Gluten-Free Food Labeling Public Meeting

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. 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)(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. Federal Register Notice on Public Meeting • Solicits comments on specific questions • 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. Categories of Questions • Definitions of “Gluten-Free” • Gluten-Free Product Development • Good Manufacturing Practices (GMPs) and Analytical Methods • Foods Marketed as “Gluten-Free” • Consumer Purchasing Practices

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

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)? • 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. 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. 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. 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. GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten (con’t): • Is the test kit/method qualitative or quantitative? • If the latter, what is the test kit’s/method’s limit of quantification? • What are the test kit’s/method’s false positive and negative rates?

12. GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten (con’t): • 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. GMPs and Analytical Methods Question 6 asks about test kits or analytical methods that detect gluten (con’t): • 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. 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. 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. 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. 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. Notice Docket # 2005N-0279 • Submit comments by 9/19/05 • Note Docket # 2005N-0279 in correspondence • Send comments by: • Land mail to: FDA’s 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”) • E-mail to: fdadockets@oc.fda.gov(enter “Docket # 2005N-0279” in subject line of e-mail; accommodates attachments)