FDA Gluten-Free Labeling Public Meeting Compiled by: Jill A. Kuzo, Food Scientist Presenter: Lee Tobin, Team Leader August 19, 2005

Reasons to Define “Gluten Free” 1. Consumer confidence Truly GF ingredients Gluten contamination 2. Direct brand comparison Equality of GF products Safety of GF products 3. Standards set by FDA will directly impact our production

Methods of Ensuring “Gluten Free” Status  With supplier statements  By testable limits  By facility dedication  Through certification

Partnerships with Ingredient Suppliers  Educate Ingredient Suppliers and Manufacturers Research ingredient sources for hidden gluten Identify points of possible contamination Identify precautionary measures: dedicated runs, lines, equipment  Gather statements No artificial colors, preservatives, or flavors Ingredient is free of gluten content or contamination  Lot tracking

Ideal GF Ingredients Crops harvested with GF equipment Crops grown in GF fields Stored in GF silos Milled in GF Environment Packaged in GF environment Tested for contamination Transported in GF trucks To bakery

Testing for Gluten  BioKits Rapid GLUTEN Test (Tepnel Biosystems) Qualitative detection of gliadin Detects gluten from wheat, triticale, rye, and barley  Testing limitations Screens for significant levels (above 50 ppm) Particulates can obscure results  Points to test for gluten Each lot of incoming ingredients Random sampling of finished products

Defining Dedication Dedicated Run Dedicated Equipment Dedicated Line Dedicated Facility

Cross Contamination Facility team members Uniforms supplied Thorough cleaning Taking breaks Other allergens Store team members Thorough cleaning Sampling procedures Other allergens

Setting Labeling Standards Consumer Needs  Standards for Safety  Consistency in Definitions  Reasonable Cost Manufacturer Needs  Feasibility of Standards  Fair comparison between products  Reasonable Cost