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)e in control of her own situation. 

When she used to go to play dates, even 

vhere the people were trained to read the labels, 

;he would say can you read it to me so I can hear 

Lt because there are some words I need to know, 

;hat I know to look for. It's also important in 

zerms of not the people who are only food allergic 

and their caretakers, but all of her friends who 

Nant to be able to sit with her or provide her 

snacks, and .it's very difficult when they're trying 

to make the effort to be nice and to be inclusive 

to say, well, you don't really understand. There 

are ten scientific terms you have to look.for. So 

don't bother, we'll take care of it. 

And here's Becky. 

MS. REBECCA DUGAL: Hi. I'm Rebecca 

Dugal. I live in Allendale, New Jersey. I'm 

entering fourth grade at nine and a half. I have 

anaphylaxis to peanuts, peas and lentils. I'm also 

allergic to wheat, eggs, apples and tomatoes. I 

believe that people need to be able to read labels 

very easily. 

Living with food allergies and labels is 

hard. It"s diff,icult in general to go places and 

do things where food is involved. Most people 

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lan't read the labels for $e'&nut allergens Unless 

ny parents have trained them. All the different 

names for peanuts make it confusing. Ingredient 

Labels are hard to read since they are small and 

nave many scientific names such as hydrolyzed 

vegetable protein. 

People for whom English is not a first 

language and children have a particularly hard 

time. Even if my parents read the labels, they are 

never sure whether there will be 

cross-contamination since only some manufacturers 

use "may contain traces of." 

Most adults I am with prefer just not to 

give me food. I cannot eat at play dates because 

of the labels. Snack times at school and camps are 

very stressful since we can't trust the labels. 

It's scary to try new food since we never know if 

cross-contamination is involved. 

Since the labels aren't clear, I don't eat 

many foods I may be able to eat. Babysitters are 

difficult to trust with reading labels. My peanut 

allergic friends and I have reacted to seemingly 

non-allergic foods where the labels have not been 

clear cross-contam'ination exists. 

Breads, candies, baked goods, other nuts 

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tnd snack foods are some of the foods I have just 

Described. As a result, 1' don't eat many 

manufactured products in these categories since I 

don't want to take the chance of having a reaction. 

Food labels should be made readable,. ' 

{istakes can have serious outcomes. There needs to 

)e a consistency in the use of "may contain" and 

"manufactured in a faculty containing." 

Lettering should be large enough to read 

easily. Highly allergic foods should be listed 

separately and not included in flavorings, spices, 

colorings. 

Symbols should be used for the eight most 

commonly allergic foods in addition to the actual 

ingredients. Symbols would be easy to implement 

and make labels more understandable. Foods would 

be easily identified as containing one of the eight 

allergens. Symbols would inform the consumer to 

read the detailed ingredient list more carefully. 

Non-English speakers and children would be 

able to use the symbols easily. Training of 

non-allergic adults would be simple and they would 

have confidence in knowing whether a food is 

dangerous. Standardized symbols.would reduce the 

risk of mistakes and horrible reactions. 

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Simple symbols will be the easiest to 

recognize and take up less space than words. Here 

is an example of the peanut symbol and wheat 

symbol. 

The next steps you should take: you should 

aggressively pursue the use of standard symbols; 

make font symbol size large enough to read easily; 

agree on a standard use of "may contain" statements 

always with the eight most commonly allergic foods 

separately; educate the manufacturers and 

consumers; and review labeling of cosmetics, 

medicines and in restaurants, including food 

service packages. 

You can help make my allergies easier to 

cope with. Thank you. 

[Applause.] 

DR. LEWIS: Thank you very much, Rebecca, 

and to her mom as well. Next is Anne Whelan, who 

would be followed by Colleen Parr, if she's here. 

If not, Leila Leoncavallo. 

MS. WHELAN: Good afternoon. My name is 

Anne Whelan and for the last six years I have 

published Gluten-Free Living, a national newsletter 

for people who like myself are gluten sensitive. 

Without going into the details of the 

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disease, as you know, it has a cure, the gluten 

free diet, using cure in the sense of remission as 

long as there is no gluten in the diet. There is 

no true for celiac disease in the sense of a 

complete resolution. 'Once a celiac, always a 

celiac. 

At diagnosis, we are advised to follow a 

life long gluten-free diet. Gluten is found in 

wheat. In fact, wheat is probably the main source 

of gluten for American celiacs. It's also found in 

rye I barley and derivatives of these grains. Wheat 

is far and away the most problematic because wheat 

seems to be everywhere in this country and to be 

found in the vast majority of American foods. 

For the record, barley, too, can be 

difficult. Rye is relatively easy to avoid. We 

have to become proficient at reading labels and as 

we've all learned this morning, that is not easy. 

The best case example where wheat is concerned is 

modified food starch. We would like to see 

modified wheat starch, modified corn starch. 

In this area, another issue that comes up 

for celiacs is spelt. Spelt, kamut, and triticale, 

or triticale, are three less common grains that 

celiacs have to avoid. Only spelt is problematic. 

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In plain language, spelt is a form of wheat. It 

may not bother some of those who are allergic to 

wheat, but it does bother those who are sensitive 

to wheat. 

Some food processors now label foods that 

contain spelt as wheat free, and sometimes even as 

gluten free. Neither term is correct and it should 

not be permitted as it is misleading and dangerous. 

It relates here because of the inclusion of wheat 

on the list of allergens, and the unde,rstanding, 

which may not be universal, that spelt does not 

have the allergenic potential that wheat does. So 

spelt should be labeled as spelt, and a product is 

not wheat free or gluten free if it contains spelt. 

I think specific source or plain English 

terms should be mandatory, not voluntary, for all 

the good reasons that we've heard this morning. 

The phrases nmade on shared equipment" or 

"made in a dedicated facility" are a little 

different. To a celiac, "dedicated" would mean 

gluten containing products are not processed in the 

same facility. And "made on shared" would mean 

shared referring to gluten-containing products. To 

a certain extent, those are helpful to us. They 

don't tell us about glut,en content, but they do, 

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tell US about contamination, and celiacs are 

particularly interested in contamination because 

the effects of gluten can be cumulative. 

Helpful those these phrases may be, they 

should not substitute for disclosure. Celiacs have 

long hoped for source declarations of the contents 

of flavoring, spice or color. They're three of the 

main ingredients that make us uneasy. I think 

there should be a generally applicable policy in 

this area. I know with flavorings that the problem 

of trade secrets is sticky. Processors should be 

able to keep their secrets secret. That's what 

celiacs hear when they call a food processor to 

find out what's in it. 

At the same time, we should be able to 

know what's in our foods and to fill comfortable 

about the foods that we eat. 

In conclusion, the celiac community is 

thankful for the opportunity to speak here and 

looking forward to working with the FDA and with 

the other groups on better labeling for people who 

are celiac. I would like to thank the FDA, the 

CPSI, and particularly the FAAN for all they have 

done in the wheat area which helps us enormously. 

Thank you very much. 

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[Applause,] 

DR. LEWIS: Thank you. I believe Colleen 

Parr is no longer with us and will not be speaking. 

You are here? Is this Colleen Parr? 

MS. LEONCAVALLO: No, I'm Leila 

Leoncavallo. 

DR. LEWIS: You're Leila Leoncavallo. 

MS. LEONCAVALLO: Leila Leoncavallo. 

Before I begin, I just want to disclose that I am a 

former employee of CSPI, but today I'm here solely 

representing myself and my daughter who is three 

years old and suffers severe allergies to both 

peanuts and shellfish. 

I would just like to focus my remarks on 

the issue of precautionary labeling. And I 

certainly support good manufacturing practices to 

clean up the factories as much as possible to 

ensure that allergens are eliminated or reduced, 

but at the same time I think that it is still 

imperative that labeling occur even in instances 

where the factory is cleaned, because I want to 

make those decisions for my daughter. 

We just heard Ms. Katie state earlier that 

cleaning will not succeed in removing all 

allergens. We've also seen numerous instances of 

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food recalls whe.re presumably large companies or 

companies that presumably would be cleaning up the 

allergens from their machines shouldn't be having 

to recall their foods after the contamination takes 

place. 

For example, Kellogg's--this is a company 

that does,not label foods on shared equipment and 

presumably employs 'good manufacturing 

practices--they had two major recalls in the past 

year. And I don't want my daughter to be a guinea 

pig to find out when food 'is safe and when it's not 

safe. I want to see the label in place in addition 

to the good manufacturing practices by all these 

companies. 

I know a lot of people have expressed 

concerns with the issue of reducing food choices. 

My daughter's food choices are already reduced. I 

have to call all of these companies to find out 

whether this is on dedicated equipment or not. Her 

choices are reduced. I just want her to have safe 

food choices. I don't think that having voluntary 

guidelines is going to ma'ke a bit of difference. 

It has to be regulated. 

The label must be readable and it must be 

reliable. As many people have mentioned today, 

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children are having to read the label, caretakers 

are having to read the label, family members are 

having to read the label, and it's impossible to 

fully educate people as to what terms to look for 

or where to look for on the label unless it is 

regulated and reliable and easy to read. 

Labeling must be mandatory or the 

situation will simply be no different than the 

status quo. We will still need to call companies 

to get this information. This method is not only 

time consuming and frustrating, but it's often 

unreliable, and I just want to share a couple of 

examples from my experiences in talking to 

companies, and these are not just small companies. 

These are major companies that you think would know 

better. 

I have a letter from April 2001 from 

Quaker responding to whether or not their Quaker 

Life cereal is safe for my daughter to consume, 

whether it's made on dedicated lines, and they say, 

and I quote: "Although we would like to help you 

find products that meet your special dietary needs, 

we are ,not able to provide the information you 

requested. Unfortunately, the federal labeling 

laws are not designed to indicate the presence of 

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peanuts." 

Then I have thi,s. These are notes from my 

conversation with Kellogg's when I inquired about 

their labeling policies. They say for their 

cereals, you must look under the "best before date" 

for these letters, B, L or S. If it says K, it's 

not a nut-free plant. 

Their regular and Double Chocolate Rice 

Krispie Treats are on dedicated lines but not in 

nut free plants. If I could just continue. 

Scotchie and Caramel Rice Krispie Treats are on the 

same line as peanut butter. Pop Tarts could be 

made on the same line. Nutragrain Bars and Twists 

are made in a nut-free plant. Nutragrain Squares 

are on dedicated lines, but not in nut-free plant. 

Pancakes are in a nut-free plant, but waffles are 

not in a nut-free plant, and you must call every 

six weeks to verify. 

[Laughter.] 

MS. LEONCAVALLO: Given this, I just don't 

know how we can rely upon any type of voluntary 

system, and I think if we have voluntary guidelines 

in place, great, you know, that's one step forward, 

but I'm still going to have to call the companies, 

and I"m still going to get the same responses. 

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Thank you. 

[Applause.] 

DR. LEWIS: Thank you. The next on our 

list is Andrew Finkeistein. And following Andrew 

Finkeistein would be Daniel DuBravec. 

Are either of those prepared to present? 

Is this Daniel DuBravec? 

MR. DuBRAVEC: Dan DuBravec. 

DR. LEWIS: Please go ahead. Following 

Daniel DuBravec will be Lise Borel. 

MR. DuBRAVEC: Hi. I'm Dan DuBravec. 

I've been a chairperson for the CSA USA, the Celiac 

Sprue Association, for about six years in Boston 

and now in Northern Virginia. 

And again -1 appreciate you forming this 

panel and allowing us to speak and I think it's 

also great that there are so many people, you know, 

representing the Celiac Sprue and bringing up our 

cause. I've been taking notes kind of through the 

session here, and these are some of the statements 

1"ve heard today: 

"Is looking into," "starting baseline 

surveys," "suggesting' guidelines," "encouraging 

members to declare," "devoting energy to," "needs 

to look into further," "contemplating issue," 

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"looking at practices; ii iiarea that needs 

attention," "struggling with for decades." 

My main point I want to get across is that 

I think the time is now for the mandatory food 

labeling. I think the opportunity for voluntary 

labeling has been there and there has been some 

effort, but as you"ve heard from so many people, 

it's just not there. And I think the time to act 

for is now. 

And as a chairperson, I speak to people 

all the time. I've spoken to hundreds that are on 

the wheat-free/gluten-free diet, and, you know, 

they're always asking me what I can eat, and we try 

to, you kno'w, we contact the manufacturers and we 

also get information from them. You know it's 

information that they often do have and one.area 

and concerning cross-contamination, and I'm not 

sure was addressed, but it probably included, was 

the part concerning packaging. 

YOU know we thoroughly look at labels, and 

we go in the frozen food department and we pick up 

a package of frozen broccoli, let's say. Now, it 

could say it contains broccoli, right, and water. 

You would never assume or even think that in 

packaging that it may be dusted with flour, but 

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that does happen, &ti& ifj e$fms of--I mean 1 have a 

sheet right here telling me that. You know I came 

in. I was just so shocked, and I had been with CSA 

for a long time, and this was even surprising to me 

that, you know, just buying frozen vegetables that 

I have to be cautious about that. 

so I, you know, mandatory labeling, 

please. And, you know, "may contain, rl even though 

it may eliminate many products that may or may not 

contain it is very helpful for people who are on 

such a sensitive gluten-free diet. Thank you. 

[Applause.] 

DR. LEWIS; Thank you. Next would be Lise 

Borel. And if Lise Bore1 is not here, I understand 

Wendy Reinhardt will be substituting for Dave 

Schmidt. 

MS. REINHARDT: Hi. My name is Wendy 

Reinhardt. I'm with the International Food 

Information Council Foundation, and just a quick 

note, as we consider many ways to try to make food 

allergy more understandable for consumers. The 

International Food Information Council would like 

to make everyone aware of our foundation resources 

which are informational resources on food allergy. 

Particularly outside you can get a copy of our 

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1 > 

latest IFIC Review! ~B,~~~~fanding Food Allergy, 

which is a reference white paper for Winion 

leaders. 

And you can also get a copy of our 

consumer brochure, Understanding Food Allergy, 

outside. These resources as well as many other 

resources related to food allergy are available 

outside and then also on our website, ific.org. 

Thanks. 

[Applause.] 

DR. LEWIS: Thank you. Next on our list 

is Jerry Shier. And following Jerry Shier would be 

Kimberly Scott. 

DR. SHIER: Good afternoon. I'm Jerry 

Shier. I'm a board certified allergist 

immunologist in private practice in Rockville and 

Silver Spring, Maryland, as well as an Assistant 

Clinical Professor at George Washington University 

School of Medicine. 

Today, I'm representing the American 

Academy of Allergy, Asthma and Immunology. This is 

the largest academic organization in the United 

States representing physicians who care for 

individuals with allergic diseases. Food allergy 

is of great concern to the Academy, so much so 

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_, c1 $ih $.. i .* there's a speciai academic &ctfon within the 

organization to further its members' education, 

monitor research, and create treatment guidelines. 

There are approximately six to seven 

million Americans with true food allergy, with 

children being the largest group. Food allergy is 

the leading cause of anaphylaxis outside the 

hospital. Anaphylaxis is a full-bodied allergic 

reaction that can occur in minutes. Symptoms 

including hives, welts on the skin, asthma like 

symptoms, gastrointestinal symptoms, cramping, 

diarrhea, bloody stools, swelling of the lips, eyes 

and tongue. 

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An estimated 200 deaths occur each year * 

from anaphylaxis from foods. There are 

approximately 30,000 emergency room visits from 

food allergic reactions. In my practice, I hear 

about food allergic reactions on a daily basis. 

Since there is no cure, the physician's goal is to 

teach the patient how to recognize and manage an 

allergic reaction. 

But more important is preaching strict 

food avoidance. Part of the avoidance is vigilant 

label reading. The subject of label reading is why 

we're all here today. I have no other treatment 

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'hi J;, I/ $ y"> recommendations other Man avoidance. In the case 

of asthma, another common allergic disease, I can 

preach avoidance of airborne allergens, but I also 

have numerous medicines to prevent the symptoms, 

medicines to treat active symptoms, and a method 

to desensitize patients to allergens that 

precipitate their symptoms. 

~t"s clear from this comparison to other 

allergic diseases that the consumer's ability to 

identify food allergens is their only treatment 

because the use of medicine is not the treatment of 

food allergy, it is the treatment of either an 

accidental or unknowing exposure that led to an 

acute, potentially life threatening allergic 

reaction.' 

Our goal should be to prevent this from 

occurring. The American Academy of Allergy, 

Asthma, Immunology is in full support of the easy 

identification of the most common food allergens on 

all labels. These include milk, egg, wheat, soy, 

tree nuts, peanuts, fish and shellfish. 

What do I mean by easy identification? 

Let consumers know that these allergens are in the 

products they are purchasing by using the real name 

of the food: milk, egg or wheat, not casein, 

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ovalbumin or farina. This should not be Russian 

Roulette. The FDA must make it mandatory that 

major food allergens appear on labels if they are 

used as an ingredient in a way that our food 

allergic patients can easily identify the allergen. 

What does "ingredient exempted from 

declaration" mean? If the food allergen is in a 

processed food, what's labeled as such. Major 

allergens are found in ingredients labeled as 

flavoring or spices or colors. Low levels of 

allergens can be responsible for an allergic 

reaction which sometimes can be life threatening. 

Please just let me finish. The FDA needs 

to require food manufacturers to place the names of 

major food allergens on' labels regardless of the 

amount. 

Finally, I applaud the companies that have 

voluntarily instituted labeling that a major food 

allergen may be present, even though it's not a 

known ingredient. This is usually due to the use 

of shared equipment to produce a food that does and 

one that does not. have a food allergen. 

Unfortunately, there are companies now 

that have been begun labeling foods as having major 

allergens, purely on a liability basis, versus a 

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true risk. In ad&tis%,, !&here is no uniformity on 

how the information is presented. 

The American Academy looks to the FDA to 

create standards for the food industry's proper use 

of these statements and consistent verbiage of 

these statements so that we can educate our 

patients. 

In conclusion, although I sit here today 

representing a large body of health care providers, 

I can tell you first hand that labeling systems 

need fixing, and that there are many Americans, 

especially parents of children, that have a fear 

that is indescribable, a fear of food that can be 

paralyzing. 

The solution appears simple. If the major 

food allergen is present, label it so we can all 

understand it. If there is a real contamination, 

then label it in a uniform way. The food allergic 

individual is already restricted from eating 

outside the home because it's so difficult to 

identify all the ingredients and the potential for 

cross-contamination in restaurant foods. So let's 

make eating at home safe for those with potentially 

life threatening conditions. Thank you. 

[Applause.]' 

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DR. LEWIS: tiext is Kimberly Scott, to be 

followed by Sarah Gitlin. 

MS. SCOTT : Good afternoon. My name is 

Kimberly Johnson Scott, and I appreciate this 

opportunity to provide oral comments on allergen 

related labeling issues. Today I am speaking both 

as a mother of Sidney Scott, our energetic 21 month 

old, and as the co-founder of the SOS Foundation. 

On March 27 of this year, my husband and I 

were shocked to learn that our daughter Sidney had 

1 

a life-threatening allergy to peanuts, tree nuts 

and eggs.- In a moment, the security we had 

previously felt in selecting food for our family 

evaporated into thin air. 

The exact same labels upon which we had 

previously relied and which as parents we found 

reassuring suddenly took on a potentially life or 

death prominence in our household. Questions 

replaced confidence. 

What does it mean when "contains peanuts" 

isn't on the label, but '"natural flavorings*' is? 

Did I read over those ingredients with 15 syllables 

in it and did not recognize that it was an egg 

protein because I didn't see the word Ilegg"? Why 

would the label say "may contain nuts" when I read 

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, : 

the label ten times and f didnlt see nuts anywhere? 

While devoting time to reading food labels 

clearly and deliberately is a small sacrifice to 

make for those we care about, we need the FDA to 

help empower parents by requiring clear and 

comprehensive labeling of products. Through our 

desire to help our daughter and other similarly 

situated families, my husband Stuart and I have 

co-founded the SOS Foundation, a not-for-profit 

organization which has pledged financial, emotional 

and practical support to those who struggle to meet 

the challenges of living with a chronic condition. 

In order to help improve the lives of 

individuals with food allergies, SOS will serve as 

an additional vehicle to-advocate for accurate food 

labeling, practical food labeling legislation, 

effective research and increased awareness. In the 

coming year, the SOS Foundation will join forces 

with organizations and individuals who have long 

dedicated themselves to this effort. We hope to 

work in partnership with the FDA in bringing 

together industry, consumer, medical and scientific 

groups for the purpose of better educating the food 

industry and enhancing the level of public 

awareness of the public health risk of incomplete, 

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inaccurate, inconsistent, and incomprehensible 

labeling of food products. 

I would like to briefly comment on the 

specific matters under consideration at this 

meeting. A condition such as anaphylaxis is 

unpredictable enough without the added stress of 

trying to decipher food labels. Plain English in 

the labeling of food ingredients is critical to 

empowering individuals to take control of their 

condition, restoring a certain amount of 

independence and equally as important is the power 

and freedom it gives to friends and relatives of 

non-food allergic individuals to make responsible 

selection of food items to share with or entertain 

their food allergic friends and relatives as will 

responsible use of advisory labeling. 

When a food company manufactures five 

products without nuts but also manufactures one 

with nuts, and places advisory labels on all six 

products, this greatly reduces the already limited 

choices of those who are searchzing for a list of 

can haves in a world of cannot haves. 

Finally, we must realize that listing the 

major food allergens must not be limited to those 

found in significant amounts, but also extend to 

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those found in trace amounts. This boils down to 

an issue of trust. Can I trust what is on the food 

label is actually what's in the product? 

With that trust comes the opportunity to 

regain the power to monitor and maintain one's 

health to the best of their ability until the day a 

cure is found. This is a chance to be free of the 

agonizing choice of whether to risk an anaphylactic 

reaction every time you take a bite. 

With the FDA's help, we have before us the 

opportunity to release those who suffer from this 

condition from a food prison so that they may not 

just eat to live, but that they may also eat and 

live. I thank you for this opportunity. 

c 

[Applause.] 

DR. LEWIS: Next will have Carol Schrager. 

Sarah Gitlin, first. Sarah Gitlin is here. 

MS. GITLIN: Good afternoon. My name is 

Sarah Gitlin, I am ten years old. I am deathly 

allergic to peanuts, tree nuts and fish. When I 

learned to read, five years ago, in kindergarten, I 

started with Dr. Seuss, Mother Goose, and 

ingredients labels. 

[Laughter.] 

MS. GITLIN: I knew that Dr. Seuss and 

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Mother Goose wouldn"t lie to me, but ingredients 

labels, I couldn't be so sure. I have to be able 

to trust these labels. For if I eat something I'm 

allergic to, even a tiny trace of it, and couldn't 

get proper treatment, I could die within minutes. 

I try very hard only to eat what I know is 

safe, not to risk it if the food might contain 

anything I'm allergic to. But who would guess that 

a common popcorn brand would use the word.s "natural 

flavors" to mean peanuts? And who would guess that 

the words "vegetable protein" and "plant protein" 

would be food companies' code words for tree nuts. 

These words as well as incomplete 

ingredients labels are life threatening for food 

allergic children. That is why I am here today to 

urge the FDA to enact regulations that require 

ingredients labels with an accurate list of every 

ingredient in the product. 

Some food companies already do this 

voluntarily. And that's great. But I need 100 

percent to do it. My life depends upon it. I'm 

not asking you to tell food manufacture,rs to change 

their recipes. I'm not asking you to tell them 

what they can or'can' t add to their products. I'm 

not asking you to tell them that they have to 

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change their manufacturing processes. 

~11 I'm asking you to do is to make them 

tell me what recipes they're using, tell me what 

they already add to their products, tell me whether 

they"re manufacturing processes result in adding 

even traces of the food I am so deathly allergic 

to * 

Eeading ingredients is a large part of 

food allergic children's lives. So large that the 

Food Allergy and Anaphylaxis Network published this 

story: 

A mother was trying to teach her food 

allergic child not to talk to strangers. So, she 

asked her daughter, if a stranger in a car pulled 

up and offered you a candy bar, what would you do? 

Without missing a beat, the little girl responded I 

would ask them to read me the ingredients. 

[Laughter.] 

MS. GITLIN: That girl knew what was 

really dangerous. Because food allergies are so 

dangerous, food allergic kids and their families 

around the country urge you to protect our lives by 

requiring ingredients labels to be complete, 

accurate and in plain English so that we can really 

know what's in the food we are eating. Thank you. 

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[Applause.] 

DR. LEWIS: Thank you, Sarah. I now 

believe itfs Carol Schrager. 

MS * SCHRAGER: Good afternoon. I'm 

Sarah's Mom, and I'm a member of the Food Allergy 

Initiative and the Food Allergy and Anaphylaxis 

Network. 

Raising a food allergic child without 

complete and accurate ingredients labeling is like 

walking through a mine field. No matter how 

carefully you watch your step, you never know when 

there will be an unexpected explosion. It's hard 

enough to avoid the dangers that we know about, but 

it's impossible to rest easy when we know that 

there are dangers h,idden in foods that Sarah might 

eat, but we don't know which foods and we don't 

know which dangers. 

So we turn to you, the Food and Drug 

Administration, the agency charged with protecting 

American lives by regulating the practices of food 

and drug manufacturers. 

We need you to help us protect the lives 

and health of the seven million Americans with food 

allergies by enacting regulations that are 

stunningly simple, the kind of regulations that 

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most Americans assGe@ &x&&ady ex 

regulations that most people are 

out do not already exist. 

ist, the kind of 

shocked to find 

What we urge you to require is merely 

this: that every packaged food has a label that 

states in plain English every ingredient that is in 

the product, both ingredients that are part of the 

recipe, including spices and natural flavors, and 

ingredients that are unavoidably present because of 

cross-contamination with other foods. 

These regulations would save lives with 

;rirtually no downside for food manufacturers. Yes, 

it may cost the manufacturers a little bit more to 

assure that their labeling is accurate, but such 

zests are trivial when balanced against the 

precious irreplaceable lives of, our children. And 

remember, the number of Americans with food 

allergies is growing exponentially. So 

nanufacturers actually have a lot to gain from 

these regulations' because the market for their 

products will expand. 

As food allergic consumers and their 

iamilies and friends who now will not buy products 

-hat are said to contain, for example, natural 

Flavors will feel safe consuming them once they are 

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assured that the alle?gCns are not present. 

,Dnder the regulations we support, food 

manufacturers would not have to change a single 

thing that they do. They could include any or all 

allergens in any or all of their products. They 

could process foods on shared, equipment without 

cleaning the production line in between runs. They 

could do anything they want to do, anyway they want 

to do it. All that we ask you.to require them to 

do is tell us what they're doing and tell us how 

they're doing it, so that we can make intelligent 

choices to protect our children's lives, so that we 

can walk through a field with our children without 

fear of an explosion. 

Thank you very, much for listening to our 

concerns and to giving my daughter a close-up and 

personal lesson in participatory democracy. We 

appreciate it very much. 

[Applause.]' 

DR. ,LEWIS: Thank you. Next we have 

listed Barbara Solan. And following Barbara Solan, 

we have Ben Wilson. 

MS. .SOLAN: Thank you for the opportunity 

zo.speak, I don't usually do podiums. I think 

democracy is a wonderful opportunity and to stand 

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find them confusing. Arid 1, think they will only 

muddle the issue. 

I like the General Motors--General 

Motors--I come from the Detroit area--General Mills 

model that says food allergy consumer or allergy 

information: contains nuts, soy. That helps me. 

And I'll go very quickly on this. I think we need 

to set priorities. There's a lot of issues about 

food allergies. I've lived with them for 11 years. 

Some are bigger than others. And we should grab 

the big ones. We should think out of the-box and 

we should be creative in our problem solving. 

Thank you. 

[Applause.] 

DR. LEWIS: Thank you. Next we have 

listed Ben Wilson, who will be followed by C. 

Gordon Brown. 

MR. WILSON: I'm Ben Wilson and I'm 

Director of Regulatory Compliance for Sensient 

Flavors, a food flavor company. I'm feeling a 

little at risk on this side of the audience this 

afternoon. 

[Laughter.] 

MR. WILSON: But we need some help from 

r'DA as well. I answer the questions from our 

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customers and from their customers, the consumers, 

about allergens and whatIs contained in a food, but 

the questions I get go much beyond the simple 

allergens. Today people want to know about GMO, 

they want to know about organic, they want to know 

about consumer interests in different things, they 

want to know about specific issue products. 

They're very important to these people 

that ask them. In some cases, they're 

significantly life threatening like allergens, but 

the responses that we give and when trying to 

provide the information seem to confuse the f,ood 

companies. They will ask us does this product 

contain soy? And we will answer yes, but the soy 

that's in it may be a partially hydrogenated 

soybean oil, has no protein, has-no allergen issue. 

It's been highly refined, it's been modified, the 

proteins are gone. 

That may be of interest to a specific few 

who have a different type of soy reaction. It may 

be of interest to our customer because he's looking 

at a GM0 issue for soy. He may be looking for 

Europe. We need some clarification from FDA as 

they look into these products and allergen and 

either guidelines or rules or whatever, but what 

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are the allergens, what are the things that we need 

to talk about? 

Are we going to talk about the big eight 

in general as alle,rgens, not the big eight of soy, 

which contains a lot of things that aren't 

allergens, or of corn, which is an issue, but for 

most people not an allergen? Wheat--is that an 

allergen issue to wheat or is that an issue of 

sprue celiac where it includes the glutens, the 

spelt, the rye, the barley? 

Does this include different extracts which 

may or may not have allergen potential? We need to 

make that clear. That needs to be very clear in 

what we're doing of whether we're addres-sing 

allergens, whether we're addressing big groups, and 

that's it. And that's what I want to say for 

today. Help us help the food manufacturer put the 

correct information on the label by giving us some 

clear guidelines, of w,hat we're talking about and 

what the things are of concern. Thank you. 

[Applause.] 

DR. LEWIS: Thank you. Next, we have C. 

Zordon Brown, who would be followed by Carolyn 

3arrett. 

MR. BROWN: Thank you very much. I'm 

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Gordon Brown, Senior Vice President of Scientific 

and Regulatory Affairs for the International Dairy 

Foods Association. We thank you very much for 

providing this forum and for providing an 

opportunity for us to get our positions out there. 

The following comments are made on behalf 

of the International Dairy Foods Association. IDFA 

is the nation's leading trade association 

representing the dairy industry. Our member 

companies manufacture the entire range of dairy 

products and include processorsI manufacturers, 

marketers, distributors and suppliers. 

IDFA consists of three constituent 

organizations: the Milk Industry Foundation, the 

International Ice Cream Association, and the 

National Cheese Institute. 

Member companies in these groups account 

for 85 percent of the dairy products consumed in 

the United States. IDFA i,s a member of the Allergy 

Issues Alliance, the coalition of food trade 

associations and a leading food allergy consumer 

group. IDFA helped develop new guidelines for 

clear labeling of allergenic compounds. 

IDFA strongly supports implementation of 

these guidelines, encourages disclosure of 

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allergenic ingredients in clear and simple language 

and is dedicated to assisting dairy processors t0 

prevent cross-contamination. 

Cur commitment to the allergen initiative 

is demonstrated through our member outreach. 

Although dairy processors are conscientious about 

compliance with labeling requirements for 

allergenic ingredients, IDFA still urges all 

members to review their policies and verify that 

they are operating within the new allergen 

guidelines and we provide a whole lot of one on one 

contact and information to our members who request 

information. 

Further, we recommend that member 

companies follow the following recommendations: 

(1) Review formulations to identify the 

presence if any of the eight major allergens; 

(2) Contact ingredient suppliers to 

determine if ingredients they supply contain any 

allergens including components of flavors, colors, 

incidental additives and processing aids that may 

not be required to be labeled. 

We also suggest they review their current 

labels to ensure that if any allergens are present, 

they are included in the ingredient declaration in 

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terms that are easily understood by consumers. 

Number four, advisory statements should 

not be used as a substitute for good manufacturing 

practices. Only use advisory label statements such 

as "may contain" blank when all of the criteria 

established in the allergen guidelines are met, and 

I won't go into those now, but they are available. 

The dairy industry has a good track record 

on the allergen issue. Re'calls for undeclared 

allergens and dairy products are rare. However, we 

are committed to continuous improvement and this is 

demonstrated by our efforts to educate our members 

on the important issues through a variety of 

outreach programs. 

These programs include (1) providing 

publications to member companies on implementation 

of the voluntary food allergen labeling guidelines 

(2) instructions for labeling manuals for milk, 

cheese and ice cream; (3) we provide workshops on 

allergens and proper food labeling on a periodic 

base. These are open to the entire dairy industry 

as well as ingredient suppliers. (4) We provide 

education for ice cream manufacturers through a 

tiorkshop entitled "Ice Cream Best Practices" to 

explain the allergen issues'and industry's labeling 

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requirements. 

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In summary, the dairy industry is 

committed to maintaining the safety of its products 

and is currently engaged in this effort to make 

sure that we protect the health of allergenic 

consumers. Thank you. 

[Applause.] 

DR. LEWIS: We now have Carolyn Garrett on 

our list. Carolyn Garrett is not here. That 

completes my list of registered speakers. so I 

relieve that the meeting is now coming to an end. 

My closing comments are quite succinct. I 

zhink this was an extremely useful meeting for the 

Igency. I felt a lot of important information was 

obtained by us. 

Again, the docket is open so comments are 

still possible to this particular series of 

questions by the agency. I do want to thank all 

-he members of the panel who provided some very 

useful discussion points for us, as well as the FDA 

support staff who made this meeting possible. 

So thank you very much. The transcript 

vi.11 be available in about a month and information 

)n obtaining that is in your Federal Register 

jocuments. Thank you. 

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[Applause.j 

[Whereupon, at 3~2'0 p.m., the meeting was 

adjourned. 1 

MILLER REPORTING COMPANY, INC. 

735 8th Street, S.E. 

Washington, D.C. 20003-2802 

(202) 546-6666 
I, VICZORSA S. MCLAUGHLIN, the Official Court Reporter for Miller 

Reporting Company, Inc., hereby certify that I recorded the foregoing 

I proceedings; that the proceedings have been reduced to typewriting by me, or 

under my direction and that the foregoing transcript is a correct and accurate 

record of the proceedings to the best of my knowledge, ability and belief. 

VICTORIA S. MCLAUGHLIN