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Celiac Support Association Serving the Gluten-Free Community 40 + years Copyright 2014 Celiac Support Association 1 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 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 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 Celiac Profile • • • • • 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) Copyright 2014 Celiac Support Association 5 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 Voluntary GF Food Claims Must meet requirements of new regulation or claim will be deemed to be misbranding. Applies to: “gluten-free” “no gluten” “free of gluten” “without gluten” Final rule of Food Allergen Labeling and Consumer Protection Act of 2004 Copyright 2014 Celiac Support Association 7 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 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 Copyright 2014 Celiac Support Association 9 Voluntary Gluten-Free Genus: Triticum Secale Hordeum 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 Copyright 2014 Celiac Support Association 10 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 “May Contain” Statements FDA’s perspective, is claim truthful and not misleading under FDC Act § 403(a)(1) 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. Copyright 2014 Celiac Support Association 12 Infractions • Misbranded and would be subject to regulatory enforcement action – FDA Warning Letters Copyright 2014 Celiac Support Association 13 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 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 Responsibility of Patient: Citizens • Design own decision-making process to maintain optimal health • Seek information to evaluate choices • Read Labels • Contact food companies • Advocate Copyright 2014 Celiac Support Association 16 Citizens Be a Super Sleuth! CSA is looking for excellent examples of gluten-free labeling. Take a picture and send it to [email protected]. Copyright 2014 Celiac Support Association 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, 1-888-6746854 (toll free) 4. • TTB Fraud, Diversion, and Illegal Activity hotline: 855-TTBTIPS (855-882-8477); or by email [email protected]; TTB’s Market Compliance Office Customer Service Line: 202-453-2250; or 866927-2533; or email [email protected]. 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 Buyer Beware Copyright 2014 Celiac Support Association 19 Food and Drug Act, January 1907 Legislative • 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 Copyright 2014 Celiac Support Association 20 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 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 Gold Standard -- zero • Completely eliminate toxic fractions (prolamins & glutelins) • From genus triticum, secale, hordeum, some avena Some ---- 0 ---- None Copyright 2014 Celiac Support Association 23 Food Safety Shared Responsibility in US Executive Legislative State Judicial Citizens Copyright 2014 Celiac Support Association 24 www.thomas.loc.gov * Introduced * Reported * Engrossed as agreed to or passed by the house * Referred to Senate Committee Copyright 2014 Celiac Support Association 25 US Cabinet • Department of Agriculture Secretary Thomas J. Vilsack http://www.usda.gov • Department of Health and Human Services Secretary Sylvia Mathews Burwell http://www.hhs.gov Department of the Treasury Secretary Jack Lew http://www.treasury.gov Copyright 2014 Celiac Support Association Executive USDA FDA TTB 26 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 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 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 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 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 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 FDA grows 1906 1938 1950 1958 1962 1966 1988 1990 2004 2005 2011 2014 Pure Food and Drug Act - Misbranding The Federal Food, Drug, and Cosmetic Act, major amendment Delaney Committee - Cancer Food Additives Amendment - GRAS Consumer Bill of Rights Fair Packaging and Labeling Act Department of HHS Nutrition Labeling and Education Act Food Allergy Labeling and Consumer Protection Act Drug Safety Board FDA Food Safety Modernization Act Definition of Gluten-free for Voluntary Labeling Copyright 2014 Celiac Support Association 33 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 34 Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II) of Veterinary Bill REQUIRED on Labels – Milk – Eggs – Fish – Crustacean Shellfish – Tree nuts – Peanuts – Wheat – Soybeans VOLUNTARY Define the use of the term gluten-free Copyright 2014 Celiac Support Association 35 • Food Allergen Labeling and Consumer Protection Act of 2004 Exemptions • Restaurants • Oils • Grains – grain standards regulated Copyright 2014 Celiac Support Association 36 Copyright 2014 Celiac Support Association 37 2006 A proposed rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods 2008 Final rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods 2009 SEC. 206. GLUTEN LABELING Focus groups in D.C.; Newark; Los Angeles Labeling of gluten-free products Copyright 2014 Celiac Support Association 38 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 Copyright 2014 Celiac Support Association 39 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 33-mer Gliadin Alpha 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 Copyright 2014 Celiac Support Association 41 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 Contamination Contamination means the unintended presence in food of potentially harmful substances, including microorganisms, chemicals, and physical objects. E. coli Cross Contact term is weaker. Wheat and Oats Listeria Shigella 43 Copyright 2014 Celiac Support Association Yes, if less than 20 ppm and … Gluten-Free 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.” Wheat* Allergy Required labeling: or “ Copyright 2014 Celiac Support Association 44 Labeling Oats? • • • • 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 Copyright 2014 Celiac Support Association 45 Proposed Label Format Copyright 2014 Celiac Support Association 46 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 Estimating Risk 20 ppm 50 gram 100 200 300 400 500 600 700 800 900 2 4 6 8 10 12 14 16 18 x.02 1 mg Copyright 2014 Celiac Support Association 48 1 tsp. vital wheat gluten = 3000 mg Cumulative Toxic portion 10 – 50 milligrams per day Catassi 2007 1 ½ teaspoon teaspoon ¼ teaspoon 3000 mg 1500 mg 750 mg 1/8 teaspoon 1/16 teaspoon 1/32 teaspoon 375 mg 187.5 mg 93.75 mg 1/64 teaspoon 46.88 mg 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.” * 1/128 teaspoon 1/256 1/512 1/1024 1/2048 1/4096 1/8192 teaspoon teaspoon teaspoon teaspoon teaspoon teaspoon 23.44 mg 11.72 mg 5.86 mg 2.93 mg 1.46 mg .73 mg .37 mg * 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 Copyright 2014 Celiac Support Association 49 Front-of-Package Symbols 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 50 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 51 Certification Programs Sin T.A.C.C. Copyright 2014 Celiac Support Association 52 CSA Recognition Seal • FREE of Wheat, barley, rye, oats, crosses and derivatives • Product • Processing • Packaging • Testing -- verification the protocol works Copyright 2014 Celiac Support Association 53 CSA Position • Full disclosure source of ingredients Mandatory label -- barley • Regardless the level in the product. 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 Copyright 2014 Celiac Support Association 55 Living Well Gluten-Free “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 56 References: • 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, Van Dyke C, Plevak MF, Dierkhising RA, Zinsmeister AR, Melton LJ 3rd. 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. Copyright 2014 Celiac Support Association 57 Promoting a Gluten-Free You • http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegul atoryInformation/Allergens/ucm362510.htm (Best summary) • https://www.federalregister.gov/articles/2013/08/05/2013-18813/foodlabeling-gluten-free-labeling-of-foods Copyright 2014 Celiac Support Association 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 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 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 http://www.csaceliacs.org/csa_2011_letter.jsp Copyright 2014 Celiac Support Association Advocacy Protects You Be motivated Have a “zealous” attitude Seek “evidence based” information LOYALTY Call CSA Stay involved – Join CSA Copyright 2014 Celiac Support Association 60 Thank you! Copyright 2014 Celiac Support Association 61 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 Presenters 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. Copyright 2014 Celiac Support Association 63