1. Celiac Support Association Serving the Gluten-Free Community 40 + years Copyright 2014 Celiac Support Association 1

2. USA Gluten-free Labels, Today! Brought to You By: The CSA Foundation A 501(c)(3) non-profit, funding breakthrough initiatives which empower individuals affected by celiac disease and gluten disorders, including Celiac Support Association programs. Featured Lecturer: Mary Schluckebier, Executive Director Celiac Support Association CSACeliacs.org The CSA Foundation Donate at HelpingCeliacs.com Copyright 2014 Celiac Support Association 2

3. Details on the Regulation Impact to the Gluten-Free Community What will change? Consumer impact? Retail/wholesale perspective? Certifications? Perspectives from food scientists? For CSA Summary of the Regulation and the FDA References including the July 2014 Final Regulatory Impact Analysis and Regulatory Flexibility Analysis, visit the CSA website at www.csaceliacs.org. Copyright 2014 Celiac Support Association 3

4. Sale of Gluten-Free Foods Provides food companies with a bench mark for marketing and legal implications Supplier information – required by FDA Food Modernization Act 2011 Encourage international GF imports Implications of ADA - compliance Growing market segment Copyright 2014 Celiac Support Association 4

5. 5 No known gluten threshold Damage is cumulative No simple test for all amino acid fractions in foods Treatment - is strict elimination of gluten for life Health complications most common in those not keeping a STRICT diet -National Institutes of Health (NIH) Celiac Profile Copyright 2014 Celiac Support Association

6. Gluten-Free FDA Regulation Truthful and not misleading labels Packaged food Reduce shopping time for those with celiac disease Protect health of those with celiac disease Does not address Non-Celiac Gluten Sensitivity Copyright 2014 Celiac Support Association 6

7. “gluten-free” “no gluten” “free of gluten” “without gluten” Final rule of Food Allergen Labeling and Consumer Protection Act of 2004 Voluntary GF Food Claims Must meet requirements of new regulation or claim will be deemed to be misbranding. Applies to: Copyright 2014 Celiac Support Association 7

8. Rule Covers The final rule applies to all FDA-regulated foods, including dietary supplements. The rule excludes those foods whose labeling is regulated by the U.S. Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Copyright 2014 Celiac Support Association 8

9. Prohibited Grain / Gluten Containing Grain Prolamins and glutelins, grains or crossbred hybrids e.g., triticale Wheat, any species belonging to the genus Tritium Rye, any species belonging to the genus Secale Barley, any species belonging to the genus Hordeum 9 Copyright 2014 Celiac Support Association

10. Does not contain any one of the following: An ingredient that is a prohibited grain An ingredient that is derived from a prohibited grain and that has not been processed to remove gluten An ingredient that is derived from a prohibited grain and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food 20 ppm or more gluten 10 Voluntary Gluten-Free Copyright 2014 Celiac Support Association Genus: Triticum Secale Hordeum

11. Not Regulated “made with no gluten-containing ingredients” “not made with gluten-containing ingredients” Unless used with “gluten-free” “no gluten” “free of gluten” “without gluten Copyright 2014 Celiac Support Association 11

12. “May Contain” Statements  Voluntary manufacturers  Must be truthful and not misleading  No laws govern or require these statements  FDA’s guidance to the food industry on this issue,  advisory labels should not be used as a substitute for good manufacturing practices  Manufacturers use advisory labeling for a variety of reasons  to advise consumers of the potential presence of an allergen  to avoid the need to develop and use multiple labels  to reduce legal liabilities.  If you are unsure, call the manufacturer to ask about their ingredients and manufacturing practices. FDA’s perspective, is claim truthful and not misleading under FDC Act § 403(a)(1) Copyright 2014 Celiac Support Association 12

13. Infractions Misbranded and would be subject to regulatory enforcement action – FDA Warning Letters Copyright 2014 Celiac Support Association 13

14. Compliance Manufacturers are responsible Foods bearing a gluten-free claim Meet the requirements of the final rule Testing is not required Applies to imported food Copyright 2014 Celiac Support Association 14

15. FDA Regulation Does not apply to Medications Restaurants FDA Advises “if use the gluten-free claim adhere to the FDA definition.” Copyright 2014 Celiac Support Association 15

16. Responsibility of Patient: Copyright 2014 Celiac Support Association Design own decision-making process to maintain optimal health Seek information to evaluate choices Read Labels Contact food companies Advocate Citizens 16

17. Be a Super Sleuth! CSA is looking for excellent examples of gluten-free labeling. Take a picture and send it to info@csaceliacs.org. Citizens Copyright 2014 Celiac Support Association

18. Food and Drug Contact Information by Agency 1. Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System: 240-402-2405. 2. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food Information Line: 1-888-SAFEFOOD, 1-888-723-3366 (toll free), 10 AM to 4 PM ET, Monday through Friday. Or visit the FDA website at www. fda.gov. 3. USDA Meat and Poultry Hotline: 1-888-MPHotline, 1-888-674- 6854 (toll free) 4. TTB Fraud, Diversion, and Illegal Activity hotline: 855-TTBTIPS (855-882-8477); or by email attips@ttb.gov; TTB’s Market Compliance Office Customer Service Line: 202-453-2250; or 866- 927-2533; or email alfd@ttb.gov. 5. Report restaurant food problems to City Health Department. Take a sample of uneaten food home and refrigerate or freeze. Copyright 2014 Celiac Support Association

19. Buyer Beware Copyright 2014 Celiac Support Association 19

20. Food and Drug Act, January 1907 20 Federal crime to sell adulterated food or drugs Set up a system of federal inspections Food had to be labeled Illegal to misstate the contents Legislative Copyright 2014 Celiac Support Association

21. Nutrition Labeling and Education Act 1990 Manufacturer is responsible for declaring what is in the product Use of free implies none and if not true product considered mislabeled CSA Requested gluten-free to be defined FDA Response -- better to use common names of parent grains wheat, barley, rye, oats Copyright 2014 Celiac Support Association 21

22. The Term Free truthful and not misleading Taken to mean zero Especially in view of the lack of a definition of a tolerance level for presence in the product. Copyright 2014 Celiac Support Association 22

23. 23 Gold Standard -- zero Completely eliminate toxic fractions (prolamins & glutelins) From genus triticum, secale, hordeum, some avena Some ---- 0 ---- None Copyright 2014 Celiac Support Association

24. Food Safety Shared Responsibility in US 24 ExecutiveJudicialCitizensStateLegislative Copyright 2014 Celiac Support Association

25. 25 www.thomas.loc.gov * Introduced * Reported * Engrossed as agreed to or passed by the house * Referred to Senate Committee Copyright 2014 Celiac Support Association

26. US Cabinet Department of Agriculture Secretary Thomas J. Vilsack http://www.usda.gov http://www.usda.gov Department of Health and Human Services Secretary Sylvia Mathews Burwell http://www.hhs.gov http://www.hhs.gov Copyright 2014 Celiac Support Association 26 Department of the Treasury Secretary Jack Lew http://www.treasury.gov http://www.treasury.gov USDA FDA TTB Executive

27. US Department of Agriculture USDA provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on sound public policy, the best available science, and efficient management. Copyright 2014 Celiac Support Association 27

28. USDA USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). Copyright 2014 Celiac Support Association 28

29. Alcohol and Tobacco Tax and Trade Bureau TTB enforces compliance with alcohol, tobacco, firearms, and ammunition laws and regulations, in the interest of collecting all appropriate excise taxes, and promoting a marketplace for alcohol beverages that complies fully with federal production, labeling, advertising, and marketing standards. Copyright 2014 Celiac Support Association 29

30. Alcohol and Tobacco Tax and Trade Bureau TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops. Copyright 2014 Celiac Support Association 30

31. US Food and Drug Administration FDA is responsible for ensuring the safety and high quality products that are critical for the survival and well-being of all Americans – some 80 percent of the United States food supply, all human health care products, electronic products that emit radiation, animal drugs and feed, and cosmetics. Copyright 2014 Celiac Support Association 31

32. Cooperation Among Agencies FDA will work with USDA and TTB on the issue of gluten-free food labeling to harmonize the requirements for foods labeled gluten-free among agencies whenever possible. Copyright 2014 Celiac Support Association 32

33. FDA grows 33 1906 Pure Food and Drug Act - Misbranding 1938 The Federal Food, Drug, and Cosmetic Act, major amendment 1950Delaney Committee - Cancer 1958 Food Additives Amendment - GRAS 1962 Consumer Bill of Rights 1966 Fair Packaging and Labeling Act 1988 Department of HHS 1990 Nutrition Labeling and Education Act 2004 Food Allergy Labeling and Consumer Protection Act 2005 Drug Safety Board 2011 FDA Food Safety Modernization Act 2014Definition of Gluten-free for Voluntary Labeling Copyright 2014 Celiac Support Association

34. 34 Congress Keeps Adding Responsibilities— 60 since 1994 FDA 1994 - Animal Medicinal Drug Use Clarification Act 1994 - Dietary Supplement Health and Education Act 1995 - Federal Reports Elimination and Sunset Act 1995 - Unfunded Mandates Reform Act 1995 - The Paperwork Reduction Act 1996 - Freedom of Information Act (FOIA) 1996 - Safe Drinking Water Act Amendments 1996 - Animal Drug Availability Act 1996 - Food Quality Protection Act 1996 - Economic Espionage Act of 1996 1996 - Electronic Freedom of Information Improvement Act 1996 - Comprehensive Methamphetamine Control Act 1996 - Health Insurance Portability and Accountability Act 1996 - Drug-Induced Rape Prevention Punishment Act 1997 - Food & Drug Administration Modernization Act (FDAMA) 1997 - Better Pharmaceuticals for Children Act 1997 - PDUFA II 1998 - Antimicrobial Regulation Technical Corrections Act 1998 - Sec. 615 Ag. Research, Extension and Education Reform Act 1998 - MQSA Reauthorization 1998 - Sec. 654, Omnibus Approps. (Family Impact Assessments) 1999 - Government Employees Training Act 1999 - Fed. Financial Assistance Management Improvement Act 2000 - Responsible for Clinical Laboratory Improvement Amendments (CLIA) 2000 - Approps Act (FDA) - FY 2001 2000 - Medicine Equity and Drug Safety Act 2000 - Prescription Drug Import Fairness Act 2000 - Approps. Act (HHS), Sec. 516, HPV-Condom Labeling Review 2000 - Ryan White AIDS Care Act 2000 - Date Rape Drug Prohibition Act 2000 - Children’s Health Act 2000 - Technology Transfer Commercialization Act 2001 - Animal Disease Risk Assessment 2002 - Medical Device User Fee and Modernization Act (MDUFMA) 2002 - Hatch-Waxman-Amendments 2002 - Drug Importation Report 2002 - Farm Security & Rural Investment Act 2002 - Bioterrorism Act 2002 - PDUFA III 2002 - Best Pharmaceuticals for Children Act 2002 - Rare Diseases – Orphan Product Development 2002 - E-Government Act 2003 - Mosquito Abatement for Safety and Health Act 2003 - Animal Drug User Fee Act 2003 - Pediatric Research Equity Act (PREA) 2003 - Medicare Prescription Drug and Modernization Act 2004 - Minor Use and Minor Species Animal Health Act 2004 - Food Allergen Labeling and Consumer Protection Act 2004 - Medical Devices Technical Corrections Act 2004 - National Defense Authorization Act 2004 - AIDS (PEPFAR) 2004 - Project BioShield 2004 - Anabolic Steroid Control Act 2004 - MQSA Reauthorization 2004 - Homeland Security Pres. Directive (HSPD) #12, ID Standard 2005 - Protecting America in the War on Terror Act 2005 - Patient Safety & Quality Improvement Act 2005 - Medical Device User Fee Stabilization Act (MDUFSA) 2005 - Stem Cell Therapeutic and Research Act 2006 - Combat Meth Act Copyright 2014 Celiac Support Association

35. Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II) of Veterinary Bill – Milk – Eggs – Fish – Crustacean Shellfish – Tree nuts – Peanuts – Wheat – Soybeans 35 VOLUNTARY Define the use of the term gluten-free Copyright 2014 Celiac Support Association REQUIRED on Labels

36. Food Allergen Labeling and Consumer Protection Act of 2004 Exemptions Restaurants Oils Grains – grain standards regulated 36 Copyright 2014 Celiac Support Association

37. 37 Copyright 2014 Celiac Support Association

38. SEC. 206. GLUTEN LABELING A proposed rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods Final rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods Focus groups in D.C.; Newark; Los Angeles Labeling of gluten-free products 38 Copyright 2014 Celiac Support Association 2006 2008 2009

39. Ultimate testing device Gluten Analysis Accurate testing device is our own body Commercial Allergen Analyses Kits – Neogen Corporation, Lansing, MI – R-Biopharm Inc., Marshall, MI. – Romer Labs AgraQuant Gluten G12 Romer Labs AgraQuant 39 Copyright 2014 Celiac Support Association

40. Commercial Testing Sandwich Enzyme Immunoassay Food allergens are protein fractions in food that can evoke an immune response in sensitive individuals. Gluten is the characteristic term for the protein mixture of glutelins and gliadins (prolamins) found in cereals. The proportion of glutelin to gliadin in the protein mixture is approximately the same. Copyright 2014 Celiac Support Association 40

41. 33-mer Gliadin The gliadin test can detect gluten from wheat, rye and barley quantitatively with a limit of quantitation of 5 ppm. Testing Fermented and Hydrolyzed protein may result in a false negative or underestimate any toxic grain Enter the competitive peptide gliadin test Alpha gliadin Copyright 2014 Celiac Support Association 41

42. Future Rule-Making The FDA is planning rule-making for gluten-free claims on fermented or hydrolyzed foods, or foods that use fermented or hydrolyzed ingredients. In the meantime, the FDA is allowing gluten-free claims on these products provided they meet all of the requirements for bearing a gluten-free claim even though the gluten content cannot be reliably measured. Note: This provision applies to fermented or hydrolyzed ingredients derived from gluten-containing foods and ingredients that have been processed to remove gluten, such as wheat starch hydrolysates (e.g., wheat-based glucose syrup, wheat-based maltodextrin). It does not apply to ingredients derived from gluten-containing grains that have not been processed to remove gluten (e.g., malt, malt extract, malt syrup). Copyright 2014 Celiac Support Association 42

43. Contamination 43 Contamination means the unintended presence in food of potentially harmful substances, including microorganisms, chemicals, and physical objects. Cross Contact term is weaker. E. coli Shigella Listeria Wheat and Oats Copyright 2014 Celiac Support Association

44. 44 Yes, if less than 20 ppm and … Wheat* Allergy Required labeling: or Wheat processed to remove gluten. The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.” “ Copyright 2014 Celiac Support Association Gluten-Free

45. Labeling Oats? Copyright 2014 Celiac Support Association Codex country by country decision Canada Oats labeled as “wheat free” not “gluten-free” Oat varieties have lesser volume of celiac toxic fractions Look for G12 negative oats – qualify for CSA Innovative Seal CSA Survey 2005 950 Eliminate oats from diet 151 Eat oats 1101 Define as absence of WBRO 77 GF = WBR 22 No Answer 45

46. Proposed Label Format Copyright 2014 Celiac Support Association 46

47. Compliance …”FDA is aware that sandwich ELISA methods do not adequately detect gluten in fermented and hydrolyzed foods. Because scientifically valid methods currently are lacking that can do so, we intend to issue a proposed rule on this issue.” -FDA.gov Q&A Gluten Free Food Labeling Final Rule, Aug. 5, 2014 Copyright 2014 Celiac Support Association 47

48. Estimating Risk 50 gram 100200300400500600700800900 x.02 1 mg24681012141618 20 ppm Copyright 2014 Celiac Support Association 48

49. 1 tsp. vital wheat gluten = 3000 mg 1 teaspoon ½ teaspoon ¼ teaspoon 1/8 teaspoon 1/16 teaspoon 1/32 teaspoon 1/64 teaspoon 3000 mg1500 mg750 mg375 mg187.5 mg93.75 mg 46.88 mg 1/128 teaspoon 1/256 teaspoon 1/512 teaspoon 1/1024 teaspoon 1/2048 teaspoon 1/4096 teaspoon 1/8192 teaspoon 23.44 mg11.72 mg5.86 mg2.93 mg1.46 mg.73 mg.37 mg Cumulative Toxic portion 10 – 50 milligrams per day Catassi 2007 FDA Hazard Assessment, “the tolerable daily intake level for gluten in individuals with celiac disease was determined to be 0.4 mg gluten/day for adverse morphological effects and 0.015 mg gluten/day for adverse clinical effects.” * Copyright 2014 Celiac Support Association 49 * FDA Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten: Office of Food Safety, Center of Food Safety and Applied Nutrition, May 2011, pages 45-46

50. Front-of-Package Symbols 50 Accurate food labeling information can assist consumers in making healthy nutritional choices. FDA recommends that manufacturers and distributors of food products that include front-of-package symbols ensure that these claims are consistent with FDA's current laws and regulations. December 2008 Copyright 2014 Celiac Support Association

51. 51 Informed? Source information about ingredients that may or may not contain WBR common Oats or derivatives in Product Processing Packaging Copyright 2014 Celiac Support Association

52. Certification Programs Sin T.A.C.C. Copyright 2014 Celiac Support Association 52

53. CSA Recognition Seal 53 Copyright 2014 Celiac Support Association FREE of Wheat, barley, rye, oats, crosses and derivatives Product Processing Packaging Testing -- verification the protocol works

54. CSA Position Full disclosure source of ingredients Mandatory label -- barley Regardless the level in the product.

55. HACCP Hazard Analysis Critical Control Points Total handbook of the facility What comes in What, how, when, where and by whom in the facility What leaves the facility 55 Copyright 2014 Celiac Support Association

56. Living Well Gluten-Free 56 “The more we find, the more we see, the more we come to learn. The more that we explore, the more we shall return.” Sir Tim Rice, Aida, 2000 Copyright 2014 Celiac Support Association

57. References: Copyright 2014 Celiac Support Association CSA Member Survey 2004, Celiac Support Association, Summary Reports to Membership CSA Member Survey 2005, Celiac Support Association, Summary Reports to Membership Diet Management -Three Stage Food Plan – CSA Brochures 2000-2005 Jean Guest, MS RD LMNT Peräaho M, Collin P, Kaukinen K, Kekkonen L, Miettinen S, Mäki M. Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. J Am Diet Assoc 2004;104:1148-50. Murray JA, Watson T, Clearman B, Mitros F, Links Effect of a gluten-free diet on gastrointestinal symptoms in celiac disease. Am J Clin Nutr. 2004 Apr;79(4):669-73. Murray JA, Watson T, Clearman B, Mitros, Murray JA, Van Dyke C, Plevak MF, Dierkhising RA, Zinsmeister AR, Melton LJ 3 rd. Trends in the identification and clinical features of celiac disease in a North American community, 1950-2001.Clin Gastroenterology Hematology. 2003 Jan;1(1):19-27. Murray JA, Van Dyke C, Plevak MF, Dierkhising RA, Zinsmeister AR, Melton LJ 57

58. Promoting a Gluten-Free You http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegul atoryInformation/Allergens/ucm362510.htm (Best summary) http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegul atoryInformation/Allergens/ucm362510.htm https://www.federalregister.gov/articles/2013/08/05/2013-18813/food- labeling-gluten-free-labeling-of-foods https://www.federalregister.gov/articles/2013/08/05/2013-18813/food- labeling-gluten-free-labeling-of-foods Copyright 2014 Celiac Support Association

59. Three Special FDA References FDA Defines Gluten-Free (less than 20ppm) Gluten-Free Labeling The FDA Health Hazard Assessment for Gluten Exposure in Individuals with Celiac DiseaseThe FDA Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten be 0.4 mg gluten/day for adverse morphological effects and 0.015 mg gluten/day for adverse clinical effects. FDA Small Entity Compliance Guide to Gluten-free Labeling FDA Small Entity Compliance Guide to Gluten-free Labeling no undo burden FDA Final Regulatory Impact & Regulatory Flexibility AnalysisFDA Final Regulatory Impact & Regulatory Flexibility Analysis Used analytical basis rather than safety for definition. Use of CSA provided test results that most gf labeled products are below 5 ppm http://www.csaceliacs.org/csa_2011_letter.jsp

60. Advocacy Protects You 60 Be motivated Have a “zealous” attitude Seek “evidence based” information LOYALTY Call CSA Stay involved – Join CSA Copyright 2014 Celiac Support Association

61. 61 Copyright 2014 Celiac Support Association Thank you!

62. Please Support Breakthrough Gluten Free Nutrition Training Programs in Your City Today at HelpingCeliacs.com. Brought to You By: The CSA Foundation A 501(c)(3) non-profit, funding breakthrough initiatives which empower individuals affected by celiac disease and gluten disorders, including Celiac Support Association programs. THANK YOU, Mary Schluckebier! The CSA Foundation Donate at HelpingCeliacs.com Copyright 2014 Celiac Support Association 62

63. Presenters Copyright 2014 Celiac Support Association 63 Steve Taylor, Ph.D., Co-Director Food Allergy Research and Resource Program Professor, Department of Food Science and Technology University of Nebraska Mary Schluckebier, B.S., M.A, Nebraska. She has earned degrees in Home Economics and Administration of Adult Education. She has been living with celiac disease for the past 28 years and has written materials, served as a consultant for various projects, given presentations at non-professional, professional and international meetings and conferences. Mary has been the executive director of the Celiac Support Association since October of 2000.