Docket Management
Docket: 02D-0449 - The Administrative New Animal Drug Application Process; Draft Guidance for Industry
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Manush. S. Mohammed Date/Time 2003-01-02 07:59:59
Organization Central Institute of Fisheries Education
Category Academic

Comments for FDA General
1. General Comments Dear Dr. Joan Gotthardt, In response to the publication Guidance for Industry- Status of Clove oil and Eugenol for Anesthesia of Fish, I would like to clarify some of the doubts regarding the use of Clove oil in animal studies. I would like know about the possibility of using Eugenol/Clove oil as an anesthetic. It is told that 21 days withdrawl time is enough for the use of Eugenol. What is present status of approval of Eugenol or Clove oil as an anesthetic ? whether the use of clove oil for post larvae will affect the human beings since it will be consumed after 4 months ( attaining marketable size of 30 g )? It is true that it is carcinogenic but whether any maximum possible level for use specified in the case of Eugeol or Clove oil? It is a GRAS anaesthetic as per New Zealand FDA. Any other GRAS anesthetic available as per USFDA ?

EC -1