1. Everything but the Gluten-Free Kitchen Sink: Addressing your concerns about labeling, confusing ingredients, and gluten content of food Part One Pam Cureton RD, LDN pcureton@mgh.harvard.edu

2. Disclosure Statement Brand Ambassador for Schar, USA

3. After 4-6 months of a GFD, serology levels may return to normal. 1 month on the GFD can change the result of the biopsy. Never start the GFD before proper testing is completed! First, Get the Right Diagnosis

4. Get the Right Diagnosis… Why? Mother rushed to hospital with severe stomach cramps … and gave birth to baby boy she had no idea she was expecting Teresa Howard, 43, thought she was suffering from a wheat intolerance She was rushed to hospital and gave birth to her third son two hours later T tp://www.dailymail.co.uk/news/article-2537626/Mother-rushed-hospital-severe-stomach-cramps-gives-birth-baby-boy-no-idea-exphecting.html#ixzz2tbFmSntu tp://www.dailymail.co.uk/news/article-2537626/Mother-rushed-hospital-severe-stomach-cramps-gives-birth-baby-boy-no-idea-exphecting.html#ixzz2tbFmSntu

5. Gluten Free Diet Consumers Medical Necessity Wheat Allergy (IgE-mediated) (~0.5%) Celiac Disease (Autoimmune-based) (~1%) Gluten Sensitivity (Innate Immunity?) (??) No Medical Necessity The Gluten Free Diet: Not Only Celiac Disease

6. “I’m trying to cut back/avoid Gluten in my diet.” Source: The NPD Group/Dieting Monitor, 52 week data year ending January 30, 2013 As of this January about a third of U.S. adults say they want to cut down or be free of gluten in their diets, NPD reports that 30 percent of adults, one in every three adults, claimed to cut down on or avoid gluten completely in January 2013.

7. Reasons for the Occasional Consumer: Not Medical necessary Weight loss (?) –27% of consumers who eat or used to eat gluten-free foods do so because they feel they aid in their weight loss efforts.* Better nutrition & other health benefits (?) –65% of consumers who eat or used to eat gluten-free foods do so because they think they are healthier* Celebrity Endorsements –Lady Gaga, Miley Cyrus Popular Press

8. Who benefits from the use of the GFD? –Use of the GFD Celiac disease Non-Celiac gluten sensitivity Wheat/gluten allergies

9. Wheat Barley Rye Wheat Bran Wheat Starch Wheat Germ Barley Malt /Extract Spelt Kamut Emmer Einkorn Semolina Faro Triticale Bulgur Couscous Durum Other Types of Wheat: Gluten Containing Ingredients to Avoid

10. Frequently Overlooked Foods That May Contain Gluten Broth Candy Communion wafers Imitation bacon Imitation seafood Marinades Processed meats Roux Sauces Soup base Soy sauce Thickeners Medications

11. Gluten Free Labeling 101

12. Labeling101 In 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that companies identify in “plain English” the eight most prevalent food allergens: egg, fish, milk, peanuts, shell fish, soybean, tree nuts and WHEAT

13. Example of FALCPA Including the ingredient list with parentheses Ingredients: Enriched flour (wheat flour, malt flavoring, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, high fructose corn syrup, whey (milk), eggs, salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono- and diglycerides (emulsifier) Use a “Contains” statement Ingredients: Enriched flour (wheat flour, malt flavoring, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, high fructose corn syrup, whey (milk), eggs, salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono- and diglycerides (emulsifier) Contains Wheat, Milk, Egg, and Soy or

14. FALCPA does not include… 1.Barley (malt), rye or oat (but not “hidden” ingredients) 2.Meat products covered by USDA, including meats, poultry and certain egg products (although 90% of manufactures follow FALCPA guidelines) 3.FALCPA covers ingredients not the contamination of the product (oats) 4.Over the counter or prescription medications (www.glutenfreedrugs.com )www.glutenfreedrugs.com 5.Alcoholic beverages (Distilled beverages are gluten free)

15. Labeling Law…shopping made easier! Only 6 basic ingredients you need to look for on the label of food not labeled Gluten Free include: Wheat Rye Barley Malt Oats Brewer’s yeast

16. Safe Vinegar (except malt vinegar) Distilled Alcohol Carmel color Citric acid Spices MSG Maltodextrin Mono and Diglycerides Artificial flavor and color Natural flavor and color HVP or HPP (wheat will be identified if used) Stamps and envelopes Shampoo, deodorants, lotions (not absorb through the skin)

17. What about Manufactured in a plant… “Before we come in, was any part of your house produced In a facility that also handles wheat, milk, eggs or soy?”

18. Page 18 Allergen Advisory Statements “Manufactured in a plant that contains wheat” –Voluntary statements manufacturers use in labeling their products that could indicate the “potential” unintended presence of a food allergen –Not reliable way to determine whether a food product is contaminated with gluten. Products with this statement have been tested to less than 5 ppm while other products with no statement test above 20 ppms

19. The Gluten Free Rule is Finally Here! Summary of the FDA Gluten Free Label Rules enacted August 2013 A food label gluten free must: –Be inherently gluten free (raw vegetables, water, 100% juice) –Does not contain an ingredient that is a gluten containing grain such as wheat, rye, barley –Does not contain an ingredient derived from a gluten containing grain that has not been processed to remove gluten –May contain an ingredient derived from a gluten containing grain that has been processed to remove gluten (wheat starch) as long as the food does not contain more that 20 ppm gluten –The food product contains less than 20 parts per million gluten Any unavoidable presence of gluten in the food is less than 20 ppm gluten

20. Summary of the FDA Gluten Free Label Rules Terms synonymous with gluten free are: –No gluten –Free of gluten –Without gluten Oats are not considered a gluten containing grain Applies to foods that are regulated by the FDA –Does not cover pet food, cosmetics, drugs, foods regulated by the USDA and beverages regulated by Alcohol Tobacco Tax and Trade Bureau (TTB) Manufactures are not required to test either the ingredients or the end product. Manufactures must be in compliance with the rule by August 2014

21. Hydrolyzed, Fermented and Distilled Foods FDA will engage in additional rule making to establish how it will determine compliance for hydrolyzed and fermented foods In the interim, hydrolyzed, fermented and distilled foods that meet the definition may bear a gluten free claim IF they meet all the requirements of the final rule Distilled foods such as vinegars will be addressed in the proposed rule for gluten free labeling of hydrolyzed and fermented foods. Source: “Gluten-Free Food Labeling Final Rule” webinar presented by Carol D’lima, Center for Food Safety and Applied Nutrition FDA

22. Translating 20 ppm 20 parts per million = 2 mg/100 gm (<0.002%) 1 slice of Bread -2500 mg of gluten 125,000 ppm gluten One minute in two years

23. Tolerable Daily Intake of Gluten & PPM Gluten in Food 50 g100 g200 g300 g 200 ppm 10 mg 20 mg40 mg60 mg 100 ppm 5 mg 10 mg20 mg30 mg 50 ppm 2.5 mg 5 mg10 mg15 mg 20 ppm 1 mg 2 mg4 mg6 mg

24. Translating 20 ppm into Daily Food Intake At 20 ppm, 500 grams or 1 pound of gluten free food can safely be eaten daily by the vast majority of people with celiac disease. That equals: 18 slices of a gluten free bread = 1440 calories 18.5 cups of a gluten free rice cereal = 1908 calories 9(½ cup) servings of gluten free pasta = 1710 calories

25. True or False… All foods that meet the definition of ‘gluten free’ are required to be labeled gluten free. False The labeling of the term “gluten free” is voluntary

26. True or False… On August 5, 2014, the day manufactures of gluten free foods must have the labels in compliance with the gluten free rule, the FDA started sending inspectors to begin testing. False A consumer complaint must be filed with the FDA at 240-402-2405

27. True or False A product can be labeled ‘gluten free’ even if it contains wheat starch. True If it has been processed to remove the gluten and if the use of that ingredient is less than 20 ppm in the final product. If the product has a “Contains” statement, the word “wheat” must be listed under the “Contains” statement and followed by an asterisk and the statement, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”

28. Which term does not have to meet the gluten free standard? A. Gluten free B. No gluten C. Free of gluten D. Without gluten E.GF Products with statements such as “made with no gluten containing ingredients” or just the use of the letters “GF” do not have to meet the requirement for labeled gluten free food

29. True or False The FDA will adapt a universal symbol or logo for gluten free foods. False The FDA does not require or recommend any particular symbol.

30. Organization certifying gluten free foods

31. GF certifications GFCO –Sponsored by the Gluten Intolerance Group –Test – type is up to manufacturer (Skerritt or R 5 Elisa) 10 ppm –Initial audit, follow up as needed GFCP The GFCP is endorsed by North America's celiac organizations, the Canadian Celiac Association in Canada and the NFCA in the United States –Canadian Celiac Association –ELISA test method – 20 ppm –Annual audit NSF – gluten free –Non sponsored certification –Annual audit –R 5 ELISA Mendez – 10 ppm CSA –Celiac Society of America –no oats, no ingredients from gluten containing grains –R 5 ELISA Mendez – 5 ppm

32. True or False… The new rule does not apply to food products imported from other countries. False All foods imported in the US must meet the same federal requirements as foods domestically produced.

33. True or False… The final rule also applies to restaurants. True The FDA is encouraging the restaurant industry to ensure that’s its use of ‘gluten free’ is consistent with the federal definition

34. Restaurants and the Gluten Free Label FDA has stated that restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition –The use of the word “should” in Agency guidance documents means that something is suggested or recommended, but not required If a complaint is made to FDA regarding unpackaged food (e.g., food sold in restaurants) this information will be shared with state and local governments Source: FDA. Questions and answers: Gluten-free food labeling final rule. August 5, 2014. Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allerge ns/ucm362880.htm

35. Another label to read…

36. The GFD can be missing important nutrients needed for optimal health and wellness –Lacks fiber –Lacks iron –Lacks B vitamins- folate, niacin, B12 –Lacks calcium –Phosphorous –Zinc Nutrition deficiencies lead to: –Reduced bone mineral density –Constipation –Iron deficiency anemia Special Dietary products (Gluten Free, Diabetic, Low Salt, etc.) are not required to enrich or fortify by the FDA. Weight gain on GFD due to high fat, sugar and calorie content Nutritional Aspects of the GFD http://www.adaevidencelibrary.comhttp://www.adaevidencelibrary.com. Saturni et al. Nutrients. 2010; 2(1): 16–34.

37. Academy of Nutrition and Dietetics Resources Medical Nutrition Practice Group –Dietitians in Gluten Intolerance Diseases (DIGID) – www.mnpgdpg.orgwww.mnpgdpg.org Evidence Analysis Library (EAL) on CD www.adaevidencelibrary.com Celiac Disease Toolkit Companion to AND’s Evidence-Based Nutrition Practice Guideline

38. Books The Gluten-Free Nutrition Guide by Tricia Thompson Gluten-Free Diet: A Comprehensive Resource Guide by Shelley Case Real Life with Celiac Disease by Melinda Dennis and Daniel A. Leffler ADA Pocket Guide to Gluten-Free Strategies for clients with Multiple Diet Restrictions by Tricia Thompson Gluten Freedom by Alessio Fasano