# Presentation: 495066

## Protecting Food Allergic and Celiac Consumers

- FDA Public Meeting on Advisory Labeling
- September 16, 2008

## Scott MandellCEO/President and Co-founder Enjoy Life Foods

- Founded company in 2001; **pioneered allergy-friendly food market**
**Leading allergy-friendly AND gluten-free food company** in U.S. and Canada
**Solely dedicated to offering foods to more than **_**45 million**_** Americans who follow special diets** due to:
**Food allergies** (12 million; 6 - 8% children and 3.5 – 4% adults)
**Food intolerances** (~30 million)
**Celiac Disease** (1 in 100 Americans or ~3 million)
**Autism** (1in 150 or ~2 million)
- Other health concerns
**Deep understanding and expertise** in meeting needs of people with dietary restrictions
**Actively involved **in Celiac Disease and food allergy organizations
- Member, American Celiac Disease Alliance (ACDA)
- Board member, Gluten Free Certification Organization (GFCO)
- Food Allergy & Anaphylaxis Network (FAAN); Food Allergy Initiative (FAI); Eat Learn Live
- Invest in extensive consumer and professional education programs

## Unique mission and focus

All foods are free of the eight common allergens (as defined by FDA) and gluten-free

Most products made in company-owned, dedicated nut- and gluten-free facility

Proprietary ingredient qualification, supplier oversight and risk rating protocol to ensure product safety

All products certified gluten-free by the Gluten-free Certification Organization (first company to receive certification)

Clear, FALCPA-compliant product labels to make it easy for food allergic consumers to get critical ingredient information

- All foods are **free of the **_**eight**_** common allergens **(as defined by FDA) and **gluten-free**
- Most products made in company-owned, _**dedicated**_** nut- and gluten-free facility**
**Proprietary ingredient qualification, supplier oversight and risk rating protocol** to ensure product safety
- All products **certified gluten-free** by the Gluten-free Certification Organization (first company to receive certification)
**Clear, FALCPA-compliant product labels** to make it easy for food allergic consumers to get critical ingredient information

- Company mission is to produce great-tasting foods that most everyone can ***eat freely***

## Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) was important first step in helping special dieters get information needed to make informed food choices

However, despite industry’s best efforts at truthful food labeling, grocery stores are still a dangerous minefield for food allergic, food intolerant and Celiac shoppers

Hidden allergens (including gluten) in foods can be caused by*:
Formulation errors
Packaging/labeling errors
Undeclared use of rework or leftovers
Presence of ingredients derived from allergenic source
Use of shared equipment and/or facilities

Advisory warnings are confusing, inconsistent and do not provide adequate information to make smart and safe decisions

Gluten currently not required to be listed on FALCPA-compliant labels
Gluten-free definition expected to be announced shortly

- However, despite industry’s best efforts at truthful food labeling, **grocery stores are still a dangerous minefield** for food allergic, food intolerant and Celiac shoppers
**Hidden allergens** (including gluten) in foods can be caused by*:
- Formulation errors
- Packaging/labeling errors
- Undeclared use of rework or leftovers
- Presence of ingredients derived from allergenic source
- Use of shared equipment and/or facilities
**Advisory warnings are confusing**, inconsistent and do not provide adequate information to make smart and safe decisions
**Gluten currently not required to be listed** on FALCPA-compliant labels
- Gluten-free definition expected to be announced shortly

- * Source: FAAN

- Current regulations not sufficient to fully protect food allergic & Celiac consumers

## Almost 1⁄2 of food allergic people have serious problems using food labels to help them avoid certain foods (Source: FDA)

FAAN has documented over 30 different advisory warnings on food products (Source: FAAN)

Advisory labeling is voluntary, therefore different companies have different criteria for using various warning statements

In absence of clear standards, consumers are making their own risk assessments based on statements
May incorrectly assume one food is safer than another based on its label
For those with Celiac Disease, a gluten-free diet is sole course of treatment
No remedy for accidental exposure to gluten (i.e. Epi-pen or Benadryl)
Accidental consumption of gluten over time can cause damage to system
May avoid eating a particular food unnecessarily due to advisory warning
May assume that warning is added due to liability/legal reasons rather than real safety issue

Consumers are increasingly ignoring advisory labeling due to overuse and inconsistent criteria
In 2006, 75% of food-allergic consumers said they would “never” purchase a product with an advisory warning, down from 85% in 2003 (Source: FAAN)
Decreased vigilance in label reading could lead to negative and potentially life threatening reactions

- FAAN has documented over **30 different advisory warnings** on food products (Source: FAAN)
- Advisory labeling is **voluntary**, therefore **different companies have different criteria** for using various warning statements
- In absence of clear standards, **consumers are making their own risk assessments** based on statements
- May incorrectly assume **one food is safer than another** based on its label
- For those with Celiac Disease, a gluten-free diet is sole course of treatment
- No remedy for accidental exposure to gluten (i.e. Epi-pen or Benadryl)
- Accidental consumption of gluten over time can cause damage to system
- May **avoid eating a particular food unnecessarily** due to advisory warning
- May **assume that warning is added due to liability/legal reasons** rather than real safety issue
- Consumers are **increasingly ignoring advisory labeling** due to overuse and inconsistent criteria
- In 2006, **75% of food-allergic consumers said they would “never” purchase a product with an advisory warning**, down from 85% in 2003 (Source: FAAN)
- Decreased vigilance in label reading could lead to negative and potentially life threatening reactions

- Consumers do not have information required to make ***smart*** and ***safe*** food choices

## Enhanced regulations required to adequately inform and protect food allergic & Celiac consumers

- Commend FDA’s commitment to develop labeling that is **truthful**, **not misleading**, **clear, uniform **and that **adequately informs** special diet consumers
- Strongly support development of **consistent, risk-based guidelines for the use of advisory statements**
- Support **more stringent enforcement** for manufacturers who do not comply fully with FALCPA regulations
- Recommend development of **free, comprehensive consumer database** of mislabeled or misleading food products
- Consider implementation of **third-party allergy certification system** to identify those manufacturers following ‘safe’ procedures and standards
- Enjoy Life/ACDA provided comments on **FDA’s proposed rule for gluten-free labeling** and look forward to final ruling in near future

## On behalf of all food allergic and Celiac Americans...

*Thank you!*