2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC1260
Submitter : Ms. Sharon Lehwalder Date & Time: 09/20/2005 05:09:05
Organization : Ms. Sharon Lehwalder
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear FDA:

My mother and grandmother both died at a young age from celiac sprue--a time before the connection was made with gluten. Both of my adult children and I have been diagnosed with celiac sprue, and our attempts to maintain a gluten-free diet are often thwarted by incomplete labeling of processed products. Consequently, we unnecessarily avoid many products to protect ourselvs from the damage done by gluten. All three of us have called companies to find out if the "modified food starch" used in their products--from yogurt to chili--contains gluten. Often companies cannot answer the question-- sometimes even their chemist cannot answer the question.

Therefore, 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:
http://www.celiac.com/st_main.html?p_catid=15

Sincerely,

Sharon M. Lehwalder