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Current View
1 May 1998
Office of Premarket Approval (HFS-200)
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
200 C Street SW
WASHINGTON DC 20204
UNITED STATES OF AMERICA
Attention
: Dr AM Rulis
Dear Dr Rulis
I have corresponded with Linda
Kahl of your office regarding the recognition by the
Archer Daniels Midland (ADM) Company that
soy isoflavones are generally recognised
as safe (GRAS). I have also r
eceived ADM’s support document entitled ‘An
information document reviewing the safety of
soy isoflavones used in specific dietary
applications’.
I understand that the FDA’s procedure for
evaluating ADM's notice does not involve
rulemaking and that there is no formal m
echanism for submission of comments within
the context of ‘notice and comment’ rulemaki
ng. However, I also understand that the
FDA welcomes fact-based info
rmation on food safety issues.
With regard to GRAS Notice Number GR
N 000001, and acting on instructions from a
client, I would like to submit the attached information to your office for your
consideration
Yours faithfully
KINGETT MITCHELL & ASSOCIATES LTD
Mike Fitzpatrick PhD MNZIC
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KINGETT MITCHELL & ASSOCIATES LTD
ENVIRONMENTAL CONSULTANTS
cc Dr L Kahl