2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC286
Submitter : Mrs. Susan Zelisko Date & Time: 09/01/2005 05:09:30
Organization : Mrs. Susan Zelisko
Category : Individual Consumer
Issue Areas/Comments
I am a 40 year old, female consumer with celiac disease and was diagnosed with the disease a little over three years ago. I would like to offer comments on the sections stated as: D) Foods Marketed as ?Gluten-Free?; and E) Consumer Purchasing Practices.

Question 8 in Section D of the notice asks: My answer is ?not much, if at all.? In fact, I am not aware of any studies pertaining to this question. From my experience in searching for material on this matter on the internet, talking with support groups and reading scientific studies, I have come to the conclusion there has not been adequate study of consumers with celiac disease. The focus of research data has been on the discovery of the disease, but very little education of the celiac consumer by the food industry or the medical community.

Question 9 in Section E of the notice asks: My response to this question is again ?not much, if at all.? I am not aware of any studies that pertain to these questions. From my own experience, I have learned to read labels very carefully. The amount of time to shop for gluten free products at stores depends upon the market where the celiac consumer lives. In my case, it takes me over an hour, three times a week, to complete my shopping for gluten free products. Additionally, I would have to visit two or more specialty stores that actually market gluten-free products. In contrast, before I was diagnosed, it would take me 30-45 minutes at one store (once a week), to complete my food shopping.

Question 10 in Section E of the notice asks: My answer is that I am not aware of any research data or findings in how celiac consumers shop. I have found that a gluten free label certainly will influence my decision on whether to purchase a product, especially if the store is a standard grocery store, or even a Wal-Mart. Except for meat, fruit and vegetables, and dairy products, all packaged food I purchase are exclusively foods labeled ?gluten-free?.

I recommend the Food and Drug Administration obtain an emergency clearance from the Office of Management and Budget, for the purpose of sponsoring ?information collection data? on these questions you have addressed in this notice. In obtaining data directly from Celiac disease consumers and their caregivers, the FDA will be able to obtain an objective and empirical sample, which would be difficult to refute. The results from the information collection sample would assist the Food and Drug Administration in its quest to comply with the law.

In addition to the information collection sample, I further recommend that the FDA contact various celiac support groups for advocacy and assistance. This would allow the FDA to obtain the highest possible sample of consumers with celiac disease.

Thank you for considering my comments and recommendations today. If you need to contact me about them, please call me at (708) 216-5765 during the day, or at szelisk@lumc.edu.
Thank You
Susan Zelisko
10724 Silver Lake Dr.
Frankfort, IL 60423