To Whom it May Concern:

In response to how the FDA should define "gluten-free" for food labels,
I would like to respond to the following questions:

1\) What should "gluten-free" mean on a food label? Why?

1.  \"Gluten-free\" should mean absolutely no wheat, oat, rye or barley.
    In other words,

> \"gluten-free\" should mean there is zero tolerance for gluten, even
> trace amounts, found in a product. Also, \"gluten-free\" should mean
> there is zero chance for cross contamination. I feel this way because
> the word \"free\" means zero, none, etc. If we are attaching \"free\"
> to the word \"gluten\" then \"gluten-free\" inherently means zero
> gluten. To then go against this word\'s definition and say that a
> product is \"gluten-free\" when really there are trace amounts of
> gluten, or there is a chance for cross contamination, is deceptive and
> confusing. As far as I know, the medical community cannot definitely
> say what \"trace\" amounts of gluten are safe for a celiac patient or
> for one with gluten sensitivity, especially since a \"safe\" amount of
> gluten can vary with each individual. So as far as I can tell, for me,
> as one with celiac disease, ingesting trace amounts of gluten is a
> gamble. Because ingesting trace amounts of gluten may or may not be
> harmful to me, I want the power to be able to make the decision for
> myself as to whether or not I choose to ingest trace amounts of
> gluten. If \"gluten-free\" comes to mean that trace amounts of gluten
> may be present, then I will have no way of determining which products
> have zero gluten and which have trace amounts. As a consumer I find
> this predicament a hazard to my health. It is time-consuming enough to
> have to call about products that are not labeled as gluten-free to
> determine whether or not they contain gluten, the idea of having to
> also call manufacturers of products labeled as \"gluten-free\" to find
> out whether or not trace amounts of gluten may be present is
> disheartening and would be a major step backwards. The whole point of
> having gluten-free products is to give those who cannot eat gluten,
> products that they can, without question, safely eat. Having trace
> amounts of gluten or the possibility for cross contamination in
> products labeled as \"gluten-free\" would strip away the safety and
> the convenience of gluten-free products.

2\) How do you identify foods that do not contain gluten? Time spent
identifying foods?

2.  I identify foods that do not contain gluten by checking the label.
    If the label says \"gluten-free\", I have, up to this point, been
    under the impression that the product has no gluten and no chance
    for cross contamination. If the label doesn\'t say "gluten-free,"
    then I check the ingredients. If the ingredients don\'t have any
    obvious or hidden sources of gluten, then I assume the product\'s
    ingredients are gluten-free but the product may or may not have been
    subjected to cross contamination. If the ingredients have no obvious
    sources of gluten but have hidden sources of gluten, which most do,
    then I call the manufacturer and ask if the product is gluten-free
    and if the product has a chance for cross contamination.

> I would say each time I have to call a manufacturer, I spend anywhere
> from 10-30 minutes doing so. I have only been on a gluten-free diet
> since the beginning of June 2005, but already I have spent many, many
> hours calling companies, not to mention the extra time it takes to
> read all food labels. Overall, identifying which foods contain gluten
> and which do not is extraordinarily time consuming. It would be far
> less time consuming if companies were forced to identify any sources
> of gluten on their labels.

3\) What percentage of foods and which types purchased are marked
"gluten-free"?

3.  I would say 80% of the foods I purchase for myself are marked as
    \"gluten-free.\" All cereals, crackers, bread, cookies, brownies,
    rice cakes, snack bars, pepperoni, pasta, soup, waffles, \"nut
    clusters\", pizzas, and frozen entrees that I buy are marked
    \"gluten-free.\"

4\) Does "gluten-free" printed on a product label influence your
decision to purchase products having the same ingredients? To what
extent? Example:Two cans of tomato sauce on the shelf both contain only
tomatoes and salt and only one is marked gluten-free.

4.  \"Gluten-free\" printed on a product label absolutely influences my
    decision to purchase a product that may have the same exact
    ingredients as a product not labeled as \"gluten-free.\" Rice cakes
    are one example. I purchase the brand of rice cakes labeled \"gluten
    free\" over the brands of rice cakes that are not labeled as
    \"gluten-free,\" even though the ingredients are exactly the same.
    My reason being is, again, I have been under the impression that
    \"gluten-free\" means zero tolerance for gluten, so I have figured
    the product that is not labeled as \"gluten-free\" might have the
    chance for cross contamination, whereas the product marked
    "gluten-free" would not.

5\) Would you consider a two or more level definition of gluten-free
helpful?

Example: If Level A meant the absence of any wheat, barley, rye, oats
and any of their derivatives and level B meant the presence of trace
amounts, less than \"X\" parts per million, of wheat, barley, rye, oats
and any of their derivatives and level C meant the presence of small
amounts, less than \"Y\" parts per million, wheat, barley, rye, oats and
any of their derivatives. (Using \"X\" and \"Y\" to identify quantities
to be determined by the FDA.)

5.  My first choice would be for products labeled as "gluten-free" to be
    truly gluten-free. I think a company should be able to stand behind
    their product and should take responsibility for checking all the
    sources of its ingredients and be able to vouch for its products
    labeled as "gluten-free" as being completely gluten-free all the way
    back to the source of its ingredients.

> However, if my first choice of "gluten-free" meaning across the board
> zero tolerance for gluten is not viable, then, yes, definitely, I
> would want to see a two or more level definition of gluten-free. As I
> said in my response to question one, if there are trace amounts of
> gluten found in a product, I want to know about it. I want to know
> which products are truly 100% gluten free and which are not, so that I
> can make educated decisions for myself. And, it makes my life as a
> celiac patient a whole lot easier if the above stated information is
> clearly printed on the product label.
>
> I feel that the two or more level gluten-free definition could be a
> good compromise between the "zero tolerance" gluten-free stance and
> the opposing side that promotes the idea that trace amounts of gluten
> should be acceptable in products labeled as "gluten free."

Thank you for your consideration of my comments.

Sincerely,

Michelle Warner