2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC3
Submitter : Mrs. Rachelle Hartze Date & Time: 07/28/2005 07:07:21
Organization : Mrs. Rachelle Hartze
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
My daughter, Shelby, was diagnosed with Type I (IDDM) at the age of 9. As a result of this diagnosis she was also screened for related autoimmune disorders such as adrenal disorders, thyroid dysfunction and celiac disease; she was positive for celiac disease. The National Institute of Health reports that celiac disease may occur in as many as one in every 250 Americans and the American Diabetes Association estimates that diabetes affects 18.2 million people in the US; statistics indicate that one in 20 people with diabetes also have celiac disease. Some studies also suggest that the autoimmune response triggered by gluten exposure in a person with celiac disease may also trigger the autoimmune response that causes beta cell destruction in the pancreas leading to Type I diabetes. Because celiac disease and diabetes are genetic disorders, our other children are also at risk.

In addition to being a possible link in the chain of causes for diabetes, celiac disease may also affect blood sugar control for diabetics. We immediately started a gluten-free diet for Shelby and saw significant improvement in blood glucose control; we now also attribute her uncontrolled blood glucose levels to accidental gluten exposure. From the perspective of a parent and consumer, being able to correctly identify gluten in products is a necessity in protecting the health of our daughter. Of further concern is the availability of products that are considered "gluten-free." Malt-O-Meal Consumer Relations has recently indicated their intention to add wheat starch to foods that did not previously contain gluten because their products were processed on shared equipment that may cause contamination; as a result they could not guarantee their products were gluten-free and they would have difficulty with new, safe labeling guidelines.

Very few brand name products are currently available that do not contain one of the 85 common food ingredients or additives that contain gluten; this makes grocery shopping and meal preparation for a family a very frustrating and expensive task. In addition to the 85 common food ingredients that are known to contain gluten, there are several ingredients that are questionable depending on the source they originated from, for example; caramel coloring and alcohol. I have contacted several food manufactures to get more information on ingredients listed on their labels to make certain a product was made without gluten. The standard response is that no gluten was added to the product but they could not guarantee that gluten contamination did not occur at some point during the transportation of the raw ingredients or as a result of using shared equipment. Some products we have had to exclude through a process of trial and error. We are fortunate to currently live in a community where gluten-free products can be purchased from specialty food stores; however, many communities do not have access to organic or specialty food stores and gluten-free products must be purchased by mail order, increasing the expense and difficulty of maintaining a gluten-free diet.

I hope you will not only consider the labeling practices of food manufactures, but also their food processing practices and encourage the use of more dedicated equipment to protect otherwise gluten-free foods from contamination. Thank you for the opportunity to express my concerns; this is a significant problem for my family and others.

Rachelle Hartze