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 my
> wife, 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 her, she should have the power to be able to make the
> decision for herself as to whether or not she choose to ingest trace
> amounts of gluten. If \"gluten-free\" comes to mean that trace amounts
> of gluten may be present, then she will have no way of determining
> which products have zero gluten and which have trace amounts. I find
> this predicament hazardous to her health. It is time-consuming enough
> for her to have to call about products that are not labeled as
> gluten-free to determine whether or not they contain gluten, the idea
> of her 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.  My wife identifies foods that do not contain gluten by checking the
    label. If the label says \"gluten-free\", she has, 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 she checks the ingredients. If the ingredients
    don\'t have any obvious or hidden sources of gluten, then she
    assumes 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 she calls the manufacturer
    and asks if the product is gluten-free and if the product has a
    chance for cross contamination.

> I would say each time she has to call a manufacturer, she spends
> anywhere from 10-30 minutes doing so. She has only been on a
> gluten-free diet since the beginning of June 2005, but already she has
> 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 for her. 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 my wife purchases for herself 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
    wife's 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. She purchases 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. Her reason being is, again, she has been under the impression
    that \"gluten-free\" means zero tolerance for gluten, so she has
    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, for my
> wife's sake, I would want to see a two or more level definition of
> gluten-free. I would want my wife to know which products are truly
> 100% gluten free and which are not, so that she can make educated
> decisions for herself. And, it would make her 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,

Steve Warner