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Subject:
From:
Teigh Southworth <[log in to unmask]>
Date:
Thu, 25 Mar 1999 15:09:11 -0400
Content-Type:
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<<Disclaimer: Verify this information before applying it to your situation.>>

Here is a copy of the letter we are sending, you are welcome to plagiarize:


Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

Subject: FDA-Docket No. 98N-1265

To whom it may concern:

I have Celiac Disease, a non-contagious auto-immune condition that causes me
to become ill if I eat anything containing or derived from wheat, oats,
barley, rye or malt.

Many over the counter and prescription medications contain ingredients which
are harmful to me, including excipients, such as stabilizers, preservatives,
colorings, flavorings, sweeteners, binders, dilutants, disintigrants,
lubricants, coatings, additives and inert agents.  If I need an over the
counter or prescription medication, I must do extensive research to see if it
contains anything harmful to me.  Many times there isn't a product available
commercially, and so I have to have a product custom made.  Stokes Pharmacy,
in New Jersey, is one place where I can get a custom replacement for a
product that would otherwise be harmful to me.

If the subject restriction were implemented, then a safe source of both over
the counter and prescription medications will be denied to me.  More
important these sources will be denied to the thousands of other people who
have dietary restrictions and allergies.

Thank you!

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