2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC341
Submitter : Mrs. Debra Harding Date & Time: 09/09/2005 05:09:53
Organization : Mrs. Debra Harding
Category : Individual Consumer
Issue Areas/Comments
Dear to Whom it May Concern in the FDA:

I have Celiac's disease and although I had been misdiagnoised for 46 years, the symptoms were off and on. Like most diseases, how a person is effected is individual. By having a no tolerance policy of gulten, could cause greater problems for the companies who are trying to do right. What may be most effective would be a tier of 3 colored levels of gluten-free. Green colored Gluten free including free of any type of processing that may expose the product to Gluten or wheat (including Codex Alimentarius quality wheat starch). Yellow colored Gluten free including free of any type of processing that may expose the product to Gluten or wheat except Codex Alimentarius quality wheat starch). Red colored Gluten free made in a company that also processes gluten, wheat, rye, barley or oats within that same environment.
Not enough is known about how each person can react physically to the ingestion of gluten. People have to be responsible for making their own decision as to how much they expose themselves to gluten. They can't be responsible if they are not informed of what they may be eating. It is ridiculous to not give consumers acurate information on the product they are ingesting or exposed to as one would on a carton of cigaretes. Both can seriously negatively affect one's health. The long term ingestion of gluten products are found to contribute to other serious disorders due to malabsorption or sensitivity. Not knowing what is safe to eat is not just frustrating but leathal for some, and costly in medical bills and unnecessary expense. Before I was diagnoised with Celiac's Disease, the amount of money spent both by myself and my insurance company for doctor appointments that never discovered what was wrong until after 4 children, multiple miscarriages and defects my children received due to my malabsorption. Now you might say that changing the type of warning or what should be considered in the warning would have nothing to do with doctors and insurance. If a person so chooses to use products that have incrimental warnings: if they feel worse at one level than another, they are closer to knowing how to become healthier.

I encourage you to adopt a regulation on the use of a green colored 'gluten-free' on product labels that is in line for products that contain naturally gluten-free ingredients, and yellow colored gluten free for those including 200 PPM for products that have been rendered gluten-free such as those that may contain Codex Alimentarius quality wheat starch. Red colored gluten-free for those exposed to gluten base products in processing or made in same environment. The formal adoption of these existing regulations will allow for the continued importation of excellent, safe European products that are labeled 'gluten-free.' People need to be held responsible for their decisions but this can only happen if they are making an informed decision.

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: