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I was just about to point out that FDA note as well,
The guidance document basically states that while
clove oil and its components are considered safe as food
additives, if you use it on fish which could be eaten
by people there are still safety concerns ( as viewed by the regulations)
And you are not allowed to do that.
Welcome to the world of the FDA, where the same rules that
apply to large drug companies and the development of human drugs,
also apply to minor applications of animal 'drugs'. And basically
anything is considered a drug if it effects the fish in almost anyway
and not just the treatment of disease.
Fortunately 'ice' and a few other 'drugs' were given exemptions
from further regulation several years ago.
The folks in FDA/CVM try to help as best they can, but the
regulations they are forced to operate under can make the approval
process a long and tedious journey and it takes lots of patience to
see it through. I don't know the status of 'clove oil' but I would
suspect it may still be a few years way from full approval
- Pete Hagen
George Nandor wrote:
> Please note that "neither clove oil nor eugenol is approved as a new animal drug to treat or mitigate any diseases in any species in the U.S. Therefore, the use of either clove oil or eugenol as an anesthetic for fish makes them unapproved new animal drugs" according to the U.S, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine - June 11, 2002
> see:
> www.fda.gov/cvm/guidance/guide150.pdf
>
> The FDA document also states that "eugenol may not be used in any form on animals (fish) that could possibly be consumed by humans..."
>
> The US Fish and Wildlife Service holds an Investigational New Animal Drug (INAD) exemption for the purpose of studying the drug to gather data to support FDA approval. This product has been given an investigational 21 day withdrawal time for the dosing regimen in the current studies, which is the same as exists for the approved fish anesthetic MS-222.
>
> >>> [log in to unmask] Tuesday, October 01, 2002 >>>
>
> In an unpublished experiment undertaken by members of our local Trout Unlimited chapter (Ken Preiser, Tom Friedrich, Peter Renne), the investigators found quicker induction and recovery times of fish anaesthetized w/ clove oil vs. MS-222; in addition, there is no
> withdrawl period associated with clove oil (i.e., fish can be stocked or consumed immediately), and clove oil is about 5x less expensive than MS-222. Also - see Anderson et al. 1997. The use of clove oil as an anesthetic for rainbow trout and its effects on swimming performance. North American Journal of Fisheries Management 17:301-307.
> hope this helps -
> Steve
>
> Stephen M.Coghlan Jr.
>
> Teaching Assistant / Research Assistant
>
> 248 Illick Hall
>
> State University of New York
>
> College of Environmental Science and Forestry
>
> Syracuse, New York 13210
>
> (315) 470 - 6949
>
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