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issues. Th,at kind of thinking underscores the need 

for aggressive FDA action. 

Consumers must be informed whenever an 

allergen unavoidably might sneak into a food in 

which it does not belong. The challenge is to 

define when contamination is unavoidable and it is 

appropriate to say "may contain" and to distinguish 

that from situations of manufacturer sloppiness 

where "may contains" labels are not appropriate. 

At one end of the spectrum, contamination 

clearly is avoidable when companies intentionally 

add rework or other material that contains an 

I 

allergen into a food that is not supposed to 

contain that allergen. 

On the other extreme, ensuring that every 

last residue of peanuts is cleaned out of complex 

equipment or a shipping container before a food 

that is not supposed to contain an allergen is made 

in that equipment or shipped in that container may 

be very, very difficult, especially for smaller 

companies. 

When "may contain" statements are 

appropriate, they should be provided in an allergy 

information section of'an ingredient facts label, 

and it should say something like: "Allergy 

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102 

information: corn, 

4 i& ;~j zi tihqqt i may contain peanuts." 

IsMay containll statements should be stated simply 

using standardized working and without explanatory 

language such as "manufactured on equipment that 

sometimes also processes peanuts." Such verbiage 

simply adds clutter and raises questions as Ms. 

Munoz-Furlong indicated in consumer's minds. 

The industry's Food Allergy Issues 

Alliance makes a reasonable stab at deciding when 

'Imay contain" language is appropriate, but it needs 

improvement. First, companies that only visually 

inspect for allergenic ingredients, not test for 

them, would not use "may contain" language. 

Also, the industry's guidelines are 

totally voluntary and some of their lawyers are 

advising against tests. As I mentioned, five years 

ago, the FDA sent a warning level to the food 

industry to eliminate cross-contamination. Judging 

from the FDA's study and the other two studies I 

mentioned, not enough has happened. 

I think the time has long past for all 

this total voluntary flexible action on the part of 

industry. 

[Applause.] 

DR. JACOBSON Therefore, the FDA should 

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/, . .< ‘, 

-103 

amend its GMP regulationstiith a iequirement for 

companies to take all practical measures to exclude 

contamination of foods with unlabeled allergens. 

Companies should develop HACCP plans to ensure 

proper cleaning of shared equipment, use of 

separate equipment for allergen-containing and 

allergen-free foods whenever possible, regular 

testing of products for unwanted allergens and 

other measures. 

The best way to ensure that companies are 

using "may contain" only when possible 

contamination is unavoidable is regular unannounced 

FDA inspections and testing of products for major 

allergens. 

[Applause.] 

DR. JACOBSON: The FDA has already stated 

in its April 19 Compliance Policy Guide that 

undisclosed cross-contamination may cause the food 

to be considered adulterated. Seizures of 

contaminated products would protect consumers and 

send a clear signal to the industry that the FDA is 

truly concerned about food allergens and will 

vigorously enforce its complia.nce policy. 

That kind of independent oversight should 

encourage manufacturers to maximi'ze their 

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104 

precautions. Currentiy FDA inspectors rarely visit 

factories that make cookies, pastries and other 

foods that may contain dangerous and unlabeled 

allergens. The FDA simply lacks the funds and so 

companies don't even have to worry about 

inspections. 

We urge the FDA to use some of its budget 

increases to hire additional inspectors. In 

addition, we urge the FDA to seek new funding on 

the order of roughly $10 million a year for more. 

inspectors, more tests, educational efforts and 

research to develop quick reliable testing methods. 

[Applause.] 

DR. JACOBSON: I hope that the food 

industry would recognize the value of that 

investment to the .public's health and to its own 

reputation and support a funding request. In that 

regard, I was delighted to hear Lisa Katie say that 

FDA should have a strong enforcement presence, and 

I hope they'll join with us to lobby Congress to 

provide that $10 million or so in additional 

funding. 

[Applause.] 

DR. JACOBSON: Finally, to further assist 

consumers, as the Attorneys General recommended, 

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105 

the FDA should require lab&is to bear a toll-free 

telephone number that people could call to get 

up-to-date information about ingredients and 

possible contaminants. Companies periodically 

modify product composition and manufacturing 

practices. 

Many people with severe allergies like to 

contact companies just to make sure that labels are 

still correct and that accidental or incidental 

additives have not crept into a food that had been 

safe to eat. 

In sum, the FDA should press industry to 

clean up their manufacturing practices; "may 

contain*' statements should be used to inform 

consumers, but only when cross-contamination is 

unavoidable. And the FDA should enforce its 

policies by conducting more inspections and testing 

more products. Thank you very much 

[Applause.] 

DR. LEWIS: I'd like to thank all of our 

panel speakers for Panel II Advisory Labeling, and 

we will now begin a discussion either among the 

panel members themselves or with the FDA listening 

panel. Does anyone have an opening question, 

comment? 

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.,; 

Dr. WilcoA? 

DR. WILCOX5: I'd like to address a 

question to Ms. Munoz-Furlong. Much of the 

industry discussion on good manufacturing practice 

and labeling focus on the eight major allergens. 

Does your organization agree that at this time 

that's the appropriate focus or do you think 

additional efforts also need to be placed on the 

less common allergens? 

MS. MUNOZ-FURLONG: My belief is that if 

we focus on the eight major allergens, we've 

covered 90 percent of the problem, and once we 

clear that up, we should start looking in other 

areas, but keep it to the eight so that we can 

focus there. 

DR. LEWIS: Another question? 

DR. FALCI: This is Ken Falci of the Food 

and Drug Administration. W,ell , first of all, I 

think it kind of disturb me that when you take a 

look at the different kinds of advisory statements 

like "may contain" compared to "peanuts were also 

made in this facility," that consumers get a 

different kind of perspective, and that was brought 

out pretty well by Anne's slides. 

I was just wondering does the panel feel 

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107 

that that makes sense? '@hat there is a different 

perception and risk as far as when people read 

these different kinds of terms, and is there any 

other survey that industry is potentially doing or 

anybody else that has other data that could 

confirm? 

MS * HILDWINE: I would say that this is an 

area that concerns the food industry as well, and 

while we have not actually done a survey, I mean 

it's appropriate to survey consumers as to their 

perceptions of that labeling, and our members 

really aren"t in a position to be able to provide 

that information. However, that said, the food 

industry is,working with food companies to help 

them improve their good manufacturing practices to 

the best of the ability of those food companies. 

In other words, do the best job you can. 

We as the association representatives are here to 

help you. At NFPA in particular, we have a lot of 

scientific expertise on staff that can be of 

assistance to members relative to good 

manufacturing practices. 

Now if good manufacturing practices are 

sharpened, are applied in the correct way, and food 

products are produced in accordance with those good 

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108 

manufacturing practices, then any use of a 

supplementary or advisory label statement that 

follows that will have true meaning behind it. It 

won't be used simply as a theoretical precaution. 

It will mean something, and that's what the food 

industry wants with those label statements. 

They want them to mean something to the 

food allergic consumer because they want the food 

allergic consumer to believe them. The food 

industry wants food allergic consumers to see these 

statements and to take away the meaning that if 

they're allergic to the substance that's named in 

that statement, they should not consume that food. 

Noti, do we have a long way to go? We have 

a lot of work to do. NFPA has been working on this 

for a number of years. We recognize that we need 

to help our members more and more all the time. 

But we're committed to doing that and we're working 

on that everyday. 

DR. FALCI: As a follow-up, but again the 

two different kinds of statements that would be out 

there like "may contain" or "made in a processing 

facility," and these would be like suggestives, 

precautionary statements, that the agency might 

uant to look at maybe in the future as guides or' 

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109 

regulations, and the problem there is the 

consistency in the mind of the consumer when they 

actually read these kinds of different statements, 

and I'm just wondering that it sounds like you do 

agree that there is some inconsistency when you do 

use these kind of advisory statements. 

MS. HILDWINE: The issue of the 

inconsistency is something that we're going to have 

to work on, but I would say that, first of all, 

since it is a label statement, it has to be true. 

If the food is not processed on shared equipment, 

then it should not use the shared equipment type 

statement. If it's not processed in a shared 

facility, it shouldn't use a shared facility type 

statement. 

So those statements have to be true. And 

in order for those statements to be true, those 

good manufacturing practices have to be applied 

first. 

DR. FALCI: I guess as another follow-up, 

when you look at "may contain," and you look at the 

other statement like "made in a plant that 

processes peanuts," though, you still get, I mean 

as a consumer why not not use "made in a plant that 

processes peanuts" even though it might be true? 

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Why not use "may contain"? 

MS. HILDWINE: Well, "may contain" would 

be true, 

DR. FALCI 

confusing? 

: Right. And less maybe 

MS. HILDWINE: This is something that we 

certainly do have to continue to look at. 

DR. JACOBSON: Can I ask a question? 

DR. LEWIS: Dr. Jacobson, please. 

DR. JACOBSON: May I ask a question? And 

Ill1 just be very blunt about this. Can I ask both 

of the industry representatives, and especially 

Lisa, you know that the FDA doesn't have resources 

to inspect very many manufacturing facilities. You 

know that the FDA has been focused on 

microbiological problems and looking at those 

factories, not factories that use food allergens. 

Would your two associations support $10 

million in increased funding for the FDA to conduct 

more testing, enforcement and research in this 

area? 

MS. KATIC: Actually, Michael, I'll be 

very blunt right back. Our associations are both 

actively looking at more than. $10 million in 

funding for FDA, whether it be for allergy, 

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111 

microbiological inspection, or anything else that's 

under their purview. We think that that gives. or 

maintains the credibility of FDA both domestically 

and internationally and, you know, we have seen a 

decline in resources, as you have, for FDA, and we 

think that's in the best interest of everybody 

including the industry that they get that funding. 

[Applause.] 

MS. HILDWINE: And I would just add that 

we're certainly not just going to wait for FDA to 

advance the ball relative to the research. NFPA is 

conducting research into testing for rapid methods 

that can be validated. I mean that's part of the 

problem, that there are some problems relative to 

the number of validated test methods that are out 

there for food allergens, and certainly NFPA is 

doing its part, and I know a lot of other 

organizations are doing their .part to advance 

research in this area as well. 

DR. LEWIS: Other questions, panelists? 

DR. FALCI: Just one more-- 

DR. LEWIS: Dr. Falci. 

DR. FALCI: --I promise. This word 

"unavoidable" is a troublesome word because when 

one has to make a decision, I guess, in industry or 

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112 

in processing plants when an allergen is 

particularly unavoidable, and I would encourage 

everyone in the industry to just be more clear 

about the conditions that are around this term 

'lunavoidablel' in the future so that we can get a 

better feel for what's particularly involved. 

And I guess if you want to expand on that 

thinking, and you start thinking about different 

kinds of food industries, that the word 

Vtunavoidablel' might mean different things to 

different industries. So that you had mentioned 

that I believe peanuts, peanut butter plants or 

chocolate plants were difficult to clean, for 

instance, with water, and so these kinds of 

industries might have different kinds of 

unavoidable kinds of problems and maybe different 

kinds of good manufacturing practices that you 

mentioned. 

And so one could lead oneself to the 

thinking in the future that there might be good 

manufacturing practices that might be applicable to 

different industries if one were to think about 

allergen control procedures. And so that's sort of 

a question, but it's sort of a statement, and if 

you have comments on that, I would be glad to take 

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MS. HILDWINE: When we talk about 

unavoidable, it is always in connection with good 

manufacturing practices, and essentially it's, you 

know, the bottom line where a company goes through 

i 

a process and evalua es its practices and at the 

end, that company sa s we have done the best that 

we can, and we still can't get rid of it. And in 

that case, voidable. 

different sizes of companies, 

different sectors of the industry, certainly are 

going to have to dif erent kinds of applications of 

good manufacturing p And we are committed 

to working with all f our members regardless of 

size to help them im So that if 

they go through the recess and then have to use or 

have to consider sup ng, that that 

supplementary labeli meaning tthe food allergic co 

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I think that you're going 

to have to end up deciding what's avoidable and 

what's unavoidable. I mean drawing a distinction, 

it's like drawing a line in the Potomac River. 

24 

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It's not going to be very clear. But it's going to 

be, I'd much rather trust FDA inspectors evaluating 

113 

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when a umay contaifii"" _ i" w&@fi, an ingpedient is 

avoidable or unavoidable than a manufacturer's 

discretion. 

DR. LEWIS. Kathy. 

MS. GOMBAS: Yes, this is Kathy Gombas 

with FDA, and this is actually an Alliance question 

so either GMA or NFPA. We're talking about GMPs, 

I'm wondering if the Alliance has started looking 

at and identifying specific GMPs for the various 

products and processes that are out there that 

would minimize allergen cross-contact? 

MS. HILDWINE: Okay. I'm doing this one, 

too. First of all, just to clarify, Anne 

Munoz-Furlong is also a member of the Food Allergy 

Issues Alliance, but that said, a number of the 

associations that are members of the, Food Allergy 

Issues Alliance have already developed guidance 

relative to GMPs for their members, and these 

associations within the Alliance, many of them are 

specialized associations that represent particular 

sectors of the industry. I don't know if you guys 

want me to name you, but there's bakers, there's 

candy and convection, there's dairy product 

associations, there are a number of associations 

whose manufacturing practices have some very 

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115 

specific concerns relate&to food allergies and 

they have already done a lot of this work. 

They"ve, shared this work with the Alliance 

and so we're all learning from that. NFPA is 

working on this now. This issue is what resulted 

in our code of practice. And now we are developing 

some additional guidance to help our members 

regardless of what sector they are in to improve 

their GMPs. So there's a lot of work to go around 

for everybody and every association that's in the 

Food Allergy Issues Alliance has been dedicating a 

lot of energy over the past several years to this 

particular issue on behalf of their members and 

we're no exception. 

MS. KATIC: Just adding on to that, ditto 

everything that Regina said, but we have looked at 

that as an item for future discussion and further 

review specifically because we've been focusing so 

much on our labeling program. That's obviously 

taken up the bulk of our time, but certainly have 

not discounted that there might be a need to look 

further into what you asked down the road once 

we've got the labeling part well defined. 

DR. LEWIS: Other comments from panelists? 

Well, while you're cogitating for a few moments 

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oecause your titie is .&& tip, we'll move to some of 

the questions we have. We have quite a few. I do 

tiant to mention that we've received several 

questions for Theresa Dziuk, who reported on the 

Food Allergen FDA/State Partnership. Relative to 

any of those types of questions, you may access any 

information that the agency has on the website. It 

is at cfsan.fda.gov. And the search for the word 

'"food allergens," which again is on our web page. 

In addition, we mentioned the state 

attorneys general petition. That also is available 

at Dockets and the contact information is in your ji. 

?ederal Register. So questions on that can be 

answered elsewhere. 

We do have a series of questions. Again, 

if the panel has something to add, please do feel 

free to jump in. But one question is how would the 

panel, and this is obviously directed to all of 

YOU I how would the panel suggest dealing with 

imports? States haye reported more allergy 

labeling problems with imported foods than with 

domestically produced foods, according to this 

question. 

MS. MUNOZ-FURLONG: I'm going to give you 

the consumers' per'spective. You raise an 

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interesting point becausewe have consistently 

found that when one of our members has a problem, 

and it's caused by an imported food, we have no 

recourse. We can't call the company like we could 

with a domestic product, and they're on it and 

instantly we are correcting the information, 

getting the news out to our membership. 

So as a result of that, we advise our 

members not to eat imported products because we 

can't guarantee that the label is correct, and that 

we will be able to trace back any information they 

might need if they have a reaction. 

MS. HILDWINE: Imports are a particularly 

challenging issue. I mean if you look at recall 

track record, there is amlot of imports on a 

regular basis and food allergen related recalls. 

All the audience may not know this, but 

this is a true fact. Imported foods are subject to 

the same requirements as foods that are produced 

and sold domestically. So imports should be 

observing good manufacturing practices and labeling 

accuracy as well as domestic production. 

Now, that said, the Food Allergy Issues 

4lliance has, in fact, worked some outreach 

relative to other nations. As we were developing 

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118 

our food allergen labeling guidelines, we had 

representative from the Canadian food industry who 

worked with us on that, and we are of the 

understanding that food allergen labeling 

guidelines and, of course, the good manufacturing 

practices sector that's included in there on 

supplementary labeling, that that's under review 

for adoption by the food industry in Canada. 

In addition, we as a food industry have 

liaisons with food industry around the world. 

We've made sure that the Food Allergen Labeling 

Guidelines are in the hands of a number of 

representatives for sharing with their producers in 

other countries, and certainly we are doing the 

best that we can as an Alliance to make sure that 

the concepts in the Food Allergen Labeling 

Guidelines, that these are known around the world. 

A number of our members are multinational 

corporations that are disseminating food allergen 

GMP and labeling information to their companies in 

other nations. So we are r'eally I would say 

engaged in a vigorous effort to make sure that this 

information gets known around the world. 

The United States is probably in the lead 

in terms of its contemplation of this issue. 

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Certainly, the advih&&@$$ af science in the u.s. 

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is far ahead, I think, of what's going on in other 

nat,ion,s, and we are trying to bring the rest of the 

world along on this issue. 

DR. LEWIS: Any other comments on- imports? 

We have a,question concerning legal liability. The 

question is really in two parts. What is the legal 

liability risk to a manufacturer if a consumer is 

injured by an undeclared allergen? And then also 

the legal liability risk if undeclared allergens 

are found in a food, thereby putting a significant 

number of individuals at risk? 

So again I think the question is asking 

for some clarification as to how legal liability is 

perceived here. 

MS. HILDWINE: I'll do this one. I'm not 

a lawyer. I don't think we have any attorneys on 

this panel. And so I'm not going to be able to 

answer this question directly. However, the last 

thing that any food company wants to do is to cause 

harm to anybody. And so the issue of risk is 

certainly something that all food companies have to 

take into consideration as they engage in their 

normal operations. 

DR, LEWIS : This question talks about 

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preventing manufacturers from using "may contain.1' 

That is how can you prevent manufacturers from 

using slmay contain" as a substitute for GMPs? What 

controls are or should be in place? And this is 

important since it artificially restricts 

consumption of those products, artificially 

restricts consumptions of products for those who 

already have limited choices. 

Does anyone care to address that question? 

Regina, I have a question directly for you next so 

I would suggest you hold off for a second. 

MS. KATIC: Could you repeat the beginning 

of it? It's about how to prevent? 

DR. LEWIS: How can you prevent 

manufacturers from using "may contain" as a 

substitute for GMPs? 

MS. KATIC: Well, I think this has already 

come up in some form briefly, but certainly I think 

Dr. Jacobson and I are in agreement that FDA has 

the authority to enforce and we certainly support 

full enforcement of FDA inspecting and maintaining 

these practices within plants. 

As I stated in my comments, this is being 

done within all of our member companies which make 

up probably 90 percent of, as Anne stated, the 

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allergens that we're talking about. So, you know, 

you could mandate the fact that we can't use "may 

contain, s1 but then you're faced with as, I tried to 

lay out, some very clear examples of when "may 

contain"' is absolutely necessary to preserve for 

manufacturers. 

This is also why the industry responded so 

quickly and got on board with our labeling program 

through the Allergy Issues Alliance because we 

understand that this is a critical problem. It's 

one that we want to fix or work toward providing a 

solution so that "may contain" can be preserved and 

therefore believed and used by the food allergic 

consumer. 

DR. LEWIS: Go ahead, Dr. Jacobson. 

DR. JACOBSON. When you say the industry 

reacted so speedily, were you referring to the 

response to the 1996 letter? 

MS. KATIC: Well, I think we've, you know, 

as has been indicated by both Regina and I, this is 

an issue that the industry has been dealing with 

much longer than the '96 letter. 

I don't think you can point out from that 

letter, unless you have some very specific 

examples, I don't think tha't you can say that 

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industry has not,responded or developed good 

manufacturing practices. 

Certainly, they continue to look at their 

practices to see where they can do better. You 

know I'm sure that most of our member companies 

have done that since the letter in '96. I guess 

that's pretty much it. 

DR. LEWIS: And actually building on a 

point you raised earlier, Lisa, we have two 

questions that are more or less related. How many 

companies in the U.S. are not members of GMA or 

NFPA and how does GMA and NFPA plan to ensure 

compliance of its new labeling and manufacturing 

guidelines both among members and what might you do 

about non-members? 

And then related to that, is there 

currently a penalty for companies using "may 

contain" warnings when not meeting the four 

criteria? If so, what is it? If not, what 

motivation do they have? 

MS. KATIC: Well, I guess I wish we knew 

how many companies are out there that are not 

members of either association. I don't know that 

anybody has those numbers or figures. As I stated 

earlier, we do see that as an area in need of some 

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attention, and also have stated that we've already 

looked at through the Alliance how we would reach 

2ut not only to members, smaller members within our 

associations, but also those small manufacturers 

that are not members of associations. 

And I think through the Alliance as we've 

said we have a broad group of about 20 

associations. I think every association knows, you 

know, who some of those members are that aren't a 

part of their association. So just by nature of 

the type of business that they do, we would already 

be able to name I would say quite a few. 

You know the,real challenge is getting to 

the real mom and pop type operations and I think we 

probably need to have a discussion about that 

collectively on how we reach those types of I 

operations. I've now forgotten the rest of the 

question so I-- 

DR. LEWIS: It regards penalties for using 

"may contain" 

" 

when not meeting the four criteria. 

MS. KATIC: Penalties within our, I 

g ess-- 

DR. LEWIS: Presumably, yes. 

MS. KATIC: --our program. Well, we don't 

have anything necessarily laid out. I can tell you 

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that in wor,king with the industry for some time, we 

mentioned earlier that we have a baseline survey 

that we"re starting and will continue to survey 

membership amongst all of the trade associations in 

the Alliance, and it's generally that when industry 

seems a program picking up, and really gaining some 

significance, it's rare that--I mean certainly 

there are companies that don't adopt it, but it 

just adds to, I think, the importance of the 

program and makes it almost imperative that 

companies do adopt the program and basically get on 

board. 

So I think just by nature of them hearing 

that this is something that's really gaining 

significance amongst the entire industry, by nature 

of competition, if you will, it encourages those 

that are outside the program to participate. So 

there is not an outright penalty, but there is an 

incentive there. 

MS. HILDWINE: And just to elaborate a 

little further on some of'the things that Lisa 

said, the Food Allergen Labeling Guidelines have 

been made public. They certainly are in a public 

area of NFPA's website. I know they're in the 

pub1 ic area of a lot of food companies' web sites. 

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I personally sent, made " sure that companies that 

are not members of NFPA received the guidelines 

when they asked for them. Now that was followed up 

with a call from our membership office. 

Nevertheless, we have reached out beyond 

our memberships to other food companies and, of 

course, every member of the Alliance has been 

presenting on their website Food Allergen Labeling 

Guidelines, 

I think, Anne, you have them on your 

website, too * So these are not a secret. They are 

readily available, and if anybody is not a member 

of NFPA and would like the Food Allergen Labeling 

Guidelines, just give me a call, and we'll make 

sure that you get a copy of the guidelines so that 

you can start to get on board with this very 

important initiative. 

DR. LEWIS: And while you still have the 

microphone, a question specifically for you. Does 

the food industry currently have standard 

definitions for the various precautionary 

statements? If so, can they be located? If not, 

whLat can a consumer use as a guide for 

interpreting? 

MS. HILDWINE: Right now through the work 

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f the Food Allergy Issues Alliance, we did discuss 

hree types of statements, and they're the 

tatements that FDA has asked questions about in 

he Federal Register notice. 

Now, as to standard definitions, 

nfortunately there are none. However, since any 

nformation that appears on a food label has to be 

rue, those statements would have to represent what 

hey say. In other words, if itrs processed on 

hared equipment, it would have to mean that it's 

recessed on shared equipment. Now, as to a 

easure of risk, which I understand is probably at 

he underpinning of this question, again, I don't 

hink that this is an area where the food industry 

ants to encourage food allergic consumers to try 

nd understand relative risk. 

The whole pur'pose of those supplementary 

r advisory statements "may contain" is to send a 

essage to the food allergic consumer do not eat 

his product if you are allergic to this food. In 

ther words, to believe what it says, because we 

elieve that food companies are using these 

tatements responsibly. And that proportion is 

ncreasing because of the Food Allergen Labeling 

uidelines, and certainly we hope that over time 

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these statements will become increasi,ngly more 

believed, and secondly, increasingly rare. 

DR.' LEWIS: For Anne Munoz-Furlong, we 

have a question. Isn"t the lesson here that it's 

important to look at all food labels all the time? 

Why is there a different standard if the label adds 

"may contain" versus peanut as an ingredient? 

MS. MUNOZ-FURLONG: Absolutely, you need 

to read the label all of the time. We are talking 

about the additional inf ormation that is being put 

on these labels and how the consumer is 

interpreting them, and what the impact of the 

proliferation of these statements has been on the 

consumer's purchasing decisions and purchasing 

habits. 

127 

But the first place that a food allergic 

individual has to go is that ingredient statement. 

Unfortunately, if you take the example that I gave 

with the raisins on the airplane, there's, a bag of 

raisins. There ar‘e raisins in the bag. You have 

looked at the ingredient declaration. It says 

raisins and then underneath it, it says may contain 

peanuts. What are you going to do if you're 

allergic to peanuts? That's the answer we are 

looking for from industr:y and the FDA. 

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128 

Are you never to eat raisins again because they all 

may contain peanuts? That's unclear to'us at this 

point. 

DR. LEWIS: This next question is to Dr. 

Jacobson as well as all members of the panel. It 

says Ms. Katie stated that cleaning will not 

succeed in removing all allergens. Given this, 

would you support precautionary labeling for all 

food manufactured on safe equipment and if not, why 

not? 

DR. JACOBSON: What was that? Would I 

support? 

DR. LEWIS: Support labeling for all food 

manufactured on shared equipment. 

DR. JACOBSON: Well, I would assume that 

some--that it's possible to clean well some shared 

equipment. And it's something where the FDA would 

have to go in and make some evaluations. Maybe 

chocolate, you can't clean it adequately and maybe 

that's where dedicated lines should be used if at 

all possible. But I would think it's a judgment 

call, not a blanket rule saying always use "may 

contain." 

DR. LEWIS: Others have comments on that? 

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MS. MUN6Z.Fu-.L(jR& f would agree with 

that. What we want to do is move away'from "may 

contain,'" not add it to every single ingredient, 

because as we see now, there is so much confusion 

and limited food choices perhaps unnecessarily. We 

want to move away from that. 

DR. LEWIS: This question goes to the four 

pronged test. It's know that microscopic amounts 

of allergens can harm sensitive people. Please 

expPa,in why the first prong of your four-prong test 

for precautionary labeling is adequate. It allows 

for visual inspections alone. 

MS. KATIC!: I think, first off, what we 

mean by visual is you know you're using, you know, 

an ingredient that has an allergen in it. so I 

think to me that's kind of obvious. Maybe that's 

not to everybody else. It also states there that 

analytical testing can be used for purposes or 

situations where it might not be as visually 

obvious. 

MS. HILDWINE: The first prong of the 

four-prong test reads exactly: The presence of a 

major food allergen is docum'ented through visual 

examination or analytical testing of the processing 

line equipment, ingredient or product or other 

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means, so visual examination is only one thing 

that"s mentioned there. Lisa mentioned also that 

analytical testing is there. 

Certainly documentation, paper trail, may 

also demonstrate that the major food allergen is in 

that environment. So we're not relying on visual 

examination alone. 

DR. LEWIS: I"m going to stop with the 

questions there, but turn back to both the FDA 

listening panel as well as our presenters and ask 

if there are any further comments or questions from 

you folks. Kathy,. 

MS. GOMBAS: Kathy Gombas with FDA. 

Regina, in the first panel, you had indicated that 

perhaps it was the Alliance that was going to 

conduct a survey to get more information on who had 

gone to voluntary labeling for plain English. Are 

you going to do the same. thing for the advisory 

labeling, and if so, are you going to ask them why 

they're using advisory labeling? 

MS. HILDWINE: That's in the survey as 

well. The survey covers all of the are'as that were 

addressed in the Food Allergen Guidelines. So we 

do ask them if they have control procedures and 

various other questions related to.supplementary or 

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131 

advisory labeling. And the data that we're 

collecting will essentially be baselines. 

DR. JACOBSON: Can I ask a question of FDA 

for informational purposes only? 

DR. LEWIS: As I recall, we're in a 

listening mode, Dr. Jacobson, but feel free to put 

it on the table. 

DR. JACOBSON: For informational purposes, 

I wonder if Dr. Falci could give us some sense of 

how frequent inspections are, say, of a cracker or 

cookie company of $25 m'illion .a year in sales? How 

many times a year, a decade, ever an FDA inspector 

will look at these allergen issues? 

DR. LEWIS: We actually get frequently 

questions about how often that happens, and to be 

honest, Dr. Jacobson, I don't have that information 

for you right now, but we'll try to get back to you 

with it. 

I do want to turn to some administrative 

issues concerning the public speakers who are 

scheduled to present this afternoon. We will be 

using the fir& three rows of what for you is the 

left-hand section, for me the right-hand section. 

So for those of you that have registered 

to speak as public co,mmenters, please either gather 

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a little earlier from lunch or at least plan to sit 

here as soon as you return. Our lunch break is 

scheduled to go until one o'clock, and I can 

promise you we will begin promptly at one o'clock, 

so please do feel free to take a lunch break, but 

remember we will be starting at one o'clock, with 

our third panel. Thank you. 

[Whereupon, at 12:lO p.m., the meeting was 

recessed, to reconvene at 1:05 p.m., this same 

day.1 

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[1:05 p.m.1 

DR. LEWIS: Panel III focuses on the 

labeling of ingredients exempted from declaration. 

There's two categories here: common or usual names 

and incidental additives. 

Before I begin, I would like to introduce 

a new member of our panel, Mr. John Hallagan. As 

we said, he was General Counsel for FEMA, ASTA and 

IACM, and he's replaced Ms. Katie on our panel. 

Our procedure at this point will be to 

allow our four panel members, Dr. Jacobson, Ms. 

Munoz-Furlong, Ms. Hildwine, and Mr. Hallagan, to 

each address the topic of labeling ingredients 

exempted from declaration, and then we will move to 

discussion. 

Dr. Jacobson. 

DR. JACOBSON: Currently, food labels are 

not formally required to disclose allergens such as 

peanuts, wheat, casein or car,mine when they serve 

as flavorings, spices or non-certified colorings, 

However, undeclared colorings and flavorings have 

caused occasional allergic reactions. Examples 

include carmine, saffron and annatto colorings, 

partially hydrolyzed casein and peanut flour. Also 

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such spices as all$p%c>ei cardamom and coriander 

have caused occasional allergic reaction. 

While disclosure is not required, in 1996, 

the FDA sent a warning label to companies urging 

that they voluntarily declare on labels any 

allergenic components of such ingredients. I agree 

with University of Nebraska food allergy experts, 

Steve Taylor and Sue Hefle, who wrote in a paper if 

an ingredient is known to be allergenic even on a 

rare basis, such as carmine or papain, then it 

should be declared on the ingredient statement. 

Unfortunately, the FDA has not determined 

that it has legal authority to require labeling of 

those additives when health is at issue. It should 

assert that authority,by commencing a rulemaking as 

requested by the nine attorneys general more than a 

year ago. CSPI also will be submitting a formal 

request for that action in the near future. 

The FDA could take several legal 

approaches. It c,ould assert that the general 

misbranding section of the act trumps the 

flavoring/spices/colors exemption because the 

ingredients can cause severe allergic reactions. 

Alternatively, for allergenic flavorings, 

spices or colors that are considered generally 

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135 

recognized as safe/ the FDA could determine that 

those substances are not safe. They can only 

determine it safe if labels disclose the presence 

of those substances. 

Third, in the cases of approved color 

additives and food additives, the Act allows the 

FDA to set conditions of use, such as label 

disclosure. Thus, FDA should amend its regulations 

to specify that any allergenic coloring or 

flavoring additive must be declared on the label, 

as it has for Yellow 5, or monosodium glutamate, 

and certain other foods. 

We urge the FDA to require disclosure not 

just of the major eight allergens but others as 

well. To someone with an allergy to corn or 

carmine, it's no satisfaction that wheat and shrimp 

are disclosed. 

The cost and inconvenience to companies of 

providing disclosure is a small price to pay for 

protecting the health of sensitive consumers. 

Therefore, as a general policy, the FDA 

should require, not just strongly encourage, labels 

to disclose allergenic ingredients in the 

flavorings, colorings, and spices. Labels should 

simply declare something like colors includes 

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136 

carmine or natural flavoring includes peanuts, and 

then in the allergy information section of the 

label, the presence of the major allergens should 

be highlighted. 

Moving now to incidental additives. Those 

are substances that are present at insignificant 

levels in food and that don't serve any technical 

or functional effect. Incidental additives have 

never been disclose,d on labels, but in 1996, the 

FDA told the food industry that such additives are 

not insignificant if they might cause serious 

allergic reactions and that they had to be labeled. 

And that was incorporated into the FDA's 

compliance policy guide earlier this year. While 

incidental additives are present at low levels, and 

to my knowledge have not caused known allergic 

reactions, it's worth noting t,hat the EPA recently 

expressed concern about the allergenicity of 

StarLink corn. It banned--it banned the presence 

in food of any amount, even under 20 parts per 

billion, of StarLink even without proof that it 

ever caused an allergic reaction. 

Today, no one is talking about banning 

wheat, corn or other allergin, but only requiring 

label disclosure. The FDA's policy concerning 

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137 

allergenic incidental additives should be 

incorporated into a regulation that states 

, 

explicitly that any incidental additive that may 

cause a serious allergic reaction should be 

presumed to pose a risk and be declared in 

ingredient list. 

the 

If an incidental additive is one of the 

main food allergens, or sulfites, it also should be 

declared in the allergy information section of the 

ingredient facts label. Regulations could allow 

waivers if companies can demonstrate that the 

amount of allergen present is truly too small to 

cause any reactions. Thank you very much. 

[Applause.] 

MS. MUNOZ-FURLONG: Before I begin, I want 

to also again clarify that when I talk about 

flavors during my presentation, I really do intend 

this to apply to flavors, colors, spices and 

incidental additives. 

Next slide, please. My objectives here 

are going to be to provide the consumer's 

perspective on these incidental additives and 

provide information about the industry's response 

to the concerns of the food allergic consumer, and 

that's going to be b'ased on information from our 

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138 

Next slide. First of all, from the 

consumer's perspective, we know that strict 

avoidance is the only way to avoid an allergic 

reaction. We know that major allergens can be 

included in flavors, spices and colors and 

incidental additives. We also know that they are 

currently not required to be listed on the label, 

and that children have had allergic reactions to 

proteins even in the low levels that you're going 

to find them in these categories. 

A good example of this came to us several 

years ago when a cereal was put on the market. 

Within weeks after launching this cereal, we 

started to receive calls all over the country about 

children having allergic reactions. We contacted 

the manufacturer. They found that, in fact, the 

flavorings contained milk ingredients. 

Now, to their credit, they changed the 

label to reflect that information, and we have not 

had any reports of incidences to that cereal since 

then. 

Next slide. When a consumer sees natural 

flavors on the market, they have several options. 

The first one is. avoid that product completely. If 

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any of you have ever looked at the ingredient 

statement, you will know that if you avoid the 

products that say flavors, colors, or spices, 

you're going to have no food choices at all. 

The second is to take a chance. Again, 

we're talking about children, so this is not 

acceptable as an option. 

The third is to decide to call the 

manufacturer and ask very specifically does the 

flavor contain whatever the protein you're trying 

to avoid. If you make tha,t determination to be 

your decision, then you need to hope, first of all, 

that there's a phone number listed on that package 

to help you make that phone call. 

Many of these calls are being made at the 

grocery store on cell phones as people look at a 

package, want to make a purchasing decision on the 

spot, or at dinner time when they are taking a 

product off the shelf in their pantry and notice an 

ingredient that they don't understand. So the need 

for information in a timely fashion is critical in 

these situations. 

Next slide, please. Now, currently some 

companies will divulge the information willingly 

and quickly over the telephone. We applaud their 

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. . 

140 

efforts. However; oche$ companies will consider 

this information proprietary and will not release 

it. 

We have had some companies tell our 

members that if they have a reaction, their doctor 

can call the company, and then they will divulge 

all this information. This doesn't seem to be the 

way we should be doing this. 

'Some of the companies will provide the 

information, but in writing, and it takes several 

weeks to get this information that will not satisfy 

the need of our members to get information quickly, 

There are a few companies that will provide this 

information in a timely fashion. They will put it 

on the label. 

For example, natural butter flavor or 

natural flavors contains milk. This saves time. 

It's simple English and it's very easy to 

understand. 

Next sli'de. Now, again, going back to the 

survey that I've mentioned today several times. 

Second on the list of top three concerns in the 

write-in portion of our survey was natural or 

artificial flavors or colorings. The concern from 

i 

our members is that this has hidden ingredients, 

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and if you recall from,'my first presentation, 

reactions occur because someone is eating something 

they think is safe. If they don't know the 

allergen is in there, they can't avoid it. 

Next slide,. please. The conclusions from 

our survey showed that food allergic individuals 

are reading the ingredient label diligently. They 

are making purchasing decisions that affect their 

health based on that information. 

We also know that they.believe that the 

information on the package is not complete. Four 

out of five of them report calling manufacturers 

for additional information. I want to make the 

point that our members are one of the best 

educated, highly motivated people in the food 

allergy community and this country. If they are 

struggling with these labels, I can only imagine 

what the general public is going through. 

Now r the final slide, in summary, flavors, 

spices, colors and incidental additives can contain 

hidden ingredients. Even the low levels of 

allergens that would be present in this could cause 

a reaction affecting children most often. 

Therefore, we recommend that allergens should 

always be declared on the label when they're 

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present in a product, 

Thank you. 

[Applause,] 

MS. HILDWINE: Thank you. At the outset 

of the discussion on labeling allergenic components 

of flavors, colors, spices and incidental 

additives, it"s important to note that major food 

allergens are proteins. There are numerous 

components in flavors, colors and incidental 

additives that are not proteins. 

Often these components include alcohols or 

oils that may be derived from the major food 

allergens, but are so highly refined that they do 

not contain protein. Bleached, deodorized and 

refined soybean oil that may be used as a carrier 

for flavor or color or a component in a food 

additive in some food applications is a good 

example of the type of product that should be 

considered outside the scope of today's discussion. 

Furthermore, there is no spice included 

among the list of the eight major food allergens 

that is the focus of FDA's discussion today, so it 

is clear that in this session, we rmeally are 

speaking of spices only in concept. 

This observation leads one to the 

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conclusion that Ffiji shouid continue to address the 

labeli,ng of allergenic components in flavors, 

colors and spices on a case-by-case basis. 

Creating a generally applicable policy most likely 

would encompass substances that are not at issue 

for the labeling of food allergens. 

We know from our discussions with NFPA 

members that they receive information from their 

suppliers of flavors, .colors, spices and additives 

with respect to the allergenic components present. 

NFPA believes that suppliers should always 

volunteer this information to their food processor 

customers with the understanding that food 

companies are not interested in knowing the 

formulation of the flavor, color, spice or 

additive, just in knowing which allergenic proteins 

are present. 

NFPA also is of the view that food 

processors should carry forward to their own labels 

information on the pres,ence or possible presence of 

those major food allergens and flavors, colors, 

spices and incidental additives. 

NFPA believes it is appropriate to present 

plain language inf'ormation on the allergenic 

components of flavors, colors, spices and 

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incidental additives in association with the 

ingredient declaration of the finished food. 

This information should be in the 

ingredient list where the flavor is declared or at 

the end of the ingredient list as appropriate to 

the food and the flavor or other component. 

The presentation options--"contains," use 

of a reference mark or use of parentheses--as 

discussed in this morning's session on plain 

language, all are valid presentations as would be 

any plain language representation of the name of 

the allergin in the common or usual name of the 

flavor. 

NFPA would not support rulemaking to make 

mandatory the ingredient declaration of the plain 

language terms for major food allergin components 

of flavors, colors or spices. Many of our members 

already declare information on these allergenic 

components on a voluntary basis. 

NFPA believes it is'the responsibility of 

food processors to obtain this information from 

their suppliers and carry it forward to the 

finished product labeling. Many of our members use 

checklists and other techniques to ensure that 

they've received this information from their' 

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suppliers. 

Because some of the ma.jor food allergens 

ire common in the food supply, milk, wheat, egg and 

joy, for instance, our members do not limit their 

-nformation collection to the obvious or major 

ingredients. 

Egg protein that may be a component but 

lot a characterizing flavor of a sauce is a good 

illustration of this. The food processor that uses 

Ihe sauce in the formulation of the food will 

obtain information from the supplier that egg 

protein is present, usually from the ingredient 

Labeling on the sauce. And that information will 

3e carried forward to the label of the finished 

Eood. 

Regarding major food allergens that are 

components of additives that might qualify for the 

incidental additives declaration exemption, NFPA 

oelieves that FDA has already made its views very 

clear that such allergenic components are not 

exempt from declaration. NFPA advises its members 

in a way that's consistent with FDA's 

interpretation and policy. 

Although scientists have been studying the 

issues of threshold levels of allergenic proteins 

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0. 

;hat trigger an allergic re,A?tion, so far there are : : : 

10 established thresholds. This raises questions 

regarding the meaning of both insignificant 

Juantities and absence of technical or functional 

effects in the finished food with respect to those 

Eood allergens, and both those conditions must be 

net in order to qualify for the incidental 

additives exemption. 

In addition, the absence of solid 

scientific knowledge about the quantities of major 

Eood allergens needed to trigger allergic reactions 

argue strongly for FDA not to codify the specific 

exclusion of major food allergens from the 

incidental additives exemptions. The reason for 

-his is plain. As food allergy science advances, 

it is likely to become increasingly evident that 

-here are reaction thresholds. That is 

quantitative levels of food allergens below which 

allergic reactions do not occur. 

Discussing the threshold concept is a 

neeting for another day with a group of experts 

different from this panel. Nevertheless, we urge 

FDA to be cautious and refrain from codifying an 

allergen exclusion of the incidental additives 

exemption at this time. If FDA were to codify this 

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exclusion, it wou,ld be a,,very difficult and long 

process to reverse the rule or selectively reverse 

the rule which is more likely to be the case. 

Thank you very much. 

[Applause.] 

DR. LEWIS: And Mr. Hallagan, please. 

MR. HALLAGAN: I'd like to thank the 

agency and our allied associations for the 

opportunity to participate today. I'm representing 

three trade associations today: the American Spice 

Trade Association, the Flavor and Extract 

Manufacturers Association, and the International 

Association of Color Manufacturers. 

Our members manufacture spices, flavors 

and colors that are included in a wide variety of 

foods and-beverages. 

One point I'd like to make to start is 

that our products, the bulk of our products, go 

into consumer products, foods and beverages, and 

are therefore not sold directly to consumers so our 

labeling requirements are different from consumer 

product labeling requirements. 

But our main mission is to support our 

customers and to provide them with all the 

information they need to comply with all labeling 

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148 

requirements or all labeling needs such as allergy 

labeling. 

All of our member associations are members 

of the Food Allergy Issues Alliance and all support 

the guidelines. 

Spices are listed by the FDA in the Code 

of Federal Regulations. There's a very long list 

of spices and has been mentioned, none of them are 

listed as allergens or considered allergens or the 

source of allergenic protein material. 

\ 

The current FDA labeling rules do allow 

for the generic declaration of spice as providing 

for the inclusion of a variety of spices in a food 

product. Other materials that may be included in a 

mixture must be labeled and are subject to other 

labeling requirements, but an important point to 

keep in mind is that the spice industry is fully 

committed to providing information to its 

customers, in other words, food and beverage 

companies that incorporate spices into finished 

foods. 

So if a material that originates from one 

of the eight materials that,are considered 

allergens, if proteinaceous materials from those 

eight are used in a spice mixture, then the spice 

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manufacturer is commi?!ked~to providing that 

information on its label so its customer can label 

as well. 

In terms of flavors, the FDA has listed a 

variety of flavor materials in the CFR, and I've 

provided the citation. In addition, there is a 

longstanding industry GRAS panel known as the FEMA 

expert panel, which has done thorough safety 

evaluations on about 2,000 flavoring substances, 

and this list is available from FEMA and we're 

happy to provide it upon request. 

Thi,s information has also been shared with 

FDA and these additives are included in the 

agency's database. None of the single chemically 

defined flavoring substances are considered 

allergens. These are individual substances that 

may be derived from natural sources or produced 

synthetically. None of them include proteinaceous 

material which would cause an allergic reaction. 

The current FDA labeling-rules, as I 

provided the citation for here, allow that flavor 

may'be declared in a generic manner, but it's 

important to note that other materials included in 

a flavor would have to be labeled for with the 

exception, of course, of incidental additives and 

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processing aids, but the fiavor industry, like the 

spice industry, is committed to providing 

information on allergenic materials that may be 

used in a spice mixture because flavors are complex 

mixtures. 

They are a number of individual flavoring 

substances and other materials- that are combined to 

provide the flavor that provides the taste to the 

variety of foods and beverages that we all consume. 

FEMA has been very active in the allergy 

area beginning in 1997 when FEMA sponsored an 

education session for its members, the FEMA Allergy 

Workshop. The impetus for this workshop was the 

release of the 1995 FAO Technical Consultation on 

Food Allergens, and FEMA took the big eight list 

from that FAO consultation, made it available to 

its members, and in a self-regulation program 

established guidelines for the labeling of 

flavoring substances that are sold to consumer 

products companies. We had very good compliance 

with self-regulatory initiatives, as evidenced by 

the FEMA GRAS program. So we've had very good 

compliance so far with the allergy guidelines. 

The FAO guidelines are very largely 

consistent with the Food Allergy Issuance Alliance 

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guidelines as well. 

In terms of colors, the last group of 

substances I'd like to deal with this afternoon, 

large number of color additives are listed for use 

by FDA. They've been v'ery thoroughly evaluated for 

safety. None of them are listed as allergens, but 

as Dr. Jacobson mentioned earlier, some scientific 

data indicate that carmine and cochineal may be 

able to cause allergic reactions. 

We have encouraged our members, of course, 

to declare that whenever it's present in a mixture, 

and a number of consumer products companies also 

voluntarily declare it. 

Certif-ied colors must be labeled already 

specifically on the ingredient line. Exempt colors 

may be declared generically, but again any 

components that are derived from the big eight, we 

are encouraging our members to declare. 

Thank you. 

[Applause. 

DR. LEWIS: 

1 

Just before we begin our panel 

discussion, let me remind you that if you do have 

questions, please do write them on the cards, pass 

them to the aisles. They will be collected. 

Okay. For this particular panel, who 

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would 1ik.e to open with a comment or a question? 

Dr. Falci. 

DR. FALCI: This is Dr. Falci of the Food 

and Drug.Administration. My question is generally 

I guess about flavors and colors and spices in the 

sense that I agree with you. A lot of them 

apparently don't appear to be allergenic per se, 

and I was trying to get a feeling for exactly how 

many times, for instance, you would put a flavor, 

for instance, as a single chemical entity into a 

food per se, or would it be mostly put into a food 

via a delivery system where the flavor would be on 

some set of substances and then potentially sprayed 

on a food product, for instance? 

Isn't it mostly true that the delivery 

system for flavors, even colors and spices, would 

be sprayed on foods and that the delivery system 

would have potentially allergenic components in it, 

and that it wouldn't necessarily be that a matter 

of the flavor being there in a small amount, but 

the fact that the allergen is in the delivery 

system, per se? 

MR. HALLAGAN: Well, flavors are used in a 

variety of ways. Dr. Falci has just described what 

we refer to as a spray dry flavor system. Dr. 

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Falci is correct. Flavors may be used in that way 

in addition to other ways. If a flavor is 

delivered on a system, in other words, incorporated 

into the food on a system which, for example, may 

contain a carbohydrate matrix or a carbohydrate 

substance to carry the flavor, then we have 

encouraged our members to declare that substance 

if, in fact, the delivery system contains a 

proteinaceous material from one of the eight listed 

groups of allergens. 

so, yes, flavors are used in that way, and 

we have asked our members to declare those 

substances if they are contained in the delivery 

system. 

DR. FALCI: And how often would this 

particular type of delivery system by used per se? 

I mean are flavors, colors and spices delivered 90 

percent of the time in this matter in a food 

product? 

MR. HALLAGAN: I don't know what the 

actual proportion is, but tie could certainly get 

that information for you, but it is accurate to say 

that all three--flavors, colors and spices--can be 

used in that way. And, for example, flavors going 

into a beverage woul,d not be delivered that way, 

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and that's a very large pro,portion of the flavor 

Ised; same with the candy. Spray dry flavors or 

colors or spices would be used on snack foods, for 

example, and again I'm not a technologist, but I 

can get that information for you. 

DR. FALCI. Okay. Thank you. 

DR. LEWIS: Other questions, comments? 

Yichael? 

DR. JACOBSON: Mr. Hallagan, you mentioned 

that your associat.ion favors voluntary labeling of 

substances like carmine that have been demonstrated 

to cause allergic reactions. Instead of relying on 

voluntary action from companies, would you support 

mandatory labeling of those through legislation or 

?- 

regulation? 

MR. HALLAGAN: Well, our members' products 

are not the products that consumers actually 

consume in the majority of circumstances. It's our 

customers' labels that would be impacted. We're 

committed to providing that information to our 

customers and for flavors, colors and spices, as 

far as we're concerned, the initiative can be 

mandatory or voluntary. 

Our members intend to provide that 

information to the customers, and that's our 

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commitment and that's what we've been doing for the 

Last about four years. 

DR. LEWIS: Other questions from the 

various panelists? 

DR. FALCI: One more. Incidental 

additives--sort of it could be a learning curve 

here as far as incidental additives are concerned. 

There's been a lot of opinions or opinions 

expressed that incidental additives simply were not 

put on labels in the past, and although the agency 

has expressed the desire to have the food allergen 

in incidental additives put on the label, we 

started that policy and we suggested that policy 

back in 1996, it takes time to get through the 

industry. 

But could you, maybe members of the panel 

here, suggest ways of making iadustry more aware 

that incidental additives are really to be put on 

the label when a food allergen is present? What 

are the types of things that you would do to try to 

improve that in the industry? 

MS. HILDWINE: Well, I'll tell you the 

very first thing that I do is remind our members 

that the incidental additives exemption is not easy 

to come by. That regardless of whether your food 

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ingredient is identified as one of those suitable 

classes of ingredients that may qualify for the 

incidental additiv,es exemption, that, in fact you 

have to pass two parts of--well, you have to pass 

both parts of a two-pronged test in order to 

qualify for the exemption. 

Now, typically, these incidental additives 

are going to be ingredients carried over,from a 

previous component of a food, but the regulation, I 

think, reads very clearly that that component in 

order to be exempt from declaration must be present 

in the food at an insignificant level and have no 

technical or functional effect in the food. One of 

them is not sufficient for declaration. 

And I like to draw the example of, say, a 

flow agent in a seasoning blend. Say, the ,flow 

agent silicon dioxide has a functional effect in 

the seasoning blend. When that seasoning blend is 

added to a wet ingredient, the silicon dioxide 

loses all of its technical or functional effect. 

So when you add the seasoning, probably at a low 

level, to a food, and it's got the silicon dioxide, 

then, in fact, that substance may pass both prongs 

If the test, that it is p,resent in the finished 

food in an insignificant amount and'has no 
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technical or functional effect in the finished 

food. 

Well, what applies to silicon dioxide in 

the seasoning blend may not, for example, apply to 

say a wheat extracted ingredient that's in the same 

seasoning blend, and that would not be exempt, so 

you really have to look at this component by 

component and make sure that every component that's 

carried fo'rward passes both prongs of the test. So 

we do a lot to educate our members on just exactly 

what that exemption means. 

DR. FALCI: How do you do that? Do you 

call them in? Do you have conferences? What? 

MS. HILDWINE: Well, what I just told you 

that seemed to appear off the top of my head, you 

know, is not spontaneously there. It comes from 

years of advice to our members one on,one, as we 

go--we do their label reviews. NFPA does this, 

reviews labels, as one of its benefits to members, 

and answering their questions. When they ask for 

clarification on the incidental additives 

exemption, I get a lot of questions regarding the 

incidental additives exemption and personally walk 

them through it every time. 

DR. JACOBSON: Dr. Falci, the FDA 

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certainly could accelerate the learning process by 

identifying some products that have unlabeled 

incidental additives and find them misbranded, the 

allergenic incidental additives, and find them 

misbranded and remove them from the market. That 

would speed up the learning process considerably, I 

believe. 

[Applause.] 

DR. LEWIS: Other questions? Well, while 

you're thinking of more questions, we do have three 

from the p'articipants here today. One is for Anne 

Munoz-Furlong. It's actually a two-parter, Anne. 

Would milk allergic individuals know to 

avoid butter or cream or should'these be identified 

in the ingredient panel as milk? 

And the other is should only the top eight 

allergens be disclosed in favors and spices or 

more? 

MS. MUNOZ-FURLONG: Okay. The question 

about whether the milk ,allergic individual, what 

their understanding of milk products and byproducts 

ire is going to be depend on each individual. The 

leople that are more aware of it, probably the 

larents, the people closer to the patient, are 

Toing to be very aware that yogurt or butter are 

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milk derived. People as we move away from the 

circle of care for that child may not necessarily 

make the connection and we see this over and over 

again when we're talking to grandparents and other 

caregivers of the child. 

SO our suggestion would be to>always err 

on the side of safety and declare that it is milk 

after butter or any other of these terms to make it 

very, very simple to follow. 

The second part of the question should we 

look at only the top eight or all of the allergens, 

I know there's a study that's been done that looked 

at the foods that had been implicated in reactions, 

and there were somewhere around 160 foods on that 

list. That's an enormous task. 

What we would recommend again is to stay 

focused on the PO percent of that problem. Once we 

figure out what the solutions are there, we can 

hopefully then quickly come by and address some of 

these other issues. 

DR. LEWIS: The next~question I have is 

stated as follows: If'spices are not,considered 

allergens, then how can one have an allergic 

reaction to allspice as referenced by Ms. 

Munoz-Furlong? If there have been reactions to 

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spices, then what motions are in place to address 

these issues? 

MS s MUtiOZ-FURLONG: I want to clarify my 

position. I am not aware of any reactions to a 

particular spice. The bulk of the work that we do 

is to look at those top eight allergens. If they 

appear in anything, such as a color, spice or 

flavoring, then we want those listed out on the 

label. 

DR. JACOBSON: I was actually the one who 

mentioned allspice, cardamon and coriander. In the 

paper, Sue Hefle's paper, listing 160 or however 

many allergenic foods, those are included, and 

there are varying levels of evidence for those 

allergens, and I think there's going to be a gray 

area where there will be for some of the foods, 

there will be very limited, more anecdotal 

evidence. For other foods, there will be 

double-blind controlled studies, food challenges, 

that establish that it is allergenic, and then I 

think somebody will have to decide, well, how much 

evidence do you need? 

How many cases of demonstrated 

allergenicity do you need before you require 

disclosure? 

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DR. LEWIS: The next question I have 

focused on the concept of thresholds. What would 

be the threshold that is the minimum level of an 

allergen that would have to be declared? If the 

level is zero, how would the manufacturers test for 

that,? 

MS. HILDWINE: I brought this up so I 

think' I better field it. There is a lot of 

scientific work that's going on in this area. I'm 

not an expert on thresholds and certainly I really 

couldn"t speak to quantities, but a lot of 

scientists are devoting a lot of att'ention to 

determining what are the levels that would trigger 

allergic reactions. 

The author of this question has definitely 

pinpointed a problem, and that is that if we are 

talking absolute zero, then that's very, very 

difficult to achieve with respect to allergenic 

ingredients or for anything for that matter. 

DR. JACOBSON: I agree that it's a tough 

problem., Fortunately, the assays don't get down to 

parts per billion, but they're measuring levels 

that presumably are allergenic. I think the 

presumption should be that the substance is listed, 

the wheat or soy or whatever, if it's known to be 

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there as an incidental additive. 

But perhaps companies should have an 

opportunity to demonstrate that at such and such a 

level, something does not pose any risk of 

allergenicity. And right now I don/t know that 

there's any evidence for a threshold, but there 

should be an opportunity to exclude labeling of 

incidentals if they do fall below some demonstrated 

threshold. 

DR. LEWIS: I'll wrap my last two 

questions into one large question, although they're 

not entirely similar. The first is isn't it time 

that out of the three issues discussed today, this, 

meaning Panel III, holds the most risk for the food 

allergic consumer? Is the industry doing anything 

to prioritize this as the first issue? 

And then a second part of this: Mandatory 

labeling is a zero sum equal expense for all 

manufacturers. What incentives are there for 

manufacturers to deal with the cost of voluntary 

labeling? 

MS. HILDWINE: Well, I'm not absolutely 

certain that this is where the bulk of the problem 

of undeclared allergens is. I think we spent a lot 

of time in our second panel this morning talking 

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about good manufacturing practices, and let's say 

significant levels of food allergens that are 

undeclared in food products. So I think you've got 

some good sense of what that's like from the report 

of the FDA inspections. 

So I think that certainly manufacturing 

practices a're really where we may need to spend a 

lot of attention, you know, in resolving labeling 

things. 

The issue of undeclared allergens that may 

be present in flavors, colors, spices and 

incidental additives certainly is also a very 

important issue because it involves undeclared 

allergens and that's an important public health 

concern. But whether that is top of the list I 

think is still open to some discussion. 

As to incentives for the food industry to 

pursue voluntary labeling, nothing is quite as 

effective in the food industry as what we call peer 

pressure or the competitive marketplace, and 

certainly we know from the experience of food 

allergic consumers that they very'much appreciate 

when food companies go to the trouble of putting 

food allergen information on their labels on a 

voluntary basis. 

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More and more cdtiiipzknies are doing this, 

and they're beginning to be much more responsible 

about the way they do this, and consequently, you 

know, particularly if you're in a sector of the 

industry where you compete with some major 

companies that are already doing food allergen 

labeling of an advisory nature, this is something 

that you're considering because food allergic 

consumers more often than not are calling you up 

and asking you why isn't it there? 

And in addition to the pressures of the 

marketplace, the pressures of consumers certainly 

have something of an impact on what the food 

industry does. 

DR. LEWIS: Any last comments or questions 

from anyone else on the panel? If not, what we'll 

do now is turn to the last component of our 

program, the public comment. 

Just a couple of announcements and 

reminders before we do that. The first is that for 

these issues, the FDA docket is still open. People 

who are interested in submitting written comments 

on these particular topics are more than welcome to 

do so. The docket is still open. 

Secondarily, I need to be very clear about 

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, 

what are the issues th,at are being addressed today. 

It is food labeling. It is not latex gloves. It 

is not celiac sprue, and it is not restaurant 

labeling. Those are not topics of today's 

discussion. 

What we'll do at this point is take a 60 

second stretch break while this podium is lowered 

down so that our speake,rs will be able to make 

their comments from the floor. So bear with us for 

60 seconds while we arrange up here and then we'll 

be right back with our first speaker. 

[Whereupon, a,short recess was taken.] 

DR. LEWIS: All right. The procedure is 

that we will go down the list of persons who have 

registered to speak. We ask that you very briefly 

introduce yourself. You are being timed for three 

minutes. I do apologize if I mispronounce your 

name. I'll try the best that I can. You can 

correct me once you do get up there, but again it's 

three minutes and we would appreciate your moving 

along appropriately. 

The first on my list is Victoria Geduld. 

MS. GEDULD: My name is Victoria Geduld. 

I'm a concerned citizen and mother and I am with my 

daughter Nancy Geduld, who is six years old and a 

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student. Due to time constraints, I will not go 

into a lengthy of histery. Suffice it to say that 

aancy loves playing with her friends and sisters 

ind going to the park. 

It's a sunny day in August and rather than 

loing all these things on this Monday, she chose to 

sit with me because the most important thing in her 

Life is safe food. Misleading and unclear labels 

zan kill her and she knows this firsthand. 

My daughter Nancy has an acute 

lnaphylactic reaction to peanut proteins which is a 

fancy way to state the simple fact that trace 

amounts of a simple and common food can kill her. 

A few years ago, Nancy ate'a chocolate 

Cellogg's Rice Krispie treat that said nothing of 

peanuts or peanut traces on the label. After a few 

bites, she said, Mommy, this has peanuts. I read 

the label. Nothing, She began to swell. I gave 

her medicine and we were fine. Within a few 

months, these same treats began to carry the label 

"may contain peanuts." 

The traces must have been small. Were the 

traces larger, we know from history, Nancy would 

have had an injection and she would have been 

hospitalized, if she had survived. At four years 

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old, Nancy learned not to trust labels. 

Foods must be labeled in plain English so 

that Nancy at six and myself, her father, 

grandparents, relatives, teachers or caregivers can 

read the label and know what"s inside. If I have 

as a consumer have a question regarding the food, I 

should have a number on the label to call. 

In a recent example, the outside container 

\, 

of the same Kellogg's chocolate rice krispie treats 

said that they did not contain nuts, the 

individually wrapped treats inside said "may 

contain peanuts." As it turned out, the line had 

been changed and made peanut free, and the labels 

on the outside had been changed to reflect this. 

The individual wrappers inside had not. A 

confused consumer should be able to contact a food 

manufacturer. Small packagers can get waivers from 

the government, but luckily there are few who would 

qualify. Most packages are large and should be 

required to provide access to the company in the 

case of an accidental ingestion or an emergency or 

a question. 

In addition, any information about the 

ingredients in the food should be listed in the 

ingredients section of the label. 'IMay contain" 

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warnings do not help at the bottom of a package if 

the ingredients are printed on the top. We had a 

near accident in such a case. The warning was next 

to the company's address, catty-corner to the 

ingredient section. 

If it has to do with the ingredients, put 

it in the ingredients listing. With the purchase 

of food for an allergic individual, there is a 

ripple effect. For the millions of alie,rgic 

people, there are tens of millions who are 

affected. Think of the number of people who are 

involved in feeding a single child. 

Ail these people will be served with 

government legislation demanding accurate and 

readable labels. In addition, all these people 

will be unnecessarily inconvenienced by a "may 

contain" label spread on packages. No matter what 

manufacturers must not be allowed to put a warning 

label on foods because it is easier or more 

convenient than actually monitoring the food 

SUPPlY. The government must ensure that labels are 

accurate, not just slapped on. 

In order for my daughter to trust her food 

supply and get back to the business of being a 

child, any allergens must be included in the 

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169 

ingredients section. There can be no exemptions. 

Thank you. 

[Appiause.] 

DR. LEWIS: Thank you. Next please Pamela 

Hughes. If Pamela Hughes is not here, we wiii move 

to Joseph LaRocheiie. 

MR. LaROCHELLE: My name is Joe LaRocheiie 

and I would like to tell you what it is like to 

have a life threatening food allergy and why it is 

so important to have accurate and dependable food 

labels. I'm a 21 year old who lives in Dairy, New 

Hampshire and a senior at St. Anthem College in 

Manchester, New Hampshire. 

Besides having asthma, I'm also deathly 

allergic to peanuts and tree nuts. If I eat even a 

trace of these, I don't just get a stomachache. In 

my short life time I have had more than ten severe 

allergic reactions. When I was 13, I almost died. 

I had a chocolate chip cookie that contained 

walnuts. My symptoms started with a simple 

stomachache, but after less than one hour, I 

started having hives, itchy mouth and throat, 

breathing probiems. Ail the while my throat 

started to close and I began to lose consciousness. 

Doctors said that if I wasn't not a mile 

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from the hospital, that I probably wouldn't be 

standing here right now. After two to three 

injections of epinephrine, two shots of benedryl, 

two nebuiizer treatments and a oxygen mask, I was 

released from the hospital five hours later when my 

condition stabilized. 

Every minute of my life I must be on guard 

by reading all ingredient levels with how to read a 

label card handy and my epinephrine in the case of 

a severe allergic reaction. 

It is critical that food labels be 

accurate, clear and dependable to help me avoid 

potential life threatening allergic reactions 

because peanuts and tree nuts often show up 

unexpectedly in the most unlikely of piace,s. 

Besides reading ail ingredient labels, I 

am constantly watching for product recalls because 

of undeclared peanut or tree nuts. Because of 

that, I give high priority to the Food Allergy and 

Anaphylaxis Network's special food allergy alerts 

that notify me in the event these things happen. 

In the last few months in my state, an ice 

cream manufacturer recalled product with undeclared 

pistachios, a cereal maker had undeclared almonds, 

potato chips with undeclared peanuts, brownies with 

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undeclared almonds, yogurt raisins with undeclared 

peanuts, and I could go on. 

This simply underscores the fact they ail 

don't get it right aiithe time. I would just like 

to briefly comment on the "may contain" statements. 

I never eat foods that say may contain peanuts or 1 

tree nuts, processed in the same facility as 

peanuts or tree nuts, or processed on shared 

equipment. 

I'm grateful that some manufacturers have 

alerted me to the potential presence of an 

allergen, but would prefer they take the necessary 

steps to prevent cross-contamination in the first 

place. 

In recent years, I have seen many more 

products with these statements on the label, a 

trend that is limiting my choice for foods that I 

can safely eat. Thank you. 

IT 

[Applause. 

DR. LEWIS: 

Julie Reinhard. 

Thank you. Next, please, 

MS. REINHARD: My name is Julie Mendei 

Reinhard. I am the mother of, a three-year old 

peanut allergic son. I am here not only on behalf 

of my family, but on behalf of 2,945 consumers 

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representing 27 states WY&U have signed a national 

grassroots petition seeking regulations to make 

food labels more accurate. 

Since I learned about my son's allergy the 

hard way, in the emergency room as doctors battled 

to save his life, I have been challenged with 

keeping him in a peanut free environment. This 

means that I must read the label of every product 

that comes into our home and indeed every label of 

food my child may eat or come into contact with 

outside the home. 

But that's j,ust the beginning. After 

reading the food label, I must call the 

manufacturer to determine if the food has been made 

on shared equipment and therefore has the 

possibility of cross-contamination. 

This is because manufacturers do not 

reliably state whether peanuts are or are not in 

the product. Furthermore, even after I call the 

manufacturer, I often do not get accurate 

information. Sometimes I leave a message on an 

answering machine that can go unanswered for a 

period of weeks, and sometimes forever. 

Other times I talk to a consumer rep who 

reads from a written policy statement, but won't 

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send it, and is unable to answer basic questions. 

Often I have to make at least three calls before I 

even talk to an informed person. The first call is 

typically to get the phone number of the company. 

Worse, it is the rare occasion when I am 

told that the risk of cross-contamination is de 

minimis. Therefore, I am unable to rely on the 

label itself to know if the food is safe for my 

son, and yet strict avoidance is the only sure way 

to keep him safe. 

In addition to the FDA's inspection, 

research at the University of Nebraska documented 

that peanut residues were detected in 21 out of 111 

products with either precautionary labeling on 

peanut listed as a last ingredient and in 33 

percent of foods with no labeling in.any form. 

The researchers concluded that quote, 

"Despite vigilant monitoring of food ingredient 

statements by peanut allergic individuals, 

significant levels of unlabeled peanut residues can 

oe encountered in food products." 

Finally, a study published in 1997 found 

-hat while the ,threshold dose of peanut protein 

varies, as little as 100 micrograms provoked 

Symptoms in some peanut sensitive individuals. For 

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each of these reasons, Z strongly urge the FDA to 

prescribe regulations requiring manufacturers to 

use plain English and commonly understood terms in 

the ingredient statement like egg, milk and peanut, 

rather than a scientific term, and to adopt the 

proposed ingredient facts label put forth by CSPI. 

Further, I implore the FDA to mandate that 

allergens contained in natural flavors and spices 

be listed in a parenthetical after the general term 

is used, and to clarify the incidental additive 

regulations by stating that those containing 

allergens are significant and therefore not exempt 

from label declaration including substances 

migrating to food frbm equipment. 

Third, I ask you to adopt the allergen 

control procedures recommended in the attorneys 

general citizen petition. 

Finally, it is with profound gratitude to 

the cochairs of this national grassroots campaign 

that I submit the following petition to the FDA for 

its careful consideration. Here it is: 

11) Put allergen regulations as an II A 1, 

priority on their 2002 agenda; 

(2) Prescribe allergen control procedures 

for companies to follow in cleaning equipment to 

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reduce or eliminate the unintentional presence of a 

;nown food allergen in the finished product; 

(3) Mandate precautionary labels on foods 

if allergen control procedures and GMPs do not 

eliminate the unintentional presence of a known 

Food allergen and the presence of such allergen 

qoses a risk to human health; 

(4) Inspect manufacturing plants to 

determine if they are complying with the laws and 

regulations; and 

(5) Punish companies who are not in 

compliance with the laws and regulations. 

As the governmental body responsible to 

protect the health and safety of our Americans, 

these relatively simple measures can profoundly 

impact the safety of millions of Amer'icans who 

suffer from food allergies. Thank you. 

[Applause.] 

DR. LEWIS: Thank you. Next we have 

Zlizabeth Carus and in order not to surprise you 

Eolks, after Elizabeth Carus, we would be 

addressing Gayle Rubin. Is Elizabeth Carus here? 

MS. CARUS: My name is Elizabeth Carus, 

and in addition to being severely allergic to 

wheat, I also have celiac disease. Prior to being 

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diagnosed with celiac disease, I was trying to 

follow a wheat-free diet. I know how to read the 

labels. I know what to look for, and until I went 

and had -to follow a gluten-free diet, I was 

obviously missing a lot of hidden wheat. 

Upon going on a gluten-free diet, I ceased 

having asthma problems, which included going to the 

emergency room quite a few times, and obviously 

there was enough in the food that's hidden even 

after calling companies to have given me problems. 

Wh,en I call companies to verify whether 

things are wheat free and gluten free, the biggest 

problem I have beyond being told yes, it is, having 

the allergen so I can't eat it at all, is to find 

out that the company will tell me that they don't 

know if there's cross-contamination, not because in 

their company they have a problem, but they don't 

know from their suppliers. And when the company 

tries to find out from their suppliers, because 

they do want to know whether it's gluten free since 

that's where I'm at, it can take them months. 

They can write many letters and in the end 

they can say we don't know because we can't find 

out from our suppliers. And that to me is a big 

problem. And that's probably about half the 

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companies I call is what Ifind out. And these 

are companies that want to be able to tell me that 

things are okay, that are being careful about 

telling me what's in their food, and they don't 

feel comfortable telling me because they don't know 

if there might have been a cross-contamination. 

And basically that's what I wanted to pass 

on to you about that with the food products and 

things. 

[Applause.] 

DR. LEWIS: Thank you. Next is Gayle 

Rubin and following Ms. Rubin, if she's here, 

Judith Schreiber. 

MS. RUBIN: I brought some props. Hi. My 

name is Gayle Rubin, and I'm here supporting the 

celiac support groups. It says something different 

on your listing. I'm not sure what th.at was. 

Anyway, what I wanted to tell you is that 

gluten intolerance of celiac disease is a genetic 

disease that affects between one in 150 or between 

one in 250 Americans. And that is basically new 

information, and if you take thati and you add that 

to--figure out from what our total population is, 

you're looking at 1.5 million people roughly. 

If you take the related disorders, such as 

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Addison's Disease, other allergies, asthma, 

arthritis, attention deficit disorder, autism, 

cancer, diabetes, epilepsy, irritable bowel 

syndrome, lactose intolerance, mental disorders, 

multiple sclerosis, osteoporosis, psoriasis, 

scleria, sleep disorders, which affect another six 

or seven million people, you're talking about a lot 

of people who need label clarification. 

That"s basically the reason I want you to 

understand it's not--somebody made mention of--it's 

not about celiac disease. It's not about celiac 

disease. It's about people who have to know what's 

in the foods they eat. It's a lot of people. 

And as you do know, or you probably 

already know, celiac disease requires a strict 

adherence to 100 percent gluten-free diet for life. 

That includes.trace amounts, and we can't have it. 

So I did want to show you a picture of what 

celiac--I've taken this out of a medical book. 

It's actually Fishbind's, and I wanted to show you 

a picture of what it looks like, when you don't 

adhere to 100 percent gluten free diet. 

That comes about because the villi, which 

is the way you normally ingest food are stunted, 

they're cut off, and then what happens is, YOU 

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know, you can"t get .&Q& You start malabsorbing. 

You can't get nutrition to yourselves so I mean 

it's not minor. 

The other part, I guess, of that is that 

there's many, many places of hidden sources of 

gluten that, are found in ingredients of processed 

foods, and I can show you, you know, these Lays 

potato chips are totally'gluten free. These Lays 

potato chips are not gluten free. And without 

calling the manufacturer, you don't know that. 

Another type of example I brought you is 

this is a package from Europe, and this is what it 

looks like when they say it's gluten free. They 

actually have this little wheat symbol with like a 

no smoking slash through it, and they have that 

sign 'one, two, three places on the package, plus in 

five languages it's written gluten free, and it's 

written one location, two locations, on the top. I 

mean so there- are six locations on a label that our 

American manufacturers say there isn't enough room 

on the package to put anything. So I will cut off 

at that point. Thank you. 

[Applause.] 

DR. LEWIS: Thank,you. Judith Schreiber 

and then I believe Peter Skinner following. 

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MS. SCHREIBhR: IkillO. My name is Judy 

Schreiber. I'm a senior public health scientist in 

the New York State Office of the Attorney General 

Elliott Spitzer. And I am here today to offer our 

comments on the important public health issue,s of 

labeling food products containing allergens. 

As one of nine states' attorneys general, 

our office submitted a petition to the FDA to amend 

its regulations on food labeling and manufacturing 

practices to better protect consumers from exposure 

to potentially life threatening food allergens. We 

are grateful that the FDA is taking consumers' 

concerns seriously and has made strides to address 

these important public health issues. 

In the May 2000 petition, the attorneys 

general asked that the FDA: (1) require food 

manufacturers to label products with actual or 

possible presence of allergenic substances in 

foods; (2) require food manufacturers to provide a 

toll free number to enable consumers to contact 

knowledgeable customer service representatives 

about the ingredients contained in the foods; (3) 

to require manufacturers, food manufacturers, to 

declare natural and in,cidental additives derived 

From the big eight all,ergens; and, finally, to 

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181 

require food.manufacturers to adopt good 

manufacturing practices aimed at preventing 

cross-contact with allergenic substances. 

Regarding some of the questions that you 

posed for this hearing, we do believe that 

mandatory la,nguage is the only way to assure that 

the label contains the necessary information upon 

which the consumer can make an educated choice 

about the safety of the food for their family's 

circumstances. 

Two, we do recommend that the labeling and 

good manufacturing processes be exercised--the FDA 

should exercise its authority and adopt the 

recommendations, in the attorneys' general petition. 

The New York State Attorney General is considering 

future steps if the FDA neglects this important 

public health role. 

Finally, we agree with the FDA that the 

declaration of allergenic ingredients and 

incidental additives in flavoring, spices and 

colors is necessary for consumer protection. The 

petition of the attorneys' generals recommends 

amending certain parts of the regulation, and we 

Mill be submitting written comments elaborating on 

nrhere we feel these changes could be made. 

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We strongly urge the,FDA to codify its 

policy, to specifically state that incidental 

additives that are food allergens are not exempt 

from labeling and must be declared in the 

ingredient statement on the label. 

We also urge the FDA to require mandatory 

labeling to appear prominently and conspicuously on 

the information panel so that consumers can readily 

identify where that information is located. 

A speaker earlier today said that the FDA 

product recall program for allergenic contamination 

demonstrates that the system is working. I would 

say that that same example shows, in fact, that the 

system is broken and that it must be fixed. Having 

to recall products or having to have children and 

adults go to emergency rooms for care is not a 

preventative public health measure, and I urge that 

the system being broken, let's fix it. Let's give 

consumers the life line they need by having 

adequate labeling on food products. Thank you. 

[Applause.] 

DR. LEWIS: Thank you. Is Peter Sk 

with us today? 

inner 

MS. SCHREIBER: No. He was unable to make 

it. His wife went into the hospital. 

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DR. LEWIS: Thank you. And our next 

scheduled speaker is Catheri,ne Tretheway. 

Following Catherine Tretheway will be Javier 

Trujillo Arriaga. 

MS. TRETHEWAY: Hello. My name is 

Catherine Tretheway. I am an attorney and I 

assisted the New York State Attorney General in the 

preparation of the petition which has been the 

subject of today's discussion. More importantly, I 

am the mother of a five year old daughter who has 

a life threatening allergy to peanuts. 

I am also an active member of a support 

group for families who are dea,ling with peanut and 

nut allergies. I asked to speak today because I 1 

think it is important that the FDA know the source 

of this petition. This is truly a document 

prepared by consumers for consumers. In drafting 

the petition, I not only drew from my own 

experiences as the parent of a food allergic child, 

but also from the experiences.of the many parents 

with whom I have talked or'corresponded with during 

the recent years that I have started my work on 

food,allergy issues. Many of those parents are in 

the audience today. 

The petition is not a wish list for food 

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184 I 

allergic consumers. gather it represents what 

consumers truly need to protect themselves and 

their loved ones from unintended consumption of 

food allergens. 

We need better manufacturing practices to 

avoid cross-contamination. We need accurate 

labels. We need c,lear and easy to read labels. We 

need phone numbers on the labels so we can contact 

manufacturers with our questions. Above all, we 

need consistency in labeling and manufacturing 

practices so that my mother-in-law, my child's 

babysitter, and others, and especially my own 

daughter, can look to one spot on a food label and 

readily and quickly ascertain whether a food is 

safe. 

As the parent of a food allergic child, I 

appreciate the efforts of the Food allergy Issues 

Alliance in issuing guidelines for better good 

manufacturing practices and labeling. However, 

even after all our discussion today, I can only 

conclude that consistency in labeling can only be 

achieved through regulatory reform. I urge the FDA 

zo adopt thme proposals set forth in the attorneys' 

general petition. Thank you very much for your 

zime. 

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[Applause.] 

DR. LEWIS: Thank you. Next Javier 

Trujillo Arriaga, if that person is present. If 

not, Claudette McIntyre. Neither Claudette 

McIntyre or Javier Trujillo Arriaga. Then the next 

is Ron Barenburg. 

MR. BARENBURG: Thank you. My name is Ron 

Barenburg. I'm from a company named Lynx Street. 

We're involved in bar code symbology. There's a 

new bar code called reduced space symbology and 

composite symbology that allows more information to 

be put into less space. 

Now, next on,e, please. I'm sorry. That's 

the wrong one. I"11 go from here. Just forget it. 

How reduced symbology and composite symbology, 

which are globally recognized as bar code 

standards, can alert consumers to allergies in food 

products. Today manufacturers use what's called a 

UPCA code. That's the bar code sticker that's on 

every product. The upgraded version of it approved 

by the Uniform Code Council is also a UPCA bar 

code, but what's different about it, it is a 

portable database in that it can contain a lot more 

information. 

Right now it's available today, It can be 

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implemented by manufacturers phasing into RSS-UPCA 

bar codes. Retailers can upgrade or change their 

scanners on their normal scanner cycle.' Today's 

UPCA bar code contains only the manufacture number 

and the product ID number. With the allergen 

warning using RSSCS-UPCA bar code, the following 

can contain this information. This is what today's 

bar code looks like. That's what's on every 

product that comes to market. 

With using and phasing into as an adjunct 

to the warning level in human readables, scanned 

with the same UPCA code, it can say warning: 

contains eggs. If you wanted to put a warning: 

contains eggs and best used by date, it would be a 

similar label. It would just be a little larger. 

All these can be put into the same space that a 

normal UPCA code can use today. 

The benefits to the retailer. Besides the 

obvious concern for their customer's health, it 

would provide evidence that the consumer was given 

documented warnings with receipt of their purchase. 

Zetailers will, eventually upgrade anyway to support 

produce at variable weights and measures converting 

zo RSSLCS. 

The benefits to the consumer are obvious. 

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Besides having the. "may contain" warning in human 

readables, the scan bar code would print it out on 

the receipt alerting the consumer to the allergen 

warning, and if the consumer has a question, a 

checkout clerk would scan the product and verbally 

advise about any allergen danger before purchase. 

In conclusion, RSS bar codes can provide 

more information in less space, not only for 

allergen warnings, but for best used by dates, 

contraindications for other foods or drugs, and by 

providing batch and lot numbers, trace contaminated 

foods more quickly. 

I was drawn to this when I went to do some 

research on this and realized when I picked up with 

my 57 year old eye's a label and tried to read it, 

and I didn't have my reading glasses, how nice it 

would be just to be able to scan it at the register 

and see it in big letters, and I think it would 

help consumers tremendously. Thank you. 

[Applause.] 

DR. LEWIS: Thank you. Next, Joanie 

Janicki. And following Joanie Janicki would be 

Cliff Blaker. 

MR. JANICKI: That's a bit of a 

discrepancy here. J. Janicki. 

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1 DR. LEWIS: J; ,Janicki; Our apologies. 

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MR. JANICKI: Regulation 21 CFR 1001.4(a) 

deals with food designation of ingredients, and the 

problem here is that the criteria are fairly vague. 

The regulations above, the FDA states that natural 

flavors and/or artificial flavors may be listed in 

a vague manner. As an example of this would be the 

problem that most commercial products contain 

certain ingredients such as modified food starch 

and/or natural flavorings. It is not possible to 

tell by this type of labeling what ingredients the 

product actually contains such as corn, potato or 

wheat which are common allergens. 

This type of labeling can have serious 

ramifications to individuals with food allergies 

and celiac disease. I along with many other 

individuals who have food allergies urge the FDA to 

require manufacturers to list all the ingredients 

including trace amounts. 

As a first step, my recommendation would 

be to simply add a line after the words "modified 

food starch natural." Instead of modified food 

starch or garlic oil rather than spices. In 

Europe, they specify yes or no gluten and have a 

sign in front of the package similar to that of a 

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191 

has one place to go to look for the information on 

the product label. 

Now, th.ere is one area where I think my 

experience as a businessman makes me an expert and 

that's the talk about voluntary compliance rather 

than mandatory compliance. 

Now, I think the voluntary efforts that 

have been spoken about today should be applauded, 

but they cannot really eliminate potential 

problems, Some companies will be more.proactive 

than others, but there will always be companies 

that will drag their feet and not comply. 

It's the nature of industry to resist 

regulation and to minimize costs. What we have 

here is a balance between cost and public health 

and it's the FDA"s mandate to decide in favor of 

public health. 

When statements were made about advisory 

labeling with the "may contain" wording, I think 

that what was identified as unavoidable 

cross-contamination in many cases really means 

contamination that's too difficult to avoid or too 

expensive to eliminate. Again, I think it's the 

FDA that has the responsibility to protect the 

public and not leave these critical decisions up to 

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individual companies to make, and I urge the FDA to 

keep that in mind. 

Thank you, 

[Applause.] 

DR. LEWIS: Thank you. Next Jorge 

Kernandez Baez, followed by Gustav0 Trevino. Mr. 

Baez, Mr. Trevino? Martin Shunemann. Anne Bailey. 

Mary Thorpe. Mary Thorpe will be followed by Anne 

Clarke. 

MS. THORPE: My name is Mary Thorpe. I'm 

currently working at the Center for Celiac Research 

at the University of Maryland Baltimore, and I'm 

also representing myself as a person who is 

attempting to follow a gluten-free diet and thus a 

wheat free diet. 

And as such, I can speak for other celiacs 

around the country. I would just like to focus on 

some of my frustrations in following food labels 

that haven't been touched on very well. Gayle 

Rubin mentioned secondary sources, and reading 

labels myself I notice that some cans of tomato 

paste list wheat flour as an ingredient. Don't ask 

me why it has to,be there, but it is. 

And then when I look at a jar of spaghetti 

sauce of barbecue sauce, it has tomato paste as an 

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ingredient, I'm left to wonder does that tomato 

paste have wheat flour in it or not. Sometimes you 

might see a parentheses that tells the ingredients 

in that secondary ingredient, but usually you do 

not. And that's something I haven't heard touched 

on very much. 

So this indicates that some manufacturers 

are voluntarily doing this, but others are not. 

The same thing goes for soy sauce. Again, soy 

sauce has wheat in it most of the time. When soy 

sauce is a secondary ingredient, you don't know. 

So we have to avoid these things unless the 

labeling were there. 

And I think that's what we'd like to ask 

for today is that the labeling be there so that we 

know and can make the choices for these sources of 

things. There are many products. Somebody just 

mentioned modified food starch. This is a ques,tion 

mark. You don't kno,w the source of the food 

starch. 

Some manufacturers are voluntarily saying 

modified corn starch so we can make an informed 

choice, but we'd like to see everybody doing that. 

3r ,say modified wheat starch if that's what it is. 

3ut just let us know. 

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194 

There are other products ,like citric acid, 

MSG, stabilizers, monodiglycerides, dextrines, that 

can be made from different sources--corn, sugar or 

wheat--and we would like to know the source for 

those properties. All you have to do is put it in 

parentheses--(from wheat)--for each one. It 

wouldn't take up much space. 

Alcohol and vinegar are controversial, but 

they may have wheat origins. There should not be 

protein products in those substances, but there 

might be. Some people are explicitly sensitive. 

We don't know the threshold of tolerance and so not 

knowing, we'd rather err on the side of safety. 

And just let us know what the source is so we can 

make our informed choice. 

So whether it comes down to voluntary 

compliance by manufacturers or FDA codification, I 

would agree with many who would say that the 

manufacturers are trying, but we're still not there 

yet. It's been excruciatingly slow, and we'd like 

to see whatever is needed to speed up the process. 

We would hope the regulations wouldn't slow it 

down, but we just want it to be done. Thank you. 

[Applause.] 

DR. LEWIS: Thank you. Next is Anne 

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Clark, to be followed by Esah Yip. 

195 

MS. CLARK: Good afternoon. My name is 

Anne Clark. The FDA has made the presence of 

allergens in food high priority. This is a good 

thing. Labeling food that contains peanut or tree 

nut allergens is a very good thing. 

Labeling food that has or may have been 

handled with natural rubber latex gloves is not an 

acceptable solution or labeling as contains, or may 

contain the incidental food additive allergen NRL. 

Currently.natural rubber latex, or NRL, is approved 

by the FDA as an indirect food additive in light of 

the over 500‘ NRL lawsuits working their way through 

the American justice system concerning wrongful 

death, product liability, workmen compensation, and 

American with Disabilities accommodation. 

Manufacturers of NRL gloves have already begun the 

labeling process. 

Standard wording reads something like this 

one: 

In the unlikely event of an allergic 

reaction to these latex gloves, discontinue use and 

consult your health care provider. Caution: this 

product contains natural rubber latex which may 

cause allergic reaction. .Great for food handling. 

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196 

It says that on there. This product meets the U.S. 

Department of Agriculture specifications for food 

handling. 

Now f I have seen and submitted to the USDA 

advertisements for NRL gloves which claim to be 

USDA approved and USDA accepted. I've been told by 

the USDA that they do not approve products. There 

is no such thing. 

These gloves which I purchased contain a 

warning, a label, that really disturbed me. Some 

individuals may experience an allergic reaction to 

natural rubber latex products. Discontinue use if 

any reddening, burning or irritation is 

experienced. This manufacturing company will not 

oe liable to individuals who experience allergic 

reactions to natural rubber latex. 

Now, this manufacturer understands that 

their product can harm. Those of us who have 

experienced or witnessed someone having an allergic 

reaction to food handled by latex gloves understand 

these gloves can harm. There are safe, affordable 

alternatives. The al.lergens that are transferred 

on to food do not add to the nutritional value, 

preservation or flavor enhancement of the food. 

This is important. We know of no way with 

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current scientific knowledge to determine a protein 

threshold level that would be safe for all users 

and would not trigger any allergic reaction to NRL. 

* Furthermore, the current FDA food code 

alerts the food service industry of the potential 

for serious adverse reactions from latex to latex 

sensitive individuals. Gloves made of NRL must be 

declared 'an unsuitable utensil for food handling. 

NRL approval must be amended so that gloves made of 

NRL are not an approved indirect food additive. 

Labeling in this instance is not the solution. 

Thank you. 

DR. LEWIS: Esah Yip or Anita Klein? 

Next, Carol Roberts. Carol Roberts is here. 

MS. ROBERTS: My name is Carol Roberts. 

1"m a 62 year old grandmother who has had many 

allergies to deal with most of my life underlined 

by celiac, but I'm not going to speak to that today 

at all. I'll send some information in. I would 

like to make a very simple suggestion and as I read 

through all three areas, and as I know that I've 

experienced just about every single one of the 

things that have come up in one way or another, I 

used to teach school, elementary school, and I used 

to be an elementary school principal, and I've 

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198 

worked in the corporate world and done diversity 

training and done many things. 

But what I.thought about is we have a lot 

of people in this country who don't speak English. 

We have a lot of people in this country who don't 

know how to read. We have a lot of people in this 

country who don't have any knowledge whatsoever 

about what hydrolyzed protein.or caseinate or any 

of these things are. 

And I proposed a question to one of the 

panelists before who is not here about the 

integrity of whether or not if a person is 

allergic, say, to eggs, will they be allergic or 

sensitive to any byproduct from eggs? The answer 

was yes. And so, therefore, why do we need any 

other words except rleggsll on a label in terms of 

food being contained? 

What I did was take a little bit of time 

and I used pictorial chart. And this is just an 

idea and a suggestion of taking the different food 

allergens of the eight allergies and I took and did 

a diagram of each one of them that's understandable 

3y children. In the next column, I put the 

contains fish or seafood, listing the types, 

contains wheat or byproducts in words, and listing 

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199 

all of the different nam,es. 

The symbols can have ch.ecks through them, 

next to them, into them, whatever would make the 

most sense and be least confusing to those who 

looked at a label. SO each one of these things in 

terms of the terminologies that have been developed 

by each of the groups that are working on this 

could be incorporated into a glossary, put into a 

simple pamphlet. 

These charts could be done in such a way 

that you have them in a very organized simple way. 

They could be laminated, put into posters, put into 

grocery stores, hospitals, nursing homes, anywhere 

Nhere anyone is affected by these kinds of things 

in terms of it. 

In terms of signaling where they go, using 

Zaution, yellow label--everyone knows yellow is 

caution--put it there right on'the label right 

-here and put the words in there with a little 

picture that says what it is, or use a stop sign, 

Yhich is also a universal safety sign which 

children understand, so that if anyone just picks 

up that product, they know that they need to go and 

look at information on that label. 

And so I would just suggest a very simple 

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200 

adage like this to be able to simplify it down. 

You've got eight allergens. Use those eight words. 

We really don't need all the rest of them. 

Manufacturers could help by leaving, a lot of 

products out of--a lot of these additives and so on 

out of their products in the first place and let's 

get back to basics and good nutritional food. 

[Applause.] 

DR. LEWIS: Thank you. Next, Rebecca 

Dugal, and following Rebecca Dugal, Anne Whelan. 

Rebecca Dugal. I take it this is Rebecca Dugal. 

MS * DUGAL: This is Rebecca Dugal. I just 

wanted to say a few words while she's getting set 

up* We have some slides;. 

DR. LEWIS: Please continue. 

MS. DUGAL: I wanted to thank the FDA for 

hosting this panel. I think it's wonderful that 

we're kind of moving along with food labeling and 

to all of the panel participants. I also wanted to 

thank my daughter for ur'ging us to come and for not 

letting up on me in terms of making sure we could 

make the trip down her'e from New Jersey and help 

her with her presentation. This is something 

that's very important to her since she was about 

four in terms of being able,to read the labels and 

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