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: 02/22/2023
Type: DWPE

Import Alert Name:

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

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 08/23/2022 updates the reason for alert, guidance section, charge section and PAC code. Changes to the import alert are bracketed by asterisks (***).

***Antibiotics are used in the treatment of honey bee diseases. In the United States, the Food and Drug Administration (FDA) has approved tylosin, oxytetracycline, and lincomycin for therapeutic use in bees and established tolerances for the residues in honey at 500, 750*, and 750 parts per billion (ppb), respectively (*Sum of tetracycline residues). However, certain drug residues are a concern to human health. 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 unapproved treatments of the bees, the honey is deemed to be adulterated under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (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).

Guidance:

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

***Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). DIO will coordinate with CFSAN for concurrence.***

***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment detained pursuant to this import alert, the importer should provide evidence which verifies the product does not contain non-permitted antibiotic residues. Such evidence may include a third-party laboratory analysis of samples. Products from firms on the import alert due to violative enrofloxacin or ciprofloxacin (fluoroquinolones) need to be analyzed for both enrofloxacin and ciprofloxacin with results reported as a sum.

Such evidence should be submitted to the appropriate FDA division compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. ***

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 a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FFDCA. For guidance on removal from detention without physical examination (DWPE), refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from DWPE 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 Division of Import Operations (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 with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at 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 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

AND/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 ***

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


ALBANIA


EUGEN SKERMO (MORAVA HONEY)
Date Published : 03/16/2020
Rr. Nacionale Korce-Kapshtice , Km.6 , Korce, Korce - District ALBANIA
36 C - - 04 Honey
Date Published: 03/16/2020

Desc: Honey
Problems: STREPTOMYCIN; SULFATHIAZOLE;

36 C - - 99 Honey, N.E.C.
Date Published: 03/16/2020

Desc: Honey
Problems: STREPTOMYCIN; SULFATHIAZOLE;


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;

Eurasia Bee's Products Co., Ltd.
Date Published : 02/03/2014
Fuqiangnanlu , Yicheng , Zhumadian, Henan 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 SAR


Rainbow Products Co., Ltd
Date Published : 02/01/2013
Rm. 601 , Cac Tower; 165 Hoi Bun Road , Kwun Tong, Kowloon HONG KONG SAR
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 , Ludhiana Bypass , Doraha, 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
Circuito Circunvalacion Oriente 146-301 , Fracc. CIUDAD SATELITE , Naucalpan de Juarez, Mexico 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;


PAKISTAN


DAWN TRADERS
Date Published : 06/23/2022
Babu Garhi Warsak Roadpeshawar , Pakistan, PAKISTAN
36 C - - 04 Honey
Date Published: 06/23/2022

Desc: Honey
Problems: CIPROFLOXACIN;

HONEST FOOD PRODUCTS
Date Published : 08/19/2022
L4 A/3 Block 22 F.B Area , Karachi, Sindh PAKISTAN
36 C - - 04 Honey
Date Published: 08/19/2022

Desc: Honey
Problems: CIPROFLOXACIN; (AMOZ) 3-amino-5-morpholinomethyl-2- oxazolidinone;

HONEST FOOD PRODUCTS
Date Published : 08/19/2022
6-1 Wall Centre Sb , Karachi, PAKISTAN
36 C - - 04 Honey
Date Published: 08/19/2022

Desc: Honey
Problems: CIPROFLOXACIN; (AMOZ) 3-amino-5-morpholinomethyl-2- oxazolidinone;

YOUNG'S (PRIVATE) LIMITED
Date Published : 04/12/2021
Floor 4 Th , Plot St-1, A2 Main Shahr , Karachi, PAKISTAN
36 C - - 01 Comb Honey
Date Published: 04/12/2021

Desc: Honey
Problems: CIPROFLOXACIN;

Youngs Food Products
Date Published : 04/12/2021
C1-(D). Sector 16, Korangi Industrial , Karachi, PAKISTAN
36 C - - 01 Comb Honey
Date Published: 04/12/2021

Desc: Honey
Problems: CIPROFLOXACIN;


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;


SAUDI ARABIA


AL WAFA AL METHALY FOR HONEY & SPICE CENTER
Date Published : 02/22/2023
Bab Sharif Johra Trading Ctr. , Jeddah, SAUDI ARABIA
36 C - - 04 Honey
Date Published: 02/22/2023

Desc: Honey
Problems: CIPROFLOXACIN;


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;


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;