Import Alert 36-03

"Detention Without Physical Examination of Honey Due to Chloramphenicol"

NOTE: The revision of this import alert, dated August 31, 2011 updates the applicable charges for this Import Alert, and updates the Guidance section to provide information on requesting removal from DWPE. Changes are noted and bracketed by three asterisks (***).

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 (21CFR 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.

*** Analysis of honey samples collected by FDA and others continues to reveal the presence of chloramphenicol in honey.
***

*** Districts may detain without physical examination all shipments of honey and honey products from the firms listed in the Red List of this Import Alert.

In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain chloramphenicol.

If a firm wishes to request removal from detention without physical examination (DWPE), information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future shipments of honey and honey products will not be adulterated.

Additional information regarding being removed from Import Alert can be found at:

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179271.htm

In its request, the firm should forward information supporting its position to FDA at the following address:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive
ELEM - 3109
Rockville, MD 20857

Or via e-mail: Importalerts2@fda.hhs.gov

For questions or issues concerning import operations, contact DIOP Operations and Policy Branch at (301) 796-6585.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

***

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 a food additive that is unsafe within the meaning of section 409 [Adulteration 402(a)(2)(C)(i)].
OASIS Charge Code: UNSAFE ADD

Or

If FDA obtains evidence (i.e., labeling) to demonstrate the use of Chloramphenicol as a new animal drug, use the 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: VETDRUGRES