2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC1471
Submitter : Ms. Tracey Grant Date & Time: 09/20/2005 06:09:01
Organization : Ms. Tracey Grant
Category : Individual Consumer
Issue Areas/Comments
Consumer comments - Docket: 2005N-0279

'Gluten-free' labeling of food and products is a crucial guidance which assists the celiac population to make informed food consumption decisions, and is a critical factor in the health and nutrition of the celiac population. As stated in Federal Register: July 19, 2005 (Volume 70, Number 137), '...to prevent severe and sometimes life-threatening complications of celiac disease, sensitive individuals need to avoid all offending sources of gluten.' Accordingly, a 'gluten-free' food or other product label should indicate and guarantee that the food or product contains NO source(s) of gluten, and the food or product is exposed to NO source(s) of gluten. The consumption or use of any food or product by a member of the celiac population is potentially health-threatening and potentially life-threatening. A rule defining and permitting the use of the term 'gluten-free' will be of immeasurable value to protecting the safety and improving the quality of life of celiac consumers.

'Gluten-free' on a food label should indicate and guarantee that the labeled product contains no gluten or traces of gluten (as measured by an approved gluten test kit), and should indicate and guarantee that the product is not manufactured, processed, or packaged in a facility where any products containing gluten are manufactured, processed, or packaged. This indication and guarantee should also extend to relatives/derivatives of gluten, if any.

Currently, to identify foods/products that do not contain gluten, I start with extensive research performed in advance of 'shopping' for 'gluten-free' foods/products. I consult with celiac-knowledgeable physicians (there are few), celiac-knowledgeable nutritionists (there are few), and other experts (there are few), and research celiac and nutrition texts/newsletters/publications, paper and online (there are few), for sources of 'gluten-free' foods/products (there are few), consult with other members of the celiac population, and consult with supermarkets/stores regarding their 'gluten- free' selections (who frequently have no information, and limited selections). When 'shopping' for 'gluten-free' foods/products, I first look for 'gluten-free' on the product label. If 'gluten-free' does not appear on the product label, I call the customer service number on the package, if available. If there is no contact information on the package, I obtain contact information for the product manufacturer from directory assistance. Once contact information is obtained, I call and provide the manufacturer representative with the 'SKU' number of the product, and inquire whether the product contains gluten. This process takes approximately one hour or more per product inquiry. This process also results in the purchase of a large volume of products that I ultimately cannot consume due to gluten content discovered/determined/suspected after purchase. Furthermore, telephone representations regarding gluten-content from manufacturers cannot always be obtained, nor can they be guaranteed. Lastly, due to the non-uniformity of current product labeling, even when a product label indicates that product is 'gluten-free,' I routinely attempt to contact the manufacturer for further confirmation.

Currently, approximately less than 1% of foods are currently marked 'gluten-free.' Other products are marked 'gluten-free' with even less frequency. Food products that I am aware of that are currently marked 'gluten-free' are certain brands of rice, pudding, and vitamins, products sold at gluten-free bakeries, and products advertised for certain restaurants.

'Gluten-free' printed on a product label greatly influences my decision to purchase products, and influences my decision to purchase (or not
purchase) unmarked products containing the same ingredients. When choosing between two products, one marked 'gluten-free' and one not, I select the product marked 'gluten-free' 100% of the time.