2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC993
Submitter : Mrs. Connie Gratias Date & Time: 09/14/2005 06:09:48
Organization : Mrs. Connie Gratias
Category : Health Professional
Issue Areas/Comments
Dear FDA:

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:

I am a Family Nurse Practitioner and also a person who is Gluten Intolerant (Celiac Disease) as are my father and my daughter. I see several patients with gluten intolerance in my practice and it is very important for all of us to be careful label readers and and know that when we see the term "Gluten Free" that it has consistency across all product lines. We have successfully used many European gluten free products for several years and welcome their use in our homes.
Thank you for taking my comments into consideration.


Connie M Gratias RN CNP, Family Nurse Practitioner