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Date: | Mon, 3 Feb 1997 11:28:15 -0500 |
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<<Disclaimer: Verify this information before applying it to your situation.>>
On February 1 mike wrote calling for letters to the FDA.
At the last meeting of the Healthy Villi, a CSA chapter that covers
greater Boston our speaker was Joseph Raulinaitis, Public Affairs
Specialist, FDA. He suggested that every celiac support group develop a
relationship with the district office of the FDA.
He also suggested that the group become familiar with the FDA code
and in particular the section that would apply to the problems they are
concened with.
As a regulatory agency the way to change the code is by formal petition.
He stressed that numbers of letters did not impact them. The way to
change the regulation is by being able to meet the requirements of the
petition process which includes submitting formal scientific research that
substantiates the need for the change requested.
I would like to ask the list if we could but together the evidence to
formally provide the evidence needed to change the labeling laws.
What amount of gluten over what period would establish changes in the
intestine or T-cells. Do we have in-vitro evidence? Is there evidence
based on animal studies? Have there been any controlled human studies?
This is probably the kind of evidence they would be looking for.
Unfortunately there may be no funding available to support researchers to
work on the kind of studies we may need.
Mr. Raulinaitis suggested the way to use lots of letters is to impact the
people that we elect or who are appointed by people that we elect. Contact
Senators, Representatives, the President and Presidential Appointees.
Address letters to the Commissioner of the FDA, as he is appointed.
Irma
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