vice president, operations canadian celiac association · she joined the cca as a member in 1996...

THE 2016 GLUTEN-FREE STAKEHOLDER UPDATE & PLANNING SESSION PRESENTED IN COOPERATION WITH:

Vice President, Operations Canadian Celiac Association

SUE NEWELL

Vice President Beyond Celiac (formerly the NFCA)

JENNIFER NORTH


Sue Newell, Canadian Celiac Association Jennifer North, Beyond Celiac

GLUTEN-FREE CONSUMER PERSPECTIVE


ABOUT YOUR PRESENTERS

© 2016 Beyond Celiac

Jennifer North is the Vice President Beyond Celiac. She joined the organization in 2009, three months after her daughter was diagnosed with Celiac Disease. Jennifer oversees NFCA’s gluten-free industry initiatives and works heavily with food industry partners in the marketing, promotion and development of gluten-free initiatives. She has 20 years of experience in the nonprofit sector with expertise in marketing and communications, development, strategic planning and organizational development.

Sue Newell is the Operations Manager of the Canadian Celiac Association. She joined the CCA as a member in 1996 after her diagnosis with celiac disease . She volunteered on local and national boards and education initiatives before joining the CCA full time 3 years ago. Sue spent 18 years in the high-tech sector in Waterloo as a techie and a manager, usually working on large problems that required cross-sector input for resolution.


CCA MISSION

The Canadian Celiac Association is the national voice for people who are adversely affected by gluten, and is dedicated to improving diagnosis and quality of life.


CCA HISTORY

• Federally incorporated charitable organization with a national office based in Mississauga, ON.

• Started in 1972 by two women who , from personal experience, realized the needs of people with celiac disease

• Grew to 29 chapters in all 10 province • Governed by a national Board of Directors • Advised by a Professional Advisory Council of

physicians, dietitians and food scientists


CCA OUTREACH TO CONSUMERS

• Local support to individuals through chapters and satellites in over 50 communities

• Online support with a moderated Facebook forum with a North American reach

• Direct support to individuals through email and telephone

• Media resource on key issues

• CCA Membership is not a requirement for individual support.


CCA CERTIFICATION HISTORY

• First venture into logo licensing in the early 1990’s – popular but little oversight and a lot of liability

• Ended in 1995

• 2009 began work with QMI to develop and administer a GF Certification Program with 3rd party auditing – Similar to systems operating elsewhere – Integrity of 3rd party scheme – International recognition of certifier – Based on CCA standards

• 2011 entered into an agreement with the Allergen Control Group to

administer the program. First products launched May 2011 (Pepsico)


CCA CURRENT PRIORITIES

• The gluten problem. Found. Treated. Cured.

• Education and resources for medical professionals and consumers

• The Right to Safe Food is a guiding principle for efforts – Gluten-Free Certification Program – Gluten-Free Food Program – Ongoing dialog with regulators on labelling

and food safety concerns

• J. A. Campbell research program supporting Canadian research


Beyond Celiac advances widespread understanding of celiac disease

as a serious genetic autoimmune condition and works to secure its early

diagnosis and effective management. We empower our community to

live life to the fullest, and serve as a leading and trusted resource that

inspires hope, accelerates innovation and forges pathways to a cure.


BEYOND CELIAC MISSION


Beyond Celiac History

Beyond Celiac was founded in 2003 as the National Foundation for

Celiac Awareness with two primary goals

Raise awareness of

celiac disease

Ensure gluten-free food

is affordable, accessible,

safe, tasty and understood



BEYOND CELIAC PRIORITIES 2016/2017

• Rebrand celiac disease as a serious, genetic autoimmune disease

• Improves diagnosis rate by influencing guidelines and raising awareness

among at-risk populations

• Ensure access to safe and medicines by collaborating with industry and

regulators

• Advance a patient-centered research agenda that will accelerate

improved quality of care and more effective treatment options



Facebook: 137,000+ fans

Twitter: 25,000+ followers

Web: 2 million unique visitors in the past year

Email: 50,000 subscribers

Symptoms Checklist: 200,000+ online participants (since 2009)

Primary Care CME: 7,000 health care providers

Family Talk: 100,000+ page views since launch

Gluten-Free in College: 40,000 page views to date

Webinars: Hot topics garner more than 1,200 registrants

Recent Press: Associated Press, LA Times, New York Times, US News & World Report, USA Today, CNBC, WSJ's MarketWatch, Huffington Post, Web MD

BEYOND CELIAC REACH



} 23% of population

Who is Eating Gluten-Free?



• bloating, gas and/or abdominal pain • hard to flush, bulky or loose stools • diarrhea or constipation • fatigue • itchy skin rash • tingling/numbness in hands or feet • discolored teeth or loss of enamel • canker sores • joint pain • irritability or behavior changes • significant unexplained weight loss • poor weight gain • delayed growth • missed menstrual periods • fractures or thin bones

Celiac Disease is a genetic autoimmune disorder triggered by the protein gluten.

Left untreated, celiac can lead to infertility, osteoporosis, neurological conditions, other autoimmune diseases and some cancers

Left untreated, celiac can lead to infertility, osteoporosis, neurological conditions, other autoimmune diseases and some cancers

• bloating, gas and/or abdominal pain • bulky or loose stools • diarrhea or constipation • fatigue • itchy skin rash • tingling/numbness in hands or feet • discolored teeth or loss of enamel • canker sores • joint pain • irritability or behavior changes • significant unexplained weight loss, poor weight gain or dddelayed growth • missed menstrual periods • fractures or thin bones

WHAT IS CELIAC DISEASE?



A self-initiated diagnosis:

– Lack of educated doctors

– Misinformation online

– Misuse of gluten-free diet

– Patients can wait 6-10 years

– Frustration, anger and despair with

the medical system gives way to

relief and acceptance

– 83% still undiagnosed

A self-managed disease:

– Difficult to find value in most

healthcare providers

– Inherent challenges and flaws

of gluten-free diet

– Significant impact on

psychosocial well-being

– Patient needs and attitudes

evolve throughout disease

lifecycle

– Fad aspect of the gluten-free

diet and a lack of available

data has undermined the

seriousness of the disease

A CONTINUUM OF BURDENS



THE BURDEN IS REAL


Patients with celiac disease have “excellent disease specific health”

BUT they also report 2nd highest perceived treatment burden

020

40

60

80

100

Vis

ual A

nalo

gue S

cale

CD GERDHTN DMESRD CHF IBD IBS

Perceived Treatment Burden

Shah, S, Akbari, M,

Vanga, R, Kelly, CP,

Hansen, J, Theethira,

T, Tariq, S, Dennis, M,

& Leffler D. (2014).

Patient perception of

treatment burden is

high in celiac disease

compared with other

common conditions.

American Journal of

Gastroenterology,

109(9), 1304-11.


A DAILY CHALLENGE



CONSUMER FEEDBACK AND CONCERNS


Beyond Celiac Gluten-Free Consumer Survey July 2016


• Approximately 900 responses in just a few hours

• Held one on one conversations with community

• Vast range of experiences – no two cases alike

”WHAT HAPPENS WHEN YOU GET GLUTENED?”



CONSUMER FEEDBACK AND CONCERNS

Beyond Celiac Gluten-Free Consumer Survey July 2016


CLINICAL RECOMMENDATIONS CONFUSE PATIENTS


“Previous research based on purity protocol”

“Are all processes safe?”

“But I thought nothing could ‘touch’ gluten”


NASSCD STATEMENT, CONTINUED


“But I know more about celiac disease than my doctor does”

“I don’t understand how to determine this”


23

VOICES OF CELIAC DISEASE



25

VOICES OF GLUTEN FREE


Here's a head scratcher...Farm Boy Curry Coconut Lentil soup says "made without gluten", BUT it contains a may contain statement that lists wheat. Does "made without gluten" fall under the same thing as Gluten Free? Or have they gotten creative with the "made without gluten"?

Why would peanuts in the shell have a “may contain” warning?

Are these OK? Please tell me yes.


THE RULES - CANADA

• As of August 4, 2012, section B.24.018 of the Food and Drug Regulations states that

It is prohibited to label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition “gluten”)


THE RULES - CANADA

• Subsection B.01.010.1(1) : “gluten” any gluten protein from the grain of any of the following cereals or the grain of

a hybridized strain created from at least one of the following cereals: (i) barley, (ii) oats, (iii) rye, (iv) triticale, or (v) wheat, kamut or spelt; or any modified gluten protein, including any gluten protein

fraction, that is derived from the grain of any of the cereals referred to in subparagraphs (a) (i) to (v) or the grain of a hybridized strain referred to in paragraph (a). (gluten)


THE RULES - CANADA

• A "food for special dietary use" is defined in B.24.001 of the FDR as a food that has been specially processed or formulated to meet the particular requirements of a person:

a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury; or

b)for whom a particular effect, including but not limited to weight loss, is

to be obtained by a controlled intake of foods.


PRECAUTIONARY STATEMENTS - CANADA

When used, precautionary statements aim to: (1) alert the consumer to the possible presence of an allergen in a food, and

(2) prevent the consumption of products labelled with a precautionary statement by persons having a food allergy.

Health Canada's policy has been non-prescriptive with respect to the wording of precautionary statements, requiring only that such statements be truthful, clear and non-ambiguous, and that they not be a substitute for Good Manufacturing Practices.


PRECAUTIONARY STATEMENTS - CANADA

Precautionary labelling should only be used when, despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable.

Furthermore, the use of a precautionary statement where there is no real risk of an allergen being present in the food is contrary to the Department's goal of enabling a variety of safe and nutritious food choices for the allergic consumer.


WHEN “GLUTEN-FREE” IS NOT CALLED OUT

U.S. Food and Drug Administration’s Food Allergen Labeling Consumer Protection Act (FALCPA):

• Wheat is listed as one of top eight allergens

• Allergen must be named in either the ingredients list or a separate “Contains” statement immediately following or next to the ingredients list

• Barley and rye are not listed as an allergen

Labeling is voluntary – but manufacturers that use “gluten-free” label MUST comply. Under the FDA’s rule, food labeled gluten-free must meet all four of the following criteria:

① Will not contain an ingredient that is a prohibited grain ② Will not contain an ingredient derived from a prohibited grain if it has not been processed

to remove gluten ③ Can contain an ingredient derived from a prohibited grain if it has been processed to

remove gluten provided that the final food product contains less than 20 ppm of gluten ④ Must contain less than 20 parts per million of gluten

THE RULES - US REGULATIONS


• Manufacturers may also use the terms interchangeably “free of gluten,” “no gluten” or “without gluten.” These terms must comply with the <20ppm standard.

• Statements like “Made with no gluten containing ingredients” or “Not made with gluten-containing ingredients” are not prohibited on labels; however, consumers should not assume the product meets the <20ppm standard unless the term “gluten-free” is also on the label. Terms like “low gluten” and “reduced gluten” are not regulated.

• It is also permissible for a product to bear a “gluten-free” label claim, while also including an allergen advisory statement (made in the same facility/shared equipment with wheat), as long as the product meets the <20ppm standard.

• Naturally gluten-free food (i.e bottled water or carrots) can be labeled as “gluten-free”. (however, it is not necessary to restrict to buying only products like this labeled gluten-free)

OTHER CONSIDERATIONS



USDA-REGULATED FOODS

U.S. Department of Agriculture (USDA) regulates:

• Meat products, poultry products and egg products

• Mixed food products that generally contain more than 3% raw meat or 2% or more cooked meat or poultry (i.e.. soups, chilis, frozen entrees)

80% - 90% of USDA-regulated products are aligned with FALCPA:

• Look for the word “wheat”

Alcohol and Tobacco Tax and Trade Bureau (TTB) enforces the Federal Alcohol Administration Act (FAA Act) to ensure that only qualified persons engage in the alcohol beverage industry:

• Ensure that labeling and advertising of alcohol beverages provide adequate information to the consumer concerning the identity and quality of the product;

• Prevent misleading labeling or advertising that may result in potential consumer deception regarding the product.


http://www.gpo.gov/fdsys/pkg/USCODE-2011-title27/html/USCODE-2011-title27-chap8.htm





IS THE COMPANY CONFUSED OR AM I?

Salt and Malt Vinegar Chips INGREDIENTS: Potatoes, Corn and/or Sunflower and/or Canola Oil, Lactose, Sea Salt, Corn Maltodextrin, Sodium Diacetate, Malt Vinegar, Malic Acid, Citric Acid.

The consumer reported this product to CFIA and provided them with the package.



The CFIA has let me know that they previously investigated a report on this product and deemed it to be against the labelling regulations set by Health Canada and the CFIA. In response to this, the manufacturer was required to update their packaging to remove "gluten free". This update was to be completed by January 30th of this year (2016). However, it appears that the original report was on the 226g version of the packaging, not this smaller 56g version, and the manufacturer may have neglected to update both.



Is this product safe? It carries a gluten-free claim.



• Are strict GMPs enough?



How do I interpret this? There is gluten-free claim and a certification mark and this warning about the equipment. Do they clean it at all? Do they clean it well enough?



Is this a real risk or just a list of every allergen they use?



INGREDIENTS: Organic Brown Rice Flour, Filtered Water, Organic Agave, Organic Tapioca Flour, Safflower Oil, Organic Chia Seeds, Fresh Yeast, Vegetable Gum (Xanthan, Cellulose) Rice Bran, Sea Salt. MAY CONTAIN: Wheat, Soya, Almond, Pecans

How an it be GF and maybe contain wheat?



• Mixed Messages: – Gluten Free: “gluten-free foods, prepared under good manufacturing

practices, which contain levels of gluten not exceeding 20 ppm as a result of cross-contamination”

– May contain: “despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable.”

• Are they both allowed to both appear on a product? • Which claim takes precedence?

• Sadly, the answer appears to depend on who you happen to talk to at CFIA



• Is this a cross-contact concern?



• Is yeast extract the same as barley yeast extract? If there is no “barley” listed did the company make a mistake or did they do things right?



If you purchase this beer in Saskatchewan the label says Gluten Free and the ingredient list contains barley malt.



But in Ontario there is a warning on the LCBO web site and on the bottle.



CFIA Guidance Document: Based on a position provided by Health Canada that there is uncertainty around the complete removal of gluten from beer or beer-like products made using barley, oats, rye, triticale, wheat or their hybridized strains, the CFIA will object to the use of a "gluten free" claim on beers produced from one of these grains [B.01.101.1(1)].

But only in some provinces? Consumers shouldn’t have to be the ones to figure it out.



• Consumers don’t understand subtle distinctions:

“only foods made in the GF section of our facility will be labelled as gluten-free.”

– One of your products has a GF claim, an almost identical one has no GF

claim. No gluten-containing ingredients listed, no precautionary statements, and it is not a grain, nut or seed- based product.

– Should the consumer have to understand your manufacturing model to know whether to go beyond the ingredient list to make a decision?


DON’T MAKE YOUR CUSTOMERS MAD!

• Make sure customer service knows about the product before you release it – “We don’t have any gluten free products” is not a good message to send

about your new releases

• Don’t try word games: – “we sometimes purchase flavoring, color or spice ingredients from

suppliers who do not list every possible source of gluten beyond what is required by law.”

– Isn’t what is required by law of you required by law of your ingredient suppliers too?



Try really hard to fix your manufacturing problems.



Realize that price differences still hurt even though they are justified


KEEP THINKING OUTSIDE THE BOX


53

YOU NORMALIZE LIFE TOO


Is there any place better to eat GF Brownies than by a beautiful river. (Newfoundland vacation) • Maybe by the microwave because you

just warmed one up, topped it with ice cream and smothered it in hot fudge sauce.

• Love them frozen • Roast them over the fire… • Cut them in half, slide in a peppermint

patty, wrap in tinfoil and roast over fire/bbq till melty.


QUESTIONS?

vice president, operations canadian celiac association · she joined the cca as a member in 1996...

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