"When you have a choice to make and don't make it, that is in itself a choice." -- William James
*NEW*
"When you have a choice to make and don't make it, that is in itself a choice." -- William James
*NEW*
David A. Kessler, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
5600 Fishers Lane, Room 14-71
Rockville, Maryland 20857
Dear Dr. Kessler:
The Ohio State Dental Board is urgently requesting that the Food and
Drug Administration provide guidance to the states regarding the status
of the dental drug Sargenti Paste, Sargenti Compound, or N2.
I understand that a Sargenti formulation is now under FDA review, and
must assume this is being done under a new drug application (NDA) process.
Over the years, there have been many formulas used, most of which contain
paraformaldehyde, a drug we feel is unsafe and should not be used on
the general public.
I have before me a certification and affidavit dated October 30, 1990,
and signed by Carolann W. Hooton, that states in part that there is not
on file, nor has there ever been on file, an approved NDA, permitting
the distribution of Sargenti Paste, Sargenti Compound, or N2, in
interstate commerce for use in humans.
In late 1990, the Ohio State Dental Board received a copy of a letter
from Associate Commissioner for Legislative Affairs, Hugh Cannon, to
U.S. Senator Howard Metzenbaum, regarding Sargenti Paste [link]. In closing,
Mr Cannon states that “we have forwarded your letter to the appropriate
office within FDA’s Center for Drug Evaluation and Research (CDER) for
Review, and any appropriate followup . . .” The board has received no
advice, guidance, etc, from CDER. We are in need of guidance from the
FDA regarding the status of Sargenti Paste, Sargenti Compound, or N2.
This Board has proposed a rule banning the use of Sargenti Paste con-
taining paraformaldehyde in our state. The Ohio Dental Association
lobbied members of our legislature to stop us from taking such an action.
Enclosed are letters from Representative Cliff Skeen to the ADA, and
their reply.
We are willing to hold up action on this rule, allowing time for the
FDA to once again study the use of this drug and, hopefully, issue
guidance to state regulatory agencies and boards. Our problem then
becomes time, as we should take action, if this becomes necessary, before
the end of this year. Thus, we ask that you give this request special
consideration, and your immediate attention.
Thank you for your assistance.
MHY:sc
cc: J.R. May, PH.D., Division of Federal-State Relations
Dr. William Allen, American Dental Association
Rep. Cliff Skeen, Ohio House of Representatives
Board Members
Omar P. WHisman, Executive Director
File
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