IA #36-04, 12/28/07, IMPORT ALERT #36-04, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF HONEY AND *** BLENDED SYRUP *** DUE TO PRESENCE OF
CIPROFLOXACIN AND ENROFLOXACIN" ATTACHMENT A 6/27/08
NOTE: The revision of this import alert dated 12/28/2007 changes the
name of the import alert, updates the product codes, and amends the text
to reflect blended syrups as products of concern. Changes are bracketed
by asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert contains guidance to FDA field personnel
only. It does not establish any requirements, or create any
rights or obligations on FDA or on regulated entities).
PRODUCT: All honey products (comb honey, strained honey, whipped
honey, honey)
*** Blended Syrups ***
PRODUCT
CODE: 36C[][][][]
*** 36B[][]10 ***
PROBLEM: Fluoroquinolone (Ciprofloxacin and Enrofloxacin)
residues
PAF: FAD (Food additive)
ANT (Drug residues)
PAC: 04F800
09006A
COUNTRY: See attachment
MANUFACTURER/
SHIPPER: See attachment
MANUFACTURER/
SHIPPER ID#: N/A
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)]."
*** [Charge code = UNSAFE ADD] ***
or
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be
adulterated in that it bears or contains the new
animal drug (or conversion product thereof) that is
unsafe within the meaning of section 512
[Adulteration, 402(a)(2)(C)(ii)]."
*** [Charge code = VETDRUGRES] ***
OASIS CHARGE
CODE: UNSAFE ADD
VETDRUGRES
RECOMMENDING
OFFICES: CFSAN, OC, DE, Imports Branch (HFS-606)
ORA, ORO, DIOP (HFC-170)
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. ***
GUIDANCE: Districts may detain without physical examination
(DWPE) all shipments of honey, honey products and ***
blended syrups *** from the firms listed in the
attachment of 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.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required.
KEYWORDS: Honey, Antibiotics, Animal drugs, Food additive,
Fluoroquinolone, Ciprofloxacin, Enrofloxacin, ***
Blended Syrup ***
PREPARED BY: Nawab A Siddiqui, DIOP (301) 594-3871
Ted Poplawski, DIOP (301) 594 3849
Julie Mayer, CFSAN, OC, DE, Imports
*** Nawab A Siddiqui, DIOP (301) 594-3871 (Revision, 12/28/2007) ***
DATE LOADED
INTO FIARS: December 28, 2007
Attachment A 6/27/08
Firms Recommended for DWPE
China (CN)
Firm Name: Residue: *** Product/
Product code ***
Hubei Yusun Co., Ltd. Ciprofloxacin Blended syrup
168 Jingwu, Hankou 36B[][]10
Wuhan 1/4/08
China
FEI# 3005404645
Inner Mongolia Altin Bee-Keeping Co.,Ciprofloxacin *** Honey ***
Ltd. Jinshan Development Area ***6C[][][][] ***
Hohhot, China 11/3/2006
FEI# 3005402797
Jiangsu Kanghong Natural Health Ciprofloxacin *** Honey ***
Foods Co., Ltd *** 36C[][][][] ***
Tngyu North Road, Funing County 11/3/2006
Yancheng, China
FEI# 3004299426
Shanghai Talside Trading Co., Ltd. Ciprofloxacin *** Honey ***
216 Lane 1735 Zhen Nan Rd. *** 36C[][][][] ***
Shanghai, China 11/3/2006
FEI# 3005132954
Shunchang Industry Co., Ltd Ciprofloxacin Blended Syrup
Jingmen Hi Tech Industrial 36B[][]10
Development Z 36B[][]10
Hubei, Jingmen City 2/12/08
China (Mainland)
FEI # 3006378204
Wuhan Shino-Foods Trade CO., Ltd. Ciprofloxacin *** Honey ***
515 Luoshi Avenue, Hongshan *** 36C[][][][] ***
Wuhan, China 11/3/2006
FEI# 3005109776
INDIA (IN)
Little Bee Impex Ciprofloxacin Honey
Shahzada S. Kapoor 36C[][]04
Kashmir House 6/27/08
G.T. Road, Doraha
Ludhiana, Punjab, India
FEI# 2000000395
VIETNAM (VN)
FIRM NAME AND ADDRESS RESIDUE PRODUCT/CODE
Chaochin Industrial Co., Ltd. Norfloxacin Honey
Industrial Service Zone (Fluoroquinolone 36C[][][][]
National Highway 15 family)
Long Binh Ward 9/4/08
Bien Hoa City, Dong Nai
Vietnam
FEI # 2000009921
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