2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC1185
Submitter : Ms. Rita Cox Date & Time: 09/20/2005 05:09:52
Organization : Ms. Rita Cox
Category : Food Industry
Issue Areas/Comments
Please increase some labeling requirements to specify what grain is used in "modified food starch". Right now this can mean soy, corn or wheat. For me it is a a gamble to eat anything labeled containing "modified food starch". Only a few products break it down and state what the base ingredient is from. If it involved milk or peanuts, a very hot issue, it would be labeled speically. We celiac patients are only asking for the same treatment. We might not die from a reaction now to wheat or gluten but repeated exposure puts us at a 60% greater risk for lymphoma. Would you let someone hide tobacco or asbestos in a product and not inform anyone? These are known carcinogens just as wheat gluten is to celiac patients. Please help us. It is estimated that 1 in every 300 people in the US have this problem and don't know it. Please make it easier for all of us. I feel proper labeling is key. It has been shown that minute levels may not have harmful effects. I also agree with the following opinions:

We encourage you to adopt a regulation on the use of "gluten-free" on product labels that is in line with that which has been used in Europe and other countries (including the USA via the Codex Alimentarius) for many years--20 PPM for products that contain naturally gluten-free ingredients, and 200 PPM for products that have been rendered gluten-free such as those that may contain Codex Alimentarius quality wheat starch. The formal adoption of these existing regulations will allow for the continued importation of excellent, safe European products that are labeled "gluten-free."

It is very important that you do not adopt a "zero tolerance" regulation in this matter because doing so will cause many gluten-free food companies to discontinue their use of the term "gluten-free" on their labels out of fear of litigation--which is counterproductive for all people with this disease (most, if not all, gluten-free food companies do not grow, transport or mill the gluten-free grains that they use as ingredients--a fact that will make them vulnerable to litigation if a zero tolerance level is adopted). Last, the inclusion of trace levels of gluten in the diets of those with celiac disease have been shown to be safe in many scientific studies, for more details please see:

Thank you,

Rita A Cox