IA #36-03 - 10/18/02, IMPORT ALERT #36-03, "DETENTION WITHOUT PHYSICAL EXAMINATION OF HONEY DUE TO CHLORAMPHENICOL" ATTACHMENT REVISED 3/23/04 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 3/23/04 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 - Po Sang Yuen Bee Farm Hk. Ltd. All Honey/ 36C---- 8 Wu Tip Shan Road 3/11/03 Fanling Hong Kong FEI #3003745729 - Lolliga S.A All Honey/36C---- Piura,Peru 3/23/04 FEI# 3003907140