2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC755
Submitter : Ms. Diane Henzey Date & Time: 09/13/2005 06:09:40
Organization : Ms. Diane Henzey
Category : Health Professional
Issue Areas/Comments
Dear FDA:

Diagnosis of Gluten intolerance in its many forms is dramatically on the rise, partly due to the better diagnostic tests now available. Significantly more people are at risk for problems related to injestion of gluten. Specifying the presence of gluten in food products is essential to the health of this growing population. I personnally developed gluten intolerance at the age of 45.

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,
Diane Henzey RN