2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC604
Submitter : Miss. Melinda Maxwell Date & Time: 09/12/2005 06:09:20
Organization : Miss. Melinda Maxwell
Category : Food Association
Issue Areas/Comments
Dear FDA:

Thank you so much for finally addressing this issue that takes up much time in my life. I'd like to 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:

The only sure way I have of identifying whether or not a food item has gluten is to contact the manufacturer. This takes hundreds of hours (literally) of my time trying to find the correct phone number, call and get ahold of the right person in the right department and at the right time. It is very frustrating on weekends if I need to know whether a product is gluten-free or not. This is one reason why correct labeling of gluten-free foods would be helpful. A very, very large percentage of the food that I eat are the ones that are labeled 'gluten-free.' If a product is labeled 'gluten-free,' I am about 100% more likely to buy it than another product with the same ingredients that does not have the label 'gluten-free.' It will be nice when the government defines 'gluten-free' so that I can know what to expect in terms of gluten in products labeled 'gluten-free.'
Thank you,
Melinda Maxwell