2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC433
Submitter : Ms. Sherri Zann Rosenthal Date & Time: 09/09/2005 06:09:13
Organization : Ms. Sherri Zann Rosenthal
Category : Individual Consumer
Issue Areas/Comments
Dear FDA:

I am writing to encourage you to adopt a regulation on the use of 'gluten-free' on product labels which differentiates between two categories of products: 1. Those which have 20 ppm or less, and 2. Those that have between 20 ppm and 200 ppm.

I have celiac disease, and stay on a strict gluten-free diet. The worst thing is to eat something with gluten in it when I thought it was safe.

What happens when I get gluten-containing food by mistake (usually when someone tells me it is safe, and it turns out to have white flour in it), is that within an hour, my intestinal system just blows out. Then, for a week or two, I am more or less nauseated and feel bad every time I eat. For two or three months, depending on how long the antibodies remain in my bloodstream, I don't digest food well. I feel very low energy, and get other symptoms, such as body aches and joint pain, and very itchy rashes in characteristic spots.

The reason the effects last so long is because the celiac reaction is an auto-immune reaction due to the antibodies produced when my body sees the protein strings of gluten and mistakes it for the nucleus of a viral or bacterial invader. Unlike allergic food reactions which are histamine-based, the celiac reaction is not very amount-sensitive. A little bit can create a long-lasting affect.

Therefore, I encourage you to adopt a regulation on the use of 'gluten-free' on product labels which differentiates between products that have 20 ppm or less or 200 ppm or less. It is important that foods labeled 'gluten-free' from Europe and other countries (including the USA via the Codex Alimentarius) be allowed to be marketed here with labeling consistent with those used in Europe, to allow for the continued importation of excellent, safe European products that are labeled 'gluten-free.'

At the same time, many of us want to be able to know when products have 20 ppm or less of gluten. Celiac studies have shown no effects of residual gluten up to 300 mg per day, which roughly corresponds to 100 ppm. I will personally feel unable to trust labels reading 'gluten-free' if the food so-labelled could have 200 ppm of gluten. The cummulative burden of gluten in such foods is too risky, in my estimation.

Therefore, to accommodate both European labelling and allow for more precise identification of even more strictly gluten-free foods, I propose that an additional phrase be adopted to signify foods that have 20 ppm or less of gluten. That phrase might be something like, 'celiac safe,' or 'low- limit gluten-free.'

Nomenclature already in use in Europe is to refer to some foods as 'naturally gluten-free,' which usually distinguishes these foods from those containing wheat starch. I believe that 'naturally gluten-free' can only be used on foods containing less than 20 ppm of gluten. Therefore, it might be both acceptable and consistent with existing EU product labeling to adopt 'naturally gluten-free' as a label phrase which can be used in this country only on foods containing 20 ppm or less.

Thank you for what I hope will be quick action on gluten-free labeling of foods. It really matters on a daily basis to those of us with severe reactions to gluten.


Sherri Zann Rosenthal
Attorney at Law