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From:
L and N Matsui <[log in to unmask]>
Reply To:
L and N Matsui <[log in to unmask]>
Date:
Tue, 20 May 2003 22:23:36 +0000
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<<Disclaimer: Verify this information before applying it to your situation.>>

My summary is about what I have further uncovered in regards to the
possibiliities of gluten in products.  It is interesting to note that the
customer reps. from each of these companies volunteered info. to me as to
"grain" alcohol being in one of the vanilla ingredients of one of the
products (Haagan-Dazs) and a vinegar being in the modified tapioca starch of
the other product (Gerber).  Yet, a further response of one company was that
the type of grain alcohol/vanilla ingredient in one product was proprietary
to the flavor vendor.  In the other companies response, they stated that I
had asked if vinegar was present in their product even though I didn't ask
this question but the customer rep. had volunteered this information
herself;  The company went on to say that no vinegar was used to modify the
tapioca starch.
After contacting a separate company entirely, I asked the spokesperson
whether she was familiar with grain vinegar being used to modify a starch in
a modified food starch ingredient.  She affirmed that her own company had
such ingredients but that the supplier doesn't have to disclose any of the
top allergens in such an ingredient if it is below the 2 percent threshold.
As a person with knowledge of Fed. regs. which I used and applied
extensively in my work with the Federal Government, I was told to
corroborate her information by going to
Title 21 of the Code of Federal Regulations and I found the following in
reference to the 2% threshold:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=101.4:

This is 21CFR101.4 (Title 21, Part 101.4) and it says,
"(2) The descending order of predominance requirements of paragraph
(a)(1) of this section do not apply to ingredients present in amounts of
2 percent or less by weight when a listing of these ingredients is
placed at the end of the ingredient statement following an appropriate
quantifying statement, e.g., ``Contains __ percent or less of ______''
or ``Less than __ percent of ______.'' The blank percentage within the
quantifying statement shall be filled in with a threshold level of 2
percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as
appropriate. No ingredient to which the quantifying phrase applies may
be present in an amount greater than the stated threshold.

Of course, each company interprets the application of this regulation
differently and may argue what this particular spokesperson divulged to me
but I'm concerned that if we don't know how little gluten it takes to
relapse a CD patient, we have to all take notice of this potential loophole.
  According to my interpretation and what I have seen in practice, I have
yet to find a label that uses such a quantifying statement ``Contains __
percent or less of ______''
or ``Less than __ percent of ______'' to disclose an ingredient and
according to the anonymous spokesperson, she knows of white vinegar in the
ingredients of her company's "modified food starch" (which is declared)  but
claims that her supplier does not have to disclose the vinegar in the
"modified food starch" to her company since it is less than 2 percent.
Therefore, why does her company have to disclose it since it's the
supplier's responsibility and supposedly the supplier doesn't have to anyway
because it meets the less than 2 percent threshold, according to the
spokesperson.   However, the question becomes if this is white "distilled"
vinegar, present at less than 2%, then does it have to be disclosed anyway
if it is considered allergen-free and as some "distilled" white vinegar is
thought to be gluten-free?

The following are two other sources of the CFR which appear to read as
potential loopholes in the declaration of gluten in foods but they would
vary with interpretation and application:

Sec. 101.22 Foods; labeling of spices, flavorings, colorings and chemical
preservatives.
" (2) An incidental additive in a food, originating in a spice or
flavor used in the manufacture of the food, need not be declared in the
statement of ingredients if it meets the requirements of
Sec. 101.100(a)(3)"

Sec. 101.100 Food; exemptions from labeling.

You can do a search on the above at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

I would like to know of anyone who works in the food industry and can shed
some knowledge of the application of 21CFR in practice in relevance to the
presence of potential undeclared gluten.

Laura Yick

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