1. 1 Gluten-Free Food Labeling Public Meeting August 19, 2005 Rhonda R. Kane, M.S., R.D. Consumer Safety Officer Food Labeling & Standards Staff Office of Nutritional Products, Labeling & Dietary Supplements Center for Food Safety & Applied Nutrition (CFSAN) Food & Drug Administration (FDA)

2. 2 Public Meeting Purpose Assist FDA to comply with mandates of Section 206 of Public Law 108-282: Title II-- Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) ( Assist FDA to comply with mandates of Section 206 of Public Law 108-282: Title II-- Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (http://www.cfsan.fda.gov/~dms/alrgact.html) :http://www.cfsan.fda.gov/~dms/alrgact.html –Consult with appropriate experts and stakeholders to define and permit use of the term gluten-free in the labeling of foods –Issue a proposed rule on 8/2/06 and final rule on 8/2/08 to establish a definition for gluten-free

3. 3 Federal Register Notice on Public Meeting Solicits comments on specific questionsSolicits comments on specific questions Uses the following terms for the purpose of the Notice:Uses the following terms for the purpose of the Notice: –Gluten: proteins found in any grains that can cause harm to persons with celiac disease –Grains of concern: wheat, rye, barley and oats and their related species (e.g., durum, spelt, kamut) or crossbred hybrids (e.g., triticale) –Gluten-free foods: foods marketed in the U.S. that are represented/labeled to be free of gluten

4. 4 Categories of Questions Definitions of Gluten-FreeDefinitions of Gluten-Free Gluten-Free Product DevelopmentGluten-Free Product Development Good Manufacturing Practices (GMPs) and Analytical MethodsGood Manufacturing Practices (GMPs) and Analytical Methods Foods Marketed as Gluten-FreeFoods Marketed as Gluten-Free Consumer Purchasing PracticesConsumer Purchasing Practices

5. 5 Definitions of Gluten-Free Question 1: –How do food manufacturers define gluten- free? –Does the food industry have a generally accepted definition of gluten-free? –Does any entity certify finished foods or raw ingredients to be gluten-free, and if, so how is that term defined and how is a food determined to satisfy that definition?

6. 6 Gluten-Free Product Development Question 2: –How are gluten-free foods produced? –What methods are most commonly used to remove gluten from food?

7. 7 Gluten-Free Product Development Question 3: –Is it technologically and economically feasible to produce: gluten-free flour milled from grains other than those of concern (e.g., corn and millet)? gluten-free flour milled from grains other than those of concern (e.g., corn and millet)? oat-based products that do not contain gluten from grains of concern other than oats (e.g., wheat)? oat-based products that do not contain gluten from grains of concern other than oats (e.g., wheat)? –If so, what additional measures in the milling or manufacturing process would be needed to produce these products and what would be the incremental costs?

8. 8 GMPs and Analytical Methods Question 4: What measures are in place during the manufacturing, packaging or holding of gluten-free foods to prevent them from coming in contact with any grains of concern?

9. 9 GMPs and Analytical Methods Question 5: –What analytical method(s) are used to evaluate gluten-free products? –How often are these analyses performed (e.g., test every batch of finished product or bulk containers of each ingredient)? –What is the cost of such testing?

10. 10 GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten: –In what grains can the test kit/method detect gluten? –What specific mechanism is used to indicate the presence or absence of gluten? –What is the sensitivity or lowest level of detection of the test kit/method?

11. 11 GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten (cont): –Is the test kit/method qualitative or quantitative? –If the latter, what is the test kits/methods limit of quantification? –What are the test kits/methods false positive and negative rates?

12. 12 GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten (cont): –Is the effectiveness of the test kit/method affected by the nature of the processing of the gluten-free food or by the food matrix, and if so, how? –If the test kit/method has been validated, by whom and at what level (e.g., parts per million) of detection was it validated?

13. 13 GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten (cont): –If the test kit/method has not been validated, have the results of its performance or an evaluation of its performance been published in a peer-reviewed scientific journal? –What is the cost of the test kit or the cost to perform the method of analysis?

14. 14 GMPs and Analytical Methods Question 7: –What analytical methods are currently available or under development to detect the presence of oat proteins in food? –Which oat proteins are detected and what is the cost to conduct this analysis? –Have these methods been validated or published in a peer-reviewed scientific journal?

15. 15 Foods Marketed as Gluten-Free Question 8 asks if research data or findings are available on: What consumers with celiac disease (CD) or their caregivers believe the term gluten-free means (e.g., which specific grains or other ingredients should not be present in foods labeled as gluten-free)?

16. 16 Consumer Purchasing Practices Question 9 asks if research data or findings are available on: –How do consumers with CD or their caregivers identify packaged foods that do not contain gluten? –How much time do these consumers devote to identifying such foods?

17. 17 Consumer Purchasing Practices Question 10 asks if research data or findings are available on: –Are the packaged foods that consumers with CD or their caregivers currently purchase or consume primarily or exclusively those foods labeled gluten-free? –What types of gluten-free packaged foods are purchased or consumed by persons with CD or their caregivers? –Does a gluten-free label influence the purchasing decision of persons with CD or their caregivers when presented with products having identical ingredient lists?

18. 18 Notice Docket # 2005N-0279 Submit comments by 9/19/05Submit comments by 9/19/05 Note Docket # 2005N-0279 in correspondenceNote Docket # 2005N-0279 in correspondence Send comments by:Send comments by: –Land mail to: FDAs Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 –Internet to: http://www.fda.gov/dockets/ecomments (click Docket Search, enter 2005N-0279 in Docket ID window, and click Find) http://www.fda.gov/dockets/ecomments –E-mail to: fdadockets@oc.fda.gov (enter Docket # 2005N- 0279 in subject line of e-mail; accommodates attachments) fdadockets@oc.fda.gov