2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC908
Submitter : Mrs. Donna Hesse Date & Time: 09/14/2005 05:09:36
Organization : Mrs. Donna Hesse
Category : Individual Consumer
Issue Areas/Comments
Dear FDA:
I was diagnosed with Celiac Sprue July 12, 2005. I have been struggling and suffering while trying to eliminate all gluten from my diet. Not only do I not know if food products contain gluten, I can't interpret the list of ingredients to make the determination. It is crucial that I eliminate gluten for the rest of my life. If I inadvertantly ingest gluten as it has been a hidden ingredient not disclosed on the label, I am ill for days and am not a valuable member of society. Diabetics have an easier time of reading labels than Celiacs. I'm one of the lucky ones. I've just recently been diagnosed and will welcome the benefit of this labeling legislation. Others who have been suffering for years haven't been so lucky.
I 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,
Donna Hesse
Highlands Ranch, CO