我们导读:2009年11月9日,美国FDA报道,我国蜂蜜和混合糖浆产品因含有喹诺酮类药物而被美国自动扣留。
原文报道:
(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: 11/09/2009
Type: DWPE
import alert Name:
"Detention Without Physical Examination of Honey and Blended Syrup Due to Presence of Fluoroquinolones"
Reason for alert:
Fluoroquinolone antibiotics, including ciprofloxacin and enrofloxacin, have been used in the treatment of diseases. Enrofloxacin is approved for use in cattle (21 CFR 522.812)but there are no other approvals for use in other food animals. The use of fluoroquinolones in honey bees or their environment can result in residues in honey. Fluoroquinolones are not generally recognized as safe to treat any honey bee diseases nor are they approved for such use. In addition, fluoroquinolones have been prohibited from extra label use in food producing animals as per 21 CFR
530.41 because of concerns about the threat to public health. Fluoroquinolones used to treat any honey bee disease is considered to be an unapproved new animal drug use within the meaning of Section 512.
Furthermore, fluoroquinolones are not generally recognized as safe for any use in a manner that could reasonably be expected to result in their becoming a component of honey nor are they approved for this use. Therefore, fluoroquinolones in honey are considered to be unsafe food
additives within the meaning of Section 409 of the Food, Drug, and Cosmetic Act.
In February 2006, the Florida Department of Agriculture and Consumer Services (FDACS) became aware of a problem concerning adulteration of honey with fluoroquinolones. FDACS collected and analyzed samples of honey for residues of two of the fluoroquinolones of concern, ciprofloxacin and enrofloxacin. The state reported that residues of these antibiotics were found in honey that was traced back to a
firm from the People's Republic of China.
Because of concerns about the presence of fluoroquinolones in the food supply, the U.S. is continuing to develop methods and strategies to detect illegal residues and prevent their introduction into the U.S. food supply.
In 2007, two shipments of products declared and labeled as "blended syrups" were analyzed and found to contain ciprofloxacin. For that reason, in December, 2007, blended syrups were added to this import alert as a product of concern.
530.41 because of concerns about the threat to public health. Fluoroquinolones used to treat any honey bee disease is considered to be an unapproved new animal drug use within the meaning of Section 512.
Furthermore, fluoroquinolones are not generally recognized as safe for any use in a manner that could reasonably be expected to result in their becoming a component of honey nor are they approved for this use. Therefore, fluoroquinolones in honey are considered to be unsafe food
additives within the meaning of Section 409 of the Food, Drug, and Cosmetic Act.
In February 2006, the Florida Department of Agriculture and Consumer Services (FDACS) became aware of a problem concerning adulteration of honey with fluoroquinolones. FDACS collected and analyzed samples of honey for residues of two of the fluoroquinolones of concern, ciprofloxacin and enrofloxacin. The state reported that residues of these antibiotics were found in honey that was traced back to a
firm from the People's Republic of China.
Because of concerns about the presence of fluoroquinolones in the food supply, the U.S. is continuing to develop methods and strategies to detect illegal residues and prevent their introduction into the U.S. food supply.
In 2007, two shipments of products declared and labeled as "blended syrups" were analyzed and found to contain ciprofloxacin. For that reason, in December, 2007, blended syrups were added to this import alert as a product of concern.
Guidance:
Districts may detain without physical examination (DWPE) all shipments of honey, honey products and blended syrups from the firms listed in the attachment for this import alert.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605.
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 a food additive, namely, fluoroquinolone(s), that is unsafe 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 8Ol(a)(3) in that it appears to be adulterated in that it bears or contains a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512 [Adulteration, 402(a)(2)(C) [ii)"
(OASIS Charge code = VETDRUGS]
(OASIS Charge Code = UNSAFE ADD]
OR
"The article is subject to refusal of admission pursuant to Section 8Ol(a)(3) in that it appears to be adulterated in that it bears or contains a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512 [Adulteration, 402(a)(2)(C) [ii)"
(OASIS Charge code = VETDRUGS]
List of firms and their products subject to Detention without Physical Examination (DWPE) under this import alert (a.k.a. Red List)
(3005404645) HUBEI YUSUN CO.,LTD
Date Published : 09/18/2009
168 JINGWU RD., HANKOU , wuhan, CN-42 CN
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 09/18/2009
Notes:1/4/08; blended syrup
Problems: CIPROFLOXACIN;
(3005402797) Inner Mongolia Altin Bee-Keeping Co.,Ltd.
Date Published : 09/18/2009
Jinshan Development Area , Hohhot, Cn-15 CN
36 C - - -- Honey
Date Published: 09/18/2009
Desc:Honey
Notes:11/3/06
Notes:11/3/06
Problems: CIPROFLOXACIN;
(3004002927) Jiangsu Kanghong Natural Health Foods Co., Ltd.
Date Published : 09/18/2009
Tongyu North Road , Funing County , Yancheng, FN CN
36 C - - -- Honey
Date Published: 09/18/2009
Notes:11/3/06; honey
Problems: CIPROFLOXACIN;
(3005132954) Shanghai Taiside Trading Co., Ltd.
Date Published : 09/18/2009
No.216,lane 1735, Zhen Nan Rd., , Shanghai, Cn-31 CN
36 C - - -- Honey
Date Published: 09/18/2009
Notes:11/3/06; Honey
Problems: CIPROFLOXACIN;
(3005109776) WUHAN SHINO-FOOD TRADE CO., LTD.
Date Published : 09/18/2009
515 LUOSHI AVENUE HonGSHAN , WUHAN, P.R.CHINA , WUHAN, CN-42 CN
36 C - - -- Honey
Date Published: 09/18/2009
Notes:11/3/2006; honey
Problems: CIPROFLOXACIN;
(2000040803) Wuhan Jiabao Syrup Factory
Date Published : 09/18/2009
515 Luoshi Road, Hongshan District , Wuhan, CN-42 CN
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;
(3004257438) Wuhu Qinshi Tangye Co., Ltd.
Date Published : 11/09/2009
SanShan Green Foods Industrial Park; , Guihua Bridge, Wufan Rd, Matang Dist , Wuhu City, Anhui CN
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 11/09/2009
Notes:DWPE date - 8/10/2009
Problems: CIPROFLOXACIN; NORFLOXACIN;
36 B - - 99 Syrups and Molasses, N.E.C.
Date Published: 11/09/2009
Notes:DWPE date - 8/10/2009
Problems: CIPROFLOXACIN; NORFLOXACIN;
(3006378204) shunchang industry co.,ltd
Date Published : 09/18/2009
jingmen hi-tech industrial development z , jingmen, CN-42 CN
36 B - - 10 Blended Syrups, Pancake and Waffle Syrup
Date Published: 09/18/2009
Notes:2/12/08; blended syrup
Problems: CIPROFLOXACIN;
(3006299696) Inner Mongolia Youth Trade Dev.C
Date Published : 09/18/2009
No 47 Xincheng Xijie Hotel, Fl#3 , Hohhot, FN MN
36 C - - -- Honey
Date Published: 09/18/2009
Desc:honey
Notes:1/5/9
Notes:1/5/9
Problems: NORFLOXACIN;
(3004285196) KENTWE PRODUCTS (M) SDN. BHD.
Date Published : 10/01/2009
St 524, Lot A1, , Kaw Ind Miel, Pengkalan Balak , MASJID TANAH, MY-M MY
36 C - - -- Honey
Date Published: 10/01/2009
Problems: NORFLOXACIN; CIPROFLOXACIN;
(2000023125) THA YU INTER TRADING CO.,LTD.
Date Published : 09/18/2009
3/6 MOO 11KWANG SIKAN KHET DonMUANG , BANGKOK THAILAND , BANGKOK, TH-10 TH
36 C - - -- Honey
Date Published: 09/18/2009
Desc:Honey
Notes:3/10/09
Notes:3/10/09
Problems: CIPROFLOXACIN;
(2000009921) Chaochin Industrial Co., Ltd.
Date Published : 09/18/2009
Industrial Service Zone, , National Highway 15, Long Binh Ward , Bien Hoa City, VN-39 VN
36 C - - -- Honey
Date Published: 09/18/2009
Notes:fluoroquinolone family; 9/4/08
Problems: NORFLOXACIN;
(3000200757) Donhnai Honeybee Company
Date Published : 10/01/2009
143, Nationl Road 15 , Bienhoa City, VN
36 C - - -- Honey
Date Published: 10/01/2009
Problems: NORFLOXACIN;
详情见:http://www.accessdata.fda.gov/cms_ia/importalert_111.html