IA #36-03 - 10/18/02, IMPORT ALERT #36-03, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF HONEY DUE TO CHLORAMPHENICOL" ATTACHMENT REVISED 3/19/07
TYPE OF ALERT: Detention Without Physical Examination
(Note: 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 any rights for or on any person, and does not
operate to bind FDA or the public.)
PRODUCT: All honey products (comb honey, strained honey, whipped
honey, honey)
PRODUCT CODE: 36C[][][][]
PROBLEM: Chloramphenicol (CAP) residues
PAF: ANT
PAC: 04F800
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 be adulterated in
that it bears or contains the new animal drug
chloramphenicol (or conversion product thereof) that is
unsafe within the meaning of section 512 [Adulteration
402(a)(2)(C)(ii)]".
OASIS CHARGE
CODE: CHLORAMP
RECOMMENDING
OFFICES: DET-DO (HFR-CE740)and CFSAN, IMPORT BRANCH, HFS-606
REASON FOR
ALERT: Analysis of 2 samples of honey (#167615 & 169229) by DEN-DO
found Chloramphenicol (CAP). CAP has been found in honey
from China by Canada, the United Kingdom, the European
Union, and Japan. Preliminary test results from Canada
indicate about 80% of the samples they have analyzed are
positive for CAP.
Chloramphenicol is a broad-spectrum antibiotic that is not
approved for use in food producing animals and has been
prohibited from extra-label uses in food producing animals,
including bees (21 CFR 530.41). Use of the antibiotic in
humans is reserved for treatment of certain serious
infections. Therapeutic doses correlate with a low
incidence (1:30,000 to 1:50,000) of serious or even fatal
blood disorders, such as idiosyncratic aplastic anemia.
Therapeutic doses are from one thousand to one million
times the levels typically found in these products.
However, since the adverse reactions are not dose related,
it is not possible to identify a safe level of exposure to
chloramphenicol.
GUIDANCE: Districts may detain without physical examination (DWPE)
all shipments of honey and honey products 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, Chloramphenicol
PREPARED BY: John E. Klemmer, DET-DO, (313) 226-6264
John Bryce, CFSAN, (301) 436-1960 and
Standra Purnell, CFSAN, (301) 436-1613
Doug Randes, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: August 13, 2002
IMPORT ALERT #36-03 - ATTACHMENT 3/19/07
Firms Subject to DWPE:
- Falcon Products Malaysia Sdn Bhd All Honey/36C----
No. 2 Jalan Gelam 9/5/02
Port Klang
Malaysia
FEI# 3003692633
- Sea Empress Logistics (M) Sdn Bhd All Honey/36C----
No. 4B, 1st Floor Lorong Berangan 9/5/02
4200 Port Klang
Selangor Darul
Malaysia
FEI# 3003744483
- Miel Mex S.A. de C.V. All Honey/36C----
Cto. Circunvalacion Ote. 146-303 9/5/02
Naucalpan
Mexico, D.F.
FEI# 3000062418
- OZF Co. Ltd. All Honey/36C----
225/116 Sanpawut Rd. 9/5/02
Bangkok, 10260
Thailand
FEI# 3003363171
- Hansa Mieles S.A. De C.V. All Honey/36C----
Veracruz, Ver. Mexico 9/20/02
FEI #3002645021
- Donaco Company Ltd. All Honey/36C----
90424 Nguyen Chi Thanh
Ho Chi Minh City, Vietnam 9/20/02
FEI #3003736235
- Kunshan Foreign Trade Co. All Honey/36C----
270 Mid Quianjin Rd. 10/30/02
Kunshan, Jiangsu, China
FEI: 3001644652
- Cosmic Quality SDN BHD All Honey/36C----
9A Jalan Perindustrial 10/30/02
Silibin 1, Silibin Light Industrial
Estate
Perak Darul Ridzuan
Ipoh, Malaysia 30100
FEI: 3003765731
- Apiprodex Saigon All Honey/36C----
24h Le Van Sy St Dist 3 10/30/02
Ho Chi Minh City
Vietnam
FEI: 3000041229
- Lolliga S.A All Honey/36C----
Piura,Peru 3/23/04
FEI# 3003907140
-Eurasia Bee's Products Co., Ltd. All Honey
South Economic Development Zone 36C----
Zhumadian, Henan 12/17/04
China
FEI# 3004676151
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