Import Alert Name:

"DETENTION WITHOUT PHYSICAL EXAMINATION OF HONEY AND BLENDED SYRUP DUE TO UNSAFE DRUG RESIDUES”

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 to this import alert dated 05/13/2019 updates ‘Guidance’ section by adding information to have third-party laboratory analysis include results for enrofloxacin and ciprofloxacin as a sum; updates the instructions for removal from detention without physical examination; updates the import alert contact information; updates the charge section. Changes are noted and bracketed by three asterisks (***).

NOTE: The revision to this import alert dated 01/28/2014 changes the name of the import alert and amends the scope of the alert to include all forms of non-permitted antibiotic residues; updates the applicable charges; and provides information on removal from detention without physical examination. Changes are noted and bracketed by three asterisks (***).

Previous revisions to this import alert dated ***11/17/2013, ***12/10/2008 and 12/28/2007 changed the name of the import alert and amended the scope of the alert to include all forms of fluoroquinolone and nitrofurans antibiotics, and include blended syrups as products of concern, respectively.

Antibiotics are used in the treatment of honey bee diseases. However, certain drug residues are a concern to human health. In the United States, the Food and Drug Administration (FDA) has not approved the use of chloramphenicol, nitrofurans and/or fluoroquinolones as drugs to treat honey bees.

Extra-label uses of chloramphenicol, nitrofuran and/or fluoroquinolone drugs are prohibited in food producing animals. Therefore, if they are used as drugs to treat honey bees, they are considered to be unsafe new animal drugs within the meaning of Section 512. If there are residues of these drugs in honey as a result of treatments of the bees, the honey is deemed to be adulterated under section 402(a)(2)(C)(ii) of the FFDCA.

Furthermore, chloramphenicol, nitrofurans and/or fluoroquinolones are considered to be food additives if the intended use of these substances results in or may reasonably be expected to result in their becoming a component of food. Chloramphenicol, nitrofurans and/or fluoroquinolones are not generally recognized as safe for use in food, nor is there a food additive regulation authorizing their use in food. Consequently, residues of these drugs in foods are unsafe food additives within the meaning of Section 409 of the FFDCA and would render the food adulterated under section 402(a)(2)(C)(i).

Note: ORS contact information updated on 08/16/2019

Guidance:

***Divisions*** may detain without physical examination all shipments of honey and honey products from the firms listed in the Red List of this Import Alert.

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 non-permitted antibiotic residues. ***Products from firms on the import alert for enrofloxacin or ciprofloxacin violations need to be analyzed for both enrofloxacin and ciprofloxacin with results reported as a sum.***

If a firm wishes to request removal from detention without physical examination (DWPE), 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 shipments of honey and honey products will not be adulterated.

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

For further guidance on removal from detention without physical examination, refer to FDAs 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 sent via E-mail to:
Importalerts2@fda.hhs.gov;
or mail to:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857***

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

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@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 oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues on policy, sample collection recommendations, or any additional questions, should be addressed to CFSAN/Division of Enforcement’s Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

All honey products (comb honey, strained honey, whipped honey, honey), Blended Syrups

Charge:

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409. [Adulteration, Section 402(a)(2)(C)(i)]***

(OASIS Charge Code = UNSAFE ADD)

OR

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains [Adulteration, Section 402(a)(2)(C)(ii)]

(OASIS Charge Code = VETDRUGRES)***


COUNTRY: ALL COUNTRIES

FIRM(S): SEE RED LIST

PRODUCT(S): SEE RED LIST

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


ARMENIA


Artashes LLC
Date Published : 07/05/2016
5 Barekamutyan , Abovyan, Kotayki ARMENIA
36 C - - 04 Honey
Date Published: 07/05/2016

Desc: Honey
Notes: Problem: 3-amino-2-oxazolidinone (AOZ)
Problems: CHLORAMPHENICOL;

36 C - - 99 Honey, N.E.C.
Date Published: 07/05/2016

Desc: Honey
Notes: Problem; 3-amino-2-oxazolidinone (AOZ)
Problems: CHLORAMPHENICOL;


CHINA


CHENG DU WAI YUAN BEE PRODUCTS CO., LTD
Date Published : 09/21/2010
No 490 Shuhua Road , Chengdu, Sichuan CHINA
36 C - - -- Honey
Date Published: 09/21/2010

Desc: Honey
Problems: NORFLOXACIN;

CHENGDU WAIYUAN BEE PRODUCTS CO., LTD.
Date Published : 09/21/2010
No. 490 Shuhua Road , Chengdu, Sichuan CHINA
36 C - - -- Honey
Date Published: 09/21/2010

Desc: Honey
Problems: NORFLOXACIN;

Eurasia Bee's Products Co., Ltd.
Date Published : 02/03/2014
South Economic Development Zone , Zhumadian, Henansheng CHINA
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

GUSHI XINXIN MALTOSE CO., LTD.
Date Published : 08/22/2011
FENSHUIXIANG SUB-DISTRICT, GUSHI COUNTY, , XINYANG CITY, HENAN PROVINCE, CHINA , X¿ny¿ngsh¿, CN-41 CHINA
36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 08/22/2011

Desc: Fructose (Compound Malt Sweetener)
Notes: Note; Fructose or compound malt sweetener consists of the following ingredients - Rice Syrup; Honey; and solid matter

HUBEI YUSUN CO.,LTD
Date Published : 09/18/2009
168 JINGWU RD., HANKOU , wuhan, CN-42 CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 09/18/2009

Notes: 1/4/08; blended syrup
Problems: CIPROFLOXACIN;

Inner Mongolia Altin Bee-Keeping Co.,Ltd.
Date Published : 09/18/2009
Jinshan Development Area , Hohhot, Cn-15 CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 02/03/2014

Desc: Honey
Notes: 11/3/06
Problems: CIPROFLOXACIN;

36 C - - -- Honey
Date Published: 09/18/2009

Desc: Honey
Notes: 11/3/06
Problems: CIPROFLOXACIN;

Jiangsu Kanghong Natural Health Foods Co., Ltd.
Date Published : 09/18/2009
Tongyu North Road , Funing County , Yancheng, FN CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 02/03/2014

Desc: Honey
Notes: 11/3/06
Problems: CIPROFLOXACIN;

36 C - - -- Honey
Date Published: 09/18/2009

Notes: 11/3/06; honey
Problems: CIPROFLOXACIN;

Kunshan Foreign Trade Co
Date Published : 02/03/2014
270 Mid Qianjin Rd , Kunshan, Jiangsu CHINA
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

Shanghai Taiside Trading Co., Ltd.
Date Published : 09/18/2009
No.216,lane 1735, Zhen Nan Rd., , Shanghai, Cn-31 CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 02/03/2014

Desc: Honey
Notes: 11/3/06
Problems: CIPROFLOXACIN;

36 C - - -- Honey
Date Published: 09/18/2009

Notes: 11/3/06; Honey
Problems: CIPROFLOXACIN;

WUHAN SHINO-FOOD TRADE CO., LTD.
Date Published : 09/18/2009
515 LUOSHI AVENUE HONGSHAN , WUHAN, P.R.CHINA , WUHAN, CN-42 CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 02/03/2014

Desc: Honey
Notes: 11/3/06
Problems: CIPROFLOXACIN;

36 C - - -- Honey
Date Published: 09/18/2009

Notes: 11/3/2006; honey
Problems: CIPROFLOXACIN;

Wuhan Jiabao Syrup Factory
Date Published : 09/18/2009
515 Luoshi Road , Hongshan , Wuhan, Hubei CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 09/18/2009

Notes: 12/10/08; honey syrup
Problems: NORFLOXACIN;

36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 09/18/2009

Notes: 12/10/08; honey syrup
Problems: NORFLOXACIN;

shunchang industry co.,ltd
Date Published : 09/18/2009
jingmen hi-tech industrial development z , jingmen, CN-42 CHINA
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 09/18/2009

Notes: 2/12/08; blended syrup
Problems: CIPROFLOXACIN;


EGYPT


Imtenan Health Shop for Healthy Functional Foods
Date Published : 02/08/2018
13 Dr Mohammed Kamel Hussen , Cairo, Al Qahirah EGYPT
36 C - - 04 Honey
Date Published: 02/08/2018

Desc: Spring Flowers Honey
Problems: CIPROFLOXACIN;


HONG KONG


Rainbow Products Co., Ltd
Date Published : 02/01/2013
Rm. 601 , Cac Tower; 165 Hoi Bun Road , Kwun Tong, Kowloon HONG KONG
36 A - - 99 Sugar Products, N.E.C.
Date Published: 02/01/2013

Desc: Blended Syrup Honey
Problems: CIPROFLOXACIN; ENROFLOXACIN; NORFLOXACIN;

36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 02/01/2013

Desc: Blended Syrup Honey
Problems: CIPROFLOXACIN; ENROFLOXACIN; NORFLOXACIN;

36 C - - -- Honey
Date Published: 02/01/2013

Desc: Blended Syrup Honey
Problems: ENROFLOXACIN; NORFLOXACIN; CIPROFLOXACIN;

36 D - - -- Imit Syrup/Molasses/Honey
Date Published: 02/01/2013

Desc: Blended Syrup Honey
Problems: CIPROFLOXACIN; ENROFLOXACIN; NORFLOXACIN;

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 02/01/2013

Desc: Blended Syrup Honey
Problems: NORFLOXACIN; ENROFLOXACIN; CIPROFLOXACIN;


INDIA


Bee Hive Farms Pvt. Ltd.
Date Published : 12/04/2019
Main Road , Lakhowal, Punjab INDIA
36 C - - 04 Honey
Date Published: 12/04/2019

Desc: EUCALYPTUS HONEY
Problems: NORFLOXACIN;

36 C - - 99 Honey, N.E.C.
Date Published: 12/04/2019

Desc: EUCALYPTUS HONEY
Problems: NORFLOXACIN;

36 Y - - 99 Food Sweetners (Nutritive) N.E.C.
Date Published: 12/04/2019

Desc: EUCALYPTUS HONEY
Problems: NORFLOXACIN;

Eskay Impex Corporation
Date Published : 03/01/2011
Mansouza Apts , 774 Hall Village Road , Mumbai, Maharashtra INDIA
36 C - - 04 Honey
Date Published: 03/01/2011

Desc: Honey
Problems: NORFLOXACIN;

Kashmir Apiaries Exports
Date Published : 02/03/2014
G.T Road, Doraha , Ludhiana, Punjab INDIA
36 C - - 04 Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

36 C - - 99 Honey, N.E.C.
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

Sresta Natural Bio Products Pvt Ltd
Date Published : 04/27/2017
H. No 8-2-468/A/1/2, 2nd And 3rd FLOOR, Road No. 5, , Lane Opposite GVK Mall, Banjara Hills, , Hyderabad, INDIA
36 C - - 04 Honey
Date Published: 04/27/2017

Desc: Honey
Problems: CIPROFLOXACIN;

36 C - - 99 Honey, N.E.C.
Date Published: 04/27/2017

Desc: Honey
Problems: CIPROFLOXACIN;

Sresta Natural Bioproducts Pvt. Ltd. (Unit 1)
Date Published : 04/27/2017
69 Gundlapochampally Village , Medchal, Telangana INDIA
36 C - - 04 Honey
Date Published: 04/27/2017

Desc: Honey
Problems: CIPROFLOXACIN;

36 C - - 99 Honey, N.E.C.
Date Published: 04/27/2017

Desc: Honey
Problems: CIPROFLOXACIN;


MALAYSIA


Cosmic Quality SDN BHD
Date Published : 02/03/2014
9A Jalan Perindustrian Silibin 1 , silibin Light Industrial Estate , Ipoh, MALAYSIA
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

Falcon Products Malaysia Sdn Bhd
Date Published : 02/03/2014
No. 2 Jalan Gelam , Port Klang, MALAYSIA
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

KENTWE PRODUCTS (M) SDN. BHD.
Date Published : 10/01/2009
St 524, Lot A1, , Kaw Ind Miel, Pengkalan Balak , MASJID TANAH, MY-M MALAYSIA
36 C - - -- Honey
Date Published: 10/01/2009

Problems: NORFLOXACIN; CIPROFLOXACIN;

SUMMER PACIFIC SDN BHD
Date Published : 11/24/2010
3 1 2 Ulu Lanang , Sibu, MY-13 MALAYSIA
36 C - - -- Honey
Date Published: 11/24/2010

Desc: Honey
Problems: NORFLOXACIN;

Sea Empress Logistics (M) SDN BHD
Date Published : 02/03/2014
No. 4B, 1st Floor Lorong Berangan , 4200 Port Klang , Selangor Darul, Ehsan MALAYSIA
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;


MEXICO


Agropecuaria Juan Diego Spr De Rl
Date Published : 12/24/2013
Miguel Aleman No. 1066 Esq. Alberto G. , Col. Municipio Libre , Cd Obregon, Son MEXICO
36 C - - 04 Honey
Date Published: 12/24/2013

Desc: Natural Honey
Problems: ENROFLOXACIN;

HANSA MIELES SA DE CV
Date Published : 02/03/2014
Carr. Veracruz-tejar K.m. 1.5 , Col. GRANJAS BOTICARIA , Veracruz, Veracruz de Ignacio de La Llav MEXICO
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

Miel Mex, S.A. De C.V.
Date Published : 02/03/2014
Cto. Circunvalacion Ote. 146-303 , Naucalpan, Mexico D.F. MEXICO
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;


MOLDOVA


S.A.Franzeluta LTD
Date Published : 02/03/2014
Sarmizegetusa 30 Street , Chisinau, Chisinau MOLDOVA
36 C - - 04 Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;


MONGOLIA


Inner Mongolia Youth Trade Dev.C
Date Published : 09/18/2009
No 47 Xincheng Xijie Hotel, Fl#3 , Hohhot, FN MONGOLIA
36 C - - -- Honey
Date Published: 09/18/2009

Desc: honey
Notes: 1/5/9
Problems: NORFLOXACIN;


PERU


Loliga S.A.
Date Published : 02/03/2014
Arequioa 642/703 , Piura, PERU
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;


RUSSIA


Honey Technology
Date Published : 08/12/2015
Ul Internacionalnaya , 105/1. office. 16 , Ufa, Bashkortostan Resp. RUSSIA
36 C - - 04 Honey
Date Published: 10/13/2015

Desc: Honey
Notes: Problem(s): 3-amino-2-oxazolidinone (AOZ)
Problems: CHLORAMPHENICOL;

36 C - - 99 Honey, N.E.C.
Date Published: 10/13/2015

Desc: Honey
Notes: Problem(s): 3-amino-2-oxazolidinone (AOZ)
Problems: CHLORAMPHENICOL;

Llc Medovaya Dolina
Date Published : 02/03/2014
Ul Verhnyaya 18a , Verhnyaa 18a , Bykovo, Moskovskaya Obl. RUSSIA
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;


THAILAND


Ozf Co., Ltd.
Date Published : 02/03/2014
225/116 8th Floorcountry Tower B , Bangkok, THAILAND
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

THA YU INTER TRADING CO.,LTD.
Date Published : 09/18/2009
3/6 Moo 11kwang Sikan Khet Donmuang , Bangkok Thailand , Bangkok, TH-10 THAILAND
36 C - - -- Honey
Date Published: 09/18/2009

Desc: Honey
Notes: 3/10/09
Problems: CIPROFLOXACIN;

Zenith One Co Ltd
Date Published : 05/17/2012
61/621 Moo, 3 Thepharak T Bangpla , Samutprakarn, THAILAND
36 C - - -- Honey
Date Published: 05/17/2012

Desc: Honey
Problems: NORFLOXACIN;


TURKEY


Manavlar Gida Sanayi Ticaret
Date Published : 08/09/2017
Kenan Evren Bulvari No: 101/5 , Dalaman, Mugla TURKEY
36 C - - 04 Honey
Date Published: 08/09/2017

Desc: Acacia Honey
Problems: ENROFLOXACIN;


UKRAINE


Med Podillya
Date Published : 11/08/2013
Saltykova-Schedrina vul. 131 , STRASSE , Vinnytsya, Vinnytska UKRAINE
36 C - - 04 Honey
Date Published: 11/08/2013

Desc: Natural Bee Honey - Motley Grass
Notes: 3-amino-2 oxazolidinone (AOZ)

36 C - - 99 Honey, N.E.C.
Date Published: 11/08/2013

Desc: Natural Bee Honey - Motley Grass
Notes: 3-amino-2 oxazolidinone (AOZ)

Meganom-AP Llc
Date Published : 01/10/2018
Okruzhna Street 12 , Kryvyj Rih, Dnipropetrovska UKRAINE
36 C - - 04 Honey
Date Published: 01/10/2018

Desc: Honey
Problems: CHLORAMPHENICOL;


VIETNAM


Apiprodex Saigon
Date Published : 02/03/2014
24h Le Van Sy St Dist 3 , Ho Chi Minh City, VIETNAM
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

Chao Chin Industrial Co., Ltd
Date Published : 09/18/2009
Industrial Service Zone , National Highway 15, Long Binh Ward , Bien Hoa City, VN-39 VIETNAM
36 C - - -- Honey
Date Published: 09/18/2009

Notes: fluoroquinolone family; 9/4/08
Problems: NORFLOXACIN;

DINH ASIA COMPANY LTD
Date Published : 07/05/2016
B, Street 61, Phuoc Long B Ward 27 , 9, District , Ho Chi Minh City, Vn-65 VIETNAM
36 C - - 04 Honey
Date Published: 07/05/2016

Desc: Honey
Problems: NORFLOXACIN;

36 C - - 99 Honey, N.E.C.
Date Published: 07/05/2016

Desc: Honey
Problems: NORFLOXACIN;

Donaco Company Ltd
Date Published : 02/03/2014
90424 Nguyen Chi Thanh , Ho Chi Minh City, VIETNAM
36 C - - -- Honey
Date Published: 02/03/2014

Desc: Honey
Problems: CHLORAMPHENICOL;

VINAHONEY CO., LTD.
Date Published : 08/28/2010
669b/2 (108b) Chau Thoi Street , Binh An Ward, Di An Town , Binh Duong, Binh Duong VIETNAM
36 C - - 04 Honey
Date Published: 08/28/2010

Desc: Vietnamese Honey
Problems: NORFLOXACIN;