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Thu, 24 Aug 1995 22:46:03 -0400
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<<Disclaimer:  Verify this information before applying it to your situation.>>

Felicia Satchell, Consumer Safety Officer, FDA, spoke July 15th,  on the
topic of Food Labeling Policy of the FDA, at the Celiac Disease Conference,
University of Maryland School of Medicine, Baltimore Maryland.

Ms. Satchell clearly and specifically addressed the issues of current food
labeling policy as they apply (or unfortunately, don't apply)  to the Celiac
patient.  She discussed FDA regulations regarding what ingredients must be
disclosed on a food ingredient label, and what ingredients may be added
without being listed.   She described in detail, for example, that FDA
regulations permit inclusion of "incidental additives" in a product without
declaring these additives on the product label.  Furthermore, there are no
threshold levels of what FDA considers "insignificant."  This regulation,
among others discussed,  bears directly on our ability to maintain a
gluten-free diet.

Ms. Satchell was direct about what is necessary for the FDA to establish
guidelines and regulations for gluten-free foods.  Currently, the FDA feels
they have not been given information based on analytical methodology as to
how to verify that a product is gluten-free.  In other words, we do not have
a reliable test for determining whether a product contains gluten, which
would be necessary for enforcing any regulation.  In addition, scientific
evidence is required as to whether there is a threshold amount of gluten that
can be tolerated by the Celiac, or whether no gluten at all is tolerable.

Ms. Satchell demonstrated well her knowledge of the current FDA food policies
as they affect the Celiac patient.  Her information was helpful in making
clear to us what the specific current regulations are that we must deal with
everytime we read a product label.  She also gave incentive to the Celiac
community for providing, through research, the evidence the FDA needs to
change the current regulations so that it can be easily determined if a
product contains gluten.

I transcribed the entire speech, which is too lengthy to be posted here to
the list.  It is definitely worth reading.   Mike Jones has made the
transcript available as a reference file from the Listserv. (Many thanks,
Mike ) To obtain the file:

Send in the body of an email to [log in to unmask]

GET CELIAC FDA-BALT

It will also be manually added to the August logfile by a Listowner for
future database searches, the first week of September.

Sue Goldstein
White Plains, NY  [log in to unmask]

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