gluten-free food product safety: misbranding and adulteration

Food Safety Risks Food Technical Consulting

Darrel Suderman, PhDFood Technical Consulting

Food Safety Risks: Adulterated & Misbranded Gluten-free

Products


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What are Glutens?

Products: Focused on

Glutens

Litigation

Opportunities

Food Safety Forensic™

Methodology

Conclusion

1 Introduction

Table of

Contents


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


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.


What are Glutens?


Gluten Examples

What are Glutens?


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


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.


What are Glutens?

What is Celiac Disease?

Celiac disease is an autoimmune disorder that can occur ingenetically predisposed people where the ingestion of gluten leads todamage of the small intestine. When people with celiac disease eatgluten (a protein found in wheat, rye and barley), their body mountsan immune response that attacks the small intestine. Theseattacks lead to damage of the villi, small fingerlike projections thatline the small intestine, that promote nutrient absorption. Whenthe villi get damaged, nutrients cannot be absorbed properly into thebody.

Celiac disease is hereditary, meaning that it runs in families. Peoplewith a first-degree relative with celiac disease (parent, child, sibling)have a 1 in 10 risk of developing celiac disease.


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.


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 environmental STRESS can activate celiac disease. In people with celiac disease, gluten exposure evokes an immune mediated response throughout the body and measurable damage to the intestinal lining. Some of the most common symptoms are joint pain, anemia, diarrhea, constipation, fatigue and irritability


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


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


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


Products: Focused on

Glutens


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,


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


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


Focused on Glutens

Udi’s & Rudi’s Products Denver, CO

French Baguettes

Muffins

Cookies

Tortillas

Bagels

Frozen Meals

Chips

Granola Bars


Litigation Opportunities



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.



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)



“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

https://www.federalregister.gov/articles/2013/08/05/2013-18813/food-labeling-gluten-free-labeling-of-foods



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

https://www.federalregister.gov/articles/2013/08/05/2013-18813/food-labeling-gluten-free-labeling-of-foods



Examples of Gluten Free Labels



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



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.



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)



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



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



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



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.



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



Incident Definition

An incident is an event that could lead to loss of, or disruption

to, an organization's operations, services, or functions. If not

properly managed, an incident can escalate into an emergency,

crisis, or a disaster.

Incident Management is therefore the process of limiting the

potential disruption caused by such an event, followed by a

return to business as usual.



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)



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



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.



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.



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



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


FSF Methodology


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)




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




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




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”



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



Pet food (Cats and Dogs)

New Frontiers



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



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.




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




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.




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

http://google2.fda.gov/search?client=FDAgov-recalls&proxystylesheet=FDAgov-recalls&site=FDAgov-recalls&filter=0&sort=date:D:S:d1&getfields=*&requiredfields=recall_category&q=food&btnG=Search

http://www.fsis.usda.gov/


Thank you!

Food Technical

Consulting Dr. Darrel Suderman

[email protected]

www.foodbevbiz.com

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