1. USA Gluten-free Labels, today! Celiac Support Association Promoting a Gluten-Free You Copyright 2015 Celiac Support Association 1

2. CSA Position Full disclosure source of ingredients Mandatory labeling barley Regardless the level in the product Zero is goal for risk-free gluten-free Introduce pure oats when health regained Copyright 2015 Celiac Support Association2

3. Estimating Risk 50 gram 100200300400500600700800900 x.02 1 mg24681012141618 20 ppm Copyright 2015 Celiac Support Association3

4. Responsibility of Consumer: Copyright 2015 Celiac Support Association Design own decision-making process to maintain optimal health Seek information to evaluate choices Read Labels Contact food companies Advocate Citizens 4

5. Manufacturer Compliance Voluntary – use of claim requires manufacturers to be responsible If product bears a gluten-free claim It must meet the requirements of the final rule of <20 ppm Testing is not required by FDA regulation Rule applies to imported food and domestic Third Party Certification is optional No FDA symbol for gluten-free Copyright 2015 Celiac Support Association5

6. Infractions Misbranded products are subject to regulatory enforcement action – FDA Warning Letters – Followed by punishment outlined by misbranded regulations Copyright 2015 Celiac Support Association6

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8. http://www.fda.gov/food/recallsoutbreaksemergencies/safety alertsadvisories/ucm465984.htm

9. Copyright 2015 Celiac Support Association

10. Gluten-Free Community What to do? Check ingredients appear gluten-free? Cross contamination risk? Gluten-free claim on the label? Third party certified gluten-free? Check company website. Call and verify with company if product is suitable for a person with celiac disease. Address cross contamination issues. Introduce new products, one at a time, a week at a time, listen to your body REPORT – thank you and misbranding concerns. Copyright 2015 Celiac Support Association10

11. Details on the Regulation Approach. Copyright 2015 Celiac Support Association11 Food Allergen Labeling and Consumer Protection Act of 2004 – define and permit voluntary use of the term “gluten-free” “Ensure consumers with CD are provided with truthful, accurate, and not misleading labeling information to better follow a gluten- free diet”

12. Copyright 2015 Celiac Support Association 12 Knowledge is Power

13. Certification Programs Sin T.A.C.C. Copyright 2015 Celiac Support Association13

14. 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 14 Copyright 2015 Celiac Support Association

15. Labeling Oats? Copyright 2015 Celiac Support Association International Codex Alimentarius Commission labeling oats GF is determined by each country Canada and Australia Oats labeled as wheat free not gluten-free United States Oats may be labeled gluten-free 15

16. Labeling Oats? Copyright 2015 Celiac Support Association Oat varieties have lesser volume of celiac toxic amino acid fractions Look for oats testing negative for G12 not proline dependent 16

17. CSA Recognition Seal FREE of Wheat, barley, rye, oats, crosses and derivatives Product Processing Packaging CERTIFICATION standards includes product testing 17Copyright 2015 Celiac Support Association

18. Food Regulations Copyright 2015 Celiac Support Association18 200 ppm gluten is questionable, 2001

19. 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 2015 Celiac Support Association19

20. US Department of Agriculture USDA provides leadership on food (unprocessed grains, meat, eggs, dairy) agriculture, natural resources, rural development, nutrition, and related issues based on sound public policy, the best available science, and efficient management. Copyright 2015 Celiac Support Association20

21. Alcohol and Tobacco Tax and Trade Bureau TTB regulates the labeling of most alcoholic beverages, including all distilled spirits and wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops. Copyright 2015 Celiac Support Association21

22. 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 2015 Celiac Support Association22

23. FDA Definition Based on Analytical Methods – gluten detection Safety Assessment – safe level for persons with CD Risk Assessment – exposure for adverse heath effect for persons with CD Statutorily-derived -- information in other FDA laws Copyright 2015 Celiac Support Association23

24. Best FDA Read The FDA Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten The FDA Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease be 0.4 mg gluten/day for adverse morphological (structural) effects and 0.015 mg gluten/day for adverse clinical effects. Copyright 2015 Celiac Support Association24

25. 25Copyright 2015 Celiac Support Association

26. FDA Chose Analytical Method to: Provide a bench mark for marketing and legal transactions Consistent with GF in Europe – Encourage international GF trade Analytical methods validated to detect gluten in foods lower than 20 ppm gluten are not available Copyright 2015 Celiac Support Association26 CSA tested 500 foods 95% were <5ppm --- < 20 ppm gluten Uncertainty about the ability of manufacturers of multi- ingredient foods to comply with a gluten threshold lower than <20 ppm

27. FDA Chose Analytical Method Questionable whether a gluten threshold level lower than <20 ppm would: make it more difficult of costly for persons with CD to adhere to a lifelong GF diet Increase the prevalence of persons with CD not adhering to a GF diet, thereby, placing them at higher risk of developing serious health complications and other diseases associated with CD Influence some US food manufacturers to discontinue labeling their product GF because they cannot consistently meet this lower gluten level. Discourage other US food companies from becoming manufacturers of products labeled GF Negatively impact international trade of foods labeled GF which could affect the availability of certain foods to persons with DC Copyright 2015 Celiac Support Association27

28. FDA Chose Analytical Method Statements by some researchers and epidemiologic evidence reported in scientific literature indicating that variable trace amounts of gluten in foods can be safely tolerated by most persons with CD Copyright 2015 Celiac Support Association28

29. Gluten-Free FDA Regulation 2014 For truthful and not misleading labels Reduce shopping time for those with celiac disease Does not address Non-Celiac Gluten Sensitivity Prescription Drugs Restaurants Caution statements Looking back, FDA rule was based upon small size of studies and old assumptions Copyright 2015 Celiac Support Association29

30. Rule Covers Packaged Food 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 2015 Celiac Support Association30

31. Prohibited Grain / Gluten Containing Grain prolamins and glutelins grains or crossbred hybrids e.g., triticale Wheat, any species belonging to the genus Triticum Rye, any species belonging to the genus Secale Barley, any species belonging to the genus Hordeum 31Copyright 2015 Celiac Support Association

32. does not contain any one of the following An ingredient that is a gluten containing grain An ingredient that is derived from a gluten containing grain and not been processed to remove gluten An ingredient that is derived from a gluten containing grain and 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 – cross contamination 32 Voluntary Gluten-Free Triticum Secale Hordeum Copyright 2015 Celiac Support Association

33. Other Influences Implications of ADA - compliance Supplier information – required by FDA Food Modernization Act 2011 Growing gluten-free market Copyright 2015 Celiac Support Association33 95% of 500 foods <5ppm

34. Not Regulated Caution Statements “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 2015 Celiac Support Association34

35. “May Contain” Statements  Voluntary use by manufacturers  Must be truthful and not misleading  No laws govern or require “may contain” 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 about a product, 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 2015 Celiac Support Association35

36. Be a Super Sleuth! CSA is looking for excellent examples of gluten-free labeling. Take a photo and send it to info@csaceliacs.org. Citizens Copyright 2015 Celiac Support Association

37. Report Food and Drug Problems Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System: 240-402-2405. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food : 1-888-SAFEFOOD, 1-888-723-3366 (toll free) USDA Meat and Poultry Hotline: 1-888-MPHotline TTB Fraud, Diversion, and Illegal Activity hotline: 855-TTBTIPS (855-882-8477) Report restaurant food problems to City Health Department. Take a sample of uneaten food home and refrigerate or freeze. Copyright 2015 Celiac Support Association

38. Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II) of Veterinary Bill 1907 FDA – milk – eggs – fish – crustacean shellfish – tree nuts – peanuts – wheat – soybeans 38 REQUIRED on Labels Voluntary Define the use of the term gluten-free Copyright 2015 Celiac Support Association

39. 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 2015 Celiac Support Association39

40. 40 No known gluten threshold Damage is cumulative Lasts a lifetime No simple test identifying 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 2015 Celiac Support Association

41. Living Well Gluten-Free 41 “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, 2000 Copyright 2015 Celiac Support Association

42. References: Copyright 2015 Celiac Support Association CSA Member Survey 2004, Celiac Sprue Association, Summary Reports to Membership CSA Member Survey 2005, Celiac Sprue 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 42

43. Promoting a Gluten-Free You http://www.fda.gov/Food/GuidanceRegulation /GuidanceDocumentsRegulatoryInformation/A llergens/ucm362510.htmhttp://www.fda.gov/Food/GuidanceRegulation /GuidanceDocumentsRegulatoryInformation/A llergens/ucm362510.htm best summary https://www.federalregister.gov/articles/2013/ 08/05/2013-18813/food-labeling-gluten-free- labeling-of-foods Copyright 2015 Celiac Support Association

44. 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 Analysis Used analytical basis rather than safety for definition. Use of CSA provided test results that most gf labeled products are below 5 ppm FDA Final Regulatory Impact & Regulatory Flexibility Analysis http://www.csaceliacs.org/csa_2011_letter.jsp Copyright 2015 Celiac Support Association

45. 45 HomsteadHealth@live.com Thank you Copyright 2015 Celiac Support Association