Transcript gluten-free - Celiac Support Association

Celiac
Support
Association
Serving the
Gluten-Free
Community
40 + years
Copyright 2014 Celiac Support Association
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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
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Details on the Regulation Impact to
the Gluten-Free Community
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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.
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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
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Celiac Profile
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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)
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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
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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
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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).
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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
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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
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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
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“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.
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Infractions
• Misbranded and would be subject to
regulatory enforcement action
– FDA Warning Letters
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Compliance
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Manufacturers are responsible
Foods bearing a gluten-free claim
Meet the requirements of the final rule
Testing is not required
Applies to imported food
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FDA Regulation
• Does not apply to
• Medications
• Restaurants
• FDA Advises
“if use the gluten-free claim
adhere to the FDA definition.”
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Responsibility of Patient:
Citizens
• Design own decision-making process to
maintain optimal health
• Seek information to evaluate choices
• Read Labels
• Contact food companies
• Advocate
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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
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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
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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
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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.
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Gold Standard -- zero
• Completely eliminate toxic fractions
(prolamins & glutelins)
• From genus triticum, secale, hordeum,
some avena
Some ---- 0 ---- None
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Food Safety
Shared Responsibility in US
Executive
Legislative
State
Judicial
Citizens
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www.thomas.loc.gov
* Introduced
* Reported
* Engrossed as agreed to or passed
by the house
* Referred to Senate Committee
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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
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Executive
USDA
FDA
TTB
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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.
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USDA
USDA regulates the labeling of meats,
poultry, and certain egg products (FDA
regulates the labeling of shell eggs).
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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.
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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.
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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.
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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.
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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
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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
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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
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•
Food Allergen Labeling and
Consumer Protection Act of 2004
Exemptions
• Restaurants
• Oils
• Grains – grain standards regulated
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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
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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
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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.
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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
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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).
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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
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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
“
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Labeling Oats?
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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
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950 Eliminate oats from diet
151 Eat oats
1101 Define as absence of WBRO
77 GF = WBR
22 No Answer
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Proposed Label Format
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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
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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
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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
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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
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Informed?

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Source information about ingredients that
may or may not contain WBR common
Oats or derivatives in
Product
Processing
Packaging
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Certification Programs
Sin T.A.C.C.
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CSA Recognition Seal
• FREE of Wheat, barley, rye, oats, crosses
and derivatives
• Product
• Processing
• Packaging
• Testing -- verification the protocol works
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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
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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
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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.
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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
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Be motivated
Have a “zealous” attitude
Seek “evidence based” information
LOYALTY
Call CSA
Stay involved – Join CSA
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Thank you!
Copyright 2014 Celiac Support Association
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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.
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