|2005N-0279||Food Labeling; Gluten-Free Labeling of Foods; Public Meeting|
|FDA Comment Number :||EC1093|
|Submitter :||Dr. Margaret English||Date & Time:||09/20/2005 03:09:28|
|Organization :||Dr. Margaret English|
|Category :||Health Professional|
| Dear FDA:
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."
The gluten free diet is quite restrictive. One must assume that many ingredients are contaminated when, in fact, they may be safe in that particular product. Celiac disease is being recognized in more people and is estimated to occur in approximately 1 in every 133 people. That is a significant percentage of the public.
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:
Magaret English, MD, FAAP (fellow of the American Acedemy of Pediatrics)