1. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods Celiac Support Association Promoting a Gluten-Free You Copyright 2016 Celiac Support Association 11/2016

2. CSA positions Full disclosure: source of ingredients Mandatory labeling of barley M eaningful, V erifiable, C onsistent labels Zero is goal for risk-free – gluten-free Introduce pure oats when health regained – hulless variety Copyright 2016 Celiac Support Association21/2016

3. 3 No known gluten threshold Damage is cumulative Lasts a lifetime No simple test identifying amino acid fractions in all 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 2016 Celiac Support Association1/2016

4. Copyright 2016 Celiac Support Association 4 Knowledge is power 1/2016

5. Future Rule-Making Docket No. FDA-2014-N-1021 http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2014-N- 1021;fp=true;ns=true http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2014-N- 1021;fp=true;ns=true 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). COMMENT NOW! FEBRUARY 15, 2016 make your thoughts known! Copyright 2016 Celiac Support Association51/2016

6. Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods 11-18-2015-Proposed FDA Ruling 1/2016Copyright 2016 Celiac Support Association6 “There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we (FDA) propose to evaluate compliance of such fermented and hydrolyzed foods that bear a “gluten-free” claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the “gluten-free” claim and made available to us (FDA) for inspection and copying. ” FDA Proposed excerpt https://www.federalregister.gov/articles/2015/11/18/2015-29292/food- labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods#h-21 https://www.federalregister.gov/articles/2015/11/18/2015-29292/food- labeling-gluten-free-labeling-of-fermented-or-hydrolyzed-foods#h-21

7. Comments from your CSA Members will be emailed a copy of the letter from the Celiac Support Association when it is submitted to the docket. When you make a submission, and please do, include that you are a member of the Celiac Support Association. http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2014-N-1021;fp=true;ns=true 1/2016Copyright 2016 Celiac Support Association7

8. To read comments mark “Public Submission” 1/2016Copyright 2016 Celiac Support Association8

9. Estimating Risk at 50 gram 100200300400500600700800900 x.02 1 mg24681012141618 20 ppm concentration Copyright 2016 Celiac Support Association91/2016 55 grams Example: 55 X.02 = 1.1 mg

10. Celiac Support Association perspective: “ Your Knowledge is power!” The best gluten identification instrument is a person who experiences noticeable repeatable symptoms when exposed to products with gluten! The more we know about—gluten lab tests, the more we understand the benefits and shortcomings. Hands on experiences adds to understanding. 1/2016Copyright 2016 Celiac Support Association10

11. 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 2016 Celiac Support Association111/2016

12. Digestive Disease Public Policy Forum 1/2016Copyright 2016 Celiac Support Association12 First Sunday and Monday of March Phoenix Park Hotel, 520 N. Capitol Street, Washington, DC Come advocate for the gluten-free community. Register: DDNC.orgDDNC.org

13. CSA Recognition Seal FREE of Wheat, barley, rye, oats, crosses and derivatives Product Processing Packaging Third Party Certification Ingredient and procedure review with testing -- verification 13Copyright 2016 Celiac Support Association1/2016

14. CSA reviews the company HACCP and ingredient sourcing 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 2016 Celiac Support Association1/2016

15. Certification Programs Sin T.A.C.C. Copyright 2016 Celiac Support Association151/2016

16. 16 Mary.s@csaceliacs.org Thank you Copyright 2016 Celiac Support Association1/2016