June 14, 2002
CVM ISSUES GUIDANCE ON USE OF CLOVE OIL AND EUGENOL FOR FISH
FDA's Center for Veterinary Medicine (CVM) has issued level 2 guidance that provides information regarding the use of clove oil and its components for the anesthesia of fish. This Guidance for Industry, Status of Clove Oil and Eugenol for Anesthesia of Fish (Guidance # 150), is posted on the CVM Home Page. Single copies of the Guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. Please send one self-addressed adhesive label to assist in processing your request.
Clove oil is actually a mixture of different compounds. The three significant active ingredients are eugenol, isoeugenol and methyleugenol. Clove oil is 85 to 95% eugenol. Isoeugenol and methyleugenol make up 5 to 15% of the remaining ingredients. Neither clove oil nor any individual active ingredient of clove oil (eugenol, isoeugenol, or methyleugenol) is approved for use for the anesthesia of fish. Therefore, the use of either clove oil or eugenol as an anesthetic for fish makes them unapproved new animal drugs.
This Guidance document includes information about anesthetic choices for use in fish, human food safety of clove oil and its active ingredients, one publicly-disclosable Investigational New Animal Drug (INAD) Exemption file for isoeugenol as a fish anesthetic, and use of investigational drugs in a laboratory setting.
This Guidance document does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used as long as it satisfies the requirements of the applicable statute and regulations.
Comments and suggestions regarding this Guidance document should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. All comments should be identified with the exact title of the document.
For questions regarding information about the drug approval process and INAD files, contact Dr. Joan Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7571.
For questions regarding information about regulatory discretion, contact Ms. Fran Pell, Center for Veterinary Medicine (HFV-235), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0188.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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