2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC743
Submitter : Mrs. Betty Reynolds Date & Time: 09/13/2005 06:09:34
Organization : Celiac Sprue Association
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear Ladies and Gentlemen:
Thank you for allowing me the opportunity to provide comments regarding the issue of defining "gluten-free" for food labels. As someone who has struggled for over 20 years to find digestible food sources, I applaud the FDA's efforts to alleviate the difficulty of surviving with celiac disease.

1. What should "gluten-free" mean on a label? -
a. Gluten-free should mean the absence of wheat, barley, rye, oats and any of their derivatives (especially in flavorings, spices, mono and diglycerides, etc.).
b. The label should also indicate if the product is processed in a facility which also processes gluten-containing items as cross-contamination could cause me a problem.
c. This is critical information to me as small amounts (or even trace amounts) of gluten cause me to experience immediate, severe reactions such as digestive difficulties, distended stomach, crippling joint pain and dermatitis herpetiformis.
d. Over the years, the difficulty (and subsequent failure at times) in identifying safe food sources has also caused me to start experiencing the more chronic (and costly) conditions common in the celiac population, such as thyroid disease.

2. How do I identify food that does not contain gluten? -
a. I look for food items which are marked "gluten-free".
b. In addition, I spend about 2 hours per shopping trip calling food companies on my cell phone to inquire about products that appear to be safe but do not have a "gluten-free" label.
1) This is an ongoing challenge as most companies state that they will not label their products as they "reserve the right to change the sources of their ingredients at any time." In other words, the product might be gluten-free one month and not gluten-free the next month, despite the fact that the label has not changed. That is why most companies state that I must call before each purchase and provide the operator with the product bar code number before they can respond to my inquiry.
2) Frequently, the operator does not understand my inquiry or does not check a resource list. In such cases, I cannot rely upon the information given to me.
c. Also, at least once a week I travel 15-20 miles to health food stores which may have lists of gluten-free products or are more likely to offer foods labled "gluten-free." These products are usually considerably more expensive than mainstream products. (Bread is usually $4-$5 per loaf, when it is available.)

3. What percentage of foods and which types purchased are marked "gluten-free"?
a. Out of a typical $100 shopping trip at a conventional grocery store, approximately 7% is spent on foods marked "gluten-free. These items are salad dressing and cereal which are found in the very small specialty aisle of the store.
b. Out of a typical $50 shopping trip at a health food store, 100% of the items are marked "gluten-free." These items are chicken strips, fish sticks, bread, soup, pasta, snacks, desserts, and vitamins.

4. Does "gluten-free" printed on a product label influence my decision to purchase products having the same ingredients?
a. Definitely!
b. As stated in 2(b) above, those companies which do not label their products "gluten-free" have told me that they choose not to do so in order to have the ability to change the sources of their ingredients at any time without changing their labels. Therefore, I cannot rely upon the safety of those products unless a knowledgeable person at that company verifies that the product in hand that day is safe for me to consume.

Thank you for your attention to my comments.

Sincerely,
Betty A. Reynolds