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2017 Food Label Conference
“Working together to redefine the future of food allergies.”
Overview
1. FARE: Mission and Overview
2. Allergens in the Marketplace
3. Food Allergies: Growing Public Health Issue 1. Definitions and Epidemiology
2. Reactions
4. Consumer Perspectives on Label Reading/Purchasing Behavior
5. Resources
6. Q&A
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Our Mission
To improve the LIFE and HEALTH of all individuals with
food allergies and to provide them HOPE through the
promise of new treatments.
LIFE HEALTH HOPE
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Our Mission
LIFE HEALTH HOPE
Initiatives directed toward improving the quality of every day life of those
affected by food allergies.
Initiatives directed toward improving the quality of care for those affected
by food allergies.
Expanding the field of food allergy research and accelerating the pace
for discovery of new treatments.
• Conferences & Events• Online Learning• Online & Grassroots Advocacy• K-12 & College Programs• Food Allergy Awareness Week• Teal Pumpkin Project®
• FARE Clinical Network• Patient Registry Project• Patient Access Initiatives
• World’s leading private funder of food allergy research
• New Investigator Awards• Mid-Career Awards• Outcomes Research Project
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Unparalleled Reach to the Target Audience
156,000 recipients ofbi-monthly e-newsletter
2.5 million visitors to foodallergy.org annually
20,000+ event & program participants annually
130,000 + followers acrosssocial media channels
25 million + impressionsthrough awareness campaigns
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Food Allergy Heroes Walk
▪ Over 20,000 people walk each
year to support the cause.
▪ 39 events taking place across
the US beginning May 2017
▪ High visibility national and local
branding combined with day-of-
event sampling opportunities
Food Allergy Awareness Programs
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Food Allergy Action Week
• Spotlight on food allergy and anaphylaxis by
engaging the community to raise awareness,
educate others and take action.
The Teal Pumpkin Project®
Encourages households to place a teal pumpkin
in front of homes to show non-food treats
available and support safety and inclusion
• Growing national media attention and
support from retailers
• Participation in 50 states and 14 countries
• Generated more than 22 million media
impressions in 2016
Food Allergy Awareness Programs
Allergens in the Marketplace
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What does the law say: Allergen Labeling
Food Allergen Labeling and Consumer Protection Act
(FALCPA) (Effective January 1, 2006)
▪ Created “Top Eight” list of major allergens
• Directed that labels of foods (including
conventional foods, dietary supplements, infant
formulas, and medical foods) containing a ‘major
allergen’ note the allergen in plain English, either
in ingredient list or via the word “Contains”
followed by name of allergen.
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What does the law say: Free From Labeling
The term “allergen-free” is not defined by the FDA or
other regulatory body.
Free-from claims growing in number. Murky space for
consumers and manufacturers alike.
Is there a positive control in place?
Is there end-product testing in place?
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What does the law say: Advisory Labeling
The use of advisory labeling (i.e., precautionary
statements such as “may contain,” “processed in a
facility that also processes,” or “made on equipment
with”) is voluntary and optional for manufacturers.
According to the FDA’s guidance to the food industry
on this issue, advisory labels:
“should not be used as a substitute for adhering to
current good manufacturing practices and must be
truthful and not misleading.”
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What does the law say: Manufacturing
Food Safety Modernization Act (Passed 2011,
implementation began fall of 2015)
▪ In September 2015, the FDA announced new
regulations related to food allergen cross-contact.
• Elevates allergen control to “term of art” on same level
as bacterial controls for cross-contamination.
Documented, specific preventive controls required.
May lead to future changes in precautionary allergen
labeling rules?
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Food Allergies: Definition and
Epidemiology
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▪ A food allergy occurs when the immune system
mistakenly targets a harmless food protein – an
allergen – as a threat and attacks it.
▪ Food allergies can be life-threatening.
▪ There is no cure for food allergy.
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What is a food allergy?
Food Intolerance
▪ A reaction to food that does not involve the immune system and is not life-threatening.
• Example: Lactose intolerance – trouble digesting lactose, a natural sugar found in milk, resulting in gas, bloating, stomach cramps, diarrhea.
Food Allergy
▪ A potentially serious reaction to food that DOES involve the immune system.
▪ Can be life-threatening.
• Example: Milk allergy – an immune response to milk protein, ingestion of milk can result in hives, wheezing, low blood pressure, and potentially death.
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Food Intolerance vs. Food Allergy
Peanut Tree nuts Milk Egg
Wheat Soy Fish Shellfish (Crustacean
– crab, lobster, etc.)
Common Food Allergens
▪ Eight foods are responsible for the majority of food allergy reactions in the United States:1
▪ A person can be allergic to virtually ANY food
▪ ALL food allergies need to be taken seriously
1 U.S. Food and Drug Administration (FDA). Food Allergies: What You Need to Know. U.S. Department of Health & Human Services; 2014. www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm. Accessed Oct. 20, 2014.
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Food Allergy Is On the Rise
▪ According to a 2013 report by the
Centers for Disease Control and
Prevention, there was a 50 percent
increase in food allergy between
1997 and 2011.1
▪ In addition, almost 1 in 3 children
with a food allergy have multiple
food allergies. 2
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1 Jackson, K., Howie, L, Akinbami, L. Trends in Allergic Conditions Among Children: United States, 1997-2011. National Center
for Health Statistics Data Brief . 2013. Retrieved from www.cdc.gov/nchs/data/databriefs/db121.pdf.2 Gupta RS, Springston, MR, Warrier BS, Rajesh K, Pongracic J, Holl JL. The prevalence, severity, and distribution of childhood
food allergy in the United States. J Pediatr.2011; 128.doi: 10.1542/peds.2011-0204.
50%
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Food Allergy in Context :
A Growing Public Health Issue
• 1 in 13 children has a food allergy
• Nearly 40% of these kids has had
a severe of life threatening
reaction
• Number of children with food
allergies is up 50% 1997-2001
• Someone sent to emergency room
every 3 minutes
• Caring for food allergies costs
families $25 b a year
Food Allergies: Reactions
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Food Allergy- Mild Symptoms of a Reaction
▪NOSE: Itchy/runny nose, sneezing
▪MOUTH: Itchy mouth
▪ SKIN: A few hives, mild itch
▪GUT: Mild nausea/discomfort
Food Allergy – Severe Symptoms of a Reaction
• LUNG: Short of breath, wheezing, repetitive cough
• HEART: Pale, blue, faint, weak pulse, dizzy
• THROAT: Tight, hoarse, trouble breathing/swallowing
• MOUTH: Significant swelling of the tongue, lips
• SKIN: Many hives over body, widespread redness
• GUT: Repetitive vomiting, severe diarrhea
• OTHER: Feeling something bad is about to happen,
anxiety, confusion
• Anaphylaxis, shock, possible death in as little as 30
minutes post exposure
What is anaphylaxis?
▪ Anaphylaxis is a severe allergic reaction that is
rapid in onset, and may cause death.
▪ It is a medical emergency and time is of the
essence.
▪ Studies show fatal reactions are associated with a
delay in receiving epinephrine.1, 2
▪ Food allergy is the leading cause of anaphylaxis
outside of the hospital setting.
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1 Bock SA, Muñoz-Furlong A., Sampson H. Further fatalities caused by anaphylactic reactions to food, 2001-2006.
J Allergy Clin Immunol. 2007; 119(4): 1016-8.2 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin
Immunol. 2001; 107(1): 191-3.
How common is anaphylaxis?
▪ 40 percent of children with food
allergies have experienced a
severe or life-threatening
reaction.1
▪ A food allergy reaction sends
someone to the emergency room
every 3 minutes, resulting in
210,000 visits each year.2
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1 Gupta RS, Springston, MR, Warrier BS, Rajesh K, Pongracic J, Holl JL. The prevalence, severity, and distribution of childhood
food allergy in the United States. J Pediatr. 2011; 128.doi: 10.1542/peds.2011-0204.2 Clark S, Espinola JA, Rudders SA, Banerji A, and Camargo CA. Favorable trends in the frequency of U.S. emergency
department visits for food allergy, 2001–2009. Allergy Asthma Proc. 2013 Sep-Oct;34(5):439-45.
Reaction data in school-age children
▪ One in six children with food allergies have had an
allergic reaction while at school.1
▪ About 25 percent of severe reactions at school
happened to individuals with no previous diagnosis
of a food allergy.2
1 Centers for Disease Control and Prevention (CDC). Voluntary Guidelines for Managing Food Allergies in Schools and
Early Care and Education Programs. Washington, DC: US Department of Health and Human Services; 2013.
2 Sicherer, S., Mahr, T., & the Section on Allergy and Immunology. (2010). Clinical Report – Management of Food
Allergy in the School Setting. Journal of the American Academy of Pediatrics. doi: 10.1542/peds.2010-2575
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How is anaphylaxis treated?
▪ Immediate treatment with an epinephrine auto-
injector is critical and may mean the difference
between life and death.
▪ Antihistamines will NOT help with a severe
reaction.
▪ A SECOND DOSE of epinephrine may need to be
administered if symptoms are not improving in 5-
10 minutes.
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RECOGNIZE: What will a reaction look like?
▪ Severity of reactions can vary.
▪ Once a reaction starts, there is no way to predict
how it will go.
▪ A seemingly mild reaction can turn life-threatening
within minutes.
▪ It is possible to have anaphylaxis, including severe
and fatal anaphylaxis, without skin symptoms. Do
not discount an allergic reaction or anaphylaxis
because you do not see hives.
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RECOGNIZE: Symptoms of an Allergic Reaction
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Skin• Hives (reddish, swollen, itchy
areas on the skin)
• Eczema (a persistent dry, itchy
rash)
• Redness of the skin or around the
eyes
• Turning blue
Mouth• Itchy mouth or ear canal
• Nasal congestion or a runny nose
• Sneezing
• Slight, dry cough
• Odd taste in mouth
• Trouble swallowing
• Obstructive swelling of the lips,
tongue, and/or throat
Abdomen• Nausea or vomiting
• Diarrhea
• Stomach pain
• Uterine contractions
Emotional• Sense of impending doom
• Change in alertness
• Mood change
Chest• Drop in blood pressure (feeling
faint, confused, weak, passing
out)
• Loss of consciousness
• Chest pain
• A weak or “thread” pulse
RESPOND: Act Fast, Seconds Count
▪ For serious reactions, act quickly:
• Give epinephrine.
• Call 911 and tell the operator that a student is having an anaphylactic reaction.
• Ask for an ambulance equipped with epinephrine and staff trained to use it.
• Lay person flat, raise legs and keep warm. If breathing is difficult or they are vomiting, let them sit up or lie on their side.
▪ Second dose of epinephrine may be necessary if symptoms have not subsided in 5-10 minutes.
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Consumer Perspectives on Label
Reading and Purchasing Behavior
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Label Reading
Confusion Abounds
▪ To gather preliminary information regarding consumer perspective of food allergen labeling practices from multiple countries
▪ To share summary data to help advance the dialogue amongst key stakeholders (i.e. food industry, food scientists, clinicians and researchers, government regulators, and patient groups)
▪ Subjects included those with food allergy, those with family members with food allergy, and caregivers of those with food allergy
▪ Survey captured information about the prevalence of specific food allergies, severity of reaction, buying practices in response to different type of labeling such as ‘may contain’
Labeling Study Objectives and Methods
▪ 6,684 respondents: 5,507 (82.4%) from the U.S and 1,177 (17.9%) from Canada
▪ Up to 40% of respondents purchase food with common precautionary allergen labeling (PAL)
▪ Severe allergic reaction history made respondents less likely to purchase foods containing PAL
▪ Canadians had higher odds of buying “may contain allergen” labeling
▪ The US had lower odds of buying products that utilized the “manufactured in a facility that also processes allergen” or “manufactured on shared equipment with products containing allergen”
Labeling Study Results
Variable Frequency, % (n)
All Respondents (US & Canada)
United States Canada
Purchase Product with the
Following Label:
“May Contain Allergen”
Never 87.7% (5,574) 89.9% (4,730) 77.2% (844)
Sometimes 11.3% (716) 9.4% (492) 20.5% (224)
Always 1.0% (63) 0.7% (37) 2.4% (26)
“Manufactured in a Facility that Also Processes Allergen”
Never 59.7% (3,795) 58.9% (3,098) 63.5% (697)
Sometimes 34.2% (2,174) 35.0% (1,841) 30.4% (333)
Always 6.1% (389) 6.1% (322) 6.1% (67)
“Manufactured on Shared Equipment with Products Containing Allergen”
Never 83.3% (5,301) 83.0% (4,375) 84.7% (926)
Sometimes 14.2% (904) 14.5% (762) 13.0% (142)
Always 2.5% (160) 2.6% (135) 2.3% (25)
Respondent Purchasing Behavior
Marchisotto MJ & Harada L; Kamdar O, Smith BM, Khan K, Sicherer S, Taylor S, LaFemina V, Muraro A, Waserman S, Gupta RS. Food Allergen Labeling and Purchasing Habits in the US and Canada. J Allergy Clin Immunol Pract. 2016. In Press.
Variable Frequency, % (n)
All Respondents (US & Canada)
United States Canada
Food Source Names
of Major Allergens
Required by Law
True 71.7% (4,522) 70.7% (3,740) 72.7% (782)
False 17.2% (1,092) 17.6% (929) 15.2% (163)
Don’t Know 11.8% (749) 11.7% (618) 12.2% (131)
Advisory Label Required by Law
True 28.8% (1,831) 25.6% (1,355) 44.1% (476)
False 54.4% (3,460) 57.9% (3,061) 37.0% (399)
Don’t Know 16.9% (1,075) 16.5% (871) 18.9% (204)**
Advisory Label Not Based on Amounts
True 63.3% (4,024) 63.3% (3,345) 63.3% (679)
False 8.5% (539) 8.3% (441) 9.1% (98)
Don’t Know 28.2% (1,746) 28.4% (1,501) 27.5% (295)
Respondent Knowledge about Labeling Laws
Global perceptions of food allergy
thresholds in 16 countries
▪ To better understand the knowledge/attitudes of consumers on food allergy thresholds and food purchasing habits related to PALs
▪ Patient support organizations from 16 countries (Australia, Canada, Chile, France, Germany, Ireland, Israel, Italy, Japan, Mexico, New Zealand, South Africa, Spain, the Netherlands, UK, and US) recruited adults w/FA or caregiver of someone w/FA for online survey on consumer perspectives on thresholds and labeling.
Results
▪ Less than 1/4 of participants in 11 of 16 countries reported that they would be willing to purchase foods containing their allergen if the amount would be incapable of causing an allergic reaction.
▪ When asked whether they would purchase foods containing their allergen if it were capable of only triggering a mild reaction, rates were lower across all countries (weighted average of 3%).
▪ 16% of respondents reported that they would be willing to purchase products with “May Contain Allergen”
What is a threshold and can it be ascertained?
▪ Threshold: Maximum amount of an allergenic food
that can be tolerated without producing any adverse
reaction.
▪Double-blind, placebo-controlled oral food challenge
: allergist administers increasing doses of food to
determine amount that elicits reaction.
▪Not optimal: illness, body temp, activity level,
menstruation, other factors can change reactivity
▪ Population thresholds not possible to discern for
most allergens at this time.
Conclusions
▪ Consumers seem to trust PAL to estimate allergen reaction risk. This risk assessment seems to occur at different rates depending on both country and the PAL statement used.
▪ Imperative that we educate consumers with food allergy on thresholds and PAL, develop effective policies for labeling, and change the way physicians advise their patients about avoidance.
▪ All stakeholders, including consumers, physicians, and food industry, need to be engaged to build understanding and trust in labels based on validated allergen thresholds when they can be reliably ascertained.
Resources
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For More Information
▪ Food Allergy Research & Education (FARE)
• Website: www.foodallergy.org
• Email: [email protected]
▪ Centers for Disease Control and Prevention (CDC)
Adolescent and School Health page
• Website: www.cdc.gov/healthyyouth/foodallergies/
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For More Information
▪ Food and Drug Administration
• Website: www.fda.gov
▪ U.S. Department of Agriculture
• Website: www.usda.gov
▪ Food Allergy Research & Resource Program
• Website: http://farrp.unl.edu
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Questions?
