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Again. This time it is honey from China.|
Banned in Canada, USA and the European Union.
Because it contains high levels of Chloramphenicol.
Import Alert 36-03
Import Alerts by Numbers
(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 # 36-03
Published Date: 01/14/2010
Import Alert Name:
"Detention Without Physical Examination of Honey Due to Chloramphenicol"
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.
Districts may detain without physical examination (DWPE) all shipments of honey and honey products from the firms listed in the Red List 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.
All honey products (comb honey, strained honey, whipped honey, honey)
"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)]".