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