Gluten-free Product Safety Risks: Adulteration, Misbranding, and Litigation

Food Safety Risks
Food Technical Consulting
Darrel Suderman, PhD
Food Safety Risks: Adulterated & Misbranded Gluten-free Products

Food Safety Risks
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3
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What are Glutens?
Products: Focused on Glutens
Litigation Opportunities
Food Safety Forensic™ Methodology
Conclusion
1
Introduction
Table of Contents

Food Safety Risks
Introduction
Facts about Darrel Suderman, PhD
Presenter Background
Education
•Ph.D. Food Science @ Kansas State University
•Adjunct Professor @ Johnson and Wales Culinary University in Food Product Development
Experience
•20+ yrs Restaurant Product Development, Quality, and Food Safety
•5 years legal Expert Witness food litigation experience
•Gluten-Free Consultant
•Co-Author of a food processing book and holds 2 patents
IT Consulting
•SAP Business Intelligence Software Partner
•INFOR Software Company Partner
•10 yrs of food & beverage manufacturing and supply chain management Information Technology software systems consulting

Food Safety Risks
Resources
TASA Papers & Webinars
Protecting Food & Beverage Recipe and Process Ownership: TASA White Paper (2010)
Emerging Issues In Food Products Litigation-TASA Webinar-Sept. 14, 2011
Top 5 Consumer Liability Risks The Public Ignores-TASA Webinar- Feb 8, 2012
Public Safety Liability for Mobile Food Retailers & Quick Serve Restaurants: The Trial Lawyer magazine, Summer 2011, Vol. 1, No.3 pp 18-20.

Food Safety Risks
What are Glutens?

Food Safety Risks
Gluten Examples
What are Glutens?

Food Safety Risks
What are Glutens?
Gluten-free, high-protein and “total indulgence”, those are the phrases of inspiration for General Mills’ newest grocery products.
Healthy & Otherwise, July 8, 2014
General Mills Unveils 150 New Products

Food Safety Risks
What are Glutens?
What are Glutens?
Gluten is known as the protein in wheat and related plants such as barley and rye. There are two main groups of proteins that comprise gluten, called gliadin (short molecular chains) and the glutenins (long molecular chains). Gluten gives elasticity to dough, helping it rise and keep its shape. Gluten is like most allergens in that they are proteins.

Food Safety Risks
What are Glutens?
What is Celiac Disease?
̶Celiacdiseaseisanautoimmunedisorderthatcanoccuringeneticallypredisposedpeoplewheretheingestionofglutenleadstodamageofthesmallintestine.Whenpeoplewithceliacdiseaseeatgluten(aproteinfoundinwheat,ryeandbarley),theirbodymountsanimmuneresponsethatattacksthesmallintestine.Theseattacksleadtodamageofthevilli,smallfingerlikeprojectionsthatlinethesmallintestine,thatpromotenutrientabsorption.Whenthevilligetdamaged,nutrientscannotbeabsorbedproperlyintothebody.
̶Celiacdiseaseishereditary,meaningthatitrunsinfamilies.Peoplewithafirst-degreerelativewithceliacdisease(parent,child,sibling) havea1in10riskofdevelopingceliacdisease.

Food Safety Risks
What are Glutens?
Long Term Health Effects
Celiac disease can develop at any age after people start eating foods or medicines that contain gluten. Left untreated, celiac disease can lead to additional serious health problems.
These include the development of other autoimmune disorders like Type I diabetes and multiple sclerosis (MS), dermatitis herpetiformis (an itchy skin rash), anemia, osteoporosis, infertility and miscarriage, neurological conditions like epilepsy and migraines, short stature, and intestinal cancers.

Food Safety Risks
What are Glutens?
Treatment
̶Currently, the only treatment for celiac disease is lifelong adherence to a strict gluten-free diet. People living gluten- free must avoid foods with wheat, rye and barley, such as bread and beer. Ingesting small amounts of gluten, like crumbs from a cutting board or toaster, can trigger small intestine damage.
̶Celiac disease is also known as coeliac disease, celiac sprue, non-tropical sprue, and gluten sensitive enteropathy.
̶An environmentalSTRESS can activate celiac disease.In people with celiac disease,gluten exposure evokesan immune mediated responsethroughout the body and measurable damage to the intestinal lining. Some of the most common symptoms are joint pain, anemia, diarrhea, constipation, fatigue and irritability

Food Safety Risks
What are Glutens?
Secondary Gluten Health Risks
̶Iron deficiency anemia
̶Early onset osteoporosis or osteopenia
̶Infertility and miscarriage
̶Lactose intolerance
̶Vitamin and mineral deficiencies
̶Central and peripheral nervous system disorders

Food Safety Risks
What are Glutens?
Secondary Gluten Health Risks
̶Pancreatic insufficiency
̶Intestinal lymphomas and other GI cancers (malignancies)
̶Gall bladder malfunction
̶Neurological manifestations, including ataxia, epileptic seizures, dementia, migraine, neuropathy, myopathy and multifocal leucoencephalopathy

Food Safety Risks
What are Glutens?
5 Myths About Gluten Free
1.Myth 1: It's a Weight-Loss Guarantee –yet 32% doctors recommend it
2.Myth 2: Your Taste Buds Will Suffer –yet people rate gluten-free products and gluten products equal in taste
3.Myth 3: Less Gluten Means a Less Upset Stomach –but only if you have celiac disease
4.Myth 4: You’ll Improve Your Diet –but the opposite may occur if nutrients aren’t supplemented
5.Myth 5: Gluten-Free Foods Are Healthier Than Their Counterparts –yet this hasn’t been proven
Source: Prevention Magazine, August, 2014, Zahra Barnes

Food Safety Risks
Products: Focused on Glutens

Food Safety Risks
Focused on Glutens
Popular Gluten Product Ingredients
̶Gluten-free Ingredients
̶Rice, corn, oats, gums, and other milk, soy, and egg proteins
̶Ingredients with Gluten
̶Wheat and related varieties, Rye, Barley,

Food Safety Risks
The gluten-free products market is projected to grow at a CAGR of 10.2% from 2014 to 2019. North America is estimated to be largest market, followed by Europe and Asia-Pacific in 2014. North America is projected as the fastest-growing market, followed by Europe and Rest of the World.
Focused on Glutens
2012–2019
Annual Gluten-Free Products Market Share
Source: MarketsandMarkets Analysis
2012
2013
2014-e
2015-p
2016-p
2017-p
2018-p

Food Safety Risks
Focused on Glutens
Most Popular Gluten-free Products
̶Breads (Gluten-free)
̶Corn Bread
̶Pancakes
̶Batters and Breadings
̶Hamburger/Hot Dog Buns
̶Danish
̶Sweet Rolls
̶Brownie Mixes
̶Pizza Crusts

Food Safety Risks
Focused on Glutens
Udi’s & Rudi’s Products Denver, CO
̶French Baguettes
̶Muffins
̶Cookies
̶Tortillas
̶Bagels
̶Frozen Meals
̶Chips
̶Granola Bars

Food Safety Risks

Food Safety Risks
FDA Labeling Law
What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004?
̶FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a "major food allergen " declare the presence of the allergen in the manner described by the law.

Food Safety Risks
Principle Litigation Opportunities
Adulteration-If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength. And if any substance has been substituted wholly or in part for the article (FDA)
Misbranding-If it be labeled or branded as to deceive or mislead the purchaser (FDA)

Food Safety Risks
“The use of an ingredient that results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed to be misbranded.” Federalregister.gov
Udis branded products owned by Boulder Brands has set a 10ppm limit –above and beyond the Federal limit.
(8/5/2013)
FDA Labeling Requirements

Food Safety Risks
FDA Labeling Requirements Cont
̶“In addition, a food whose labeling includes the term “wheat” in the ingredient list or in a separate “Contains wheat” statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim “gluten-free” will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim. Federalregister.gov

Food Safety Risks
Examples of Gluten Free Labels

Food Safety Risks
Gluten Free Certification Organizations?
̶What is the mission of the Gluten-Free Certification Organization?
̶Established in 2005, The Gluten-Free Certification Organization (GFCO) is dedicated to providing affordable certification services to producers of gluten-free products using quality assessment and control measures throughout production, in order to provide assurance to consumers of the safety of their foods.
̶What is the value added effect of GF labeling?
̶GFCO certification provides a certification seal that is easily identified and provides consumer assurance that the product meets strict standards for gluten-free.
̶How many companies utilize the GF logo in N. America, the world?
̶(4/2014) GFCO currently certifies 21,000 products, sold in 5 countries and is expanding. Audits are conducted in 25 countries around the globe.
̶What percentage of the gluten-free market uses the GFCO certification logo?
̶In 2013, GFCO certified approximately 26% of the gluten-free product market, based on SPINS data. SPINS conducts independent market trend research of a number of markets, including the gluten-free market using

Food Safety Risks
FDA/USDA Manufacturing Requirements
The food product (should not) inherently contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). This minimal criteria has been established by the FDA, but the inherent implication that each gluten-free product is monitored by a HACCP plan…
In order for products to qualify under the CSA (celiac Support Association) Innovation Category, companies must be able to validate that their processing procedures have removed the offending amino acid sequences from the wheat, barley, rye or common oats used in their product which adversely impacts those with celiac disease.The verification must show the final product has less than 5 ppm quantifiable gluten.

Food Safety Risks
Minimum FDA/USDA Manufacturing GMP Requirements
The inherent implication that each gluten-free product is monitored by any one or more of the following:
̶HACCP plan
̶Allergen Management System Certification (AMSC) –based on Allergie, Haut and Asthma (AHA) standard developed by Service Allergie Suisse (SAS)
̶Gluten-free Certification Program (GFCP)(Canada)

Food Safety Risks
̶Administration of all aspects of GFCP (Gluten Free Certification Plan) has been assigned to the Allergen Control Group. The GFCP can be integrated with GFSI or other food safety certification scheme audits.
̶Adherence to Good Manufacturing Practices (GMPs)
̶And, food allergens need to be tested at every stage of the manufacturing process.
Minimum FDA/USDA Manufacturing GMP Requirements

Food Safety Risks
Product Development-Misidentification of allergen ingredients, sub-ingredients, or carrier materials
Receiving Raw Ingredients-mishandling, storing, and documenting for traceback
Equipment-leaving trace allergens due to poor clean-up
Processing-inadequate control measures
Packaging and Labeling-inadequate redundancy checks
Finished Product Testing-using 1 of 2 methods ELISA and PCR
Manufacturing Adulteration Litigation Risks

Food Safety Risks
Greatest Risk in Restaurants through….
̶Cross Contamination
̶No HACCP Plan
̶No outside certified audit
̶No allergen tests
̶No Ingredient storage space for gluten-free
̶No segmented smallwares location
̶No allergen sample /swab testing
̶Little proof of clean environment
Restaurant Adulteration Litigation Risks

Food Safety Risks
US Restaurant Alternate Naming
Restaurants could be worst case scenario….
̶Texas Roadhouse markets its products as “gluten friendly”, and the Olive Garden makes “no guarantees regarding the gluten content of these Items”.
̶Both of these names are cop-outs!
̶BRIO restaurant menu advisory states that any of the 8 allergens could be present –the ultimate disclaimer.
̶The risk of eating an allergen in a restaurant is much greater than a manufactured complete product.

Food Safety Risks
Adulteration Incident Risk Management Best Practices
̶Every food manufacturing plant needs an incident risk management process once a food security breach is reported – that includes:
̶Incident Management Plan
̶Corrective Action Plan
̶CEO or lead spokesperson
̶Recall Plan
̶Previous Mock Recall Experience
̶Product disposal plan

Food Safety Risks
Incident Definition
̶Anincidentisaneventthatcouldleadtolossof,ordisruptionto,anorganization'soperations,services,orfunctions.Ifnotproperlymanaged,anincidentcanescalateintoanemergency, crisis,oradisaster.
̶IncidentManagementisthereforetheprocessoflimitingthepotentialdisruptioncausedbysuchanevent,followedbyareturntobusinessasusual.

Food Safety Risks
Food Safety Management
Risk Management–In simple terms, this relates to practices designed to prevent a situation from occurring.
Incident Management–A situation has occurred, and it is time to limit the damage by stopping the incident from becoming a crisis.
Heightened Incident –A situation has escalated to near crisis
Crisis Management–At this point, the damage has occurred or is continuing and the response has to be swift to clean it up and in some cases limit it (a heightened incident)

Food Safety Risks
4-Phase Incident Management Process
1.Prevention: Employing a good food safety culture, including staying current on risk factors
2.Preparation: Proactively planning for a problem and monitoring public discussion risk
3.Management: Implementing the plan using multiple messages and media
4.Recovery: Reassessing risk exposure and telling the story of changes

Food Safety Risks
ELISA Gluten Test Methodology
ELISA methods detect the actual allergen protein molecule by binding antibodies to the allergen and then using an enzyme- linked conjugate to create a colorimetric change that can be measured. There are certain instances though, that ELISA methods should not be used. Some matrices can interfere with the ELISA method, such as chocolate, or can cause cross reactivity as seen between different types of nuts. This method is also not the most suitable for cooked or heated products because the protein molecules are denatured or broken down and the allergen is no longer detectable, but may still cause problems to sensitive individuals.

Food Safety Risks
PCR Gluten Test Methodology
PCR (Polymerase Chain Reaction) methods, which are more sensitive and detect the DNA molecules of these allergens, can be used in raw and cooked products and are not affected by the heating process because DNA typically remains intact after being exposed to the cooking temperatures of most foods. PCR methods are also not subject to the typical interferences that inhibit ELISA-based methods because the DNA is purified away from these inhibitors before analysis begins. PCR, however, cannot be used on all products. Oils and other products, such as milk or egg whites, cannot be tested by PCR because they do not contain DNA. These products must instead be tested using ELISA-based methods for detection.

Food Safety Risks
Gluten Test Methodology Summary
̶Two complimentary tests available:
̶PCR –used for raw & cooked products because unaffected by heat process
̶PCR –most sensitive to DNA molecules
̶PCR cannot be used when no DNA detectible
̶ELISA detects actual allergen protein
̶ELISA does not work with chocolate
̶ELlSA does not work with heated products

Food Safety Risks
FDA Packaging & Labeling Requirements
̶Packaging must declare all known allergens in the food product following the word “contains:”
̶Country of Origin labeling requirements apply
̶Certificate of Analysis document required from domestic and foreign sourced ingredients

Food Safety Risks
FSF Methodology

Food Safety Risks
Food Safety Forensics Methodology
Food Safety Forensics™ Methodology
̶This methodology fits the Integrated Food Safety Systems approach currently championed by the Association of Food & Drug Officials (AFDO)

Food Safety Risks
Holistic Supply Chain Approach
̶Maps the manufacturing process, equipment locations, ingredient locations, and environmental air flow in grid-like schemes
̶Utilizes “back tracking” of potential allergen contamination point by bag, by lot, by truck load, by receiving date, by warehouse inventory location, to individual suppliers

Food Safety Risks
̶Utilizes forward mapping from incident infraction from individual product package, case, pallet, to in-house inventory, outside distribution center, to customer
̶Once the Incident Mapping has occurred, product swabbing for protein allergen is meticulously applied to verify or delink the mapping result.
̶The goal is allergen process tracking validation

Food Safety Risks
̶Once the mapping and verification processes have been documented, then a disposal action plan is implemented and documented
̶Upon product removal, then the contaminated production area or room is washed down to remove the protein allergen –and repeated until swab testing provides an “All Clear”

Food Safety Risks
̶Celery
̶Gluten
̶Eggs
̶Fish
̶Lupin
̶Milk and Dairy Products
̶Mollusks –clams, mussels, oysters, scallops
̶Mustard
̶Nuts
̶Seafood Crustaceans –crabs, prawns, lobsters
̶Sesame Seeds Soy
̶Sulphur Dioxide and Sulphites –at levels above 10 mg/kg or 10mg/L
Other Food Allergens/European Union

Food Safety Risks
̶Pet food (Cats and Dogs)
New Frontiers

Food Safety Risks
May 19, 2014 -Middle East Bakery of Lawrence, MA is recalling all lots of Market Basket Dairy-Free, Gluten-Free Pancakes, because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Product Recall Example #1

Food Safety Risks
̶On Monday, June 2, 2014 Frito-Lay initiated the voluntary recall of select 1 1/8 oz. packages of Oven Baked Lay’s BBQ. The product is being recalled because its package face is incorrectly labeled with the Frito-Lay gluten-free (GF) logo, while the ingredient panel and disclosures on the back of the packaging correctly indicate that the product contains wheat and barley. As a result, there could be confusion whether this product is gluten free. This was an isolated incident and we are putting parameters in place to prevent this from occurring again.

Food Safety Risks
FDA-October 24, 2012 -Bumble Bar is recalling certain lots of Gluten Free Café™ Chocolate Sesame Bars and Gluten Free Café™ Cinnamon Sesame Bars associated with Sunland Inc. peanut products, because they have the potential to be contaminated with Salmonella

Food Safety Risks
May 3, 2011 -The Raymond-Hadley Corp. of Spencer, NY is expanding the 4/26/11 recall of varieties and date codes of Better Batter Mixes to include one lot of #1 Gluten Free brand Chocolate Cake Mix and #1 Gluten Free brand White Cake Mix because they may contain the undeclared allergen MILK.

Food Safety Risks
U.S. Food and Drug Administration (FDA)
www.fda.gov
(Type in FOOD to see the complete list, then type in GLUTEN-FREE to see only GF Foods)
U.S. Department of Agriculture, Food Safety and Inspection Service
http://www.fsis.usda.gov
FDA & USDA Product Recall Websites

Food Safety Risks
Thank you!
Dr. Darrel Suderman
dsuderman@foodbevbiz.com
www.foodbevbiz.com
Contact Information

Gluten-free Product Safety Risks: Adulteration, Misbranding, and Litigation

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