1

                       FOOD AND DRUG ADMINISTRATION










                            PUBLIC MEETING ON:


                 THE CHALLENGE OF LABELING FOOD ALLERGENS









                         Monday, August 13, 2001

                                  9:05 a.m.





                            The Cohen Building
                                Auditorium
                      330 Independence Avenue, S.W.
                         Washington, D.C.  20201 
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                             C O N T E N T S

                                                     PAGE

       Welcome
         Ken Falci, Ph.D.
         Director, Office of Scientific Analysis
           and Support                                  4

       Opening Remarks                     Christine Lewis, Ph.D.
         Director, Office of Nutritional Products,
           Labeling and Dietary Supplements             8

       Congressional Update
         Kate Winkler
         Legislative Assistant
         Office of Nita M. Lowey                       18

       SOURCE OR PLAIN ENGLISH LABELING                26
         Panel I:

         Michael Jacobson, Ph.D.
         Co-Founder and Executive Director, CSPI       27

         Anne Munoz-Furlong
         President and Founder, FAAN                   31

         Regina Hildwine                     Senior Director
         Food Labeling and Standards
         Regulatory Affairs, NFPA                      36

         Lisa Katic, R.D.
         Director, Scientific and Nutritional Policy
         GMA                                           41

         Discussion Between Panelists and CFSAN        47
           Christine Lewis
           Felicia Satchell, Director
           Division of Standards and Labeling
             Regulations
           Office of Nutritional Products
           Labeling and Dietary Supplements

           Ken Falci

           Kathy Gombas, Deputy Director                       Division of
HACCP Programs
           Office of Field Programs

           Thomas Wilcox, Medical Officer
           Office of Scientific Analysis and Support

         Questions from the Public                     55 
                                                                  3

                             C O N T E N T S

                                                      PAGE

       ADVISORY LABELING (e.g. "May contain [name of
       food allergen]")

         Summary of Inspectional Findings
         FDA/Minnesota and Wisconsin Food Allergen
         Partnership                       Theresa Dziuk, Consumer Safety
Officer
           Minnesota District, FDA                      64

         Panel II:                                      74

         Lisa Katic                                     74
         Regina Hildwine                                82
         Anne Munoz-Furlong                             90
         Michael Jacobson                               98
         Discussion Between Panelists and CFSAN        105
           Christine Lewis
           Felicia Satchell
           Ken Falci
           Kathy Gombas
           Thomas Wilcox

         Questions from the Public                    116

       LABELING OF INGREDIENTS EXEMPTED FROM                   DECLARATION
(Common or unusual names of
       flavorings, spices and colors; incidental
       additives)                                     133

         Panel III:

         Michael Jacobson                             133
         Anne Munoz-Furlong                           137
         Regina Hildwine                              142
         John Hallagan, General Counsel                       FEMA, ASTA and
IACM                        147

         Discussion Between Panelists and CFSAN       151

           Christine Lewis
           Felicia Satchell
           Ken Falci
           Kathy Gombas
           Thomas Wilcox
         Questions from the Public                    158

       Public Commentsco                              164

       Closing Remarks                                237 
                                                                  4

   1                      P R O C E E D I N G S

   2             DR. FALCI:  I want to say welcome to you

   3   all.  I know some of you have come a long way and

   4   we're all glad you arrived safely.  Let me give a

   5   special welcome to our panelists.  We're very glad

   6   you're here today.

   7             They've given me a few things to say as

   8   far as announcements and sort of housekeeping kind

   9   of things.  Today is the FDA's Public Meeting on

  10   Labeling of Food Allergens, and I'd like to go over

  11   some of the administrative details.

  12             Everyone should have picked up a packet, a

  13   registration packet, at the registration desk.  In

  14   your packet, you'll see there is a list of

  15   restaurants.  There is also a cafeteria.  There are

  16   a lot of restaurants nearby here.  There is also a

  17   cafeteria in this building downstairs.  You have to

  18   go down one flight.

  19             At the registration desk or a little bit

  20   off to the side, you'll be able to see various

  21   consumer and industry handouts.  We hope you pick

  22   up a few of those.  The guards, I believe, are

  23   requesting those of you that came through the I

  24   think this is the Third Street entrance, if you

  25   have your visitor's pass on you, that you keep that 
                                                                  5

   1   with you when you enter and leave the building.

   2   Use that pass to come back in.

   3             If you have any cell phones or beepers,

   4   would you just kindly take a look at them now and

   5   shut them off.

   6             The bathrooms are located in the main hall

   7   of this building.  When you leave this room, go to

   8   the right and you go to the main hallway and

   9   they're either on the right or the left-hand side,

  10   and if you think about, if you'll think about it,

  11   too, on the second floor, it's the same kind of

  12   configuration just in case they get a little

  13   crowded here on the first floor.

  14             We have a sign language interpreter

  15   available today.  If you know of anyone who needs

  16   sign language interpretation, please see the staff

  17   people.  They'll be walking up and down the aisles.

  18             Let's see.  One more message for our

  19   panelists.  The silver microphones are not to be

  20   moved.  Those are the ones used for recording, and

  21   the black microphones are the ones you can move

  22   towards you to make any statements you wish.

  23             The press has some area here in the front

  24   seats; if the press would like to come down and

  25   come up front, you certainly may. 
                                                                  6

   1             And let's see, oh, yes, telephones.  There

   2   are telephones in this building.  You can walk out

   3   of this auditorium again and go to your right and

   4   you'll go past the guard station, and you'll see

   5   them right there by the guard station.

   6             And I'd like to just do a little summary

   7   of where we've come as far as food allergens are

   8   concerned.  It wasn't very long ago, actually in

   9   1999, that FDA first thought about being and

  10   becoming more active with food allergens, and we

  11   did have discussions and we did formulate a plan of

  12   action as far as food allergens were concerned.

  13             We formed an internal steering committee

  14   within the Center for Food Safety and Applied

  15   Nutrition, which is a center in FDA.  And we also

  16   had a general committee on food allergens made up

  17   of a number of people within different offices that

  18   are in the Center for Food Safety.  And at that

  19   time, one of the reasons for our action was because

  20   recalls of foods placed in the market, foods that

  21   contained undeclared food allergens were at high

  22   levels in the nation.

  23             And in 2000, we followed that up.  We went

  24   out with industry, we went out to industry and to

  25   consumers.  We gathered data at that time.  We were 
                                                                  7

   1   seeking advice.  We were trying to raise awareness

   2   of people in the industry as well as consumers as

   3   far as food allergens were concerned.

   4             At that time, too, we were trying to

   5   decide on accomplishable tasks, those tasks that

   6   would make a difference as far as food allergens

   7   were concerned in the nation.

   8             And in 2001, you see that we have our

   9   website established.  You can turn to our website

  10   and see a variety of different actions that the

  11   agency has taken, examples of training as far as

  12   our inspectors are concerned, as far as food

  13   allergen control measures that are used in

  14   processing plants, how the inspector should go into

  15   processing plants and look for food allergin

  16   processing.

  17             There is also a Compliance Policy Guide on

  18   our website as well, and we're actively training

  19   our inspectors over the next six months or so.

  20             Today, we seek further information, and

  21   the kinds of things we'll talk about today, you

  22   will see eventually in our action plan for fiscal

  23   year 2002.  So that's what we're trying to

  24   accomplish here today as well.

  25             On our agenda, there are three subjects.  
                                                                  8

   1   Dr. Christine Lewis, who is the Director of the

   2   Office of Nutritional Products and Labeling and

   3   Dietary Supplements, will be our moderator today at

   4   today's meeting.  Dr. Lewis will give you an

   5   overview on the issues that we will be discussing

   6   here today and mention the agency's regulatory

   7   framework.  And as your moderator, I'll turn this

   8   meeting over then to Dr. Lewis.

   9             DR. LEWIS:  Thank you, Dr. Falci.  And I'd

  10   like to add my welcome to his welcome.  We are

  11   looking forward very much to this meeting, and in

  12   our listening mode hope to be gathering a great

  13   deal of information today.  I will be taking a few

  14   minutes to orient us by highlighting the challenges

  15   of labeling foods relative to allergens, but as Dr.

  16   Falci had some housekeeping rules to say, I have

  17   some ground rules to share with you.

  18             The purpose of this meeting is to put

  19   forward and discuss information to help FDA

  20   determine what additional activities we should

  21   undertake vis-a-vis the issues surrounding the food

  22   label and allergens.

  23             So our focus today is labeling.  We're not

  24   addressing the technical aspects of food

  25   processing.  More specifically our meeting will 
                                                                  9

   1   address only the topics outlined in the Federal

   2   Register Notice, again plain English source

   3   labeling, advisory labeling, and labeling of

   4   ingredients exempted from declaration.

   5             While we recognize there are other issues

   6   such as restaurant labeling and even latex glove

   7   allergies, these issues are beyond the scope of our

   8   discussions today.

   9             In terms of ground rules for members of

  10   the press here, FDA staff will not be giving any

  11   interviews because we are in a listening mode.

  12   There are three FDA press officers here today, and

  13   they will stand right now.  One is Ruth Welch, one

  14   is Kathleen Kolar, and Sebastian Cianci.  Please

  15   see them if you have any questions or need

  16   assistance.

  17             There will be some brief opportunities to

  18   ask written questions to panelists at the end of

  19   each panel session.  A reminder: these are

  20   questions, not comments.  And as we move through

  21   the presentations, please write your questions on

  22   the cards and give them to the ushers as soon as

  23   possible.

  24             We will get to as many questions as time

  25   allows from you folks in the audience.  I do need 
                                                                 10

   1   to emphasize the questions from the public should

   2   be addressed to the panelists, not to FDA, as again

   3   we're in a listening mode.

   4             We request that the questions only be on

   5   the specific subject that the panel has just

   6   discussed.

   7             The last part of the meeting will be

   8   devoted to public comment.  For those of you who

   9   wish to make a public comment and have not

  10   preregistered, there are sign-up sheets at the

  11   registration desk, first come/first served, and

  12   these statements should be no longer than three

  13   minutes.

  14             There will be a timer set up for the

  15   public presentations.  We'll let you know if you're

  16   going beyond your three minutes and need to stop.

  17   In addition to the oral public statements at the

  18   end of the day, you and anyone else may also submit

  19   written comments.  They should be sent to Dockets,

  20   and again that information is in the Federal

  21   Register notice, and if you picked up your package,

  22   there is a copy of the Federal Register in your

  23   package.

  24             There will be a transcript of the meeting

  25   available approximately one month after the 
                                                                 11

   1   meeting.  The transcript will be available at FDA's

   2   website, again in your package, www.cfsan.fda.gov.

   3             Before I turn to highlighting our

   4   challenges today, I'd like to introduce our

   5   panelists.  In no particular order, we have sitting

   6   with us today Regina Hildwine, who is Senior

   7   Director, Food Labeling and Standards, Regulatory

   8   Affairs at the National Food Processors

   9   Association.

  10             We have Dr. Michael Jacobson, Co-Founder

  11   and Executive Director of the Center for Science in

  12   the Public Interest.

  13             With us also is Lisa Katic, Registered

  14   Dietician, and Director, Scientific and Nutrition

  15   Policy at the Grocery Manufacturers of America.

  16             And also Anne Munoz-Furlong, President and

  17   Founder of the Food Allergy and Anaphylaxis

  18   Network.

  19             We also will have with us John Hallagan,

  20   who is General Counsel of the Flavor and Extract

  21   Manufacturers Association, American Spice Trade

  22   Association, and also with the International

  23   Association of Color Manufacturers, who will

  24   participate on Panel III this afternoon.

  25             We also will have with us Kate Winkler, 
                                                                 12

   1   Legislative Assistant from the office of the

   2   Honorable Nita M. Lowey, who will give an update on

   3   congressional activities related to the labeling of

   4   food allergens.  Ms. Lowey's office was invited

   5   today because she's initiated draft legislation on

   6   the labeling of food allergens.

   7             I appropriately need to inform you at this

   8   point that the current administration has not taken

   9   a position on such labeling.

  10             And finally, I'd like to introduce the FDA

  11   listening panel, which is directly on my left.

  12   First there is Dr. Ken Falci, from whom you've

  13   already heard.

  14             We also have Felicia Satchell, who is

  15   Director of the Division of Standards and Labeling

  16   Regulations in the Office of Nutritional Products,

  17   Labeling and Dietary Supplements.

  18             We have Kathy Gombas, who is Deputy

  19   Director of the Division of HACCP in the Office of

  20   Field Programs.

  21             And Thomas Wilcox, who is a Medical

  22   Officer within the Office of Scientific Analysis

  23   and Support.

  24             And finally, Theresa Dziuk, Consumer

  25   Safety Officer, FDA's Minneapolis District Office, 
                                                                 13

   1   who will discuss the summary of inspectional

   2   findings from the FDA/Minnesota and Wisconsin Food

   3   Allergen Partnership.

   4             So, at this point, I will take just a few

   5   minutes with the slides to highlight the challenges

   6   that we're facing relative to labeling of food

   7   allergens.

   8             I believe I can do this; correct?  There

   9   we go.  Keep going.  Technology will help us some

  10   day.  We're just not there yet.

  11             As I've already mentioned, the focus of

  12   the meeting today is threefold: source or plain

  13   English labeling; advisory labeling; and labeling

  14   of ingredients exempted from declaration.

  15             And more specifically, our meeting will

  16   focus on the eight most common allergens listed

  17   here: peanuts, soy, milk, eggs, fish, crustacea,

  18   tree nuts and wheat.

  19             Next.  As a bit of background, our current

  20   regulatory framework is such that the labels of

  21   food made from two or more ingredients list each

  22   ingredient by its common or usual name in

  23   descending order of predominance by weight in the

  24   ingredient statement.

  25             Thus, consumers can obtain information 
                                                                 14

   1   about the foods that they eat by reading the

   2   ingredient list.  There are, however, two

   3   exceptions.

   4             The first is that the act provides that

   5   spices, flavorings and colorings may be declared

   6   collectively without naming each.

   7             Second, FDA regulations exempt from

   8   ingredient declaration incidental additives such as

   9   processing aids that are present in a food at

  10   insignificant levels and that do not have a

  11   technical or functional effect on the finished

  12   food.

  13             However, I need to point out that FDA's

  14   policy is that an allergenic ingredient is not

  15   insignificant and therefore is not exempt from

  16   labeling.

  17             In terms of the current state of play, FDA

  18   has two petitions in-house regarding food

  19   allergens.  One is from the Attorneys General from

  20   nine states and requests FDA require a variety of

  21   activities including allergen information on the

  22   label, an insignia, toll free telephone numbers,

  23   good manufacturing practices, and labeling of

  24   flavors and incidental additives.

  25             The second is a petition from a consumer 
                                                                 15

   1   addressing very similar issues.

   2             Next.  We also are aware of NFPA's Code of

   3   Practice on Managing Food Allergens.  This code of

   4   practice is a voluntary program adopted by NFPA's

   5   members.

   6             Most recently, we've received and are

   7   aware of guidelines from the Food Allergy Issues

   8   Alliance.  The Food Allergy Issues Alliance is a

   9   private group comprised of industry and trade group

  10   representatives and a consumer group as well as a

  11   scientific advisor representing academia.  In May,

  12   they submitted to us a consensus document on

  13   guidelines for food allergen labeling.

  14             The questions on which FDA is seeking

  15   information are spelled out in detail in the

  16   Federal Register.  So just very briefly, they are,

  17   first, questions on source labeling.  We're asking

  18   what plain English terms would be understandable.

  19   That is terms such as "milk" instead of "whey."

  20   And we're asking about what formats would be most

  21   informative.  The issues are things such as formats

  22   in the ingredient statement itself versus below the

  23   ingredient statement as one example.

  24             Also, in terms of source labeling--next

  25   slide--we're asking about whether or not multiple 
                                                                 16

   1   formats would be confusing and should source

   2   labeling be voluntary or mandatory?

   3             Second, we have a set of questions on

   4   so-called advisory labeling, advisory labeling

   5   falling into the category of such things about "may

   6   contain" and its impact on consumers.

   7             And, in the next slide, questions about

   8   the appropriateness of advisory labeling including

   9   questions should the recommendations in the State

  10   Attorneys General petition be adopted and what

  11   about the criteria in the Food Allergy Issues

  12   Alliance?

  13             Next slide.  In terms of advisory

  14   labeling, we're also asking are there better

  15   alternatives to advisory label statements and do

  16   advisory statements adequately inform consumers?  I

  17   should add that examples of current advisory labels

  18   in practice include, for instance, "may contain

  19   peanuts" or "manufactured in a facility that also

  20   processes peanuts."

  21             Next slide.  We are also asking should

  22   these advisory statements be prescriptive and what

  23   should be the location and prominence of these

  24   statements?

  25             The third set of questions focuses on 
                                                                 17

   1   flavorings, spices and colors.  We're asking if FDA

   2   should continue to address the labeling of

   3   individual allergenic flavors, spices and colors on

   4   a case by case basis.  We also raise the question

   5   of label location and the issue of mandatory versus

   6   voluntary labeling.

   7             And in the next slide, we've also asked

   8   for comments on the labeling of incidental

   9   additives.  What minor ingredients or processes

  10   would manufacturers be unlikely to recognize?  And

  11   also when products are to be further processed or

  12   repacked, is better labeling on intermediate

  13   products necessary?

  14             The questions on the labeling of

  15   incidental additives in terms of lastly, we're

  16   asking whether FDA should codify its policy that

  17   allergens cannot qualify as incidental additives

  18   that are exempt from labeling?

  19             That basically highlights the purpose and

  20   issues we'd like addressed today during our

  21   meeting, and at this point, I think we will

  22   actually begin our program.

  23             More or less without further ado, we'd

  24   like to turn to some remarks from Ms. Kate Winkler,

  25   who as we've mentioned before is from the Office of 
                                                                 18

   1   Congressman Lowey.  Ms. Winkler.

   2             MS. WINKLER:  Good morning.  I'm delighted

   3   to be here today.  It's also a pleasure to see so

   4   many people here that the Lowey office has worked

   5   so closely with.  I too have to do a little good

   6   housekeeping before we start and say that I am Mrs.

   7   Lowey's legislative assistant.  I handle her food

   8   safety and agricultural work.  However, I'm not an

   9   official spokesperson for the congresswoman.  If

  10   the press has any questions for the Lowey office,

  11   you can feel free to give us a call afterwards and

  12   speak with our press person.  I'm just not at

  13   liberty to do so.

  14             I'm here in my legislative capacity to

  15   talk about the work that my boss has been doing

  16   over the last year and a half on the food allergin

  17   issue and let you know where our piece of

  18   legislation stands at this point.  Mrs. Lowey has a

  19   long record of achievement on food safety issues.

  20   She wishes she could be here today.  She's actually

  21   up in New York catching up on a little district

  22   time, but Mrs. Lowey was formerly on the

  23   Agriculture Appropriations Subcommittee.

  24             On that subcommittee, she took a strong

  25   interest in food safety issues.  She's introduced 
                                                                 19

   1   legislation that would require manufacturers to put

   2   a "best if used by" date on all perishable foods.

   3   She's also authored legislation that would require

   4   all fresh meat and poultry products to come with a

   5   nutrition label just as prepackaged food does, but

   6   her interest in the food allergy issue has taken

   7   her pro-consumer work to a new level.

   8             I'd say about two years ago, we started to

   9   receive a number of mail and, you know, when she'd

  10   be in the grocery store making shopping visits--you

  11   know she's been a member of Congress now for more

  12   than ten years--people would come up to her and let

  13   her know their frustration with reading labels, and

  14   that's when she turned to me and said what can we

  15   do about those that have a food allergy and can't

  16   get the information that they need off of a food

  17   label?

  18             So, you know, unfortunately, misleading

  19   and insufficient labels are not only a burden for

  20   some of us who look for expiration dates, but it's

  21   a serious health hazard for the millions of

  22   Americans with a food allergy.  Food allergic

  23   consumers and the parents of food allergic children

  24   do not have a choice.  Their health and lives

  25   depend on reading labels. 
                                                                 20

   1             That's why Mrs. Lowey moved to introduce

   2   the Food Allergen Consumer Protection Act.  An

   3   estimated 30,000 Americans suffer severe and even

   4   life-threatening reaction to foods each year and

   5   about 150 of them die.  While we can't prevent

   6   allergic reactions, we can enact common sense food

   7   labeling requirements that will help consumers

   8   avoid allergen laced foods.

   9             Currently, even those with a food allergy,

  10   even if they read labels for every food product

  11   they purchase every time they shop, they still

  12   cannot be assured that a product is safe.

  13             For example, under current regulations,

  14   food manufacturers do not have to identify the

  15   products used in certain flavorings or additives.

  16   This exemption leaves critical health and safety

  17   information off our food labels.  Although

  18   flavorings and additives are present in small

  19   quantities, for the millions with a food allergy no

  20   amount is irrelevant.

  21             Furthermore, ingredient statements are

  22   written for scientists, not consumers.  For

  23   example, how many people know that surimi is

  24   another term for egg.  Food allergic children

  25   should not be expected to decipher terms like 
                                                                 21

   1   "casein, albumin, or muso."

   2             The bill that my boss has sponsored would

   3   require that food statements list in plain language

   4   what if any of the eight food allergens are

   5   contained in a product.

   6             Beyond improving the readability of

   7   labels, it's time for manufacturers to clean up

   8   their acts.  Too many manufacturers are preparing

   9   multiple products with the same cooking utensils or

  10   on the same production lines without properly

  11   cleaning the equipment.  These practices must stop.

  12   A recent FDA study found that one-quarter of all

  13   manufacturers did not list ingredients that can

  14   cause potentially fatal allergic reactions and 47

  15   percent of manufacturers did not check their

  16   products to ensure that all ingredients were

  17   accurately portrayed on the label.

  18             There is no excuse when it comes to health

  19   and well-being of our children.  Manufacturers

  20   should be taking every step possible to ensure

  21   their product safety.  And as mentioned, the

  22   industry did recently propose voluntary guidelines,

  23   and my boss has worked very, very well with

  24   organizations like Grocery Manufacturers and

  25   National Food Processors Association, and she was 
                                                                 22

   1   incredibly pleased that these guidelines were

   2   issued a couple months ago, and she has applauded

   3   the industry for taking to heart the seriousness of

   4   this health hazard.

   5             But the fact is these are voluntary

   6   guidelines.  The legislation will give some of the

   7   suggestions the weight of statutory law and ensure

   8   that every manufacturer abide by some of the

   9   suggestions made in the guidelines.  Furthermore,

  10   it will provide the Food and Drug Administration

  11   with the resources to enforce the law.

  12             As I said earlier, before we introduced

  13   the bill in the last Congress, and I should say

  14   that the bill introduced in the 106th Congress is

  15   very, very different than the one we'll be

  16   introducing in the 107th Congress.  But before we

  17   introduced that bill, companies like Kraft and

  18   General Mills were already imposing stricter

  19   labeling standards, and we did use their labels as

  20   a model to work off of.

  21             In addition, we enlisted the help of NFPA

  22   and GMA to help us raise awareness of the problem

  23   in the industry, and I think their guidelines show

  24   that they really have taken to heart some of the

  25   work that my boss has done and others. 
                                                                 23

   1             To go point for point exactly what our

   2   bill does is again it requires that food ingredient

   3   statements identify in common language what if any

   4   of the eight main allergens are in a product.  It

   5   closes the food additive loophole which requires

   6   that on the ingredient statements if an allergen is

   7   used in any of the spices or natural or artificial

   8   flavorings that it be labeled as such.

   9             It preserves the Food and Drug

  10   Administration's authority to regulate the safety

  11   of certain bio-engineered products.  It requires

  12   food manufacturers to include a working telephone

  13   number, including one for deaf persons in case a

  14   family has an emergency and they'd like to contact

  15   the actual manufacturer themselves to have

  16   questions answered.

  17             It requires food manufacturers to better

  18   prevent cross-contact between food products that

  19   are produced in the same facility or on the same

  20   production line.  It also would disallow the use of

  21   "may contain" language except for those that the

  22   Food and Drug Administration would allow.  So that

  23   would put the FDA in charge of deciding in what

  24   instances a "may contain" language label is

  25   appropriate. 
                                                                 24

   1             It would allow the Food and Drug

   2   Administration to assess civil penalties against

   3   processes and plants that are in violation of the

   4   labeling manufacturing requirements for food

   5   allergens.  Furthermore, it would require the

   6   Center for Disease Control to attract food allergic

   7   related deaths.  Fortunately, we don't have

   8   reliable and accurate statistics right now.

   9             And lastly, it would direct the NIH,

  10   National Institutes of Health, to convene a panel

  11   of experts to develop a plan for research

  12   activities concerning food allergens.  So that's

  13   the bill in sum.

  14             In closing, I'd like to say that the bill

  15   will probably be introduced just after August

  16   recess.  The bill will be introduced in both

  17   chambers.  Part of the hold-up has been we've been

  18   working with Senator Kennedy on creating a bill

  19   that is suitable for both chambers so that we can

  20   have the same bill introduced on both sides of the

  21   Hill.

  22             We've also been trying to educate other

  23   offices about the bill, let them know what we're

  24   looking to achieve, and in doing so, we've held a

  25   briefing where we had Dr. Sampson, one of the 
                                                                 25

   1   leading doctors on food allergens, from Mount Sinai

   2   come down to the Hill and brief staff.

   3             We've also been working very closely with

   4   some organizations like Food Allergy Initiative,

   5   FAAN and CSPI, and let them activate their base so

   6   that like the constituents who reached out to my

   7   boss to say that this is something that is needed,

   8   we need to have accurate, reliable, readable

   9   labels, that they can let their members of Congress

  10   know that this is important to them, and that they

  11   should get on board with Mrs. Lowey, Senator

  12   Kennedy, and cosponsor our legislation.

  13             The only way this legislation is going to

  14   move is if we show that we have bicameral,

  15   bipartisan support, and I believe we do.  But the

  16   only way that message is going to be made clear is

  17   if people contact their members and let them know.

  18   So it's very important that some of the groups here

  19   today, some of the families and children that are

  20   here today, get in touch with their members of

  21   Congress and let them know what's important to them

  22   and how a labeling law like this could make their

  23   daily lives easier.

  24             I'd also like you to know that earlier

  25   this year the House passed the agriculture 
                                                                 26

   1   appropriations bill and in that bill was report

   2   language that asked the Food and Drug

   3   Administration to act on the Attorney General

   4   petition that put forward to them suggestions on

   5   how to make labels more readable and how to address

   6   some of the concerns for food allergic families and

   7   their children.

   8             In closing, I'd like to say I'm so pleased

   9   that FDA is having this public forum, as is Mrs.

  10   Lowey.  I think this is a step in the right

  11   direction.  I also think we need to get moving now.

  12   The voluntary guidelines were a huge, huge first

  13   step, but we need to ensure that every product on

  14   our shelves is readable, accurate and reliable so

  15   that families can feel confident about the food on

  16   their tables.

  17             Thank you.

  18             [Applause.]

  19             DR. LEWIS:  Thank you, Ms. Winkler.  We'll

  20   now turn to our first panel today which addresses

  21   the source or plain English labeling.  We have with

  22   us four panelists who will each make brief five

  23   minute comments on this topic, which will be

  24   followed by a discussion among the panelists

  25   themselves with input from our own FDA listening 
                                                                 27

   1   panel.

   2             We'll begin with Dr. Michael Jacobson,

   3   followed by Ms. Anne Munoz-Furlong, Ms. Regina

   4   Hildwine, and then Ms. Lisa Katic.  Dr. Jacobson.

   5             DR. JACOBSON:  Thank you very much, Dr.

   6   Lewis, and I must say that I really appreciate the

   7   FDA holding this important meeting, the first one I

   8   can recall on food allergies.  I think it indicates

   9   that the FDA is taking this issue very seriously.

  10             Ingredient statements on food labels

  11   should be printed in a readable typeface and should

  12   clarify which ingredients might cause allergic

  13   reactions.  Unfortunately, all too many ingredient

  14   lists are unreadable due to the small size and

  15   style of typeface used.  Consumers shouldn't have

  16   to play the game of "Where's Waldo" when they're

  17   shopping to find the ingredients they're concerned

  18   about.

  19             I have two examples here of some basically

  20   unreadable ingredient lists.  The first one is a

  21   Stovetop Oven classic pasta--I guess it's pasta; I

  22   don't know what it is--for your inspection.  And

  23   another one is a Hormel Kid's Kitchen product--the

  24   next slide, please--that really challenges people

  25   to read ingredients. 
                                                                 28

   1             Labels such as these make a mockery of the

   2   FDA's requirement that ingredient lists shall

   3   appear prominently and conspicuously.  Also,

   4   ingredient labels typically give the chemical names

   5   of additives such as sodium caseinate, lactose,

   6   albumen or gluten.  That's enough of that slide,

   7   please.

   8             This Quaker product, for instance,

   9   includes whey and sodium caseinate without

  10   disclosing that they are milk derivatives.

  11             It can be tough for the average person to

  12   memorize all the possible derivatives of foods to

  13   which they're allergic.  To help people who are

  14   sensitive to the eight major allergens and the raft

  15   of less common but sometimes no less severe

  16   allergens as well as for consumers who use

  17   ingredient lists for other purposes, the FDA should

  18   require all products to bear an entirely redesigned

  19   ingredients level which is on the poster in front

  20   of you.

  21             Last month, CSPI formally petitioned the

  22   FDA to provide an ingredient facts label that is

  23   consistent with the nutrition facts label.  The

  24   ingredients label should be printed in clearer

  25   larger type using upper and lower case letters, 
                                                                 29

   1   major and minor ingredients should be separated

   2   out, and a clear allergy information section should

   3   alert sensitive consumers.

   4             That section would include such statements

   5   as contains milk, soy and wheat or may contain

   6   peanuts.  This particular label was designed by the

   7   same firm, Greenfield-Belser, that designed the

   8   nutrition facts label for the FDA about ten years

   9   ago.  The wording and location of such information

  10   should be as standardized as possible on all

  11   packages.

  12             It has been suggested that the sources of

  13   various food additives such as whey and albumen be

  14   declared after the names of the additives in the

  15   ingredient lists.  So labels would state "whey (a

  16   milk derivative). "

  17             If a clear ingredient facts label with an

  18   allergy information section is adopted, I'm not

  19   sure whether that redundancy is needed, whether the

  20   sources of the major allergens need to be stated in

  21   the ingredient list.

  22             Focus groups could explore that matter and

  23   the request by the attorneys general that an "A" in

  24   a circle be printed on the front label to alert

  25   consumers about the presence of allergens. 
                                                                 30

   1             While the FDA has focused on the eight

   2   most common allergens, I urge you to at least add

   3   sulfites to that list.  Sulfites are not allergens

   4   but still cause life threatening anaphylactic

   5   reactions and must be listed on labels when present

   6   at 10 ppm, ten parts per million, or more.

   7             Finally, the FDA should prevent consumer

   8   confusion about products that claim to be non-dairy

   9   or wheat-free or vegetarian when they actually

  10   contain additives from derived from milk, wheat or

  11   animals.

  12             The front label of this product, for

  13   instance, says "vegetarian and soy cheese," but the

  14   manufacturer told us that the natural flavoring is

  15   actually skim milk, and the ingredient listed

  16   discloses calcium caseinate, both of which

  17   ingredients people with milk allergies and strict

  18   vegetarians would avoid.  That kind of misleading

  19   labeling should simply not be allowed.

  20             In sum, people with allergies and the rest

  21   of consumers need a clear legible ingredient fact

  22   statement with an allergy information section.

  23   That would do wonders to help people avoid the

  24   major allergens as well as other ingredients about

  25   which they're concerned.  Thank you very much. 
                                                                 31

   1             [Applause.]

   2             DR. LEWIS:  Thank you, Dr. Jacobson.

   3   Before we turn to Ms. Anne Munoz-Furlong, I'd like

   4   to remind the audience that you do have the

   5   opportunity to write questions on cards.  We have

   6   several ushers who will be walking among you to

   7   pick these up.  So as questions arise, please feel

   8   free to write them on the cards.

   9             Go ahead, please.

  10             MS. MUNOZ-FURLONG:  Thank you.  I have

  11   some slides.  Shall I ask you to change them or do

  12   I--okay--fine.  As we bring up these slides, I want

  13   to make the point that FAAN is a nonprofit

  14   organization.  Our mission is to increase

  15   awareness, provide education and advance research

  16   into the conditions under which reactions and

  17   fatalities occur.  We have 23,000 members.  Most of

  18   these are parents of children with food allergies.

  19   Can we flip the slide and go on to the next one?

  20             My objectives this morning--you can flip

  21   to the next one--thank you--are to give you

  22   information about the size of this problem, who is

  23   affected, and what the confusion is with the

  24   current labels.  Next slide, please.

  25             Currently, food allergies affect about 
                                                                 32

   1   seven million Americans.  About three million

   2   Americans are allergic to peanuts and tree nuts,

   3   and study after study continues to show that

   4   peanuts and tree nuts are the leading cause of

   5   severe or fatal reactions in this country.

   6             Children are the largest group affected by

   7   food allergy.  Up to six percent of children have a

   8   food allergy and eight foods account for 90 percent

   9   of the allergic reactions.

  10             Next slide, please.  Now, we know this

  11   list.  The point I want to make here is that almost

  12   all of these foods have caused a fatal reaction to

  13   a child or an adult in this country.

  14             Next slide.  There is no cure for food

  15   allergies.  Strict avoidance is the only way to

  16   avoid a reaction.  That means the individuals must

  17   read the label for every product every time they go

  18   to the store.

  19             Next slide.  Food allergy is the leading

  20   cause of anaphylaxis.  This is a larger problem

  21   than insect sting and medication allergy combined.

  22   There are about 30,000 emergency room visits a year

  23   and tens of thousands of reactions that are taken

  24   care of at home.  Additionally, about 150 to 200

  25   people die from these reactions. 
                                                                 33

   1             Next slide.  Okay.  This is it.  The

   2   symptoms can occur within minutes, and in every

   3   case the individual is eating something they

   4   believe is safe.  So we're not talking about risk

   5   takers.

   6             Next slide.  Now let's talk about the

   7   confusion with the current labels.  The first stop

   8   is when we go to the doctor and get a diagnosis,

   9   the doctor makes a diagnosis and tells the patient

  10   go home and avoid milk or eggs or wheat.  They

  11   don't know that they're not going to see those

  12   names on very many products until they get to the

  13   grocery store.

  14             If I could have the next slide, please.

  15   Now, this is just a sampling of what we call milk

  16   words.  When someone has a milk allergy, they need

  17   to learn casein, caseinates, lactalbumin.  These

  18   are the types of terms that they need to become

  19   familiar with, yet they're looking for the word

  20   "milk."

  21             Then there is a whole host of situations

  22   under which the product may contain milk depending

  23   on the product, and that will change.  They need to

  24   learn this as well.

  25             Next slide.  When we look at eggs, you can 
                                                                 34

   1   see that some of these terms are very scientific

   2   and they certainly aren't consumer friendly.

   3             Next slide.  When we look at wheat, again

   4   the individual is going to the store expecting to

   5   see "wheat," but they're going to have to learn

   6   that semolina and durum and some of these other

   7   terms are what they need to avoid.

   8             Next slide.  Now, we have conferences

   9   across the country.  Last year, there were 760

  10   attendees.  We conducted a survey looking at

  11   labeling and had 550 respondents.

  12             Next slide.  We asked them when they see a

  13   label, do they consider that the food labels

  14   currently on the market are easy to understand?  88

  15   percent disagreed.  98 percent told us that the

  16   information on the label is not enough regarding

  17   allergens.  99 percent disagreed with the statement

  18   that the current labels can be understood by a

  19   seven year old.  A seven year old would be about

  20   the first age that you can expect a child to start

  21   to learn to look for milk or eggs or some of the

  22   words that they're allergic to.

  23             And 98 percent told us that the current

  24   labels are not easy to be understood by a new

  25   babysitter, a teacher, scout leader, anyone else 
                                                                 35

   1   who is giving information or food to a child.

   2             Now, the top three concerns--this was a

   3   write-in section to the survey--were "may contain,"

   4   natural or artificial flavoring, and non-dairy.  I

   5   know we have other panels to discuss "may contain"

   6   and non-dairy so I'm not going to stop here.  The

   7   "non-dairy" bears mentioning for another discussion

   8   at a future meeting.  This is certainly a big issue

   9   for our families.

  10             Next slide.  So when we're talking about

  11   labels, there is no cure for food allergy.  Strict

  12   avoidance is the only way these people can avoid a

  13   reaction.  Therefore, the labels must be clear and

  14   easy to understand.  They must be consistent and

  15   reliable.

  16             And the next slide.  We recommend that

  17   these labels state in simple English terms adjacent

  18   to the ingredient panel what that product contains;

  19   that the allergens be identified when they're in

  20   these products at all times; and that there be a

  21   phone number so that the individual can contact the

  22   manufacturer whenever they have a question and

  23   we'll talk more about that as we go forward.

  24             I want to sum up with one of the comments

  25   from our members is that we are not food 
                                                                 36

   1   scientists, we're just mom and dad.  Thank you.

   2             [Applause.]

   3             DR. LEWIS:  Thank you.  Regina Hildwine.

   4             MS. HILDWINE:  NFPA thanks FDA for the

   5   opportunity to participate in these panels today,

   6   and we will also be filing written comments.  The

   7   National Food Processors Association is the voice

   8   of the $460 billion food processing industry on

   9   scientific and public policy issues involving food

  10   safety, nutrition, technical and regulatory matters

  11   and consumer affairs.

  12             My remarks today are all based on the Food

  13   Allergen Labeling Guidelines issued by the food

  14   allergy issues alliance.  NFPA is a member of the

  15   Food Allergy Issues Alliance, and NFPA members

  16   support the Food Allergen Labeling Guidelines.

  17   NFPA believes that it is important to present

  18   information on the major food allergens in terms

  19   commonly understood by consumers.  NFPA believes

  20   that plain language presentation options should not

  21   replace but should rather augment current

  22   ingredient labeling requirements.

  23             NFPA also believes that the approaches

  24   outlined in the Food Allergin Labeling Guidelines

  25   are sufficiently flexible to suit various 
                                                                 37

   1   situations and serve as a useful start for this

   2   discussion.

   3             NFPA believes that plain language labeling

   4   options should be voluntary.  To require such

   5   declaration would necessitate rulemaking on several

   6   standards of identify and other existing rules, and

   7   this is an unnecessary complication.

   8             Food allergen information presented in

   9   plain language terms will help food allergic

  10   consumers including children and other challenged

  11   readers to recognize the foods they must avoid.

  12   Plain language labeling also makes it easier for

  13   the caregivers of food allergic children to

  14   recognize the food allergens to which their charges

  15   are sensitive.

  16             The major food allergens as defined by FDA

  17   are not all single foods.  Crustaceans, fish and

  18   tree nuts represent classes of foods.  Within these

  19   classes of foods, food allergen information must be

  20   presented as the common or usual name of the

  21   individual food in the ingredient declaration.

  22             For example, for crustaceans, crab,

  23   crayfish, lobster and shrimp are the terms that

  24   would be used.  For fish, the common or usual name

  25   of the fish species must be declared in the 
                                                                 38

   1   ingredient list.  Likewise, for tree nuts, the

   2   individual types of allergenic nuts must be

   3   declared.

   4             Other foods that contain allergenic

   5   proteins should include the plain language name of

   6   the allergen.  In many cases, the plain language

   7   name of the allergen is used within the ingredient

   8   declaration as the common or usual name of the food

   9   ingredient or its standardized name.

  10             For example, hydrolyzed soy protein,

  11   buttermilk, peanut butter, cracked wheat and milk

  12   chocolate all include the plain language names of

  13   major food allergens as part of their common or

  14   usual names or standardized names.  In these

  15   instances, food processors declare the plain

  16   language names of food allergens through ingredient

  17   declaration.

  18             When the plain language name of the

  19   allergen is not declared in the ingredient list,

  20   food processors should ensure that plain language

  21   terminology is present in association with the

  22   ingredient list.

  23             Now, standards of identity can complicate

  24   the issue of declaring plain language names for

  25   food allergens, but these complications can be 
                                                                 39

   1   resolved.

   2             For example, the standardized food egg

   3   albumin specifies egg, and that's required in the

   4   standard.  Dried yolks, a name permitted by that

   5   standard, should be supplemented with the term

   6   "egg."  The ingredient would be dried egg yolks, a

   7   name permitted by the standard, which could be

   8   declared on the ingredient list as egg yolks.

   9             Now, despite what you heard earlier, you

  10   would not see the word "surimi" to represent egg.

  11   Surimi is derived from fish and on the ingredient

  12   list of a surimi product, you are likely to see the

  13   term "fish protein."

  14             With respect to wheat, semolina, farina,

  15   durum flour, graham flour, and white flour, all

  16   standardized names, should include the term "wheat"

  17   and the dozens of standardized cheeses all declare

  18   "milk" as a sub-listed ingredient.

  19             Plain language terms for the major food

  20   allergens should appear within, at the end of, or

  21   in immediate proximity to the ingredient

  22   declaration.  One option is to place at the end of

  23   the ingredient declaration a statement such as

  24   "contains peanuts."  It could be prefixed by a

  25   phrase that highlights attention of the food 
                                                                 40

   1   allergic consumers such "allergy information:

   2   preceding contains peanuts."

   3             The same effect could be accomplished with

   4   the use of a reference mark, such as an asterisk

   5   next to the name of the ingredient whose common or

   6   usual name does not include the plain name of the

   7   allergen, such as farina or casein, each followed

   8   with a reference mark.  That would then refer to a

   9   corresponding notation at the end of the ingredient

  10   list that would say "wheat" or "milk ingredient."  This

  11   option takes up very little space and could be

  12   useful for long ingredient declarations.

  13             Another alternative is to use within the

  14   ingredient declaration a parenthetical statement

  15   that follows the ingredient name such as "farina

  16   (wheat)."  Any of these options, "contains,"

  17   reference mark, parentheses, could use bold in

  18   their other highlighting to feature the information

  19   about food allergens.

  20             NFPA does not believe that multiple format

  21   options should be confusing to consumers provided

  22   the food allergen information is always presented

  23   in association with the ingredient declaration.

  24   This is where food allergic consumers are

  25   instructed to look for information about the 
                                                                 41

   1   allergens in food.

   2             Finally, plain language labeling for food

   3   allergens should be permitted on a voluntary basis.

   4   A mandatory approach would necessitate FDA revising

   5   a number of rules for standards of identity and

   6   other labeling rules.  This would complicate a

   7   labeling approach that can be done, and it is now

   8   being done on a voluntary basis.  Thank you very

   9   much.

  10             [Applause.]

  11             MS. KATIC:  Good morning.  My name is Lisa

  12   Katic and I am the Director of Scientific and

  13   Nutrition Policy for the Grocery Manufacturers of

  14   America.  GMA is the world's largest association of

  15   food, beverage and consumer products and works at

  16   the federal, state and local level on regulatory

  17   and scientific issues.

  18             GMA member companies are committed to

  19   meeting the needs of the food allergic community.

  20   And I'd like to commend FDA for holding this public

  21   meeting to collect information on this very

  22   important issue.

  23             GMA along with numerous trade associations

  24   formed the Allergy Issues Alliance several years

  25   ago because the food industry wanted to be 
                                                                 42

   1   proactively out front of and address this allergy

   2   issue.

   3             The Food Allergy and Anaphylaxis Network

   4   is an integral part of the Allergy Issues Alliance

   5   and as the association that represents food

   6   allergic consumers, FAAN is best positioned to

   7   provide insight into the labeling practices that

   8   would be of most use to the subset of the

   9   population.  We really appreciated their input and

  10   work in developing our guidelines.

  11             As Regina has already mentioned, the

  12   voluntary program has been developed by the

  13   Alliance and was released this spring.  It's a

  14   culmination of several months of work by the

  15   Alliance including FAAN and some other, as was

  16   mentioned earlier, food allergy scientific experts.

  17   Unlike a regulatory process that will take several

  18   years to develop and implement, the Alliance's

  19   voluntary program is now in the implementation

  20   stage.

  21             GMA's Board of Directors has adopted the

  22   Alliance's labeling programs and the CEOs of each

  23   of our member companies have asked their companies

  24   to implement the program.  We fully expect

  25   widespread adoption and implementation of our 
                                                                 43

   1   labeling programs by our companies in the very near

   2   future and as was already mentioned, some companies

   3   have been actively making changes since the

   4   adoption of this program.

   5             With regard to the plain English labeling,

   6   the Alliance's labeling program specifically

   7   addresses this issue and requires the use of plain

   8   English names on the label of foods that contain an

   9   allergenic protein that is derived from one of the

  10   major allergens.

  11             We recognize that it can be daunting for

  12   the food allergic consumer to learn the names of

  13   all of the ingredients that may be derived from an

  14   allergin.  Milk is a classic example.  As Anne

  15   showed earlier, there are numerous ingredients

  16   derived from milk.

  17             In accordance with FDA's regulations, each

  18   of these milk-derived ingredients must be declared

  19   in the ingredient statement by a different name.

  20   Casein, sodium caseinate and whey are just a few

  21   examples of the milk-derived ingredients that must

  22   be avoided by a consumer with a milk allergy.

  23             The Alliance's labeling program makes it

  24   easier for the milk allergic consumer to identify

  25   products that he or she needs to avoid by requiring 
                                                                 44

   1   the use of the common term "milk" in addition to

   2   the name of the ingredient on the label of foods

   3   that contain an allergenic protein from milk.

   4             As the agency is well aware, we have a

   5   tremendously diverse food supply that uses a wide

   6   variety of ingredients.  Packaging materials are

   7   different as well as packaging sizes.  Given this

   8   variety, there must be flexibility in presenting

   9   the common names of the allergens.  The Alliance's

  10   labeling program provides this flexibility by

  11   offering options for presenting the major

  12   allergen's common name.

  13             For example, a manufacturer could use

  14   parenthetical statements that identify the plain

  15   English name of the allergen in the ingredient

  16   statement after the ingredient.  An allergen

  17   information statement could also be highlighted or

  18   used in the ingredient declaration panel and then

  19   it would list the common name of each of the major

  20   allergens in the food.

  21             The Alliance's program provides other

  22   means of presenting the name of the common allergen

  23   as I think Regina has already laid out.  The plain

  24   English name would appear either in the ingredient

  25   statement or in immediate proximity to the 
                                                                 45

   1   ingredient statement.

   2             In summary, we support the use of common

   3   and plain English names on labels of foods that

   4   contain major allergens, and we believe that the

   5   Alliance's labeling program sufficiently addresses

   6   how this information should be presented.

   7             Because we anticipate widespread adoption

   8   of this program by the food industry, we believe

   9   that the allergen-labeling regulations are

  10   unnecessary.  Thank you.

  11             [Applause.]

  12             DR. LEWIS:  Thank you very much to members

  13   of our panel, and as scheduled on the agenda, we

  14   will now begin a 15 minute discussion among members

  15   of the panel as well as with the FDA listening

  16   panel.  Let me remind you that that will be

  17   followed by the opportunity for us to address the

  18   questions you may be writing down on your cards,

  19   and again there are people walking the aisles so

  20   please do take advantage of that.

  21             Relative to source or plain English

  22   labeling, are there particular issues anyone among

  23   our panelists would like to address?  Dr. Jacobson.

  24             DR. JACOBSON:  I'd just like to ask Lisa

  25   how you could rely upon that voluntary flexible 
                                                                 46

   1   labeling when there are thousands of food producers

   2   that are not members of NFPA and GMA?  Many

   3   companies have never heard of these trade

   4   associations and things can change from one

   5   management to another management.  I think the

   6   consumer needs to be assured that the clear

   7   English, the labeling will always be there.

   8             MS. KATIC:  Well, no doubt I appreciate

   9   that as a definite challenge.  I would say that

  10   NFPA and GMA members represent a majority of food

  11   products on the shelves.  So certainly we have the

  12   bulk of what we're talking about covered within our

  13   membership.

  14             We've talked about--through Alliance

  15   outreach we certainly plan on doing a lot of

  16   education amongst our own industry, our own

  17   industry reaching out to other smaller

  18   manufacturers that potentially are not amongst our

  19   membership.  We've got some discussions already

  20   underway on how to do that as well as educating.

  21   You know we have lots of large and small and

  22   medium-sized companies within our own memberships

  23   and we think that it's imperative that some of the

  24   larger manufacturers that have long-term experience

  25   with how to make changes on labels would be best 
                                                                 47

   1   served by educating some of our medium and smaller

   2   sized companies.  So it's really all about

   3   education and outreach and we have plans underway

   4   to do that.

   5             DR. LEWIS:  Other questions?  Kathy

   6   Gombas.

   7             MS. GOMBAS:  Yes.  This is Kathy Gombas

   8   with FDA.  I'd like to ask a question of NFPA,

   9   Regina.  You had indicated that source or plain

  10   English labeling should be voluntary versus

  11   mandatory because there are a lot of manufacturers

  12   currently using voluntary labeling.  Do you have a

  13   prospective on how many manufacturers are doing

  14   this today?

  15             MS. HILDWINE:  I can tell you that at the

  16   present time, the Food Allergy Issues Alliance, and

  17   NFPA, of course, is a member of the Food Allergy

  18   Issues Alliance, is developing a survey so that we

  19   can collect some baseline data from the food

  20   industry regarding their awareness of the Food

  21   Allergen Labeling Guidelines and their use of

  22   various presentation techniques.  We expect to

  23   field this survey, you know, the individual

  24   associations in the Alliance to our various members

  25   probably in the next month or so. 
                                                                 48

   1             Now, there are many more food trade

   2   associations besides NFPA and GMA and the Food

   3   Allergy Issues Alliance, and many of these are

   4   specialized food trade associations that are

   5   focused on various sectors of the food industry,

   6   and we are going to be going out to our members

   7   collecting information from food companies both

   8   large and small to get a sense of how many have now

   9   begun to use the plain language labeling that was

  10   advocated along with other things that were

  11   advocated in the Food Allergen Labeling Guidelines.

  12             DR. LEWIS:  Felicia Satchell.

  13             MS. SATCHELL:  My name is Felicia Satchell

  14   and I'm with FDA.  My first question is to Ms.

  15   Katic.  You had indicated that the voluntary

  16   program is currently being implemented, and I

  17   understand from Regina's last response that you are

  18   beginning to work with the industry.  Is there any

  19   plan for follow-up, say, six, eight, ten months

  20   down the road to see if all of your members are

  21   implementing this, if they are complying with the

  22   program?  How do you plan to track follow-up?

  23             MS. KATIC:  Well, as Regina just

  24   mentioned, we are developing, in the process of

  25   developing a survey that will give us a baseline of 
                                                                 49

   1   awareness and use of the program now, and we plan

   2   on reinstituting that survey in the spring and then

   3   obviously probably next fall to track the changes

   4   in usage and awareness.

   5             MS. SATCHELL:  What type of incentive, if

   6   any, for voluntary compliance?  I mean I can

   7   appreciate your doing a survey, but let's say that

   8   you have manufacturers that for financial reasons

   9   find it too costly to relabel, what are your plans

  10   for addressing members that may not be following

  11   the guidance?

  12             MS. KATIC:  Well, I think, first of all,

  13   the incentive is that no manufacturer wants to harm

  14   any consumer, first and foremost.  They take this

  15   very seriously.  Secondarily, there are legal

  16   issues that certainly no company wants to, you

  17   know, have an issue with again harming a consumer.

  18   So this is something that the industry has been

  19   working on for decades, for a long, long time.

  20   This is nothing new.  This is something that the

  21   industry continues to look at and refine and

  22   redevelop.

  23             So, you know, as I said in my comment,

  24   this is something that has gotten to the highest

  25   levels within our member companies.  It's been 
                                                                 50

   1   presented to our board of CEOs.  Our CEOs are on

   2   board and have given their support obviously and

   3   encouragement for use of the program.

   4             And I think through the survey, you know,

   5   we're really going to have some understanding of--

   6   the trade associations within the Alliance will

   7   have some understanding of how it's being used and

   8   obviously if it's not, then that will modify or

   9   adjust our education and outreach efforts.

  10             MS. SATCHELL:  Thank you.

  11             DR. LEWIS:  Other questions?  Dr. Falci.

  12             DR. FALCI:  This is Dr. Falci of the Food

  13   and Drug Administration.  I think there is a lot of

  14   agreement that we have here and I'm pleased with

  15   that.  I'm trying to turn my head around so I can

  16   see your format of ingredients that you have there,

  17   Dr. Jacobson.  And I think that's a very

  18   interesting idea about having different kind of

  19   formats for ingredients in the ingredient

  20   statement.

  21             But my question has to do a little bit

  22   with consumer education.  Maybe you could think

  23   about that as I continue on here.  That is consumer

  24   education as far as the formats are concerned.  One

  25   of the things that I've seen is that there's a 
                                                                 51

   1   large percentage of the population that are

   2   unfortunately not interested in food allergens

   3   because they don't have that problem, they don't

   4   have to deal with it.

   5             So when you sit down and you think about

   6   trying to educate the consumer, it's hard to try to

   7   think of maybe the appropriate way of approaching

   8   people that might not be interested in it and to

   9   try to get them more interested in that.  So my

  10   question again is how would you really begin to try

  11   to educate the consumer?

  12             I know that Lisa Katic had mentioned that

  13   you're discussing that now.  I'd be interested just

  14   maybe if you could elaborate more on it, but some

  15   of the things that came to my mind, of course, were

  16   TV advertisements, of course, which are very

  17   expensive, but maybe once you get into the school

  18   programs about potential new formats as well.  So

  19   would anybody like to field that?

  20             DR. JACOBSON:  Well, I don't think we

  21   could expect any kind of well-funded government

  22   educational program that lasts for any significant

  23   period of time.  Measures should be self-actuating

  24   and that's what a clear ingredient label is.  It

  25   makes it possible for consumers to actually read 
                                                                 52

   1   the label as the law suggests.

   2             Look at some of those products in front of

   3   you.  Tom, could you pass that thing over there?

   4   These labels are designed not to be read.  You'll

   5   definitely need your glasses and a magnifying

   6   glass, too.

   7             [Applause.]

   8             DR. JACOBSON:  It's all upper case, skinny

   9   little print, very small writing that may be

  10   inevitable, but it goes--there are textbooks on how

  11   to print things legibly.  This violates every

  12   precept in those textbooks, and if the information

  13   is clear, it would make it a lot easier for

  14   consumers to read the label whether it's for food

  15   allergens or sugars or heart disease or

  16   hydrogenated fat or whatever people are concerned

  17   about.

  18             DR. FALCI:  Just as a follow-up to that, I

  19   think one of the reasons why such a package is

  20   created like that is unfortunately there is not a

  21   lot of food in the particular containers, not

  22   enough space on the container to have a large

  23   letters, but I don't know how you'd overcome that.

  24             DR. JACOBSON:  Well, I think there's

  25   certainly a variety of products.  We found very 
                                                                 53

   1   small print on very large packages also.  But even

   2   an example like that one before you, upper and

   3   lower case printing would be a lot easier to read.

   4   You know designers can make labels that are easier

   5   to read or harder to read.  Unfortunately, many

   6   companies are choosing the latter.

   7             DR. LEWIS:  One more brief comment before

   8   we move on.

   9             MS. MUNOZ-FURLONG:  In response to Dr.

  10   Falci's question about how to educate the

  11   consumers, if we're talking strictly about the

  12   simple language labeling, they are already reading

  13   labels, those that are affected, the food allergic

  14   population.  The problem is they can't understand

  15   what they're reading.  What we need to do is

  16   simplify the labels so that when the children and

  17   the adults and the teachers and so forth read them,

  18   they'll understand what they're reading, and also

  19   when that doctor makes a diagnosis and tells that

  20   patient to read the label, they will then be able

  21   to read it.

  22             So in this issue I don't think it's such a

  23   concern for education as it will be in some of the

  24   other panels.

  25             DR. LEWIS:  We'll take one more brief 
                                                                 54

   1   question from Felicia Satchell and then we'll move

   2   to the cards.

   3             MS. SATCHELL:  The question is directed to

   4   Dr. Jacobson and Ms. Munoz-Furlong.  Both Ms.

   5   Hildwine and Katic mentioned three or four options

   6   in their presentation for presenting plain English

   7   labeling in conjunction with the ingredient

   8   statement.  Allowing the flexibilities of these

   9   options, do you see that as being a stumbling block

  10   or confusing for allergic consumers?

  11             MS. MUNOZ-FURLONG:  On this issue, I don't

  12   think that it will be.  The fact is that they

  13   reading the label.  They need to have a place or a

  14   statement that they can understand.  If we're

  15   looking at what they like, and I'll cover some of

  16   that in the next panel, they would prefer that we

  17   have a statement of "contains milk and eggs"

  18   immediately after that ingredient statement because

  19   then it saves them time.  They don't have to read

  20   that entire paragraph in very small print.  They

  21   can zoom in on that and put the package back on the

  22   shelf if it's not safe for them or put it in their

  23   shopping cart.

  24             DR. LEWIS:  Thank you very much.

  25             DR. JACOBSON:  I think there should be a 
                                                                 55

   1   standardized label so consumers don't have to hunt

   2   around and say, oh, is there an asterisk here or is

   3   it boldfaced.  It should always be in the same

   4   place and as Ms. Munoz-Furlong suggested, something

   5   at the end where it would say allergy information,

   6   and then milk, soy, whatever, is the best option.

   7             DR. LEWIS:  Thank you to the panelists.

   8   We'll now move to the questions from the audience,

   9   and I have several here that I think will probably

  10   easily take up our remaining time.

  11             This question is about placement and it's

  12   directed to either Ms. Katic and/or Ms. Hildwine.

  13   Does the Alliance Allergy Labeling Program address

  14   labeling ingredients above and below the package

  15   seam?

  16             For example, a Trail Energy Bar sent our

  17   son to the hospital because we were unaware that

  18   almonds were listed under the foil seam.

  19             MS. HILDWINE:  Well, that's a very

  20   difficult situation, and a consumer shouldn't be in

  21   that situation.  Certainly, there are situations

  22   with respect to the design of packaging that are a

  23   challenge for the food industry.

  24             The food companies do try to make that

  25   information as clear as they possibly can given the 
                                                                 56

   1   constraints of the package size.  In fact, food

   2   companies know that FDA has regulations regarding

   3   the sufficient prominence of food label information

   4   and, you know, NFPA does encourage its members to

   5   follow those regulations all the time.

   6             I think you'll see in some cases, though,

   7   particular types of food are in particular types of

   8   packages that make, you know, using all the label

   9   space to present the required information very much

  10   of a challenge and we are working with our members

  11   to try and improve those situations.

  12             MS. KATIC:  The only thing I would add is

  13   that the program that was developed by the Allergy

  14   Issues Alliance does emphasize the prominence

  15   within the ingredient panel declaration, and that's

  16   what we would continue to support.

  17             DR. LEWIS:  Our second question from our

  18   attendees seems to be addressed for anyone who

  19   would like to deal with the topic.  I suspect it's

  20   more oriented towards industry.

  21             The question is what about "contains milk,

  22   wheat and egg ingredients," the way General Mills

  23   and Kellogg's are labeling?  Is this accepted to

  24   the food allergic consumer?  Is there data to

  25   support the way the industry should go for consumer 
                                                                 57

   1   clarity?

   2             MS. HILDWINE:  Well, I'll start with this

   3   one as well.  Certainly, those statements such as

   4   "contains milk, wheat or egg ingredients," this is

   5   one of the options that, in fact, the Food Allergy

   6   Issues Alliance included in our Food

   7   Allergen Labeling Guidelines.  It is the top ranked

   8   option, as a matter of fact, in our presentation of

   9   the various options for presentation.  And you know

  10   we think that a lot of food companies are starting

  11   to move in that direction to include this type of

  12   information that specifically says at the end of

  13   the ingredient statement that the product contains

  14   these ingredients.  It reinforces the information

  15   in the ingredient statement.

  16             MS. MUNOZ-FURLONG:  Well, from the

  17   consumer's perspective, General Mills and Kellogg's

  18   are one of the companies that everybody talks

  19   about.  They like their labels.  They're in simple

  20   English and "that contains," and then the allergens

  21   in simple language is perceived as a shortcut and a

  22   very handy way to teach someone else how to read

  23   that label.

  24             DR. LEWIS:  Anything else from our

  25   panelist on this topic?  We have a question to 
                                                                 58

   1   three of the panelists regarding Dr. Jacobson's

   2   presentation, and it has to do with his small board

   3   that he presented.  Do you folks support CSPI's

   4   ingredient facts proposal?  Can you discuss it?

   5   Why and why not?

   6             MS. MUNOZ-FURLONG:  I can tell you that

   7   the allergy information statement, we have

   8   conducted some focus groups and people do like

   9   allergy information.  It could also be substituted

  10   with "contain" statement and that would be

  11   acceptable as well.

  12             MS. HILDWINE:  Just focusing on the

  13   allergy information portion of the format for the

  14   moment, certainly that does present one of the

  15   options outlined in the food allergen labeling

  16   guidelines.  I think there are things, though, in

  17   the format overall that need to be taken into

  18   careful consideration.

  19             A couple weeks ago when Dr. Jacobson

  20   announced this new format, there was a side by side

  21   comparison of a current ingredient list and the

  22   proposed new format, and I, you know, just a minute

  23   ago talked about the challenges of fitting required

  24   label information on small packages, and if you do

  25   that side by side comparison, you will see that the 
                                                                 59

   1   proposed new format takes up a great deal of label

   2   space.  So that's a real practical problem that

   3   certainly needs to be explored further.

   4             DR. LEWIS:  My remaining cards focus

   5   largely on the issue of voluntary versus mandatory

   6   labeling.  In our remaining five minutes, I'll try

   7   to summarize some of those.  They are quite

   8   overlapping.

   9             There is a question for Ms. Hildwine.  Is

  10   your reason for supporting voluntary labels instead

  11   of mandatory ones that it's too confusing for

  12   manufacturers and the FDA to agree on this, and

  13   therefore it would delay implementation?  And if

  14   so, why not implement voluntary rules now and work

  15   on standard regulations for all companies?

  16             MS. HILDWINE:  Well, first of all,

  17   voluntary rules is an oxymoron.  There is really no

  18   such thing.  And certainly the work that the Food

  19   Allergy Issues Alliance has been doing is a

  20   voluntary approach and we announced this this

  21   spring, and food companies, some had already been

  22   following the precepts outlined in those

  23   guidelines.  Other companies are starting to do

  24   that now.

  25             We've been encouraging members to adopt 
                                                                 60

   1   these presentation options and these guidelines.

   2   Our concern is is that some food companies may say,

   3   well, if FDA is going to develop regulations to

   4   require this to adopt a mandatory approach, well, I

   5   think maybe I'll just wait to see what the agency

   6   does now.

   7             In plain fact, going the mandatory route

   8   will delay the adoption by the industry of those

   9   presentation options that have been outlined in the

  10   Food Allergen Labeling Guidelines.  So we would,

  11   you know, not just to mention the overwhelming

  12   complexity of this--you may not realize it, but

  13   when FDA, well, when the law changed to require

  14   declaration of ingredients of standardized foods as

  15   part of the Nutrition Labeling and Education Act,

  16   FDA had to open up the regulations on every one of

  17   the standards of identity.

  18             I believe there are about 72 regulations

  19   governing cheese, and this is only one category of

  20   standardized food.  FDA would have to make

  21   amendments to an overwhelming number of

  22   regulations.  It's not just a simple matter of

  23   requiring this in a particular section of

  24   regulations.

  25             So it would be very complicated.  It would 
                                                                 61

   1   take quite a long time.  There is no reason to

   2   wait.  The voluntary program that's been

   3   established by the Food Allergen Labeling

   4   Guidelines is in implementation now.  So we don't

   5   think that anybody should wait for rules and that

   6   it should continue to be on a voluntary basis.

   7             DR. LEWIS:  Thank you.  Lisa.

   8             MS. KATIC:  Well, just building one

   9   comment on top of that, I think Regina pretty well

  10   laid out the complexity, which then leads to the

  11   next point, why we think voluntary versus mandatory

  12   is the way to go is that down the road the industry

  13   sees this program as evolving.

  14             If there is research, enough research that

  15   is done on a particular ingredient that it does

  16   prove that it becomes an allergen or is a problem

  17   for the public, that would be incorporated into the

  18   program and can be done right away, whereas waiting

  19   for regulations to, you know, move through the

  20   process could take one to two years, where as the

  21   industry can act very quickly and institute or

  22   implement something pretty quickly.

  23             DR. LEWIS:  My remaining cards really do

  24   play on this, and you may have already made your

  25   points, but I will offer these questions to you.  
                                                                 62

   1   To Regina Hildwine, because recalls are so high, on

   2   what basis do you think voluntary guidelines will

   3   be enough, and is it enforceable?

   4             To Anne Munoz, Furlong, does FAAN support

   5   mandatory labeling and legislation in this area?

   6             And then finally, if a number of NFPA and

   7   GMA members already are labeling voluntarily or

   8   plan to, why is the industry opposed to FDA

   9   regulations which would reach all industry members

  10   since those already doing this voluntarily will

  11   just be ahead?

  12             Again, those are issues you've been

  13   addressing so I'll allow you to answer those or

  14   build on other comments you've already made if you

  15   wish.

  16             MS. HILDWINE:  Just with respect to the

  17   issue of recalls, these, as I've observed them over

  18   the past several years, are very much related to

  19   undeclared allergens, outright undeclared

  20   allergens.  The issue of plain language labeling is

  21   not question.

  22             Also, oftentimes the presence, the

  23   notation of a recall is an indication that

  24   enforcement type activity may have begun with

  25   respect to FDA.  We believe that FDA has plenty of 
                                                                 63

   1   authority to enforce regulations relative to

   2   undeclared, any undeclared ingredient including

   3   food allergens.  That's all I have to say for that

   4   one.

   5             DR. LEWIS:  Anne, did you want to make a

   6   comment?

   7             MS. MUNOZ-FURLONG:  Yes.  Regarding

   8   whether FAAN is for or against or whatever the term

   9   was for mandatory versus voluntary.  FAAN's

  10   position is that we know we need label improvements

  11   immediately.  We are going to support any and all

  12   initiatives that are going to get us there be they

  13   voluntary, regulatory, legislative, because

  14   ultimately they're going to benefit the consumer.

  15             [Applause.]

  16             DR. LEWIS:  In the last few minutes, does

  17   anyone else on the panel have one more comment or

  18   question before we take a break?  Thank you.  We

  19   will take a 15 minute break, which means we'll be

  20   back here just a little before 9:40.

  21             [Whereupon, a short break was taken.]

  22             DR. LEWIS:  All right.  Let's get started.

  23   We do have a special presentation.  I have been

  24   asked to remind the audience to please make note of

  25   the fact that there is no eating in the auditorium. 
                                                                 64

   1   That's a very important issue here.  Please do not

   2   consume vitals here in this particular auditorium.

   3             Our second panel addresses advisory

   4   labeling, and before we actually get to the panel

   5   presentations, we have with us today Ms. Theresa

   6   Dziuk.  She is with our Minnesota District at the

   7   Food and Drug Administration, and she will be

   8   presenting a summary of inspectional findings.

   9             If you would please welcome, Ms. Dziuk.

  10   Thank you.

  11             [Applause.]

  12             MS. DZIUK:  I'd like to thank the center

  13   for inviting me.  I feel very fortunate to be here

  14   today.  When this started, I was a compliance

  15   officer with the state of Minnesota.  In 2000, I

  16   joined the FDA as a consumer safety officer.  In

  17   October of 1998, the Food and Drug Administration

  18   formed a partnership with both the Minnesota and

  19   Wisconsin Departments of Agriculture.

  20             This partnership was in response to

  21   reports of consumers who experienced adverse

  22   reactions following exposure to allergic substances

  23   in foods which were not declared on the food label.

  24   In addition, there was an increase in the number of

  25   allergen related recalls, and we had concerns over 
                                                                 65

   1   manufacturing controls of undeclared allergen

   2   residues.

   3             The goal of our partnership was to

   4   eliminate duplicate inspections and sample

   5   collections, to ensure uniform enforcement and to

   6   obtain current information on allergy awareness and

   7   provide feedback to industry.

   8             While it is generally believed that nearly

   9   every food can cause an adverse reaction, eight

  10   foods are known to cause 90 percent.  FDA

  11   recognizes these as peanuts, soybean, milk and milk

  12   products, eggs, wheat, tree nuts, fish and

  13   crustacea.

  14             Although this partnership looked at the

  15   control of food allergens, we focused on industries

  16   that used peanuts and eggs.  Ice cream, bakery and

  17   candy manufacturers were selected for coverage.  86

  18   inspections were planned and 85 inspections were

  19   conducted.  Establishments inspected were 45

  20   bakeries, 13 ice cream manufacturers, and 18 candy

  21   manufacturers.

  22             Inspections performed were routine GMP

  23   inspections.  That's good manufacturing practice

  24   inspections.  State inspectors and FDA

  25   investigators were trained in August of 1999.  To 
                                                                 66

   1   ensure uniform application of current good

   2   manufacturing practices, inspectors and

   3   investigators were standardized during initial

   4   joint inspections.

   5             Inspections were conducted in September

   6   '99 through March 2000.  This was a small study.

   7   Establishment selection was not intended to be

   8   scientifically significant, but to provide an

   9   overview of current industry practices.  Selection

  10   was made randomly of small, medium and large

  11   establishments that were licensed and inspected by

  12   the state departments of agricultures, that

  13   conducted interstate commerce, and that were

  14   jointly scheduled on the agency's workplans.

  15             One measurement of establishment size used

  16   by FDA is annual gross sales.  What you'll see here

  17   on the left side, there are nine categories of

  18   annual gross sales.  We broke those down into three

  19   groupings and considered them small, medium and

  20   large.  I've broken out on the slides both

  21   Minnesota and Wisconsin.  We inspected 85 total

  22   establishments.  17 were small, 51 medium, and 17

  23   large.

  24             During our inspections, our investigators

  25   utilized a specialized questionnaire to aid in 
                                                                 67

   1   assessing industry practices.  Example of the areas

   2   investigators observed during the inspections were

   3   the use of shared equipment, production practices

   4   such as handling of rework, labeling and product

   5   changeover, and any other mechanism that related to

   6   the control of allergens.  Samples were obtained

   7   based on observation.

   8             This following series of slides has a lot

   9   of information that I will not be covering.  I'm

  10   going to be presenting totals, and it's important

  11   to recognize that there weren't differences between

  12   Minnesota and Wisconsin.

  13             Each of these graphs is broken down on the

  14   left side by total, and then they're also broken

  15   down by commodity.  There are bakeries, ice cream

  16   and chocolate.  And again, I'm only going to be

  17   focusing on the total, and I present this other

  18   information so that you can see from your own

  19   interest.

  20             The product label is the primary means to

  21   inform a consumer of potential product allergens.

  22   Our questionnaire contained a section on the use of

  23   allergenic ingredients.  Ingredients used in the

  24   formulation of the product were compared to the

  25   corresponding finished product labeling. 
                                                                 68

   1             45 of the 85 firms inspected, and that's

   2   the blue bar right here, felt that they had

   3   adequate procedures in place to verify label

   4   accuracy.  Of the 45 firms that felt that they had

   5   adequate procedures to verify label accuracy, our

   6   investigators found that 15 percent had incorrect

   7   finished product labels.

   8             Of the firms that didn't have procedures

   9   to verify their labels, 51 percent had incorrect

  10   finished product labels.  Only one of the 85 firms

  11   inspected had a policy against the use of advisory

  12   labeling.

  13             One bakery inspected reported that they

  14   had received a consumer complaint.  The consumer

  15   stated that they had an allergic reaction after

  16   consuming a product that normally would not contain

  17   peanuts.  The consumer called the bakery and said

  18   they were allergic to peanuts and had the reaction

  19   when they consumed this product.  The bakery

  20   reported to inform the consumer that the labels

  21   states it may contain peanuts.  The customer

  22   appeared to be satisfied and had no additional

  23   contact with the firm.

  24             This is an example where advisory labeling

  25   may not always be effective.  An advisory labeling 
                                                                 69

   1   statement such as "may contain" are not a

   2   substitute for good manufacturing practices.

   3             37 of the 85 firms inspected utilized

   4   rework.  Procedures for handling rework varied by

   5   industry.  Of the firms that utilized rework, 48

   6   percent had product that tested positive for

   7   undeclared allergen residues.  When using shared

   8   equipment, product changeover presents an

   9   unintentional opportunity for product that contains

  10   an allergen to contaminate a product that does not

  11   contain an allergen.

  12             Equipment cleaning is critical to the

  13   control of allergens.  While only three

  14   establishments inspected utilized analytical test

  15   methods to verify their cleaning and sanitization

  16   procedures, 41 of the 85 had standard operating

  17   procedures in place to control cross contact.

  18             During our inspections, we observed that

  19   production was frequently not scheduled.

  20   Scheduling was conducted first in/first out where

  21   the first order received would be the first order

  22   manufactured, and allergen considerations were not

  23   addressed.

  24             Scheduling was based on the color of

  25   production.  For example, a sugar cookie would be 
                                                                 70

   1   the first product manufactured, followed by various

   2   flavored chips, then peanut butter cookies and then

   3   finally ending the production run with gingersnaps.

   4             Many firms did not have dedicated

   5   equipment for allergen and non-allergen product

   6   lines.  Non-dedicated product lines were observed

   7   to be inadequately cleaned between production.

   8   Many times equipment was rinsed with only water or

   9   the equipment was cleaned at the end of the day.

  10   Only three of the 85 firms inspected utilized

  11   personnel that were trained and dedicated to

  12   allergen control.

  13             At this time, a tolerance for undeclared

  14   allergen residues has not been defined.  A standard

  15   method has not been approved by the AOAC.  For the

  16   partnership, we utilized an ELISA test kit that was

  17   developed by the University of Nebraska and

  18   manufactured by the Neogen Corporation.  This was

  19   used strictly as a screening tool.

  20             Each sample was a composite of ten

  21   eight-ounce subs and a ten part per million test

  22   kit standard and a reagent blank were used as our

  23   controls.  We determined a sample positive if it

  24   was reported positive at or above ten parts per

  25   million. 
                                                                 71

   1             Samples were not obtained at every

   2   manufacturer inspected.  Sample selection was based

   3   on manufacturing practices observed during the

   4   inspection.  Our samples were used to confirm our

   5   observational findings.  A sample was obtained if

   6   equipment was shared and a non-allergen containing

   7   product was produced after an allergen containing

   8   product without the equipment first being cleaned.

   9             We identified areas where there was a

  10   potential for cross contact and then took a sample.

  11   Our goal was to assist industry in defining

  12   critical control points in their process.

  13             We collected 118 partnership samples for

  14   analysis which was performed by the state

  15   laboratories.  73 samples were obtained for

  16   undeclared peanuts and 45 samples were obtained for

  17   undeclared eggs.  73 of the 85 firms used peanuts

  18   in their production.  18 of the 73 samples obtained

  19   were found positive for undeclared peanut residues.

  20   It's important to remember that we chose these

  21   samples based on our observational findings.  So we

  22   expected to find residues in these samples, and

  23   these 18 samples is equivalent to 25 percent of the

  24   samples obtained.

  25             When we look at the total picture 
                                                                 72

   1   comparing our observations with the sample

   2   analysis, it was observed that 49 percent of the

   3   firms had a potential for cross-contact of

   4   allergens into non-allergen containing products.

   5   Of these firms, 50 percent had positive samples for

   6   undeclared allergens.  Of the firms that utilized

   7   rework, 48 percent had samples that tested positive

   8   for undeclared allergens.  Of the firms that didn't

   9   have procedures for label verification, 51 percent

  10   had incorrect finished product labels.

  11             Allergen awareness was very high in some

  12   firms and extremely low in others.  We held

  13   industry workshops to provide feedback on our

  14   partnership.  Three workshops were held in May of

  15   2000.  We prepared an information pack with

  16   allergen education materials and for the firms that

  17   were unable to attend, we mailed this pack to them.

  18             We conducted follow-up.  All

  19   establishments that were inspected received a copy

  20   of their establishment inspection report.  They

  21   also received a copy of their analytical results.

  22   We either met or sent a letter to the firms that

  23   had samples which tested positive for undeclared

  24   allergens and explained the significance of these

  25   findings.  We conducted follow-up inspections at 
                                                                 73

   1   these firms during August of 2000.

   2             We conducted 21 follow-up inspections and

   3   collected 18 samples.  We found that industry made

   4   every effort to address and modify their good

   5   manufacturing practices.  The greatest change noted

   6   was in addressing cross-contact in the form of

   7   scheduling and sequencing.  Firms dedicated

   8   equipment to non-allergen and allergen-containing

   9   products.  They reconsidered their use of rework.

  10             Many firms corrected their labels.

  11   Sanitation practices were improved and verification

  12   testing of equipment and finished product was

  13   implemented.  Many firms trained their employees on

  14   the significance of allergen control.

  15             Through this partnership, we felt that the

  16   FDA and states gained credibility with industry.

  17   We found that the industry was very open and

  18   willing to share their manufacturing practices.

  19   Adherence to good manufacturing practices are

  20   essential in the reduction of undeclared allergen,

  21   and advisory labeling is not a replacement for good

  22   manufacturing practices.

  23             We are all in this together as consumers

  24   and labeling should be addressed as a food safety

  25   concern.  Thank you. 
                                                                 74

   1             [Applause.]

   2             DR. LEWIS:  We'll now begin Panel II which

   3   addresses the topic of advisory labeling.  We have

   4   four presenters.  First, Ms. Lisa Katic.  Second,

   5   Regina Hildwine.  Third, Anne Munoz-Furlong.  And

   6   last, Dr. Michael Jacobson.  Lisa.

   7             MS. KATIC:  Thank you.

   8             MS. KATIC:  GMA supports the use of

   9   supplemental statements such as "may contain

  10   peanuts" consistent with the criteria established

  11   in the Food Allergen Labeling Guidelines prepared

  12   by the Allergy Issues Alliance.  These guidelines

  13   clearly state that consistent with the FDA policy

  14   on this issue, supplemental allergen statements

  15   should not and cannot be used in lieu of good

  16   manufacturing practices.

  17             In addition, the guidelines restrict the

  18   instances in which a manufacturer can use these

  19   kinds of statements.  Under the guidelines,

  20   supplemental statements only can be used when:

  21             (1) The presence of a major food allergen

  22   is documented through visual examination or

  23   analytical testing of the processing line,

  24   equipment, ingredient or product or other means;

  25             (2) The risk of a presence of a major food 
                                                                 75

   1   allergen is unavoidable even when current good

   2   manufacturing practices are followed;

   3             (3) A major food allergen is present in

   4   some but not all of the product; and

   5             Last, the presence of a major food

   6   allergen is potentially hazard.

   7             If some but not all of these four criteria

   8   are met, the guidelines do not allow the

   9   manufacturer to use a supplemental allergen

  10   statement.  In such instances, the manufacturer

  11   must either consider an additional food allergen

  12   control measure and/or some other labeling

  13   strategy.

  14             With regard to the placement of the

  15   supplemental allergen statement, the guidelines

  16   require the statement to appear at the end of or in

  17   immediate proximity to the ingredient statement.

  18   The guidelines require that the statement be as

  19   accurate and as conspicuous as possible.  Examples

  20   of the type of supplemental statements that are

  21   being used include "may contain peanuts" and

  22   "processed on the same equipment as milk."

  23             The guidelines provide the manufacturer

  24   with the flexibility to determine the type of

  25   supplemental statement that will best describe the 
                                                                 76

   1   product.

   2             Supplemental allergen statements are an

   3   integral component of the Alliance's labeling

   4   document.  Although the food industry is diligent

   5   in its efforts to prevent major food allergens from

   6   inadvertently ending up in food products, the

   7   nature of the food supply and our manufacturing

   8   processes in some instances make it impossible to

   9   avoid.

  10             Farmers generally grow numerous crops and

  11   use the same equipment to harvest, store and

  12   transport corn, soybeans, wheat, peanuts and other

  13   crops.  This can lead, for example, to the presence

  14   of soy in corn or wheat in peanuts.

  15             Inadvertent contact can also occur in the

  16   manufacturing facility where the same processing

  17   equipment is used to manufacture a wide variety of

  18   products.  In an attempt to prevent the inadvertent

  19   presence of allergens in products, many in the food

  20   industry have adopted a three-tiered approach to

  21   minimize this inadvertent contact with allergens.

  22             This approach involves dedication when

  23   possible, separation, and as a last resort

  24   labeling.  First, when possible, the industry will

  25   use a dedicated system.  This may be possible for 
                                                                 77

   1   some large volume products where continual

   2   production on the same or multiple lines is needed

   3   to meet consumer demand.  It is not financially

   4   possible, however, to have a dedicated system for

   5   each product that is manufactured by a company.

   6             When a dedicated system is not a

   7   possibility, the company will use separation as a

   8   means to minimize inadvertent contact.  This can be

   9   accomplished by physical barriers, the use of

  10   dedicated containers for raw materials that contain

  11   allergens, and other means to prevent the

  12   inadvertent contact of a major allergen with

  13   non-allergenic ingredients.

  14             Companies will also schedule production so

  15   that when possible, a non-allergen containing

  16   product will be manufactured on a line before a

  17   product that contains an allergen.

  18             Companies will also thoroughly clean a

  19   line that has been used to manufacture a product

  20   containing a major food allergen before

  21   manufacturing a product that does not contain that

  22   allergen.

  23             Cleaning, however, will not always succeed

  24   in removing the allergens from all services of the

  25   equipment.  It has been proven time and time again 
                                                                 78

   1   that water is the most efficient method for

   2   removing allergenic proteins from processing

   3   equipment.  There are numerous foods and food

   4   systems, however, where water cannot be used as

   5   part of the cleaning process due to the nature of

   6   the food or due to microbiological safety concerns.

   7             Chocolate and peanut butter manufacturing

   8   systems are examples of processes where water

   9   cannot be used to clean the machinery because these

  10   foods do not readily dissolve in water and the use

  11   of water can lead to microbiological concerns due

  12   to the puddling of water somewhere in the system.

  13             Water also cannot be used in the cleaning

  14   of certain packaging and electrical equipment such

  15   as baking ovens and cooling tunnels for obvious

  16   reasons.   Water and electricity don't match.

  17             In instances when water cannot be used for

  18   cleaning, the food industry frequently will use a

  19   dry process for cleaning, such as flushing the line

  20   with a safe, non-allergenic dry ingredient or food

  21   that removes the food from the system.

  22             The use of these dry ingredients is

  23   recognized as an appropriate good manufacturing

  24   practice and in many instances is dictated by the

  25   microbiological concerns that are present by wet 
                                                                 79

   1   cleaning.

   2             The use of dry ingredients to clean a

   3   system, however, is not always successful in

   4   completely and 100 percent removal of the

   5   allergens.  Systems that rely on this type of

   6   cleaning frequently cannot be cleaned to remove all

   7   residues of a major allergen.

   8             In those instances when neither dedication

   9   nor separation can prevent the inadvertent contact

  10   with the major allergen, the industry will resort

  11   to labeling, labeling consistent with the four

  12   criteria established in the Alliance's labeling

  13   program that I stated earlier.

  14             These criteria are designed to ensure that

  15   supplemental allergen statements are used only in

  16   limited situations and not as a substitute for good

  17   GMPs.

  18             Supplemental allergen statements are

  19   designed to alert the food allergic consumer that

  20   the product in question may have an allergen that

  21   they need to avoid.  We recognize that a certain

  22   percentage of a given product bearing this

  23   supplemental allergen statement may be free of the

  24   named allergen and safe for consumption for the

  25   food allergic consumer.  However, the allergen may 
                                                                 80

   1   be present in some of the foods manufactured on

   2   that line.  Thus, necessitating the use of a

   3   supplemental statement that alerts the food

   4   allergic consumer to the possible presence of this

   5   allergen.

   6             As stated in many comments earlier, we

   7   believe that the allergen labeling issues can be

   8   best addressed through the voluntary program and

   9   that additional regulations are unnecessary.

  10   Although the existing regulations do not mandate

  11   the use of common English names or establish

  12   criteria for the use of supplemental allergen

  13   statements, the industry through the Alliance has

  14   reached agreement on these labeling issues and is

  15   now in the implementation phase.

  16             We believe that continued educational

  17   efforts will be one of the most effective means to

  18   address this issue.  GMA has educated its member

  19   companies about the importance of the allergen

  20   issue, and as stated this morning, the senior

  21   management from each of our member companies has

  22   agreed to adopt the labeling program.

  23             We recognize, however, that we also have

  24   to reach the small and medium sized companies that

  25   may not be members of GMA or of the other alliances 
                                                                 81

   1   that are part of the Allergy Issues Alliance.  The

   2   Allergy Issues Alliance is in the process of

   3   developing educational programs for these other

   4   smaller companies.  Moreover, FDA has the existing

   5   statutory and regulatory tools to take enforcement

   6   action against those companies that market products

   7   with undeclared allergens.

   8             The unacceptably high level of recalls due

   9   to the presence of undeclared allergens is perhaps

  10   the strongest evidence supporting the agency's

  11   ability under its existing regulatory framework to

  12   address this issue.

  13             We also encourage FDA to develop and

  14   maintain a strong enforcement presence for food

  15   allergens.  One of the best ways to effect change

  16   and to encourage all companies regardless of size

  17   to make certain that their products are properly

  18   labeled and that their foods are manufactured in

  19   accordance with good GMPs is through continued

  20   inspections and when necessary enforcement actions.

  21             We believe that a strong FDA presence and

  22   the knowledge that there is a "cop on the beat," if

  23   you will, would be a much more effective use of

  24   agency resources rather than additional

  25   regulations. 
                                                                 82

   1             In conclusion, GMA supports the use of

   2   supplemental allergen statements in those limited

   3   instances when the four criteria in the Alliance's

   4   labeling program are satisfied.  Consistent with

   5   FDA's guidance on this issue and the terms of the

   6   Alliance's labeling program, supplemental allergen

   7   labeling cannot and should not be used as a

   8   substitute for GMPs.  Thank you.

   9             [Applause.]

  10             MS. HILDWINE:  Thank you very much.

  11   Episodes of inadvertent cross-contact between foods

  12   that contain major allergens and foods that are not

  13   intended to contain those allergens coupled with

  14   the resultant problem of undeclared allergens in

  15   the product where they are not intended indicate

  16   that both production controls and labeling

  17   approaches must be discussed for these foods.

  18             FDA's questions focus on the issue of

  19   supplementary or advisory labeling, the so-called

  20   "may contain" statements.  But NFPA believes that

  21   this discussion may include a mention of

  22   manufacturing practices.  NFPA believes that this

  23   is the correct approach since we advocate the

  24   limited and carefully controlled use of

  25   supplementary of advisory food allergen labeling. 
                                                                 83

   1             Food processors that prepare foods that

   2   may be exposed to inadvertent contact with major

   3   food allergens acknowledge that labeling is not a

   4   substitute for good manufacturing practices.  GMPs

   5   and their resultant controls must be considered

   6   first before labeling approaches are considered.

   7   Processors should review the plant environment

   8   including storage conditions and production line

   9   architecture; should review the products, controls

  10   and practices of their supplier; should examine

  11   their own production operations, including

  12   separation, sanitation and scheduling practices;

  13   and then should create optimum conditions for food

  14   allergen control including employee training as far

  15   as they are able.

  16             When this process is completed, if the

  17   risk that the food allergens may be present, that

  18   risk still exists, then supplementary allergen

  19   labeling must be considered.  Supplementary or

  20   advisory labeling should not be an easy shortcut to

  21   bypass activities that are food processors'

  22   responsibilities, but rather should be viewed as an

  23   approach of last resort when the risk of presence

  24   of a food allergen cannot be avoided with absolute

  25   certainty. 
                                                                 84

   1             Supplementary or advisory labels should be

   2   relatively rare, not increasingly more common.

   3   Nevertheless, given the difficulties of achieving

   4   absolute certainty that there is no risk of

   5   presence of major food allergens in a variety of

   6   operational situations, supplementary or advisory

   7   labeling is necessary and should be permitted.

   8             The food industry has taken numerous steps

   9   over the past several years to change manufacturing

  10   processes to reduce the potential for cross-contact

  11   with major food allergens.  At NFPA, we have a Food

  12   Allergens Committee that has been working, meeting

  13   for several years, to discuss these practices.  As

  14   a result of these discussions, last year NFPA

  15   issued a "Code of Practice for Controlling Food

  16   Allergens," and this year we have started an

  17   elaboration of the Code of Practice, a how to

  18   implement the code of practice for the use of our

  19   members, which, by the way, cover the broad gamut

  20   of food processing, various sectors in the food

  21   processing industry.

  22             The food industry recognizes that under

  23   existing GMP regulations, reasonable precautions

  24   must be taken to prevent cross-contact with major

  25   allergenic proteins.  In instances, when 
                                                                 85

   1   cross-contact cannot be avoided even when complying

   2   with GMPs, food and ingredient manufacturers then

   3   use labeling that informs the food allergic

   4   consumer of the possible presence of allergens in

   5   the food.

   6             However, only supplementary label

   7   statements that are used in careful controlled

   8   circumstances would provide a food allergic

   9   consumer with enough information to make a clear

  10   decision about whether or not a food is appropriate

  11   for them to eat.

  12             The Food Allergen Labeling Guidelines of

  13   the Food Allergy Issues Alliance outlined four

  14   conditions that spell out the carefully controlled

  15   circumstances to govern responsible consideration

  16   of supplemental food allergen statements.  Lisa

  17   went through these and I'm going to do it again

  18   because we believe these are very important.

  19             The guidelines present a reasonable yet

  20   rigorous approach to the criteria for determining

  21   whether supplemental labeling statements should be

  22   used.  These type of food allergen statements

  23   should be used judiciously only when all four of

  24   the following criteria are met:

  25             First, the presence of a major food 
                                                                 86

   1   allergen is documented through visual examination

   2   or analytic testing of the processing line,

   3   equipment, ingredient or product, or through other

   4   means.

   5             Thus, the first step is to affirm that the

   6   major food allergen is in the environment.  This

   7   affirmation can be accomplished through examination

   8   of the physical plant, processing procedure,

   9   analytical testing where available, or through

  10   documentation.

  11             Second, the risk of presence of a major

  12   food allergen is not unavoidable even when current

  13   good manufacturing practices are followed.  This

  14   criterion signifies that all the feasible

  15   operational issues that can be addressed have been

  16   addressed with respect to control of the major food

  17   allergens, yet even under those conditions, there

  18   is not a complete certainty that one can avoid the

  19   risk that the allergen could be present.

  20             Third, the major food allergen is present

  21   in some but not all of the product in question.

  22   Clearly, if this criterion is not met, "may

  23   contain" type label statements could not apply.  If

  24   the allergen is present in all of the product,

  25   there is nothing may about it.  The product does 
                                                                 87

   1   contain the allergen.

   2             The occasional or sporadic presence of an

   3   allergen may provide additional information that

   4   allows the food processor to diagnose a situation

   5   with a supplier, the plant environment, a piece of

   6   equipment or a processing procedure.  This

   7   information would then trigger a review back to the

   8   second criterion.

   9             If one can identify a feature that would

  10   enable the processor to control further the risk of

  11   presence of an allergen, then steps should be taken

  12   to exert additional controls.

  13             This third criterion highlights that the

  14   review of allergen control procedures is not

  15   static, but dynamic.  Review of the criteria for

  16   supplemental labeling should be undertaken whenever

  17   there is a change to one of the operating variables

  18   such as ingredients, suppliers, equipment or

  19   processing techniques.

  20             The fourth criterion is that the presence

  21   of the major food allergen is potentially

  22   hazardous.  At the present time, scientists do not

  23   agree that there is a condition under which the

  24   presence of the major food allergen is not

  25   potentially hazardous, so this particular criterion 
                                                                 88

   1   at the present time would always apply.

   2             Now, if some, but not all of these

   3   criteria are met, food and ingredient manufacturers

   4   should consider food allergen control or food

   5   allergen labeling strategies other than

   6   supplemental allergen statements.  Meeting all four

   7   criteria will ensure that supplementary or advisory

   8   label statements are considered only after due

   9   diligence.

  10             Meeting all the criteria also ensures that

  11   labeling statements are not used capriciously or as

  12   a theoretical precaution.  For food processors,

  13   adhering to these criteria undoubtedly will have

  14   associated costs for reviews, self-inspections,

  15   audits, documentation of procedures,

  16   post-sanitation testing, personnel training and

  17   sometimes new equipment or facilities.

  18             However, failure to be vigilant with GMPs

  19   or such widespread use of supplemental labeling

  20   that food allergic consumers no longer believe the

  21   statements, these can have consequences that are

  22   not only costly but are tragic.

  23             If supplemental allergen labeling is used

  24   responsibly, the likelihood is that food allergic

  25   consumers will believe the statements and will 
                                                                 89

   1   avoid eating those products containing allergens to

   2   which they are sensitive.

   3             When all four criteria for supplementary

   4   food allergen labeling are satisfied and

   5   supplemental allergen labeling is used, it should

   6   be presented in close proximity to the ingredient

   7   declaration.  This is where food allergic consumers

   8   are educated to look for food allergen information.

   9             Any supplementary allergen statements

  10   should be as accurate and conspicuous as possible

  11   to help the allergic consumer make a clear decision

  12   about whether or not the food is appropriate for

  13   them to eat.

  14             FDA has asked if the supplementary

  15   advisory statements, "Made on shared equipment

  16   with" an allergen, "Manufactured in a facility that

  17   also processes" an allergen--and these would be

  18   named allergens--and "May contain" the allergen,

  19   whether these statements are adequate to inform

  20   food allergic consumers.

  21             NFPA believes that all these statements

  22   may be useful to the extent that they are truthful.

  23   NFPA supports a flexible approach to the use of

  24   these supplementary or advisory food allergen

  25   statements.  The goal of any supplemental allergen 
                                                                 90

   1   statement should be to prompt food allergic

   2   consumers to draw the conclusion that they should

   3   not consume the product.

   4             In order to provide for different

   5   production circumstances, there should be

   6   flexibility to the presentation of supplementary or

   7   advisory food allergen statements.  If such

   8   statements are to be accurate, then the

   9   one-size-fits-all approach is not feasible.

  10             For this reason, FDA should permit but

  11   should not mandate such labeling in proximity to

  12   the ingredient declaration and food processors

  13   should adhere to the necessary food allergen

  14   controls and evaluation criteria regarding the use

  15   of these statements.  Thank you.

  16             [Applause.]

  17             MS. MUNOZ-FURLONG:  I have some slides.

  18   Okay.  What I'm going to talk about I will continue

  19   to refer to as "may contain" labeling, but I really

  20   am intending for it to be all of the precautionary

  21   allergen statements.

  22             May I have the next slide?  Now my

  23   objectives here are to provide you with information

  24   about what the industry is currently doing and how

  25   that is impacting on the consumer and the consumer 
                                                                 91

   1   behavior and then wrap up with what we would like

   2   to see happen.

   3             Currently some companies are using

   4   precautionary allergen statements on many or all of

   5   their products.  Some of the other companies are

   6   using these statements judiciously so we've got

   7   people that are using a different decision tree.

   8   Every company is making their own determination and

   9   their own definition for the conditions under which

  10   "may contain" or precautionary labeling will be

  11   able to be used.

  12             The result is that we've got an uneven

  13   playing field, but we've got a consumer that is

  14   looking at this as every company is using this

  15   definition consistently and they are making their

  16   purchasing decision based on that information which

  17   is incorrect.

  18             Now, the majority of the consumers avoid

  19   products that say "may contain" statements and I

  20   have some data to show you how they behave when

  21   they see some of these other statements.  As a

  22   result, their food choices are diminishing on a

  23   weekly basis.

  24             This is a story that we get over and over

  25   again from our members, that they went shopping 
                                                                 92

   1   last week, and the product that their child has

   2   been eating for years and years has been safe.

   3   This week, they can no longer purchase that product

   4   because it says main contain on it.

   5             The only difference is that the "may

   6   contain" has been added to the ingredient

   7   declaration.  There are no other ingredients that

   8   have changed.  This is causing a lot of frustration

   9   and a lot of confusion to the allergic consumer.

  10             Can we go back on that slide one more

  11   time?  We can't go back.  Okay.  All right.  Well,

  12   I'm going to make my point anyway.  The point is

  13   that because of the proliferation of "may contain"

  14   statements, the integrity of all of the

  15   precautionary labels are being questioned by

  16   consumers.

  17             A perfect example came to our office

  18   several days ago.  One of our members was on an

  19   airplane and was given a bag of raisins.  She

  20   looked at the ingredient label simply because our

  21   members are trained to read ingredients for

  22   everything.  On a bag of raisins, it said may

  23   contain peanuts.  You have to wonder what's going

  24   on.

  25             Now, as a result of the proliferation of 
                                                                 93

   1   some of these statements, some of the physicians

   2   are telling their patients to ignore these

   3   statements because they're on everything and they

   4   don't believe that they're really there for anybody

   5   but the company's safety.

   6             As a result, some patients are making the

   7   decision on their own to ignore these statements.

   8   This to me is playing Russian roulette.  The other

   9   concern I have about this is that we are talking

  10   about children and it concerns me greatly that

  11   parents and others are making decisions because

  12   they're so confused about what's going on out

  13   there.

  14             Next slide, please.  Now, as I mentioned

  15   earlier, when we asked for the write-in to our

  16   survey, what were the three major concerns from our

  17   membership, "may contain" was at the top of the

  18   list.  Some of the comments that we got, and we got

  19   hundreds of comments in our book about some of

  20   these issues, were that "may contain" is perceived

  21   to be a defensive legal tactic or a way of avoiding

  22   good manufacturing practices.

  23             Again, this is because the consumers have

  24   been left to their own to try and decipher some of

  25   these labels. 
                                                                 94

   1             Now when we go on and look at some of the

   2   data from our study, when we asked them how the

   3   perceive these statements, if it says contains

   4   whatever the allergen is, 96 percent of the

   5   membership reported that they do not purchase that

   6   product.

   7             When they see "may contain," 92 percent do

   8   not purchase that product.  When they see

   9   "processed on shared equipment," 87 percent of the

  10   people do not purchase the product.  And

  11   manufactured in a plant that also produces nuts or

  12   peanuts or whatever the allergen is, 66 percent

  13   never purchase the product.

  14             The point I want to make here is that if a

  15   company is putting these types of statements,

  16   manufactured in a plant or processed on shared

  17   equipment, because of a risk to the consumer,

  18   because they intend that the consumer not purchase

  19   that product, we can see from this information that

  20   they're missing the mark, and there is a huge group

  21   of people that are at potential risk because they

  22   don't understand what you're trying to tell them

  23   with these labels.

  24             Now when we drilled down a little deeper

  25   and we asked about the "may contain," how do they 
                                                                 95

   1   interpret this, "may contain" to this group is a

   2   gray area.  They live in a black and white world.

   3   If you're allergic, you avoid the food.  "May

   4   contain," they ask is it in there or isn't it in

   5   there, how can we tell?

   6             When we asked about may contain any and

   7   all of the following, and then there is usually a

   8   long list of allergens, they want to know when is

   9   it in there?  How can we tell?  Is there a code on

  10   the package?  How does this happen that a

  11   manufacturer does not know what is in the product

  12   that I'm about to eat?  And then don't they clean?

  13   They're concerned that these statements are being

  14   used in lieu of good manufacturing practices.

  15             Next slide, please.  And when we ask them

  16   about manufactured in a plant that also

  17   processes--most commonly we see this with nuts or

  18   peanuts, they questions that came back to us and

  19   that are coming back to the industry, are how far

  20   is the allergen and non-allergen containing

  21   equipment from each other, and when you give me

  22   that information, can you tell me what the risk

  23   will be to me?

  24             Obviously, none of us can answer this

  25   question.  Therefore, this kind of labeling raises 
                                                                 96

   1   more questions to the consumer than it really

   2   answers and it causes again additional frustration.

   3   Another problem that we're seeing with this type of

   4   labeling is when we have multiple product packages,

   5   the outside of the product packaged does not match

   6   what's inside so we may have a may contains

   7   something on individual packages on the inside, but

   8   not on the outside.

   9             Next slide, please.  Now when we asked

  10   them about contains, and I mentioned this at the

  11   earlier panel, this to them is very black and

  12   white.  It contains it.  I'm allergic.  I can't

  13   have it.

  14             If they see the allergens bolded or

  15   highlighted or in a contains statement immediately

  16   after the ingredient declaration so that it's still

  17   within that visual range that they scan on that

  18   package, this again is a shortcut and is perceived

  19   to be a favor that a company is doing to them

  20   because it's helping them read that label very

  21   quickly and it saves time with each product that

  22   has to be read.

  23             So, in summary, the food allergic

  24   consumers need to know what is in the product.

  25   This is a health and safety issue for this 
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   1   population.  The companies have a responsibility to

   2   provide accurate, reliable, consistent information

   3   about that information, and I think we all agree

   4   that we all need a standard guideline for when

   5   these precautionary statements will be used so that

   6   we can educate the consumer about what they are

   7   supposed to do when they see these statements.

   8             We also would like all companies to use

   9   these statements judiciously.  Now, the guidelines

  10   that we worked with on the industry certainly

  11   address this issue, and I applaud the companies

  12   that worked on this with us and are already doing

  13   this.  However, I am concerned as I hear more and

  14   more smaller companies saying we're not going to do

  15   this until it's regulated and we will wait and see

  16   what FDA does.

  17             So there is a lot of work that needs to be

  18   done in this issue.  I'd also like to make a point

  19   that this is an international issue.  We are

  20   hearing the same thing from our colleagues in other

  21   countries.

  22             If we could have the lights, I want to

  23   read very quickly in my remaining two minutes an

  24   e-mail that is very typical of what we get in our

  25   office from our members.  This is from a woman who 
                                                                 98

   1   says my son has tree nut allergies.  Recently it

   2   seems that many manufacturers are placing warning

   3   statements on their packages such as "may contain

   4   nuts," "may contain traces of peanut or other nut

   5   particles due to manufacturing," or a candy corn

   6   product that the list includes "may contain

   7   peanuts, walnuts, almonds, pecans, cashews and

   8   other ingredients."

   9             I realize that the foods might be

  10   manufactured on the same machinery as foods that do

  11   contain nuts, but it is increasingly difficult to

  12   know the true ingredients.  I'm afraid it will

  13   become likened to the boy who cried wolf and we

  14   will all start doubting the ingredients.  And with

  15   that, I'd like to conclude.  Thank you.

  16             [Applause.]

  17             DR. LEWIS:  Just a quick reminder to the

  18   audience, you can write your questions on the cards

  19   and we will have someone collect them from you.

  20             DR. JACOBSON:  Contamination of food with

  21   undeclared allergens is what makes life so fearful

  22   for people with severe allergies.  They live in

  23   terror that a food contains an allergen not listed

  24   on the label.

  25             Unfortunately, such contamination occurs 
                                                                 99

   1   fairly frequently as we heard a few minutes ago

   2   from the FDA consumer safety officer who did the

   3   study in Minnesota and Wisconsin.

   4             That study found that in a selected sample

   5   of 85 ice cream cooking and candy manufacturers, 21

   6   marketed products containing undeclared peanut or

   7   egg ingredients, and those are the only two

   8   allergens studied.  If they had looked at others,

   9   there may have been other problems.

  10             Similarly, the Oregon Department of

  11   Agriculture tested 62 chocolate candies that were

  12   not supposed to contain peanuts, but 23 percent of

  13   those did contain significant levels of peanuts,

  14   and University of Nebraska researchers found peanut

  15   allergens in four out of 19 packaged foods that

  16   neither listed peanuts as an ingredient nor warned

  17   consumers that the products might contain peanuts.

  18             In some of those cases, the products may

  19   simply have been mislabeled.  Others may have been

  20   unintentionally contaminated.  Though actual

  21   problems from cross-contamination are very

  22   difficult to identify, at least three reports in

  23   the medical literature have found

  24   cross-contamination having caused allergic

  25   reactions. 
                                                                100

   1             In two different cases, toddlers suffered

   2   anaphylaxis due to milk protein in sorbets.  Peanut

   3   antigen in gingersnap cookies was the cause of a 34

   4   year old man's reaction.

   5             "May contain" language is sometimes

   6   appropriate to inform consumers of the presence of

   7   possible allergens.  But excessive use of such

   8   statements deprives sensitive consumers of choice

   9   and may cover up sloppy manufacturing practices.

  10             We strongly support the FDA's position

  11   that quote "such labeling should not be the norm

  12   and that manufacturers should strive to eliminate

  13   the presence of allergenic materials that are not

  14   intentionally added to a specific food product."

  15             That policy was first enunciated in

  16   Commissioner Kessler's 1996 letter to food trade

  17   associations stating that quote: "Precautionary

  18   labeling should not be used in lieu of strict

  19   adherence to good manufacturing practice to

  20   effectively reduce and eliminate the likelihood of

  21   cross-contamination, label mix-up or employee

  22   error."  Five years ago.

  23             Unfortunately, we have heard that some

  24   industry lawyers are advising manufacturers not to

  25   test for allergens because of product liability 
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   1   issues.  That kind of thinking underscores the need

   2   for aggressive FDA action.

   3             Consumers must be informed whenever an

   4   allergen unavoidably might sneak into a food in

   5   which it does not belong.  The challenge is to

   6   define when contamination is unavoidable and it is

   7   appropriate to say "may contain" and to distinguish

   8   that from situations of manufacturer sloppiness

   9   where "may contain" labels are not appropriate.

  10             At one end of the spectrum, contamination

  11   clearly is avoidable when companies intentionally

  12   add rework or other material that contains an

  13   allergen into a food that is not supposed to

  14   contain that allergen.

  15             On the other extreme, ensuring that every

  16   last residue of peanuts is cleaned out of complex

  17   equipment or a shipping container before a food

  18   that is not supposed to contain an allergen is made

  19   in that equipment or shipped in that container may

  20   be very, very difficult, especially for smaller

  21   companies.

  22             When "may contain" statements are

  23   appropriate, they should be provided in an allergy

  24   information section of an ingredient facts label,

  25   and it should say something like: "Allergy 
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   1   information: corn, wheat, may contain peanuts."

   2   "May contain" statements should be stated simply

   3   using standardized working and without explanatory

   4   language such as "manufactured on equipment that

   5   sometimes also processes peanuts."  Such verbiage

   6   simply adds clutter and raises questions as Ms.

   7   Munoz-Furlong indicated in consumer's minds.

   8             The industry's Food Allergy Issues

   9   Alliance makes a reasonable stab at deciding when

  10   "may contain" language is appropriate, but it needs

  11   improvement.  First, companies that only visually

  12   inspect for allergenic ingredients, not test for

  13   them, would not use "may contain" language.

  14             Also, the industry's guidelines are

  15   totally voluntary and some of their lawyers are

  16   advising against tests.  As I mentioned, five years

  17   ago, the FDA sent a warning level to the food

  18   industry to eliminate cross-contamination.  Judging

  19   from the FDA's study and the other two studies I

  20   mentioned, not enough has happened.

  21             I think the time has long past for all

  22   this total voluntary flexible action on the part of

  23   industry.

  24             [Applause.]

  25             DR. JACOBSON:  Therefore, the FDA should 
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   1   amend its GMP regulations with a requirement for

   2   companies to take all practical measures to exclude

   3   contamination of foods with unlabeled allergens.

   4   Companies should develop HACCP plans to ensure

   5   proper cleaning of shared equipment, use of

   6   separate equipment for allergen-containing and

   7   allergen-free foods whenever possible, regular

   8   testing of products for unwanted allergens and

   9   other measures.

  10             The best way to ensure that companies are

  11   using "may contain" only when possible

  12   contamination is unavoidable is regular unannounced

  13   FDA inspections and testing of products for major

  14   allergens.

  15             [Applause.]

  16             DR. JACOBSON:  The FDA has already stated

  17   in its April 19 Compliance Policy Guide that

  18   undisclosed cross-contamination may cause the food

  19   to be considered adulterated.  Seizures of

  20   contaminated products would protect consumers and

  21   send a clear signal to the industry that the FDA is

  22   truly concerned about food allergens and will

  23   vigorously enforce its compliance policy.

  24             That kind of independent oversight should

  25   encourage manufacturers to maximize their 
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   1   precautions.  Currently FDA inspectors rarely visit

   2   factories that make cookies, pastries and other

   3   foods that may contain dangerous and unlabeled

   4   allergens.  The FDA simply lacks the funds and so

   5   companies don't even have to worry about

   6   inspections.

   7             We urge the FDA to use some of its budget

   8   increases to hire additional inspectors.  In

   9   addition, we urge the FDA to seek new funding on

  10   the order of roughly $10 million a year for more

  11   inspectors, more tests, educational efforts and

  12   research to develop quick reliable testing methods.

  13             [Applause.]

  14             DR. JACOBSON:  I hope that the food

  15   industry would recognize the value of that

  16   investment to the public's health and to its own

  17   reputation and support a funding request.  In that

  18   regard, I was delighted to hear Lisa Katic say that

  19   FDA should have a strong enforcement presence, and

  20   I hope they'll join with us to lobby Congress to

  21   provide that $10 million or so in additional

  22   funding.

  23             [Applause.]

  24             DR. JACOBSON:  Finally, to further assist

  25   consumers, as the Attorneys General recommended, 
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   1   the FDA should require labels to bear a toll-free

   2   telephone number that people could call to get

   3   up-to-date information about ingredients and

   4   possible contaminants.  Companies periodically

   5   modify product composition and manufacturing

   6   practices.

   7             Many people with severe allergies like to

   8   contact companies just to make sure that labels are

   9   still correct and that accidental or incidental

  10   additives have not crept into a food that had been

  11   safe to eat.

  12             In sum, the FDA should press industry to

  13   clean up their manufacturing practices; "may

  14   contain" statements should be used to inform

  15   consumers, but only when cross-contamination is

  16   unavoidable.  And the FDA should enforce its

  17   policies by conducting more inspections and testing

  18   more products.  Thank you very much

  19             [Applause.]

  20             DR. LEWIS:  I'd like to thank all of our

  21   panel speakers for Panel II Advisory Labeling, and

  22   we will now begin a discussion either among the

  23   panel members themselves or with the FDA listening

  24   panel.  Does anyone have an opening question,

  25   comment? 
                                                                106

   1             Dr. Wilcox?

   2             DR. WILCOX:  I'd like to address a

   3   question to Ms. Munoz-Furlong.  Much of the

   4   industry discussion on good manufacturing practice

   5   and labeling focus on the eight major allergens.

   6   Does your organization agree that at this time

   7   that's the appropriate focus or do you think

   8   additional efforts also need to be placed on the

   9   less common allergens?

  10             MS. MUNOZ-FURLONG:  My belief is that if

  11   we focus on the eight major allergens, we've

  12   covered 90 percent of the problem, and once we

  13   clear that up, we should start looking in other

  14   areas, but keep it to the eight so that we can

  15   focus there.

  16             DR. LEWIS:  Another question?

  17             DR. FALCI:  This is Ken Falci of the Food

  18   and Drug Administration.  Well, first of all, I

  19   think it kind of disturb me that when you take a

  20   look at the different kinds of advisory statements

  21   like "may contain" compared to "peanuts were also

  22   made in this facility," that consumers get a

  23   different kind of perspective, and that was brought

  24   out pretty well by Anne's slides.

  25             I was just wondering does the panel feel 
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   1   that that makes sense?  That there is a different

   2   perception and risk as far as when people read

   3   these different kinds of terms, and is there any

   4   other survey that industry is potentially doing or

   5   anybody else that has other data that could

   6   confirm?

   7             MS. HILDWINE:  I would say that this is an

   8   area that concerns the food industry as well, and

   9   while we have not actually done a survey, I mean

  10   it's appropriate to survey consumers as to their

  11   perceptions of that labeling, and our members

  12   really aren't in a position to be able to provide

  13   that information.  However, that said, the food

  14   industry is working with food companies to help

  15   them improve their good manufacturing practices to

  16   the best of the ability of those food companies.

  17             In other words, do the best job you can.

  18   We as the association representatives are here to

  19   help you.  At NFPA in particular, we have a lot of

  20   scientific expertise on staff that can be of

  21   assistance to members relative to good

  22   manufacturing practices.

  23             Now if good manufacturing practices are

  24   sharpened, are applied in the correct way, and food

  25   products are produced in accordance with those good 
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   1   manufacturing practices, then any use of a

   2   supplementary or advisory label statement that

   3   follows that will have true meaning behind it.  It

   4   won't be used simply as a theoretical precaution.

   5   It will mean something, and that's what the food

   6   industry wants with those label statements.

   7             They want them to mean something to the

   8   food allergic consumer because they want the food

   9   allergic consumer to believe them.  The food

  10   industry wants food allergic consumers to see these

  11   statements and to take away the meaning that if

  12   they're allergic to the substance that's named in

  13   that statement, they should not consume that food.

  14             Now, do we have a long way to go?  We have

  15   a lot of work to do.  NFPA has been working on this

  16   for a number of years.  We recognize that we need

  17   to help our members more and more all the time.

  18   But we're committed to doing that and we're working

  19   on that everyday.

  20             DR. FALCI:  As a follow-up, but again the

  21   two different kinds of statements that would be out

  22   there like "may contain" or "made in a processing

  23   facility," and these would be like suggestives,

  24   precautionary statements, that the agency might

  25   want to look at maybe in the future as guides or 
                                                                109

   1   regulations, and the problem there is the

   2   consistency in the mind of the consumer when they

   3   actually read these kinds of different statements,

   4   and I'm just wondering that it sounds like you do

   5   agree that there is some inconsistency when you do

   6   use these kind of advisory statements.

   7             MS. HILDWINE:  The issue of the

   8   inconsistency is something that we're going to have

   9   to work on, but I would say that, first of all,

  10   since it is a label statement, it has to be true.

  11   If the food is not processed on shared equipment,

  12   then it should not use the shared equipment type

  13   statement.  If it's not processed in a shared

  14   facility, it shouldn't use a shared facility type

  15   statement.

  16             So those statements have to be true.  And

  17   in order for those statements to be true, those

  18   good manufacturing practices have to be applied

  19   first.

  20             DR. FALCI:  I guess as another follow-up,

  21   when you look at "may contain," and you look at the

  22   other statement like "made in a plant that

  23   processes peanuts," though, you still get, I mean

  24   as a consumer why not not use "made in a plant that

  25   processes peanuts" even though it might be true?  
                                                                110

   1   Why not use "may contain"?

   2             MS. HILDWINE:  Well, "may contain" would

   3   be true.

   4             DR. FALCI:  Right.  And less maybe

   5   confusing?

   6             MS. HILDWINE:  This is something that we

   7   certainly do have to continue to look at.

   8             DR. JACOBSON:  Can I ask a question?

   9             DR. LEWIS:  Dr. Jacobson, please.

  10             DR. JACOBSON:  May I ask a question?  And

  11   I'll just be very blunt about this.  Can I ask both

  12   of the industry representatives, and especially

  13   Lisa, you know that the FDA doesn't have resources

  14   to inspect very many manufacturing facilities.  You

  15   know that the FDA has been focused on

  16   microbiological problems and looking at those

  17   factories, not factories that use food allergens.

  18             Would your two associations support $10

  19   million in increased funding for the FDA to conduct

  20   more testing, enforcement and research in this

  21   area?

  22             MS. KATIC:  Actually, Michael, I'll be

  23   very blunt right back.  Our associations are both

  24   actively looking at more than $10 million in

  25   funding for FDA, whether it be for allergy, 
                                                                111

   1   microbiological inspection, or anything else that's

   2   under their purview.  We think that that gives or

   3   maintains the credibility of FDA both domestically

   4   and internationally and, you know, we have seen a

   5   decline in resources, as you have, for FDA, and we

   6   think that's in the best interest of everybody

   7   including the industry that they get that funding.

   8             [Applause.]

   9             MS. HILDWINE:  And I would just add that

  10   we're certainly not just going to wait for FDA to

  11   advance the ball relative to the research.  NFPA is

  12   conducting research into testing for rapid methods

  13   that can be validated.  I mean that's part of the

  14   problem, that there are some problems relative to

  15   the number of validated test methods that are out

  16   there for food allergens, and certainly NFPA is

  17   doing its part, and I know a lot of other

  18   organizations are doing their part to advance

  19   research in this area as well.

  20             DR. LEWIS:  Other questions, panelists?

  21             DR. FALCI:  Just one more--

  22             DR. LEWIS:  Dr. Falci.

  23             DR. FALCI:  --I promise.  This word

  24   "unavoidable" is a troublesome word because when

  25   one has to make a decision, I guess, in industry or 
                                                                112

   1   in processing plants when an allergen is

   2   particularly unavoidable, and I would encourage

   3   everyone in the industry to just be more clear

   4   about the conditions that are around this term

   5   "unavoidable" in the future so that we can get a

   6   better feel for what's particularly involved.

   7             And I guess if you want to expand on that

   8   thinking, and you start thinking about different

   9   kinds of food industries, that the word

  10   "unavoidable" might mean different things to

  11   different industries.  So that you had mentioned

  12   that I believe peanuts, peanut butter plants or

  13   chocolate plants were difficult to clean, for

  14   instance, with water, and so these kinds of

  15   industries might have different kinds of

  16   unavoidable kinds of problems and maybe different

  17   kinds of good manufacturing practices that you

  18   mentioned.

  19             And so one could lead oneself to the

  20   thinking in the future that there might be good

  21   manufacturing practices that might be applicable to

  22   different industries if one were to think about

  23   allergen control procedures.  And so that's sort of

  24   a question, but it's sort of a statement, and if

  25   you have comments on that, I would be glad to take 
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   1   them.

   2             MS. HILDWINE:  When we talk about

   3   unavoidable, it is always in connection with good

   4   manufacturing practices, and essentially it's, you

   5   know, the bottom line where a company goes through

   6   a process and evaluates its practices and at the

   7   end, that company says we have done the best that

   8   we can, and we still can't get rid of it.  And in

   9   that case, that's unavoidable.

  10             Now, again, different sizes of companies,

  11   different sectors of the industry, certainly are

  12   going to have to different kinds of applications of

  13   good manufacturing practices.  And we are committed

  14   to working with all of our members regardless of

  15   size to help them improve their GMPs.  So that if

  16   they go through the process and then have to use or

  17   have to consider supplementary labeling, that that

  18   supplementary labeling will have true meaning to

  19   the food allergic consumer.

  20             DR. JACOBSON:  I think that you're going

  21   to have to end up deciding what's avoidable and

  22   what's unavoidable.  I mean drawing a distinction,

  23   it's like drawing a line in the Potomac River.

  24   It's not going to be very clear.  But it's going to

  25   be, I'd much rather trust FDA inspectors evaluating 
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   1   when a "may contain"--when an ingredient is

   2   avoidable or unavoidable than a manufacturer's

   3   discretion.

   4             DR. LEWIS:  Kathy.

   5             MS. GOMBAS:  Yes, this is Kathy Gombas

   6   with FDA, and this is actually an Alliance question

   7   so either GMA or NFPA.  We're talking about GMPs,

   8   I'm wondering if the Alliance has started looking

   9   at and identifying specific GMPs for the various

  10   products and processes that are out there that

  11   would minimize allergen cross-contact?

  12             MS. HILDWINE:  Okay.  I'm doing this one,

  13   too.  First of all, just to clarify, Anne

  14   Munoz-Furlong is also a member of the Food Allergy

  15   Issues Alliance, but that said, a number of the

  16   associations that are members of the Food Allergy

  17   Issues Alliance have already developed guidance

  18   relative to GMPs for their members, and these

  19   associations within the Alliance, many of them are

  20   specialized associations that represent particular

  21   sectors of the industry.  I don't know if you guys

  22   want me to name you, but there's bakers, there's

  23   candy and convection, there's dairy product

  24   associations, there are a number of associations

  25   whose manufacturing practices have some very 
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   1   specific concerns related to food allergies and

   2   they have already done a lot of this work.

   3             They've shared this work with the Alliance

   4   and so we're all learning from that.  NFPA is

   5   working on this now.  This issue is what resulted

   6   in our code of practice.  And now we are developing

   7   some additional guidance to help our members

   8   regardless of what sector they are in to improve

   9   their GMPs.  So there's a lot of work to go around

  10   for everybody and every association that's in the

  11   Food Allergy Issues Alliance has been dedicating a

  12   lot of energy over the past several years to this

  13   particular issue on behalf of their members and

  14   we're no exception.

  15             MS. KATIC:  Just adding on to that, ditto

  16   everything that Regina said, but we have looked at

  17   that as an item for future discussion and further

  18   review specifically because we've been focusing so

  19   much on our labeling program.  That's obviously

  20   taken up the bulk of our time, but certainly have

  21   not discounted that there might be a need to look

  22   further into what you asked down the road once

  23   we've got the labeling part well defined.

  24             DR. LEWIS:  Other comments from panelists?

  25   Well, while you're cogitating for a few moments 
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   1   because your time is not up, we'll move to some of

   2   the questions we have.  We have quite a few.  I do

   3   want to mention that we've received several

   4   questions for Theresa Dziuk, who reported on the

   5   Food Allergen FDA/State Partnership.  Relative to

   6   any of those types of questions, you may access any

   7   information that the agency has on the website.  It

   8   is at cfsan.fda.gov.  And the search for the word

   9   "food allergens," which again is on our web page.

  10             In addition, we mentioned the state

  11   attorneys general petition.  That also is available

  12   at Dockets and the contact information is in your

  13   Federal Register.  So questions on that can be

  14   answered elsewhere.

  15             We do have a series of questions.  Again,

  16   if the panel has something to add, please do feel

  17   free to jump in.  But one question is how would the

  18   panel, and this is obviously directed to all of

  19   you, how would the panel suggest dealing with

  20   imports?  States have reported more allergy

  21   labeling problems with imported foods than with

  22   domestically produced foods, according to this

  23   question.

  24             MS. MUNOZ-FURLONG:  I'm going to give you

  25   the consumers' perspective.  You raise an 
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   1   interesting point because we have consistently

   2   found that when one of our members has a problem,

   3   and it's caused by an imported food, we have no

   4   recourse.  We can't call the company like we could

   5   with a domestic product, and they're on it and

   6   instantly we are correcting the information,

   7   getting the news out to our membership.

   8             So as a result of that, we advise our

   9   members not to eat imported products because we

  10   can't guarantee that the label is correct, and that

  11   we will be able to trace back any information they

  12   might need if they have a reaction.

  13             MS. HILDWINE:  Imports are a particularly

  14   challenging issue.  I mean if you look at recall

  15   track record, there is a lot of imports on a

  16   regular basis and food allergen related recalls.

  17             All the audience may not know this, but

  18   this is a true fact.  Imported foods are subject to

  19   the same requirements as foods that are produced

  20   and sold domestically.  So imports should be

  21   observing good manufacturing practices and labeling

  22   accuracy as well as domestic production.

  23             Now, that said, the Food Allergy Issues

  24   Alliance has, in fact, worked some outreach

  25   relative to other nations.  As we were developing 
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   1   our food allergen labeling guidelines, we had

   2   representative from the Canadian food industry who

   3   worked with us on that, and we are of the

   4   understanding that food allergen labeling

   5   guidelines and, of course, the good manufacturing

   6   practices sector that's included in there on

   7   supplementary labeling, that that's under review

   8   for adoption by the food industry in Canada.

   9             In addition, we as a food industry have

  10   liaisons with food industry around the world.

  11   We've made sure that the Food Allergen Labeling

  12   Guidelines are in the hands of a number of

  13   representatives for sharing with their producers in

  14   other countries, and certainly we are doing the

  15   best that we can as an Alliance to make sure that

  16   the concepts in the Food Allergen Labeling

  17   Guidelines, that these are known around the world.

  18             A number of our members are multinational

  19   corporations that are disseminating food allergen

  20   GMP and labeling information to their companies in

  21   other nations.  So we are really I would say

  22   engaged in a vigorous effort to make sure that this

  23   information gets known around the world.

  24             The United States is probably in the lead

  25   in terms of its contemplation of this issue.  
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   1   Certainly, the advancement of science in the U.S.

   2   is far ahead, I think, of what's going on in other

   3   nations, and we are trying to bring the rest of the

   4   world along on this issue.

   5             DR. LEWIS:  Any other comments on imports?

   6   We have a question concerning legal liability.  The

   7   question is really in two parts.  What is the legal

   8   liability risk to a manufacturer if a consumer is

   9   injured by an undeclared allergen?  And then also

  10   the legal liability risk if undeclared allergens

  11   are found in a food, thereby putting a significant

  12   number of individuals at risk?

  13             So again I think the question is asking

  14   for some clarification as to how legal liability is

  15   perceived here.

  16             MS. HILDWINE:  I'll do this one.  I'm not

  17   a lawyer.  I don't think we have any attorneys on

  18   this panel.   And so I'm not going to be able to

  19   answer this question directly.  However, the last

  20   thing that any food company wants to do is to cause

  21   harm to anybody.  And so the issue of risk is

  22   certainly something that all food companies have to

  23   take into consideration as they engage in their

  24   normal operations.

  25             DR. LEWIS:  This question talks about 
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   1   preventing manufacturers from using "may contain."

   2   That is how can you prevent manufacturers from

   3   using "may contain" as a substitute for GMPs?  What

   4   controls are or should be in place?  And this is

   5   important since it artificially restricts

   6   consumption of those products, artificially

   7   restricts consumptions of products for those who

   8   already have limited choices.

   9             Does anyone care to address that question?

  10   Regina, I have a question directly for you next so

  11   I would suggest you hold off for a second.

  12             MS. KATIC:  Could you repeat the beginning

  13   of it?  It's about how to prevent?

  14             DR. LEWIS:  How can you prevent

  15   manufacturers from using "may contain" as a

  16   substitute for GMPs?

  17             MS. KATIC:  Well, I think this has already

  18   come up in some form briefly, but certainly I think

  19   Dr. Jacobson and I are in agreement that FDA has

  20   the authority to enforce and we certainly support

  21   full enforcement of FDA inspecting and maintaining

  22   these practices within plants.

  23             As I stated in my comments, this is being

  24   done within all of our member companies which make

  25   up probably 90 percent of, as Anne stated, the 
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   1   allergens that we're talking about.  So, you know,

   2   you could mandate the fact that we can't use "may

   3   contain," but then you're faced with as, I tried to

   4   lay out, some very clear examples of when "may

   5   contain" is absolutely necessary to preserve for

   6   manufacturers.

   7             This is also why the industry responded so

   8   quickly and got on board with our labeling program

   9   through the Allergy Issues Alliance because we

  10   understand that this is a critical problem.  It's

  11   one that we want to fix or work toward providing a

  12   solution so that "may contain" can be preserved and

  13   therefore believed and used by the food allergic

  14   consumer.

  15             DR. LEWIS:  Go ahead, Dr. Jacobson.

  16             DR. JACOBSON:  When you say the industry

  17   reacted so speedily, were you referring to the

  18   response to the 1996 letter?

  19             MS. KATIC:  Well, I think we've, you know,

  20   as has been indicated by both Regina and I, this is

  21   an issue that the industry has been dealing with

  22   much longer than the '96 letter.

  23             I don't think you can point out from that

  24   letter, unless you have some very specific

  25   examples, I don't think that you can say that 
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   1   industry has not responded or developed good

   2   manufacturing practices.

   3             Certainly, they continue to look at their

   4   practices to see where they can do better.  You

   5   know I'm sure that most of our member companies

   6   have done that since the letter in '96.  I guess

   7   that's pretty much it.

   8             DR. LEWIS:  And actually building on a

   9   point you raised earlier, Lisa, we have two

  10   questions that are more or less related.  How many

  11   companies in the U.S. are not members of GMA or

  12   NFPA and how does GMA and NFPA plan to ensure

  13   compliance of its new labeling and manufacturing

  14   guidelines both among members and what might you do

  15   about non-members?

  16             And then related to that, is there

  17   currently a penalty for companies using "may

  18   contain" warnings when not meeting the four

  19   criteria?  If so, what is it?  If not, what

  20   motivation do they have?

  21             MS. KATIC:  Well, I guess I wish we knew

  22   how many companies are out there that are not

  23   members of either association.  I don't know that

  24   anybody has those numbers or figures.  As I stated

  25   earlier, we do see that as an area in need of some 
                                                                123

   1   attention, and also have stated that we've already

   2   looked at through the Alliance how we would reach

   3   out not only to members, smaller members within our

   4   associations, but also those small manufacturers

   5   that are not members of associations.

   6             And I think through the Alliance as we've

   7   said we have a broad group of about 20

   8   associations.  I think every association knows, you

   9   know, who some of those members are that aren't a

  10   part of their association.  So just by nature of

  11   the type of business that they do, we would already

  12   be able to name I would say quite a few.

  13             You know the real challenge is getting to

  14   the real mom and pop type operations and I think we

  15   probably need to have a discussion about that

  16   collectively on how we reach those types of

  17   operations.  I've now forgotten the rest of the

  18   question so I--

  19             DR. LEWIS:  It regards penalties for using

  20   "may contain" when not meeting the four criteria.

  21             MS. KATIC:  Penalties within our, I

  22   guess--

  23             DR. LEWIS:  Presumably, yes.

  24             MS. KATIC:  --our program.  Well, we don't

  25   have anything necessarily laid out.  I can tell you 
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   1   that in working with the industry for some time, we

   2   mentioned earlier that we have a baseline survey

   3   that we're starting and will continue to survey

   4   membership amongst all of the trade associations in

   5   the Alliance, and it's generally that when industry

   6   seems a program picking up, and really gaining some

   7   significance, it's rare that--I mean certainly

   8   there are companies that don't adopt it, but it

   9   just adds to, I think, the importance of the

  10   program and makes it almost imperative that

  11   companies do adopt the program and basically get on

  12   board.

  13             So I think just by nature of them hearing

  14   that this is something that's really gaining

  15   significance amongst the entire industry, by nature

  16   of competition, if you will, it encourages those

  17   that are outside the program to participate.  So

  18   there is not an outright penalty, but there is an

  19   incentive there.

  20             MS. HILDWINE:  And just to elaborate a

  21   little further on some of the things that Lisa

  22   said, the Food Allergen Labeling Guidelines have

  23   been made public.  They certainly are in a public

  24   area of NFPA's website.  I know they're in the

  25   public area of a lot of food companies' web sites.  
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   1   I personally sent, made sure that companies that

   2   are not members of NFPA received the guidelines

   3   when they asked for them.  Now that was followed up

   4   with a call from our membership office.

   5             Nevertheless, we have reached out beyond

   6   our memberships to other food companies and, of

   7   course, every member of the Alliance has been

   8   presenting on their website Food Allergen Labeling

   9   Guidelines.

  10             I think, Anne, you have them on your

  11   website, too.  So these are not a secret.  They are

  12   readily available, and if anybody is not a member

  13   of NFPA and would like the Food Allergen Labeling

  14   Guidelines, just give me a call, and we'll make

  15   sure that you get a copy of the guidelines so that

  16   you can start to get on board with this very

  17   important initiative.

  18             DR. LEWIS:  And while you still have the

  19   microphone, a question specifically for you.  Does

  20   the food industry currently have standard

  21   definitions for the various precautionary

  22   statements?  If so, can they be located?  If not,

  23   what can a consumer use as a guide for

  24   interpreting?

  25             MS. HILDWINE:  Right now through the work 
                                                                126

   1   of the Food Allergy Issues Alliance, we did discuss

   2   three types of statements, and they're the

   3   statements that FDA has asked questions about in

   4   the Federal Register notice.

   5             Now, as to standard definitions,

   6   unfortunately there are none.  However, since any

   7   information that appears on a food label has to be

   8   true, those statements would have to represent what

   9   they say.  In other words, if it's processed on

  10   shared equipment, it would have to mean that it's

  11   processed on shared equipment.  Now, as to a

  12   measure of risk, which I understand is probably at

  13   the underpinning of this question, again, I don't

  14   think that this is an area where the food industry

  15   wants to encourage food allergic consumers to try

  16   and understand relative risk.

  17             The whole purpose of those supplementary

  18   or advisory statements "may contain" is to send a

  19   message to the food allergic consumer do not eat

  20   this product if you are allergic to this food.   In

  21   other words, to believe what it says, because we

  22   believe that food companies are using these

  23   statements responsibly.  And that proportion is

  24   increasing because of the Food Allergen Labeling

  25   Guidelines, and certainly we hope that over time 
                                                                127

   1   these statements will become increasingly more

   2   believed, and secondly, increasingly rare.

   3             DR. LEWIS:  For Anne Munoz-Furlong, we

   4   have a question.  Isn't the lesson here that it's

   5   important to look at all food labels all the time?

   6   Why is there a different standard if the label adds

   7   "may contain" versus peanut as an ingredient?

   8             MS. MUNOZ-FURLONG:  Absolutely, you need

   9   to read the label all of the time.  We are talking

  10   about the additional information that is being put

  11   on these labels and how the consumer is

  12   interpreting them, and what the impact of the

  13   proliferation of these statements has been on the

  14   consumer's purchasing decisions and purchasing

  15   habits.

  16             But the first place that a food allergic

  17   individual has to go is that ingredient statement.

  18   Unfortunately, if you take the example that I gave

  19   with the raisins on the airplane, there's a bag of

  20   raisins.  There are raisins in the bag.  You have

  21   looked at the ingredient declaration.  It says

  22   raisins and then underneath it, it says may contain

  23   peanuts.  What are you going to do if you're

  24   allergic to peanuts?  That's the answer we are

  25   looking for from industry and the FDA. 
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   1             How are you to behave when you see that?

   2   Are you never to eat raisins again because they all

   3   may contain peanuts?  That's unclear to us at this

   4   point.

   5             DR. LEWIS:  This next question is to Dr.

   6   Jacobson as well as all members of the panel.  It

   7   says Ms. Katic stated that cleaning will not

   8   succeed in removing all allergens.  Given this,

   9   would you support precautionary labeling for all

  10   food manufactured on safe equipment and if not, why

  11   not?

  12             DR. JACOBSON:  What was that?  Would I

  13   support?

  14             DR. LEWIS:  Support labeling for all food

  15   manufactured on shared equipment.

  16             DR. JACOBSON:  Well, I would assume that

  17   some--that it's possible to clean well some shared

  18   equipment.  And it's something where the FDA would

  19   have to go in and make some evaluations.  Maybe

  20   chocolate, you can't clean it adequately and maybe

  21   that's where dedicated lines should be used if at

  22   all possible.  But I would think it's a judgment

  23   call, not a blanket rule saying always use "may

  24   contain."

  25             DR. LEWIS:  Others have comments on that? 
                                                                129

   1             MS. MUNOZ-FURLONG:  I would agree with

   2   that.  What we want to do is move away from "may

   3   contain," not add it to every single ingredient,

   4   because as we see now, there is so much confusion

   5   and limited food choices perhaps unnecessarily.  We

   6   want to move away from that.

   7             DR. LEWIS:  This question goes to the four

   8   pronged test.  It's know that microscopic amounts

   9   of allergens can harm sensitive people.  Please

  10   explain why the first prong of your four-prong test

  11   for precautionary labeling is adequate.  It allows

  12   for visual inspections alone.

  13             MS. KATIC:  I think, first off, what we

  14   mean by visual is you know you're using, you know,

  15   an ingredient that has an allergen in it.  So I

  16   think to me that's kind of obvious.  Maybe that's

  17   not to everybody else.  It also states there that

  18   analytical testing can be used for purposes or

  19   situations where it might not be as visually

  20   obvious.

  21             MS. HILDWINE:  The first prong of the

  22   four-prong test reads exactly: The presence of a

  23   major food allergen is documented through visual

  24   examination or analytical testing of the processing

  25   line equipment, ingredient or product or other 
                                                                130

   1   means, so visual examination is only one thing

   2   that's mentioned there.  Lisa mentioned also that

   3   analytical testing is there.

   4             Certainly documentation, paper trail, may

   5   also demonstrate that the major food allergen is in

   6   that environment.  So we're not relying on visual

   7   examination alone.

   8             DR. LEWIS:  I'm going to stop with the

   9   questions there, but turn back to both the FDA

  10   listening panel as well as our presenters and ask

  11   if there are any further comments or questions from

  12   you folks.  Kathy.

  13             MS. GOMBAS:  Kathy Gombas with FDA.

  14   Regina, in the first panel, you had indicated that

  15   perhaps it was the Alliance that was going to

  16   conduct a survey to get more information on who had

  17   gone to voluntary labeling for plain English.  Are

  18   you going to do the same thing for the advisory

  19   labeling, and if so, are you going to ask them why

  20   they're using advisory labeling?

  21             MS. HILDWINE:  That's in the survey as

  22   well.  The survey covers all of the areas that were

  23   addressed in the Food Allergen Guidelines.  So we

  24   do ask them if they have control procedures and

  25   various other questions related to supplementary or 
                                                                131

   1   advisory labeling.  And the data that we're

   2   collecting will essentially be baselines.

   3             DR. JACOBSON:  Can I ask a question of FDA

   4   for informational purposes only?

   5             DR. LEWIS:  As I recall, we're in a

   6   listening mode, Dr. Jacobson, but feel free to put

   7   it on the table.

   8             DR. JACOBSON:  For informational purposes,

   9   I wonder if Dr. Falci could give us some sense of

  10   how frequent inspections are, say, of a cracker or

  11   cookie company of $25 million a year in sales?  How

  12   many times a year, a decade, ever an FDA inspector

  13   will look at these allergen issues?

  14             DR. LEWIS:  We actually get frequently

  15   questions about how often that happens, and to be

  16   honest, Dr. Jacobson, I don't have that information

  17   for you right now, but we'll try to get back to you

  18   with it.

  19             I do want to turn to some administrative

  20   issues concerning the public speakers who are

  21   scheduled to present this afternoon.  We will be

  22   using the first three rows of what for you is the

  23   left-hand section, for me the right-hand section.

  24             So for those of you that have registered

  25   to speak as public commenters, please either gather 
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   1   a little earlier from lunch or at least plan to sit

   2   here as soon as you return.  Our lunch break is

   3   scheduled to go until one o'clock, and I can

   4   promise you we will begin promptly at one o'clock,

   5   so please do feel free to take a lunch break, but

   6   remember we will be starting at one o'clock, with

   7   our third panel.  Thank you.

   8             [Whereupon, at 12:10 p.m., the meeting was

   9   recessed, to reconvene at 1:05 p.m., this same

  10   day.] 
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   1                A F T E R N O O N   S E S S I O N

   2                                           [1:05 p.m.]

   3             DR. LEWIS:  Panel III focuses on the

   4   labeling of ingredients exempted from declaration.

   5   There's two categories here: common or usual names

   6   and incidental additives.

   7             Before I begin, I would like to introduce

   8   a new member of our panel, Mr. John Hallagan.  As

   9   we said, he was General Counsel for FEMA, ASTA and

  10   IACM, and he's replaced Ms. Katic on our panel.

  11             Our procedure at this point will be to

  12   allow our four panel members, Dr. Jacobson, Ms.

  13   Munoz-Furlong, Ms. Hildwine, and Mr. Hallagan, to

  14   each address the topic of labeling ingredients

  15   exempted from declaration, and then we will move to

  16   discussion.

  17             Dr. Jacobson.

  18             DR. JACOBSON:  Currently, food labels are

  19   not formally required to disclose allergens such as

  20   peanuts, wheat, casein or carmine when they serve

  21   as flavorings, spices or non-certified colorings.

  22   However, undeclared colorings and flavorings have

  23   caused occasional allergic reactions.  Examples

  24   include carmine, saffron and annatto colorings,

  25   partially hydrolyzed casein and peanut flour.  Also 
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   1   such spices as allspice, cardamom and coriander

   2   have caused occasional allergic reaction.

   3             While disclosure is not required, in 1996,

   4   the FDA sent a warning label to companies urging

   5   that they voluntarily declare on labels any

   6   allergenic components of such ingredients.  I agree

   7   with University of Nebraska food allergy experts,

   8   Steve Taylor and Sue Hefle, who wrote in a paper if

   9   an ingredient is known to be allergenic even on a

  10   rare basis, such as carmine or papain, then it

  11   should be declared on the ingredient statement.

  12             Unfortunately, the FDA has not determined

  13   that it has legal authority to require labeling of

  14   those additives when health is at issue.  It should

  15   assert that authority by commencing a rulemaking as

  16   requested by the nine attorneys general more than a

  17   year ago.  CSPI also will be submitting a formal

  18   request for that action in the near future.

  19             The FDA could take several legal

  20   approaches.  It could assert that the general

  21   misbranding section of the act trumps the

  22   flavoring/spices/colors exemption because the

  23   ingredients can cause severe allergic reactions.

  24             Alternatively, for allergenic flavorings,

  25   spices or colors that are considered generally 
                                                                135

   1   recognized as safe, the FDA could determine that

   2   those substances are not safe.  They can only

   3   determine it safe if labels disclose the presence

   4   of those substances.

   5             Third, in the cases of approved color

   6   additives and food additives, the Act allows the

   7   FDA to set conditions of use, such as label

   8   disclosure.  Thus, FDA should amend its regulations

   9   to specify that any allergenic coloring or

  10   flavoring additive must be declared on the label,

  11   as it has for Yellow 5, or monosodium glutamate,

  12   and certain other foods.

  13             We urge the FDA to require disclosure not

  14   just of the major eight allergens but others as

  15   well.  To someone with an allergy to corn or

  16   carmine, it's no satisfaction that wheat and shrimp

  17   are disclosed.

  18             The cost and inconvenience to companies of

  19   providing disclosure is a small price to pay for

  20   protecting the health of sensitive consumers.

  21             Therefore, as a general policy, the FDA

  22   should require, not just strongly encourage, labels

  23   to disclose allergenic ingredients in the

  24   flavorings, colorings, and spices.  Labels should

  25   simply declare something like colors includes 
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   1   carmine or natural flavoring includes peanuts, and

   2   then in the allergy information section of the

   3   label, the presence of the major allergens should

   4   be highlighted.

   5             Moving now to incidental additives.  Those

   6   are substances that are present at insignificant

   7   levels in food and that don't serve any technical

   8   or functional effect.  Incidental additives have

   9   never been disclosed on labels, but in 1996, the

  10   FDA told the food industry that such additives are

  11   not insignificant if they might cause serious

  12   allergic reactions and that they had to be labeled.

  13             And that was incorporated into the FDA's

  14   compliance policy guide earlier this year.  While

  15   incidental additives are present at low levels, and

  16   to my knowledge have not caused known allergic

  17   reactions, it's worth noting that the EPA recently

  18   expressed concern about the allergenicity of

  19   StarLink corn.  It banned--it banned the presence

  20   in food of any amount, even under 20 parts per

  21   billion, of StarLink even without proof that it

  22   ever caused an allergic reaction.

  23             Today, no one is talking about banning

  24   wheat, corn or other allergin, but only requiring

  25   label disclosure.  The FDA's policy concerning 
                                                                137

   1   allergenic incidental additives should be

   2   incorporated into a regulation that states

   3   explicitly that any incidental additive that may

   4   cause a serious allergic reaction should be

   5   presumed to pose a risk and be declared in the

   6   ingredient list.

   7             If an incidental additive is one of the

   8   main food allergens, or sulfites, it also should be

   9   declared in the allergy information section of the

  10   ingredient facts label.  Regulations could allow

  11   waivers if companies can demonstrate that the

  12   amount of allergen present is truly too small to

  13   cause any reactions.  Thank you very much.

  14             [Applause.]

  15             MS. MUNOZ-FURLONG:  Before I begin, I want

  16   to also again clarify that when I talk about

  17   flavors during my presentation, I really do intend

  18   this to apply to flavors, colors, spices and

  19   incidental additives.

  20             Next slide, please.  My objectives here

  21   are going to be to provide the consumer's

  22   perspective on these incidental additives and

  23   provide information about the industry's response

  24   to the concerns of the food allergic consumer, and

  25   that's going to be based on information from our 
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   1   members and the industry itself.

   2             Next slide.  First of all, from the

   3   consumer's perspective, we know that strict

   4   avoidance is the only way to avoid an allergic

   5   reaction.  We know that major allergens can be

   6   included in flavors, spices and colors and

   7   incidental additives.  We also know that they are

   8   currently not required to be listed on the label,

   9   and that children have had allergic reactions to

  10   proteins even in the low levels that you're going

  11   to find them in these categories.

  12             A good example of this came to us several

  13   years ago when a cereal was put on the market.

  14   Within weeks after launching this cereal, we

  15   started to receive calls all over the country about

  16   children having allergic reactions.  We contacted

  17   the manufacturer.  They found that, in fact, the

  18   flavorings contained milk ingredients.

  19             Now, to their credit, they changed the

  20   label to reflect that information, and we have not

  21   had any reports of incidences to that cereal since

  22   then.

  23             Next slide.  When a consumer sees natural

  24   flavors on the market, they have several options.

  25   The first one is avoid that product completely.  If 
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   1   any of you have ever looked at the ingredient

   2   statement, you will know that if you avoid the

   3   products that say flavors, colors, or spices,

   4   you're going to have no food choices at all.

   5             The second is to take a chance.  Again,

   6   we're talking about children, so this is not

   7   acceptable as an option.

   8             The third is to decide to call the

   9   manufacturer and ask very specifically does the

  10   flavor contain whatever the protein you're trying

  11   to avoid.  If you make that determination to be

  12   your decision, then you need to hope, first of all,

  13   that there's a phone number listed on that package

  14   to help you make that phone call.

  15             Many of these calls are being made at the

  16   grocery store on cell phones as people look at a

  17   package, want to make a purchasing decision on the

  18   spot, or at dinner time when they are taking a

  19   product off the shelf in their pantry and notice an

  20   ingredient that they don't understand.  So the need

  21   for information in a timely fashion is critical in

  22   these situations.

  23             Next slide, please.  Now, currently some

  24   companies will divulge the information willingly

  25   and quickly over the telephone.  We applaud their 
                                                                140

   1   efforts.  However, other companies will consider

   2   this information proprietary and will not release

   3   it.

   4             We have had some companies tell our

   5   members that if they have a reaction, their doctor

   6   can call the company, and then they will divulge

   7   all this information.  This doesn't seem to be the

   8   way we should be doing this.

   9             Some of the companies will provide the

  10   information, but in writing, and it takes several

  11   weeks to get this information that will not satisfy

  12   the need of our members to get information quickly.

  13   There are a few companies that will provide this

  14   information in a timely fashion.  They will put it

  15   on the label.

  16             For example, natural butter flavor or

  17   natural flavors contains milk.  This saves time.

  18   It's simple English and it's very easy to

  19   understand.

  20             Next slide.  Now, again, going back to the

  21   survey that I've mentioned today several times.

  22   Second on the list of top three concerns in the

  23   write-in portion of our survey was natural or

  24   artificial flavors or colorings.  The concern from

  25   our members is that this has hidden ingredients, 
                                                                141

   1   and if you recall from my first presentation,

   2   reactions occur because someone is eating something

   3   they think is safe.  If they don't know the

   4   allergen is in there, they can't avoid it.

   5             Next slide, please.  The conclusions from

   6   our survey showed that food allergic individuals

   7   are reading the ingredient label diligently.  They

   8   are making purchasing decisions that affect their

   9   health based on that information.

  10             We also know that they believe that the

  11   information on the package is not complete.  Four

  12   out of five of them report calling manufacturers

  13   for additional information.  I want to make the

  14   point that our members are one of the best

  15   educated, highly motivated people in the food

  16   allergy community and this country.  If they are

  17   struggling with these labels, I can only imagine

  18   what the general public is going through.

  19             Now, the final slide, in summary, flavors,

  20   spices, colors and incidental additives can contain

  21   hidden ingredients.  Even the low levels of

  22   allergens that would be present in this could cause

  23   a reaction affecting children most often.

  24   Therefore, we recommend that allergens should

  25   always be declared on the label when they're 
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   1   present in a product.

   2             Thank you.

   3             [Applause.]

   4             MS. HILDWINE:  Thank you.  At the outset

   5   of the discussion on labeling allergenic components

   6   of flavors, colors, spices and incidental

   7   additives, it's important to note that major food

   8   allergens are proteins.  There are numerous

   9   components in flavors, colors and incidental

  10   additives that are not proteins.

  11             Often these components include alcohols or

  12   oils that may be derived from the major food

  13   allergens, but are so highly refined that they do

  14   not contain protein.  Bleached, deodorized and

  15   refined soybean oil that may be used as a carrier

  16   for flavor or color or a component in a food

  17   additive in some food applications is a good

  18   example of the type of product that should be

  19   considered outside the scope of today's discussion.

  20             Furthermore, there is no spice included

  21   among the list of the eight major food allergens

  22   that is the focus of FDA's discussion today, so it

  23   is clear that in this session, we really are

  24   speaking of spices only in concept.

  25             This observation leads one to the 
                                                                143

   1   conclusion that FDA should continue to address the

   2   labeling of allergenic components in flavors,

   3   colors and spices on a case-by-case basis.

   4   Creating a generally applicable policy most likely

   5   would encompass substances that are not at issue

   6   for the labeling of food allergens.

   7             We know from our discussions with NFPA

   8   members that they receive information from their

   9   suppliers of flavors, colors, spices and additives

  10   with respect to the allergenic components present.

  11   NFPA believes that suppliers should always

  12   volunteer this information to their food processor

  13   customers with the understanding that food

  14   companies are not interested in knowing the

  15   formulation of the flavor, color, spice or

  16   additive, just in knowing which allergenic proteins

  17   are present.

  18             NFPA also is of the view that food

  19   processors should carry forward to their own labels

  20   information on the presence or possible presence of

  21   those major food allergens and flavors, colors,

  22   spices and incidental additives.

  23             NFPA believes it is appropriate to present

  24   plain language information on the allergenic

  25   components of flavors, colors, spices and 
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   1   incidental additives in association with the

   2   ingredient declaration of the finished food.

   3             This information should be in the

   4   ingredient list where the flavor is declared or at

   5   the end of the ingredient list as appropriate to

   6   the food and the flavor or other component.

   7             The presentation options--"contains," use

   8   of a reference mark or use of parentheses--as

   9   discussed in this morning's session on plain

  10   language, all are valid presentations as would be

  11   any plain language representation of the name of

  12   the allergin in the common or usual name of the

  13   flavor.

  14             NFPA would not support rulemaking to make

  15   mandatory the ingredient declaration of the plain

  16   language terms for major food allergin components

  17   of flavors, colors or spices.  Many of our members

  18   already declare information on these allergenic

  19   components on a voluntary basis.

  20             NFPA believes it is the responsibility of

  21   food processors to obtain this information from

  22   their suppliers and carry it forward to the

  23   finished product labeling.  Many of our members use

  24   checklists and other techniques to ensure that

  25   they've received this information from their 
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   1   suppliers.

   2             Because some of the major food allergens

   3   are common in the food supply, milk, wheat, egg and

   4   soy, for instance, our members do not limit their

   5   information collection to the obvious or major

   6   ingredients.

   7             Egg protein that may be a component but

   8   not a characterizing flavor of a sauce is a good

   9   illustration of this.  The food processor that uses

  10   the sauce in the formulation of the food will

  11   obtain information from the supplier that egg

  12   protein is present, usually from the ingredient

  13   labeling on the sauce.  And that information will

  14   be carried forward to the label of the finished

  15   food.

  16             Regarding major food allergens that are

  17   components of additives that might qualify for the

  18   incidental additives declaration exemption, NFPA

  19   believes that FDA has already made its views very

  20   clear that such allergenic components are not

  21   exempt from declaration.  NFPA advises its members

  22   in a way that's consistent with FDA's

  23   interpretation and policy.

  24             Although scientists have been studying the

  25   issues of threshold levels of allergenic proteins 
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   1   that trigger an allergic reaction, so far there are

   2   no established thresholds.  This raises questions

   3   regarding the meaning of both insignificant

   4   quantities and absence of technical or functional

   5   effects in the finished food with respect to those

   6   food allergens, and both those conditions must be

   7   met in order to qualify for the incidental

   8   additives exemption.

   9             In addition, the absence of solid

  10   scientific knowledge about the quantities of major

  11   food allergens needed to trigger allergic reactions

  12   argue strongly for FDA not to codify the specific

  13   exclusion of major food allergens from the

  14   incidental additives exemptions.  The reason for

  15   this is plain.  As food allergy science advances,

  16   it is likely to become increasingly evident that

  17   there are reaction thresholds.  That is

  18   quantitative levels of food allergens below which

  19   allergic reactions do not occur.

  20             Discussing the threshold concept is a

  21   meeting for another day with a group of experts

  22   different from this panel.  Nevertheless, we urge

  23   FDA to be cautious and refrain from codifying an

  24   allergen exclusion of the incidental additives

  25   exemption at this time.  If FDA were to codify this 
                                                                147

   1   exclusion, it would be a very difficult and long

   2   process to reverse the rule or selectively reverse

   3   the rule which is more likely to be the case.

   4   Thank you very much.

   5             [Applause.]

   6             DR. LEWIS:  And Mr. Hallagan, please.

   7             MR. HALLAGAN:  I'd like to thank the

   8   agency and our allied associations for the

   9   opportunity to participate today.  I'm representing

  10   three trade associations today: the American Spice

  11   Trade Association, the Flavor and Extract

  12   Manufacturers Association, and the International

  13   Association of Color Manufacturers.

  14             Our members manufacture spices, flavors

  15   and colors that are included in a wide variety of

  16   foods and beverages.

  17             One point I'd like to make to start is

  18   that our products, the bulk of our products, go

  19   into consumer products, foods and beverages, and

  20   are therefore not sold directly to consumers so our

  21   labeling requirements are different from consumer

  22   product labeling requirements.

  23             But our main mission is to support our

  24   customers and to provide them with all the

  25   information they need to comply with all labeling 
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   1   requirements or all labeling needs such as allergy

   2   labeling.

   3             All of our member associations are members

   4   of the Food Allergy Issues Alliance and all support

   5   the guidelines.

   6             Spices are listed by the FDA in the Code

   7   of Federal Regulations.  There's a very long list

   8   of spices and has been mentioned, none of them are

   9   listed as allergens or considered allergens or the

  10   source of allergenic protein material.

  11             The current FDA labeling rules do allow

  12   for the generic declaration of spice as providing

  13   for the inclusion of a variety of spices in a food

  14   product.  Other materials that may be included in a

  15   mixture must be labeled and are subject to other

  16   labeling requirements, but an important point to

  17   keep in mind is that the spice industry is fully

  18   committed to providing information to its

  19   customers, in other words, food and beverage

  20   companies that incorporate spices into finished

  21   foods.

  22             So if a material that originates from one

  23   of the eight materials that are considered

  24   allergens, if proteinaceous materials from those

  25   eight are used in a spice mixture, then the spice 
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   1   manufacturer is committed to providing that

   2   information on its label so its customer can label

   3   as well.

   4             In terms of flavors, the FDA has listed a

   5   variety of flavor materials in the CFR, and I've

   6   provided the citation.  In addition, there is a

   7   longstanding industry GRAS panel known as the FEMA

   8   expert panel, which has done thorough safety

   9   evaluations on about 2,000 flavoring substances,

  10   and this list is available from FEMA and we're

  11   happy to provide it upon request.

  12             This information has also been shared with

  13   FDA and these additives are included in the

  14   agency's database.  None of the single chemically

  15   defined flavoring substances are considered

  16   allergens.  These are individual substances that

  17   may be derived from natural sources or produced

  18   synthetically.  None of them include proteinaceous

  19   material which would cause an allergic reaction.

  20             The current FDA labeling rules, as I

  21   provided the citation for here, allow that flavor

  22   may be declared in a generic manner, but it's

  23   important to note that other materials included in

  24   a flavor would have to be labeled for with the

  25   exception, of course, of incidental additives and 
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   1   processing aids, but the flavor industry, like the

   2   spice industry, is committed to providing

   3   information on allergenic materials that may be

   4   used in a spice mixture because flavors are complex

   5   mixtures.

   6             They are a number of individual flavoring

   7   substances and other materials that are combined to

   8   provide the flavor that provides the taste to the

   9   variety of foods and beverages that we all consume.

  10             FEMA has been very active in the allergy

  11   area beginning in 1997 when FEMA sponsored an

  12   education session for its members, the FEMA Allergy

  13   Workshop.  The impetus for this workshop was the

  14   release of the 1995 FAO Technical Consultation on

  15   Food Allergens, and FEMA took the big eight list

  16   from that FAO consultation, made it available to

  17   its members, and in a self-regulation program

  18   established guidelines for the labeling of

  19   flavoring substances that are sold to consumer

  20   products companies.  We had very good compliance

  21   with self-regulatory initiatives, as evidenced by

  22   the FEMA GRAS program.  So we've had very good

  23   compliance so far with the allergy guidelines.

  24             The FAO guidelines are very largely

  25   consistent with the Food Allergy Issuance Alliance 
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   1   guidelines as well.

   2             In terms of colors, the last group of

   3   substances I'd like to deal with this afternoon,

   4   large number of color additives are listed for use

   5   by FDA.  They've been very thoroughly evaluated for

   6   safety.  None of them are listed as allergens, but

   7   as Dr. Jacobson mentioned earlier, some scientific

   8   data indicate that carmine and cochineal may be

   9   able to cause allergic reactions.

  10             We have encouraged our members, of course,

  11   to declare that whenever it's present in a mixture,

  12   and a number of consumer products companies also

  13   voluntarily declare it.

  14             Certified colors must be labeled already

  15   specifically on the ingredient line.  Exempt colors

  16   may be declared generically, but again any

  17   components that are derived from the big eight, we

  18   are encouraging our members to declare.

  19             Thank you.

  20             [Applause.]

  21             DR. LEWIS:  Just before we begin our panel

  22   discussion, let me remind you that if you do have

  23   questions, please do write them on the cards, pass

  24   them to the aisles.  They will be collected.

  25             Okay.  For this particular panel, who 
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   1   would like to open with a comment or a question?

   2   Dr. Falci.

   3             DR. FALCI:  This is Dr. Falci of the Food

   4   and Drug Administration.  My question is generally

   5   I guess about flavors and colors and spices in the

   6   sense that I agree with you.  A lot of them

   7   apparently don't appear to be allergenic per se,

   8   and I was trying to get a feeling for exactly how

   9   many times, for instance, you would put a flavor,

  10   for instance, as a single chemical entity into a

  11   food per se, or would it be mostly put into a food

  12   via a delivery system where the flavor would be on

  13   some set of substances and then potentially sprayed

  14   on a food product, for instance?

  15             Isn't it mostly true that the delivery

  16   system for flavors, even colors and spices, would

  17   be sprayed on foods and that the delivery system

  18   would have potentially allergenic components in it,

  19   and that it wouldn't necessarily be that a matter

  20   of the flavor being there in a small amount, but

  21   the fact that the allergen is in the delivery

  22   system, per se?

  23             MR. HALLAGAN:  Well, flavors are used in a

  24   variety of ways.  Dr. Falci has just described what

  25   we refer to as a spray dry flavor system.  Dr. 
                                                                153

   1   Falci is correct.  Flavors may be used in that way

   2   in addition to other ways.  If a flavor is

   3   delivered on a system, in other words, incorporated

   4   into the food on a system which, for example, may

   5   contain a carbohydrate matrix or a carbohydrate

   6   substance to carry the flavor, then we have

   7   encouraged our members to declare that substance

   8   if, in fact, the delivery system contains a

   9   proteinaceous material from one of the eight listed

  10   groups of allergens.

  11             So, yes, flavors are used in that way, and

  12   we have asked our members to declare those

  13   substances if they are contained in the delivery

  14   system.

  15             DR. FALCI:  And how often would this

  16   particular type of delivery system by used per se?

  17   I mean are flavors, colors and spices delivered 90

  18   percent of the time in this matter in a food

  19   product?

  20             MR. HALLAGAN:  I don't know what the

  21   actual proportion is, but we could certainly get

  22   that information for you, but it is accurate to say

  23   that all three--flavors, colors and spices--can be

  24   used in that way.  And, for example, flavors going

  25   into a beverage would not be delivered that way, 
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   1   and that's a very large proportion of the flavor

   2   used; same with the candy.  Spray dry flavors or

   3   colors or spices would be used on snack foods, for

   4   example, and again I'm not a technologist, but I

   5   can get that information for you.

   6             DR. FALCI:  Okay.  Thank you.

   7             DR. LEWIS:  Other questions, comments?

   8   Michael?

   9             DR. JACOBSON:  Mr. Hallagan, you mentioned

  10   that your association favors voluntary labeling of

  11   substances like carmine that have been demonstrated

  12   to cause allergic reactions.  Instead of relying on

  13   voluntary action from companies, would you support

  14   mandatory labeling of those through legislation or

  15   regulation?

  16             MR. HALLAGAN:  Well, our members' products

  17   are not the products that consumers actually

  18   consume in the majority of circumstances.  It's our

  19   customers' labels that would be impacted.  We're

  20   committed to providing that information to our

  21   customers and for flavors, colors and spices, as

  22   far as we're concerned, the initiative can be

  23   mandatory or voluntary.

  24             Our members intend to provide that

  25   information to the customers, and that's our 
                                                                155

   1   commitment and that's what we've been doing for the

   2   last about four years.

   3             DR. LEWIS:  Other questions from the

   4   various panelists?

   5             DR. FALCI:  One more.  Incidental

   6   additives--sort of it could be a learning curve

   7   here as far as incidental additives are concerned.

   8   There's been a lot of opinions or opinions

   9   expressed that incidental additives simply were not

  10   put on labels in the past, and although the agency

  11   has expressed the desire to have the food allergen

  12   in incidental additives put on the label, we

  13   started that policy and we suggested that policy

  14   back in 1996, it takes time to get through the

  15   industry.

  16             But could you, maybe members of the panel

  17   here, suggest ways of making industry more aware

  18   that incidental additives are really to be put on

  19   the label when a food allergen is present?  What

  20   are the types of things that you would do to try to

  21   improve that in the industry?

  22             MS. HILDWINE:  Well, I'll tell you the

  23   very first thing that I do is remind our members

  24   that the incidental additives exemption is not easy

  25   to come by.  That regardless of whether your food 
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   1   ingredient is identified as one of those suitable

   2   classes of ingredients that may qualify for the

   3   incidental additives exemption, that, in fact you

   4   have to pass two parts of--well, you have to pass

   5   both parts of a two-pronged test in order to

   6   qualify for the exemption.

   7             Now, typically, these incidental additives

   8   are going to be ingredients carried over from a

   9   previous component of a food, but the regulation, I

  10   think, reads very clearly that that component in

  11   order to be exempt from declaration must be present

  12   in the food at an insignificant level and have no

  13   technical or functional effect in the food.  One of

  14   them is not sufficient for declaration.

  15             And I like to draw the example of, say, a

  16   flow agent in a seasoning blend.  Say, the flow

  17   agent silicon dioxide has a functional effect in

  18   the seasoning blend.  When that seasoning blend is

  19   added to a wet ingredient, the silicon dioxide

  20   loses all of its technical or functional effect.

  21   So when you add the seasoning, probably at a low

  22   level, to a food, and it's got the silicon dioxide,

  23   then, in fact, that substance may pass both prongs

  24   of the test, that it is present in the finished

  25   food in an insignificant amount and has no 
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   1   technical or functional effect in the finished

   2   food.

   3             Well, what applies to silicon dioxide in

   4   the seasoning blend may not, for example, apply to

   5   say a wheat extracted ingredient that's in the same

   6   seasoning blend, and that would not be exempt, so

   7   you really have to look at this component by

   8   component and make sure that every component that's

   9   carried forward passes both prongs of the test.  So

  10   we do a lot to educate our members on just exactly

  11   what that exemption means.

  12             DR. FALCI:  How do you do that?  Do you

  13   call them in?  Do you have conferences?  What?

  14             MS. HILDWINE:  Well, what I just told you

  15   that seemed to appear off the top of my head, you

  16   know, is not spontaneously there.  It comes from

  17   years of advice to our members one on one, as we

  18   go--we do their label reviews.  NFPA does this,

  19   reviews labels, as one of its benefits to members,

  20   and answering their questions.  When they ask for

  21   clarification on the incidental additives

  22   exemption, I get a lot of questions regarding the

  23   incidental additives exemption and personally walk

  24   them through it every time.

  25             DR. JACOBSON:  Dr. Falci, the FDA 
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   1   certainly could accelerate the learning process by

   2   identifying some products that have unlabeled

   3   incidental additives and find them misbranded, the

   4   allergenic incidental additives, and find them

   5   misbranded and remove them from the market.  That

   6   would speed up the learning process considerably, I

   7   believe.

   8             [Applause.]

   9             DR. LEWIS:  Other questions?  Well, while

  10   you're thinking of more questions, we do have three

  11   from the participants here today.  One is for Anne

  12   Munoz-Furlong.  It's actually a two-parter, Anne.

  13             Would milk allergic individuals know to

  14   avoid butter or cream or should these be identified

  15   in the ingredient panel as milk?

  16             And the other is should only the top eight

  17   allergens be disclosed in favors and spices or

  18   more?

  19             MS. MUNOZ-FURLONG:  Okay.  The question

  20   about whether the milk allergic individual, what

  21   their understanding of milk products and byproducts

  22   are is going to be depend on each individual.  The

  23   people that are more aware of it, probably the

  24   parents, the people closer to the patient, are

  25   going to be very aware that yogurt or butter are 
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   1   milk derived.  People as we move away from the

   2   circle of care for that child may not necessarily

   3   make the connection and we see this over and over

   4   again when we're talking to grandparents and other

   5   caregivers of the child.

   6             So our suggestion would be to always err

   7   on the side of safety and declare that it is milk

   8   after butter or any other of these terms to make it

   9   very, very simple to follow.

  10             The second part of the question should we

  11   look at only the top eight or all of the allergens,

  12   I know there's a study that's been done that looked

  13   at the foods that had been implicated in reactions,

  14   and there were somewhere around 160 foods on that

  15   list.  That's an enormous task.

  16             What we would recommend again is to stay

  17   focused on the 90 percent of that problem.  Once we

  18   figure out what the solutions are there, we can

  19   hopefully then quickly come by and address some of

  20   these other issues.

  21             DR. LEWIS:  The next question I have is

  22   stated as follows:  If spices are not considered

  23   allergens, then how can one have an allergic

  24   reaction to allspice as referenced by Ms.

  25   Munoz-Furlong?  If there have been reactions to 
                                                                160

   1   spices, then what motions are in place to address

   2   these issues?

   3             MS. MUNOZ-FURLONG:  I want to clarify my

   4   position.  I am not aware of any reactions to a

   5   particular spice.  The bulk of the work that we do

   6   is to look at those top eight allergens.  If they

   7   appear in anything, such as a color, spice or

   8   flavoring, then we want those listed out on the

   9   label.

  10             DR. JACOBSON:  I was actually the one who

  11   mentioned allspice, cardamon and coriander.  In the

  12   paper, Sue Hefle's paper, listing 160 or however

  13   many allergenic foods, those are included, and

  14   there are varying levels of evidence for those

  15   allergens, and I think there's going to be a gray

  16   area where there will be for some of the foods,

  17   there will be very limited, more anecdotal

  18   evidence.  For other foods, there will be

  19   double-blind controlled studies, food challenges,

  20   that establish that it is allergenic, and then I

  21   think somebody will have to decide, well, how much

  22   evidence do you need?

  23             How many cases of demonstrated

  24   allergenicity do you need before you require

  25   disclosure? 
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   1             DR. LEWIS:  The next question I have

   2   focused on the concept of thresholds.  What would

   3   be the threshold that is the minimum level of an

   4   allergen that would have to be declared?  If the

   5   level is zero, how would the manufacturers test for

   6   that?

   7             MS. HILDWINE:  I brought this up so I

   8   think I better field it.  There is a lot of

   9   scientific work that's going on in this area.  I'm

  10   not an expert on thresholds and certainly I really

  11   couldn't speak to quantities, but a lot of

  12   scientists are devoting a lot of attention to

  13   determining what are the levels that would trigger

  14   allergic reactions.

  15             The author of this question has definitely

  16   pinpointed a problem, and that is that if we are

  17   talking absolute zero, then that's very, very

  18   difficult to achieve with respect to allergenic

  19   ingredients or for anything for that matter.

  20             DR. JACOBSON:  I agree that it's a tough

  21   problem.  Fortunately, the assays don't get down to

  22   parts per billion, but they're measuring levels

  23   that presumably are allergenic.  I think the

  24   presumption should be that the substance is listed,

  25   the wheat or soy or whatever, if it's known to be 
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   1   there as an incidental additive.

   2             But perhaps companies should have an

   3   opportunity to demonstrate that at such and such a

   4   level, something does not pose any risk of

   5   allergenicity.  And right now I don't know that

   6   there's any evidence for a threshold, but there

   7   should be an opportunity to exclude labeling of

   8   incidentals if they do fall below some demonstrated

   9   threshold.

  10             DR. LEWIS:  I'll wrap my last two

  11   questions into one large question, although they're

  12   not entirely similar.  The first is isn't it time

  13   that out of the three issues discussed today, this,

  14   meaning Panel III, holds the most risk for the food

  15   allergic consumer?  Is the industry doing anything

  16   to prioritize this as the first issue?

  17             And then a second part of this:  Mandatory

  18   labeling is a zero sum equal expense for all

  19   manufacturers.  What incentives are there for

  20   manufacturers to deal with the cost of voluntary

  21   labeling?

  22             MS. HILDWINE:  Well, I'm not absolutely

  23   certain that this is where the bulk of the problem

  24   of undeclared allergens is.  I think we spent a lot

  25   of time in our second panel this morning talking 
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   1   about good manufacturing practices, and let's say

   2   significant levels of food allergens that are

   3   undeclared in food products.  So I think you've got

   4   some good sense of what that's like from the report

   5   of the FDA inspections.

   6             So I think that certainly manufacturing

   7   practices are really where we may need to spend a

   8   lot of attention, you know, in resolving labeling

   9   things.

  10             The issue of undeclared allergens that may

  11   be present in flavors, colors, spices and

  12   incidental additives certainly is also a very

  13   important issue because it involves undeclared

  14   allergens and that's an important public health

  15   concern.  But whether that is top of the list I

  16   think is still open to some discussion.

  17             As to incentives for the food industry to

  18   pursue voluntary labeling, nothing is quite as

  19   effective in the food industry as what we call peer

  20   pressure or the competitive marketplace, and

  21   certainly we know from the experience of food

  22   allergic consumers that they very much appreciate

  23   when food companies go to the trouble of putting

  24   food allergen information on their labels on a

  25   voluntary basis. 
                                                                164

   1             More and more companies are doing this,

   2   and they're beginning to be much more responsible

   3   about the way they do this, and consequently, you

   4   know, particularly if you're in a sector of the

   5   industry where you compete with some major

   6   companies that are already doing food allergen

   7   labeling of an advisory nature, this is something

   8   that you're considering because food allergic

   9   consumers more often than not are calling you up

  10   and asking you why isn't it there?

  11             And in addition to the pressures of the

  12   marketplace, the pressures of consumers certainly

  13   have something of an impact on what the food

  14   industry does.

  15             DR. LEWIS:  Any last comments or questions

  16   from anyone else on the panel?  If not, what we'll

  17   do now is turn to the last component of our

  18   program, the public comment.

  19             Just a couple of announcements and

  20   reminders before we do that.  The first is that for

  21   these issues, the FDA docket is still open.  People

  22   who are interested in submitting written comments

  23   on these particular topics are more than welcome to

  24   do so.  The docket is still open.

  25             Secondarily, I need to be very clear about 
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   1   what are the issues that are being addressed today.

   2   It is food labeling.  It is not latex gloves.  It

   3   is not celiac sprue, and it is not restaurant

   4   labeling.  Those are not topics of today's

   5   discussion.

   6             What we'll do at this point is take a 60

   7   second stretch break while this podium is lowered

   8   down so that our speakers will be able to make

   9   their comments from the floor.  So bear with us for

  10   60 seconds while we arrange up here and then we'll

  11   be right back with our first speaker.

  12             [Whereupon, a short recess was taken.]

  13             DR. LEWIS:  All right.  The procedure is

  14   that we will go down the list of persons who have

  15   registered to speak.  We ask that you very briefly

  16   introduce yourself.  You are being timed for three

  17   minutes.  I do apologize if I mispronounce your

  18   name.  I'll try the best that I can.  You can

  19   correct me once you do get up there, but again it's

  20   three minutes and we would appreciate your moving

  21   along appropriately.

  22             The first on my list is Victoria Geduld.

  23             MS. GEDULD:  My name is Victoria Geduld.

  24   I'm a concerned citizen and mother and I am with my

  25   daughter Nancy Geduld, who is six years old and a 
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   1   student.  Due to time constraints, I will not go

   2   into a lengthy of history.  Suffice it to say that

   3   Nancy loves playing with her friends and sisters

   4   and going to the park.

   5             It's a sunny day in August and rather than

   6   doing all these things on this Monday, she chose to

   7   sit with me because the most important thing in her

   8   life is safe food.  Misleading and unclear labels

   9   can kill her and she knows this firsthand.

  10             My daughter Nancy has an acute

  11   anaphylactic reaction to peanut proteins which is a

  12   fancy way to state the simple fact that trace

  13   amounts of a simple and common food can kill her.

  14             A few years ago, Nancy ate a chocolate

  15   Kellogg's Rice Krispie treat that said nothing of

  16   peanuts or peanut traces on the label.  After a few

  17   bites, she said, Mommy, this has peanuts.  I read

  18   the label.  Nothing.  She began to swell.  I gave

  19   her medicine and we were fine.  Within a few

  20   months, these same treats began to carry the label

  21   "may contain peanuts."

  22             The traces must have been small.  Were the

  23   traces larger, we know from history, Nancy would

  24   have had an injection and she would have been

  25   hospitalized, if she had survived.  At four years 
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   1   old, Nancy learned not to trust labels.

   2             Foods must be labeled in plain English so

   3   that Nancy at six and myself, her father,

   4   grandparents, relatives, teachers or caregivers can

   5   read the label and know what's inside.  If I have

   6   as a consumer have a question regarding the food, I

   7   should have a number on the label to call.

   8             In a recent example, the outside container

   9   of the same Kellogg's chocolate rice krispie treats

  10   said that they did not contain nuts, the

  11   individually wrapped treats inside said "may

  12   contain peanuts."  As it turned out, the line had

  13   been changed and made peanut free, and the labels

  14   on the outside had been changed to reflect this.

  15             The individual wrappers inside had not.  A

  16   confused consumer should be able to contact a food

  17   manufacturer.  Small packagers can get waivers from

  18   the government, but luckily there are few who would

  19   qualify.  Most packages are large and should be

  20   required to provide access to the company in the

  21   case of an accidental ingestion or an emergency or

  22   a question.

  23             In addition, any information about the

  24   ingredients in the food should be listed in the

  25   ingredients section of the label.  "May contain" 
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   1   warnings do not help at the bottom of a package if

   2   the ingredients are printed on the top.  We had a

   3   near accident in such a case.  The warning was next

   4   to the company's address, catty-corner to the

   5   ingredient section.

   6             If it has to do with the ingredients, put

   7   it in the ingredients listing.  With the purchase

   8   of food for an allergic individual, there is a

   9   ripple effect.  For the millions of allergic

  10   people, there are tens of millions who are

  11   affected.  Think of the number of people who are

  12   involved in feeding a single child.

  13             All these people will be served with

  14   government legislation demanding accurate and

  15   readable labels.  In addition, all these people

  16   will be unnecessarily inconvenienced by a "may

  17   contain" label spread on packages.  No matter what

  18   manufacturers must not be allowed to put a warning

  19   label on foods because it is easier or more

  20   convenient than actually monitoring the food

  21   supply.  The government must ensure that labels are

  22   accurate, not just slapped on.

  23             In order for my daughter to trust her food

  24   supply and get back to the business of being a

  25   child, any allergens must be included in the 
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   1   ingredients section.  There can be no exemptions.

   2   Thank you.

   3             [Applause.]

   4             DR. LEWIS:  Thank you.  Next please Pamela

   5   Hughes.  If Pamela Hughes is not here, we will move

   6   to Joseph LaRochelle.

   7             MR. LaROCHELLE:  My name is Joe LaRochelle

   8   and I would like to tell you what it is like to

   9   have a life threatening food allergy and why it is

  10   so important to have accurate and dependable food

  11   labels.  I'm a 21 year old who lives in Dairy, New

  12   Hampshire and a senior at St. Anthem College in

  13   Manchester, New Hampshire.

  14             Besides having asthma, I'm also deathly

  15   allergic to peanuts and tree nuts.  If I eat even a

  16   trace of these, I don't just get a stomachache.  In

  17   my short life time I have had more than ten severe

  18   allergic reactions.  When I was 13, I almost died.

  19   I had a chocolate chip cookie that contained

  20   walnuts.  My symptoms started with a simple

  21   stomachache, but after less than one hour, I

  22   started having hives, itchy mouth and throat,

  23   breathing problems.  All the while my throat

  24   started to close and I began to lose consciousness.

  25             Doctors said that if I wasn't not a mile 
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   1   from the hospital, that I probably wouldn't be

   2   standing here right now.  After two to three

   3   injections of epinephrine, two shots of benedryl,

   4   two nebulizer treatments and a oxygen mask, I was

   5   released from the hospital five hours later when my

   6   condition stabilized.

   7             Every minute of my life I must be on guard

   8   by reading all ingredient levels with how to read a

   9   label card handy and my epinephrine in the case of

  10   a severe allergic reaction.

  11             It is critical that food labels be

  12   accurate, clear and dependable to help me avoid

  13   potential life threatening allergic reactions

  14   because peanuts and tree nuts often show up

  15   unexpectedly in the most unlikely of places.

  16             Besides reading all ingredient labels, I

  17   am constantly watching for product recalls because

  18   of undeclared peanut or tree nuts.  Because of

  19   that, I give high priority to the Food Allergy and

  20   Anaphylaxis Network's special food allergy alerts

  21   that notify me in the event these things happen.

  22             In the last few months in my state, an ice

  23   cream manufacturer recalled product with undeclared

  24   pistachios, a cereal maker had undeclared almonds,

  25   potato chips with undeclared peanuts, brownies with 
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   1   undeclared almonds, yogurt raisins with undeclared

   2   peanuts, and I could go on.

   3             This simply underscores the fact they all

   4   don't get it right all the time.  I would just like

   5   to briefly comment on the "may contain" statements.

   6   I never eat foods that say may contain peanuts or

   7   tree nuts, processed in the same facility as

   8   peanuts or tree nuts, or processed on shared

   9   equipment.

  10             I'm grateful that some manufacturers have

  11   alerted me to the potential presence of an

  12   allergen, but would prefer they take the necessary

  13   steps to prevent cross-contamination in the first

  14   place.

  15             In recent years, I have seen many more

  16   products with these statements on the label, a

  17   trend that is limiting my choice for foods that I

  18   can safely eat.  Thank you.

  19             [Applause.]

  20             DR. LEWIS:  Thank you.  Next, please,

  21   Julie Reinhard.

  22             MS. REINHARD:  My name is Julie Mendel

  23   Reinhard.  I am the mother of a three-year old

  24   peanut allergic son.  I am here not only on behalf

  25   of my family, but on behalf of 2,945 consumers 
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   1   representing 27 states who have signed a national

   2   grassroots petition seeking regulations to make

   3   food labels more accurate.

   4             Since I learned about my son's allergy the

   5   hard way, in the emergency room as doctors battled

   6   to save his life, I have been challenged with

   7   keeping him in a peanut free environment.  This

   8   means that I must read the label of every product

   9   that comes into our home and indeed every label of

  10   food my child may eat or come into contact with

  11   outside the home.

  12             But that's just the beginning.  After

  13   reading the food label, I must call the

  14   manufacturer to determine if the food has been made

  15   on shared equipment and therefore has the

  16   possibility of cross-contamination.

  17             This is because manufacturers do not

  18   reliably state whether peanuts are or are not in

  19   the product.  Furthermore, even after I call the

  20   manufacturer, I often do not get accurate

  21   information.  Sometimes I leave a message on an

  22   answering machine that can go unanswered for a

  23   period of weeks, and sometimes forever.

  24             Other times I talk to a consumer rep who

  25   reads from a written policy statement, but won't 
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   1   send it, and is unable to answer basic questions.

   2   Often I have to make at least three calls before I

   3   even talk to an informed person.  The first call is

   4   typically to get the phone number of the company.

   5             Worse, it is the rare occasion when I am

   6   told that the risk of cross-contamination is de

   7   minimis.  Therefore, I am unable to rely on the

   8   label itself to know if the food is safe for my

   9   son, and yet strict avoidance is the only sure way

  10   to keep him safe.

  11             In addition to the FDA's inspection,

  12   research at the University of Nebraska documented

  13   that peanut residues were detected in 21 out of 111

  14   products with either precautionary labeling on

  15   peanut listed as a last ingredient and in 33

  16   percent of foods with no labeling in any form.

  17             The researchers concluded that quote,

  18   "Despite vigilant monitoring of food ingredient

  19   statements by peanut allergic individuals,

  20   significant levels of unlabeled peanut residues can

  21   be encountered in food products."

  22             Finally, a study published in 1997 found

  23   that while the threshold dose of peanut protein

  24   varies, as little as 100 micrograms provoked

  25   symptoms in some peanut sensitive individuals.  For 
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   1   each of these reasons, I strongly urge the FDA to

   2   prescribe regulations requiring manufacturers to

   3   use plain English and commonly understood terms in

   4   the ingredient statement like egg, milk and peanut,

   5   rather than a scientific term, and to adopt the

   6   proposed ingredient facts label put forth by CSPI.

   7             Further, I implore the FDA to mandate that

   8   allergens contained in natural flavors and spices

   9   be listed in a parenthetical after the general term

  10   is used, and to clarify the incidental additive

  11   regulations by stating that those containing

  12   allergens are significant and therefore not exempt

  13   from label declaration including substances

  14   migrating to food from equipment.

  15             Third, I ask you to adopt the allergen

  16   control procedures recommended in the attorneys

  17   general citizen petition.

  18             Finally, it is with profound gratitude to

  19   the cochairs of this national grassroots campaign

  20   that I submit the following petition to the FDA for

  21   its careful consideration.  Here it is:

  22             (1) Put allergen regulations as an "A"

  23   priority on their 2002 agenda;

  24             (2) Prescribe allergen control procedures

  25   for companies to follow in cleaning equipment to 
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   1   reduce or eliminate the unintentional presence of a

   2   known food allergen in the finished product;

   3             (3) Mandate precautionary labels on foods

   4   if allergen control procedures and GMPs do not

   5   eliminate the unintentional presence of a known

   6   food allergen and the presence of such allergen

   7   poses a risk to human health;

   8             (4) Inspect manufacturing plants to

   9   determine if they are complying with the laws and

  10   regulations; and

  11             (5) Punish companies who are not in

  12   compliance with the laws and regulations.

  13             As the governmental body responsible to

  14   protect the health and safety of our Americans,

  15   these relatively simple measures can profoundly

  16   impact the safety of millions of Americans who

  17   suffer from food allergies.  Thank you.

  18             [Applause.]

  19             DR. LEWIS:  Thank you.  Next we have

  20   Elizabeth Carus and in order not to surprise you

  21   folks, after Elizabeth Carus, we would be

  22   addressing Gayle Rubin.  Is Elizabeth Carus here?

  23             MS. CARUS:  My name is Elizabeth Carus,

  24   and in addition to being severely allergic to

  25   wheat, I also have celiac disease.  Prior to being 
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   1   diagnosed with celiac disease, I was trying to

   2   follow a wheat-free diet.  I know how to read the

   3   labels.  I know what to look for, and until I went

   4   and had to follow a gluten-free diet, I was

   5   obviously missing a lot of hidden wheat.

   6             Upon going on a gluten-free diet, I ceased

   7   having asthma problems, which included going to the

   8   emergency room quite a few times, and obviously

   9   there was enough in the food that's hidden even

  10   after calling companies to have given me problems.

  11             When I call companies to verify whether

  12   things are wheat free and gluten free, the biggest

  13   problem I have beyond being told yes, it is, having

  14   the allergen so I can't eat it at all, is to find

  15   out that the company will tell me that they don't

  16   know if there's cross-contamination, not because in

  17   their company they have a problem, but they don't

  18   know from their suppliers.  And when the company

  19   tries to find out from their suppliers, because

  20   they do want to know whether it's gluten free since

  21   that's where I'm at, it can take them months.

  22             They can write many letters and in the end

  23   they can say we don't know because we can't find

  24   out from our suppliers.  And that to me is a big

  25   problem.  And that's probably about half the 
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   1   companies I call is what I find out.  And these

   2   are companies that want to be able to tell me that

   3   things are okay, that are being careful about

   4   telling me what's in their food, and they don't

   5   feel comfortable telling me because they don't know

   6   if there might have been a cross-contamination.

   7             And basically that's what I wanted to pass

   8   on to you about that with the food products and

   9   things.

  10             [Applause.]

  11             DR. LEWIS:  Thank you.  Next is Gayle

  12   Rubin and following Ms. Rubin, if she's here,

  13   Judith Schreiber.

  14             MS. RUBIN:  I brought some props.  Hi.  My

  15   name is Gayle Rubin, and I'm here supporting the

  16   celiac support groups.  It says something different

  17   on your listing.  I'm not sure what that was.

  18             Anyway, what I wanted to tell you is that

  19   gluten intolerance of celiac disease is a genetic

  20   disease that affects between one in 150 or between

  21   one in 250 Americans.  And that is basically new

  22   information, and if you take that and you add that

  23   to--figure out from what our total population is,

  24   you're looking at 1.5 million people roughly.

  25             If you take the related disorders, such as 
                                                                178

   1   Addison's Disease, other allergies, asthma,

   2   arthritis, attention deficit disorder, autism,

   3   cancer, diabetes, epilepsy, irritable bowel

   4   syndrome, lactose intolerance, mental disorders,

   5   multiple sclerosis, osteoporosis, psoriasis,

   6   scleria, sleep disorders, which affect another six

   7   or seven million people, you're talking about a lot

   8   of people who need label clarification.

   9             That's basically the reason I want you to

  10   understand it's not--somebody made mention of--it's

  11   not about celiac disease.  It's not about celiac

  12   disease.  It's about people who have to know what's

  13   in the foods they eat.  It's a lot of people.

  14             And as you do know, or you probably

  15   already know, celiac disease requires a strict

  16   adherence to 100 percent gluten-free diet for life.

  17   That includes trace amounts, and we can't have it.

  18   So I did want to show you a picture of what

  19   celiac--I've taken this out of a medical book.

  20   It's actually Fishbind's, and I wanted to show you

  21   a picture of what it looks like, when you don't

  22   adhere to 100 percent gluten free diet.

  23             That comes about because the villi, which

  24   is the way you normally ingest food are stunted,

  25   they're cut off, and then what happens is, you 
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   1   know, you can't get food.  You start malabsorbing.

   2   You can't get nutrition to yourselves so I mean

   3   it's not minor.

   4             The other part, I guess, of that is that

   5   there's many, many places of hidden sources of

   6   gluten that are found in ingredients of processed

   7   foods, and I can show you, you know, these Lays

   8   potato chips are totally gluten free.  These Lays

   9   potato chips are not gluten free.  And without

  10   calling the manufacturer, you don't know that.

  11             Another type of example I brought you is

  12   this is a package from Europe, and this is what it

  13   looks like when they say it's gluten free.  They

  14   actually have this little wheat symbol with like a

  15   no smoking slash through it, and they have that

  16   sign one, two, three places on the package, plus in

  17   five languages it's written gluten free, and it's

  18   written one location, two locations, on the top.  I

  19   mean so there are six locations on a label that our

  20   American manufacturers say there isn't enough room

  21   on the package to put anything.  So I will cut off

  22   at that point.  Thank you.

  23             [Applause.]

  24             DR. LEWIS:  Thank you.  Judith Schreiber

  25   and then I believe Peter Skinner following. 
                                                                180

   1             MS. SCHREIBER:  Hello.  My name is Judy

   2   Schreiber.  I'm a senior public health scientist in

   3   the New York State Office of the Attorney General

   4   Elliott Spitzer.  And I am here today to offer our

   5   comments on the important public health issues of

   6   labeling food products containing allergens.

   7             As one of nine states' attorneys general,

   8   our office submitted a petition to the FDA to amend

   9   its regulations on food labeling and manufacturing

  10   practices to better protect consumers from exposure

  11   to potentially life threatening food allergens.  We

  12   are grateful that the FDA is taking consumers'

  13   concerns seriously and has made strides to address

  14   these important public health issues.

  15             In the May 2000 petition, the attorneys

  16   general asked that the FDA: (1) require food

  17   manufacturers to label products with actual or

  18   possible presence of allergenic substances in

  19   foods; (2) require food manufacturers to provide a

  20   toll free number to enable consumers to contact

  21   knowledgeable customer service representatives

  22   about the ingredients contained in the foods; (3)

  23   to require manufacturers, food manufacturers, to

  24   declare natural and incidental additives derived

  25   from the big eight allergens; and, finally, to 
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   1   require food manufacturers to adopt good

   2   manufacturing practices aimed at preventing

   3   cross-contact with allergenic substances.

   4             Regarding some of the questions that you

   5   posed for this hearing, we do believe that

   6   mandatory language is the only way to assure that

   7   the label contains the necessary information upon

   8   which the consumer can make an educated choice

   9   about the safety of the food for their family's

  10   circumstances.

  11             Two, we do recommend that the labeling and

  12   good manufacturing processes be exercised--the FDA

  13   should exercise its authority and adopt the

  14   recommendations in the attorneys' general petition.The New

  15   York State Attorney General is considering

  16   future steps if the FDA neglects this important

  17   public health role.

  18             Finally, we agree with the FDA that the

  19   declaration of allergenic ingredients and

  20   incidental additives in flavoring, spices and

  21   colors is necessary for consumer protection.  The

  22   petition of the attorneys' generals recommends

  23   amending certain parts of the regulation, and we

  24   will be submitting written comments elaborating on

  25   where we feel these changes could be made. 
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   1             We strongly urge the FDA to codify its

   2   policy, to specifically state that incidental

   3   additives that are food allergens are not exempt

   4   from labeling and must be declared in the

   5   ingredient statement on the label.

   6             We also urge the FDA to require mandatory

   7   labeling to appear prominently and conspicuously on

   8   the information panel so that consumers can readily

   9   identify where that information is located.

  10             A speaker earlier today said that the FDA

  11   product recall program for allergenic contamination

  12   demonstrates that the system is working.  I would

  13   say that that same example shows, in fact, that the

  14   system is broken and that it must be fixed.  Having

  15   to recall products or having to have children and

  16   adults go to emergency rooms for care is not a

  17   preventative public health measure, and I urge that

  18   the system being broken, let's fix it.  Let's give

  19   consumers the life line they need by having

  20   adequate labeling on food products.  Thank you.

  21             [Applause.]

  22             DR. LEWIS:  Thank you.  Is Peter Skinner

  23   with us today?

  24             MS. SCHREIBER:  No.  He was unable to make

  25   it.  His wife went into the hospital. 
                                                                183

   1             DR. LEWIS:  Thank you.  And our next

   2   scheduled speaker is Catherine Tretheway.

   3   Following Catherine Tretheway will be Javier

   4   Trujillo Arriaga.

   5             MS. TRETHEWAY:  Hello.  My name is

   6   Catherine Tretheway.  I am an attorney and I

   7   assisted the New York State Attorney General in the

   8   preparation of the petition which has been the

   9   subject of today's discussion.  More importantly, I

  10   am the mother of a five year old daughter who has

  11   a life threatening allergy to peanuts.

  12             I am also an active member of a support

  13   group for families who are dealing with peanut and

  14   nut allergies.  I asked to speak today because I

  15   think it is important that the FDA know the source

  16   of this petition.  This is truly a document

  17   prepared by consumers for consumers.  In drafting

  18   the petition, I not only drew from my own

  19   experiences as the parent of a food allergic child,

  20   but also from the experiences of the many parents

  21   with whom I have talked or corresponded with during

  22   the recent years that I have started my work on

  23   food allergy issues.  Many of those parents are in

  24   the audience today.

  25             The petition is not a wish list for food 
                                                                184

   1   allergic consumers.  Rather it represents what

   2   consumers truly need to protect themselves and

   3   their loved ones from unintended consumption of

   4   food allergens.

   5             We need better manufacturing practices to

   6   avoid cross-contamination.  We need accurate

   7   labels.  We need clear and easy to read labels.  We

   8   need phone numbers on the labels so we can contact

   9   manufacturers with our questions.  Above all, we

  10   need consistency in labeling and manufacturing

  11   practices so that my mother-in-law, my child's

  12   babysitter, and others, and especially my own

  13   daughter, can look to one spot on a food label and

  14   readily and quickly ascertain whether a food is

  15   safe.

  16             As the parent of a food allergic child, I

  17   appreciate the efforts of the Food allergy Issues

  18   Alliance in issuing guidelines for better good

  19   manufacturing practices and labeling.  However,

  20   even after all our discussion today, I can only

  21   conclude that consistency in labeling can only be

  22   achieved through regulatory reform.  I urge the FDA

  23   to adopt the proposals set forth in the attorneys'

  24   general petition.  Thank you very much for your

  25   time. 
                                                                185

   1             [Applause.]

   2             DR. LEWIS:  Thank you.  Next Javier

   3   Trujillo Arriaga, if that person is present.  If

   4   not, Claudette McIntyre.  Neither Claudette

   5   McIntyre or Javier Trujillo Arriaga.  Then the next

   6   is Ron Barenburg.

   7             MR. BARENBURG:  Thank you.  My name is Ron

   8   Barenburg.  I'm from a company named Lynx Street.

   9   We're involved in bar code symbology.  There's a

  10   new bar code called reduced space symbology and

  11   composite symbology that allows more information to

  12   be put into less space.

  13             Now, next one, please.  I'm sorry.  That's

  14   the wrong one.  I'll go from here.  Just forget it.

  15   How reduced symbology and composite symbology,

  16   which are globally recognized as bar code

  17   standards, can alert consumers to allergies in food

  18   products.  Today manufacturers use what's called a

  19   UPCA code.  That's the bar code sticker that's on

  20   every product.  The upgraded version of it approved

  21   by the Uniform Code Council is also a UPCA bar

  22   code, but what's different about it, it is a

  23   portable database in that it can contain a lot more

  24   information.

  25             Right now it's available today.  It can be 
                                                                186

   1   implemented by manufacturers phasing into RSS-UPCA

   2   bar codes.  Retailers can upgrade or change their

   3   scanners on their normal scanner cycle.  Today's

   4   UPCA bar code contains only the manufacture number

   5   and the product ID number.  With the allergen

   6   warning using RSSCS-UPCA bar code, the following

   7   can contain this information.  This is what today's

   8   bar code looks like.  That's what's on every

   9   product that comes to market.

  10             With using and phasing into as an adjunct

  11   to the warning level in human readables, scanned

  12   with the same UPCA code, it can say warning:

  13   contains eggs.  If you wanted to put a warning:

  14   contains eggs and best used by date, it would be a

  15   similar label.  It would just be a little larger.

  16   All these can be put into the same space that a

  17   normal UPCA code can use today.

  18             The benefits to the retailer.  Besides the

  19   obvious concern for their customer's health, it

  20   would provide evidence that the consumer was given

  21   documented warnings with receipt of their purchase.

  22   Retailers will eventually upgrade anyway to support

  23   produce at variable weights and measures converting

  24   to RSS-CS.

  25             The benefits to the consumer are obvious.  
                                                                187

   1   Besides having the "may contain" warning in human

   2   readables, the scan bar code would print it out on

   3   the receipt alerting the consumer to the allergen

   4   warning, and if the consumer has a question, a

   5   checkout clerk would scan the product and verbally

   6   advise about any allergen danger before purchase.

   7             In conclusion, RSS bar codes can provide

   8   more information in less space, not only for

   9   allergen warnings, but for best used by dates,

  10   contraindications for other foods or drugs, and by

  11   providing batch and lot numbers, trace contaminated

  12   foods more quickly.

  13             I was drawn to this when I went to do some

  14   research on this and realized when I picked up with

  15   my 57 year old eyes a label and tried to read it,

  16   and I didn't have my reading glasses, how nice it

  17   would be just to be able to scan it at the register

  18   and see it in big letters, and I think it would

  19   help consumers tremendously.  Thank you.

  20             [Applause.]

  21             DR. LEWIS:  Thank you.  Next, Joanie

  22   Janicki.  And following Joanie Janicki would be

  23   Cliff Blaker.

  24             MR. JANICKI:  That's a bit of a

  25   discrepancy here.  J. Janicki. 
                                                                188

   1             DR. LEWIS:  J. Janicki.  Our apologies.

   2             MR. JANICKI:  Regulation 21 CFR 1001.4(a)

   3   deals with food designation of ingredients, and the

   4   problem here is that the criteria are fairly vague.

   5   The regulations above, the FDA states that natural

   6   flavors and/or artificial flavors may be listed in

   7   a vague manner.  As an example of this would be the

   8   problem that most commercial products contain

   9   certain ingredients such as modified food starch

  10   and/or natural flavorings.  It is not possible to

  11   tell by this type of labeling what ingredients the

  12   product actually contains such as corn, potato or

  13   wheat which are common allergens.

  14             This type of labeling can have serious

  15   ramifications to individuals with food allergies

  16   and celiac disease.  I along with many other

  17   individuals who have food allergies urge the FDA to

  18   require manufacturers to list all the ingredients

  19   including trace amounts.

  20             As a first step, my recommendation would

  21   be to simply add a line after the words "modified

  22   food starch natural."  Instead of modified food

  23   starch or garlic oil rather than spices.  In

  24   Europe, they specify yes or no gluten and have a

  25   sign in front of the package similar to that of a 
                                                                189

   1   no-smoking sign except that it shows a grain stalk

   2   with a slash through and says no gluten.

   3   Ultimately labeling of this would be optimal.

   4             In terms of possible environmental

   5   consequences, none really.  Economic impact, this

   6   may result in some burdens to manufacturers in

   7   coming out and researching this, back tracing, but

   8   it should also be noted that this may help attract

   9   more customers who can discover that these foods

  10   are ultimately safe.  Thank you.

  11             [Applause.]

  12             DR. LEWIS:  Thank you.  Next, Cliff

  13   Blaker, to be followed by Jorge Hernandez Baez.

  14             MR. BLAKER:  Hi.  My name is Cliff Blaker.

  15   I'd like to thank the FDA for the opportunity to

  16   participate in this hearing today and to express my

  17   comments.  I'm speaking as a private individual, as

  18   the father of a 14 year old boy with celiac

  19   disease.  I own a construction business in New York

  20   City, and I've taken the day off and made the trip

  21   to Washington today because I feel that improved

  22   food labeling is absolutely critical.

  23             Lives depend on what is being discussed

  24   here today.  I know that this hearing is not

  25   targeted at celiac concerns.  I do hope that in the 
                                                                190

   1   near future, the FDA will focus specifically on

   2   celiac disease recognizing that there are a million

   3   celiacs in the United States and acknowledging that

   4   the U.S. lags behind many other countries in

   5   identifying individuals who suffer from this

   6   disease and accommodating their dietary

   7   restrictions.

   8             I agree with what Ms. Munoz-Furlong had

   9   said earlier, that once a system is in place to

  10   address the eight key allergens that have been

  11   identified today, it will be possible to add other

  12   potentially harmful ingredients to that list in the

  13   future.

  14             Many of the comments that I wanted to make

  15   today I will not make because the points I wanted

  16   to make have been made so clearly by some of the

  17   panel participants and some of the speakers who

  18   have spoken before me.

  19             As a private individual, there's just a

  20   few things I would like to say.  I think it's

  21   critical that the name of the allergen be

  22   identified in plain English.  I don't think there

  23   should be any exemptions for allergens from

  24   ingredient lists.  I think that labeling needs to

  25   be consistent where the concerned consumer always 
                                                                191

   1   has one place to go to look for the information on

   2   the product label.

   3             Now, there is one area where I think my

   4   experience as a businessman makes me an expert and

   5   that's the talk about voluntary compliance rather

   6   than mandatory compliance.

   7             Now, I think the voluntary efforts that

   8   have been spoken about today should be applauded,

   9   but they cannot really eliminate potential

  10   problems.  Some companies will be more proactive

  11   than others, but there will always be companies

  12   that will drag their feet and not comply.

  13             It's the nature of industry to resist

  14   regulation and to minimize costs.  What we have

  15   here is a balance between cost and public health

  16   and it's the FDA's mandate to decide in favor of

  17   public health.

  18             When statements were made about advisory

  19   labeling with the "may contain" wording, I think

  20   that what was identified as unavoidable

  21   cross-contamination in many cases really means

  22   contamination that's too difficult to avoid or too

  23   expensive to eliminate.  Again, I think it's the

  24   FDA that has the responsibility to protect the

  25   public and not leave these critical decisions up to 
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   1   individual companies to make, and I urge the FDA to

   2   keep that in mind.

   3             Thank you.

   4             [Applause.]

   5             DR. LEWIS:  Thank you.  Next Jorge

   6   Hernandez Baez, followed by Gustavo Trevino.  Mr.

   7   Baez, Mr. Trevino?  Martin Shunemann.  Anne Bailey.

   8   Mary Thorpe.  Mary Thorpe will be followed by Anne

   9   Clarke.

  10             MS. THORPE:  My name is Mary Thorpe.  I'm

  11   currently working at the Center for Celiac Research

  12   at the University of Maryland Baltimore, and I'm

  13   also representing myself as a person who is

  14   attempting to follow a gluten-free diet and thus a

  15   wheat free diet.

  16             And as such, I can speak for other celiacs

  17   around the country.  I would just like to focus on

  18   some of my frustrations in following food labels

  19   that haven't been touched on very well.  Gayle

  20   Rubin mentioned secondary sources, and reading

  21   labels myself I notice that some cans of tomato

  22   paste list wheat flour as an ingredient.  Don't ask

  23   me why it has to be there, but it is.

  24             And then when I look at a jar of spaghetti

  25   sauce of barbecue sauce, it has tomato paste as an 
                                                                193

   1   ingredient, I'm left to wonder does that tomato

   2   paste have wheat flour in it or not.  Sometimes you

   3   might see a parentheses that tells the ingredients

   4   in that secondary ingredient, but usually you do

   5   not.  And that's something I haven't heard touched

   6   on very much.

   7             So this indicates that some manufacturers

   8   are voluntarily doing this, but others are not.

   9   The same thing goes for soy sauce.  Again, soy

  10   sauce has wheat in it most of the time.  When soy

  11   sauce is a secondary ingredient, you don't know.

  12   So we have to avoid these things unless the

  13   labeling were there.

  14             And I think that's what we'd like to ask

  15   for today is that the labeling be there so that we

  16   know and can make the choices for these sources of

  17   things.  There are many products.  Somebody just

  18   mentioned modified food starch.  This is a question

  19   mark.  You don't know the source of the food

  20   starch.

  21             Some manufacturers are voluntarily saying

  22   modified corn starch so we can make an informed

  23   choice, but we'd like to see everybody doing that.

  24   Or say modified wheat starch if that's what it is.

  25   But just let us know. 
                                                                194

   1             There are other products like citric acid,

   2   MSG, stabilizers, monodiglycerides, dextrines, that

   3   can be made from different sources--corn, sugar or

   4   wheat--and we would like to know the source for

   5   those properties.  All you have to do is put it in

   6   parentheses--(from wheat)--for each one.  It

   7   wouldn't take up much space.

   8             Alcohol and vinegar are controversial, but

   9   they may have wheat origins.  There should not be

  10   protein products in those substances, but there

  11   might be.  Some people are explicitly sensitive.

  12   We don't know the threshold of tolerance and so not

  13   knowing, we'd rather err on the side of safety.

  14   And just let us know what the source is so we can

  15   make our informed choice.

  16             So whether it comes down to voluntary

  17   compliance by manufacturers or FDA codification, I

  18   would agree with many who would say that the

  19   manufacturers are trying, but we're still not there

  20   yet.  It's been excruciatingly slow, and we'd like

  21   to see whatever is needed to speed up the process.

  22   We would hope the regulations wouldn't slow it

  23   down, but we just want it to be done.  Thank you.

  24             [Applause.]

  25             DR. LEWIS:  Thank you.  Next is Anne 
                                                                195

   1   Clark, to be followed by Esah Yip.

   2             MS. CLARK:  Good afternoon.  My name is

   3   Anne Clark.  The FDA has made the presence of

   4   allergens in food high priority.  This is a good

   5   thing.  Labeling food that contains peanut or tree

   6   nut allergens is a very good thing.

   7             Labeling food that has or may have been

   8   handled with natural rubber latex gloves is not an

   9   acceptable solution or labeling as contains or may

  10   contain the incidental food additive allergen NRL.

  11   Currently natural rubber latex, or NRL, is approved

  12   by the FDA as an indirect food additive in light of

  13   the over 500 NRL lawsuits working their way through

  14   the American justice system concerning wrongful

  15   death, product liability, workmen compensation, and

  16   American with Disabilities accommodation.

  17   Manufacturers of NRL gloves have already begun the

  18   labeling process.

  19             Standard wording reads something like this

  20   one:

  21             In the unlikely event of an allergic

  22   reaction to these latex gloves, discontinue use and

  23   consult your health care provider.  Caution: this

  24   product contains natural rubber latex which may

  25   cause allergic reaction.  Great for food handling.  
                                                                196

   1   It says that on there.  This product meets the U.S.

   2   Department of Agriculture specifications for food

   3   handling.

   4             Now, I have seen and submitted to the USDA

   5   advertisements for NRL gloves which claim to be

   6   USDA approved and USDA accepted.  I've been told by

   7   the USDA that they do not approve products.  There

   8   is no such thing.

   9             These gloves which I purchased contain a

  10   warning, a label, that really disturbed me.  Some

  11   individuals may experience an allergic reaction to

  12   natural rubber latex products.  Discontinue use if

  13   any reddening, burning or irritation is

  14   experienced.  This manufacturing company will not

  15   be liable to individuals who experience allergic

  16   reactions to natural rubber latex.

  17             Now, this manufacturer understands that

  18   their product can harm.  Those of us who have

  19   experienced or witnessed someone having an allergic

  20   reaction to food handled by latex gloves understand

  21   these gloves can harm.  There are safe, affordable

  22   alternatives.  The allergens that are transferred

  23   on to food do not add to the nutritional value,

  24   preservation or flavor enhancement of the food.

  25             This is important.  We know of no way with 
                                                                197

   1   current scientific knowledge to determine a protein

   2   threshold level that would be safe for all users

   3   and would not trigger any allergic reaction to NRL.

   4             Furthermore, the current FDA food code

   5   alerts the food service industry of the potential

   6   for serious adverse reactions from latex to latex

   7   sensitive individuals.  Gloves made of NRL must be

   8   declared an unsuitable utensil for food handling.

   9   NRL approval must be amended so that gloves made of

  10   NRL are not an approved indirect food additive.

  11   Labeling in this instance is not the solution.

  12   Thank you.

  13             DR. LEWIS:  Esah Yip or Anita Klein?

  14   Next, Carol Roberts.  Carol Roberts is here.

  15             MS. ROBERTS:  My name is Carol Roberts.

  16   I'm a 62 year old grandmother who has had many

  17   allergies to deal with most of my life underlined

  18   by celiac, but I'm not going to speak to that today

  19   at all.  I'll send some information in.  I would

  20   like to make a very simple suggestion and as I read

  21   through all three areas, and as I know that I've

  22   experienced just about every single one of the

  23   things that have come up in one way or another, I

  24   used to teach school, elementary school, and I used

  25   to be an elementary school principal, and I've 
                                                                198

   1   worked in the corporate world and done diversity

   2   training and done many things.

   3             But what I thought about is we have a lot

   4   of people in this country who don't speak English.

   5   We have a lot of people in this country who don't

   6   know how to read.  We have a lot of people in this

   7   country who don't have any knowledge whatsoever

   8   about what hydrolyzed protein or caseinate or any

   9   of these things are.

  10             And I proposed a question to one of the

  11   panelists before who is not here about the

  12   integrity of whether or not if a person is

  13   allergic, say, to eggs, will they be allergic or

  14   sensitive to any byproduct from eggs?  The answer

  15   was yes.  And so, therefore, why do we need any

  16   other words except "eggs" on a label in terms of

  17   food being contained?

  18             What I did was take a little bit of time

  19   and I used pictorial chart.  And this is just an

  20   idea and a suggestion of taking the different food

  21   allergens of the eight allergies and I took and did

  22   a diagram of each one of them that's understandable

  23   by children.  In the next column, I put the

  24   contains fish or seafood, listing the types,

  25   contains wheat or byproducts in words, and listing 
                                                                199

   1   all of the different names.

   2             The symbols can have checks through them,

   3   next to them, into them, whatever would make the

   4   most sense and be least confusing to those who

   5   looked at a label.  So each one of these things in

   6   terms of the terminologies that have been developed

   7   by each of the groups that are working on this

   8   could be incorporated into a glossary, put into a

   9   simple pamphlet.

  10             These charts could be done in such a way

  11   that you have them in a very organized simple way.

  12   They could be laminated, put into posters, put into

  13   grocery stores, hospitals, nursing homes, anywhere

  14   where anyone is affected by these kinds of things

  15   in terms of it.

  16             In terms of signaling where they go, using

  17   caution, yellow label--everyone knows yellow is

  18   caution--put it there right on the label right

  19   there and put the words in there with a little

  20   picture that says what it is, or use a stop sign,

  21   which is also a universal safety sign which

  22   children understand, so that if anyone just picks

  23   up that product, they know that they need to go and

  24   look at information on that label.

  25             And so I would just suggest a very simple 
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   1   adage like this to be able to simplify it down.

   2   You've got eight allergens.  Use those eight words.

   3   We really don't need all the rest of them.

   4   Manufacturers could help by leaving a lot of

   5   products out of--a lot of these additives and so on

   6   out of their products in the first place and let's

   7   get back to basics and good nutritional food.

   8             [Applause.]

   9             DR. LEWIS:  Thank you.  Next, Rebecca

  10   Dugal, and following Rebecca Dugal, Anne Whelan.

  11   Rebecca Dugal.  I take it this is Rebecca Dugal.

  12             MS. DUGAL:  This is Rebecca Dugal.  I just

  13   wanted to say a few words while she's getting set

  14   up.  We have some slides.

  15             DR. LEWIS:  Please continue.

  16             MS. DUGAL:  I wanted to thank the FDA for

  17   hosting this panel.  I think it's wonderful that

  18   we're kind of moving along with food labeling and

  19   to all of the panel participants.  I also wanted to

  20   thank my daughter for urging us to come and for not

  21   letting up on me in terms of making sure we could

  22   make the trip down here from New Jersey and help

  23   her with her presentation.  This is something

  24   that's very important to her since she was about

  25   four in terms of being able to read the labels and 
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   1   be in control of her own situation.

   2             When she used to go to play dates, even

   3   where the people were trained to read the labels,

   4   she would say can you read it to me so I can hear

   5   it because there are some words I need to know,

   6   that I know to look for.  It's also important in

   7   terms of not the people who are only food allergic

   8   and their caretakers, but all of her friends who

   9   want to be able to sit with her or provide her

  10   snacks, and it's very difficult when they're trying

  11   to make the effort to be nice and to be inclusive

  12   to say, well, you don't really understand.  There

  13   are ten scientific terms you have to look for.  So

  14   don't bother, we'll take care of it.

  15             And here's Becky.

  16             MS. REBECCA DUGAL:  Hi.  I'm Rebecca

  17   Dugal.  I live in Allendale, New Jersey.  I'm

  18   entering fourth grade at nine and a half.  I have

  19   anaphylaxis to peanuts, peas and lentils.  I'm also

  20   allergic to wheat, eggs, apples and tomatoes.  I

  21   believe that people need to be able to read labels

  22   very easily.

  23             Living with food allergies and labels is

  24   hard.  It's difficult in general to go places and

  25   do things where food is involved.  Most people 
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   1   can't read the labels for peanut allergens unless

   2   my parents have trained them.  All the different

   3   names for peanuts make it confusing.  Ingredient

   4   labels are hard to read since they are small and

   5   have many scientific names such as hydrolyzed

   6   vegetable protein.

   7             People for whom English is not a first

   8   language and children have a particularly hard

   9   time.  Even if my parents read the labels, they are

  10   never sure whether there will be

  11   cross-contamination since only some manufacturers

  12   use "may contain traces of."

  13             Most adults I am with prefer just not to

  14   give me food.  I cannot eat at play dates because

  15   of the labels.  Snack times at school and camps are

  16   very stressful since we can't trust the labels.

  17   It's scary to try new food since we never know if

  18   cross-contamination is involved.

  19             Since the labels aren't clear, I don't eat

  20   many foods I may be able to eat.  Babysitters are

  21   difficult to trust with reading labels.  My peanut

  22   allergic friends and I have reacted to seemingly

  23   non-allergic foods where the labels have not been

  24   clear cross-contamination exists.

  25             Breads, candies, baked goods, other nuts 
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   1   and snack foods are some of the foods I have just

   2   described.  As a result, I don't eat many

   3   manufactured products in these categories since I

   4   don't want to take the chance of having a reaction.

   5             Food labels should be made readable.

   6   Mistakes can have serious outcomes.  There needs to

   7   be a consistency in the use of "may contain" and

   8   "manufactured in a faculty containing."

   9             Lettering should be large enough to read

  10   easily.  Highly allergic foods should be listed

  11   separately and not included in flavorings, spices,

  12   colorings.

  13             Symbols should be used for the eight most

  14   commonly allergic foods in addition to the actual

  15   ingredients.  Symbols would be easy to implement

  16   and make labels more understandable.  Foods would

  17   be easily identified as containing one of the eight

  18   allergens.  Symbols would inform the consumer to

  19   read the detailed ingredient list more carefully.

  20             Non-English speakers and children would be

  21   able to use the symbols easily.  Training of

  22   non-allergic adults would be simple and they would

  23   have confidence in knowing whether a food is

  24   dangerous.  Standardized symbols would reduce the

  25   risk of mistakes and horrible reactions. 
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   1             Simple symbols will be the easiest to

   2   recognize and take up less space than words.  Here

   3   is an example of the peanut symbol and wheat

   4   symbol.

   5             The next steps you should take: you should

   6   aggressively pursue the use of standard symbols;

   7   make font symbol size large enough to read easily;

   8   agree on a standard use of "may contain" statements

   9   always with the eight most commonly allergic foods

  10   separately; educate the manufacturers and

  11   consumers; and review labeling of cosmetics,

  12   medicines and in restaurants, including food

  13   service packages.

  14             You can help make my allergies easier to

  15   cope with.  Thank you.

  16             [Applause.]

  17             DR. LEWIS:  Thank you very much, Rebecca,

  18   and to her mom as well.  Next is Anne Whelan, who

  19   would be followed by Colleen Parr, if she's here.

  20   If not, Leila Leoncavallo.

  21             MS. WHELAN:  Good afternoon.  My name is

  22   Anne Whelan and for the last six years I have

  23   published Gluten-Free Living, a national newsletter

  24   for people who like myself are gluten sensitive.

  25             Without going into the details of the 
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   1   disease, as you know, it has a cure, the gluten

   2   free diet, using cure in the sense of remission as

   3   long as there is no gluten in the diet.  There is

   4   no true for celiac disease in the sense of a

   5   complete resolution.  Once a celiac, always a

   6   celiac.

   7             At diagnosis, we are advised to follow a

   8   life long gluten-free diet.  Gluten is found in

   9   wheat.  In fact, wheat is probably the main source

  10   of gluten for American celiacs.  It's also found in

  11   rye, barley and derivatives of these grains.  Wheat

  12   is far and away the most problematic because wheat

  13   seems to be everywhere in this country and to be

  14   found in the vast majority of American foods.

  15             For the record, barley, too, can be

  16   difficult.  Rye is relatively easy to avoid.  We

  17   have to become proficient at reading labels and as

  18   we've all learned this morning, that is not easy.

  19   The best case example where wheat is concerned is

  20   modified food starch.  We would like to see

  21   modified wheat starch, modified corn starch.

  22             In this area, another issue that comes up

  23   for celiacs is spelt.  Spelt, kamut, and triticale,

  24   or triticale, are three less common grains that

  25   celiacs have to avoid.  Only spelt is problematic.  
                                                                206

   1   In plain language, spelt is a form of wheat.  It

   2   may not bother some of those who are allergic to

   3   wheat, but it does bother those who are sensitive

   4   to wheat.

   5             Some food processors now label foods that

   6   contain spelt as wheat free, and sometimes even as

   7   gluten free.  Neither term is correct and it should

   8   not be permitted as it is misleading and dangerous.

   9   It relates here because of the inclusion of wheat

  10   on the list of allergens, and the understanding,

  11   which may not be universal, that spelt does not

  12   have the allergenic potential that wheat does.  So

  13   spelt should be labeled as spelt, and a product is

  14   not wheat free or gluten free if it contains spelt.

  15             I think specific source or plain English

  16   terms should be mandatory, not voluntary, for all

  17   the good reasons that we've heard this morning.

  18             The phrases "made on shared equipment" or

  19   "made in a dedicated facility" are a little

  20   different.  To a celiac, "dedicated" would mean

  21   gluten containing products are not processed in the

  22   same facility.  And "made on shared" would mean

  23   shared referring to gluten-containing products.  To

  24   a certain extent, those are helpful to us.  They

  25   don't tell us about gluten content, but they do 
                                                                207

   1   tell us about contamination, and celiacs are

   2   particularly interested in contamination because

   3   the effects of gluten can be cumulative.

   4             Helpful those these phrases may be, they

   5   should not substitute for disclosure.  Celiacs have

   6   long hoped for source declarations of the contents

   7   of flavoring, spice or color.  They're three of the

   8   main ingredients that make us uneasy.  I think

   9   there should be a generally applicable policy in

  10   this area.  I know with flavorings that the problem

  11   of trade secrets is sticky.  Processors should be

  12   able to keep their secrets secret.  That's what

  13   celiacs hear when they call a food processor to

  14   find out what's in it.

  15             At the same time, we should be able to

  16   know what's in our foods and to fill comfortable

  17   about the foods that we eat.

  18             In conclusion, the celiac community is

  19   thankful for the opportunity to speak here and

  20   looking forward to working with the FDA and with

  21   the other groups on better labeling for people who

  22   are celiac.  I would like to thank the FDA, the

  23   CPSI, and particularly the FAAN for all they have

  24   done in the wheat area which helps us enormously.

  25   Thank you very much. 
                                                                208

   1             [Applause.]

   2             DR. LEWIS:  Thank you.  I believe Colleen

   3   Parr is no longer with us and will not be speaking.

   4   You are here?  Is this Colleen Parr?

   5             MS. LEONCAVALLO:  No, I'm Leila

   6   Leoncavallo.

   7             DR. LEWIS:  You're Leila Leoncavallo.

   8             MS. LEONCAVALLO:  Leila Leoncavallo.

   9   Before I begin, I just want to disclose that I am a

  10   former employee of CSPI, but today I'm here solely

  11   representing myself and my daughter who is three

  12   years old and suffers severe allergies to both

  13   peanuts and shellfish.

  14             I would just like to focus my remarks on

  15   the issue of precautionary labeling.  And I

  16   certainly support good manufacturing practices to

  17   clean up the factories as much as possible to

  18   ensure that allergens are eliminated or reduced,

  19   but at the same time I think that it is still

  20   imperative that labeling occur even in instances

  21   where the factory is cleaned, because I want to

  22   make those decisions for my daughter.

  23             We just heard Ms. Katic state earlier that

  24   cleaning will not succeed in removing all

  25   allergens.  We've also seen numerous instances of 
                                                                209

   1   food recalls where presumably large companies or

   2   companies that presumably would be cleaning up the

   3   allergens from their machines shouldn't be having

   4   to recall their foods after the contamination takes

   5   place.

   6             For example, Kellogg's--this is a company

   7   that does not label foods on shared equipment and

   8   presumably employs good manufacturing

   9   practices--they had two major recalls in the past

  10   year.  And I don't want my daughter to be a guinea

  11   pig to find out when food is safe and when it's not

  12   safe.  I want to see the label in place in addition

  13   to the good manufacturing practices by all these

  14   companies.

  15             I know a lot of people have expressed

  16   concerns with the issue of reducing food choices.

  17   My daughter's food choices are already reduced.  I

  18   have to call all of these companies to find out

  19   whether this is on dedicated equipment or not.  Her

  20   choices are reduced.  I just want her to have safe

  21   food choices.  I don't think that having voluntary

  22   guidelines is going to make a bit of difference.

  23   It has to be regulated.

  24             The label must be readable and it must be

  25   reliable.  As many people have mentioned today, 
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   1   children are having to read the label, caretakers

   2   are having to read the label, family members are

   3   having to read the label, and it's impossible to

   4   fully educate people as to what terms to look for

   5   or where to look for on the label unless it is

   6   regulated and reliable and easy to read.

   7             Labeling must be mandatory or the

   8   situation will simply be no different than the

   9   status quo.  We will still need to call companies

  10   to get this information.  This method is not only

  11   time consuming and frustrating, but it's often

  12   unreliable, and I just want to share a couple of

  13   examples from my experiences in talking to

  14   companies, and these are not just small companies.

  15   These are major companies that you think would know

  16   better.

  17             I have a letter from April 2001 from

  18   Quaker responding to whether or not their Quaker

  19   Life cereal is safe for my daughter to consume,

  20   whether it's made on dedicated lines, and they say,

  21   and I quote: "Although we would like to help you

  22   find products that meet your special dietary needs,

  23   we are not able to provide the information you

  24   requested.  Unfortunately, the federal labeling

  25   laws are not designed to indicate the presence of 
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   1   peanuts."

   2             Then I have this.  These are notes from my

   3   conversation with Kellogg's when I inquired about

   4   their labeling policies.  They say for their

   5   cereals, you must look under the "best before date"

   6   for these letters, B, L or S.  If it says K, it's

   7   not a nut-free plant.

   8             Their regular and Double Chocolate Rice

   9   Krispie Treats are on dedicated lines but not in

  10   nut free plants.  If I could just continue.

  11   Scotchie and Caramel Rice Krispie Treats are on the

  12   same line as peanut butter.  Pop Tarts could be

  13   made on the same line.  Nutragrain Bars and Twists

  14   are made in a nut-free plant.  Nutragrain Squares

  15   are on dedicated lines, but not in nut-free plant.

  16   Pancakes are in a nut-free plant, but waffles are

  17   not in a nut-free plant, and you must call every

  18   six weeks to verify.

  19             [Laughter.]

  20             MS. LEONCAVALLO:  Given this, I just don't

  21   know how we can rely upon any type of voluntary

  22   system, and I think if we have voluntary guidelines

  23   in place, great, you know, that's one step forward,

  24   but I'm still going to have to call the companies,

  25   and I'm still going to get the same responses.  
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   1   Thank you.

   2             [Applause.]

   3             DR. LEWIS:  Thank you.  The next on our

   4   list is Andrew Finkeistein.  And following Andrew

   5   Finkeistein would be Daniel DuBravec.

   6             Are either of those prepared to present?

   7   Is this Daniel DuBravec?

   8             MR. DuBRAVEC:  Dan DuBravec.

   9             DR. LEWIS:  Please go ahead.  Following

  10   Daniel DuBravec will be Lise Borel.

  11             MR. DuBRAVEC:  Hi.  I'm Dan DuBravec.

  12   I've been a chairperson for the CSA USA, the Celiac

  13   Sprue Association, for about six years in Boston

  14   and now in Northern Virginia.

  15             And again I appreciate you forming this

  16   panel and allowing us to speak and I think it's

  17   also great that there are so many people, you know,

  18   representing the Celiac Sprue and bringing up our

  19   cause.  I've been taking notes kind of through the

  20   session here, and these are some of the statements

  21   I've heard today:

  22             "Is looking into," "starting baseline

  23   surveys," "suggesting guidelines," "encouraging

  24   members to declare," "devoting energy to," "needs

  25   to look into further," "contemplating issue," 
                                                                213

   1   "looking at practices," "area that needs

   2   attention," "struggling with for decades."

   3             My main point I want to get across is that

   4   I think the time is now for the mandatory food

   5   labeling.  I think the opportunity for voluntary

   6   labeling has been there and there has been some

   7   effort, but as you've heard from so many people,

   8   it's just not there.  And I think the time to act

   9   for is now.

  10             And as a chairperson, I speak to people

  11   all the time.  I've spoken to hundreds that are on

  12   the wheat-free/gluten-free diet, and, you know,

  13   they're always asking me what I can eat, and we try

  14   to, you know, we contact the manufacturers and we

  15   also get information from them.  You know it's

  16   information that they often do have and one area

  17   and concerning cross-contamination, and I'm not

  18   sure was addressed, but it probably included, was

  19   the part concerning packaging.

  20             You know we thoroughly look at labels, and

  21   we go in the frozen food department and we pick up

  22   a package of frozen broccoli, let's say.  Now, it

  23   could say it contains broccoli, right, and water.

  24   You would never assume or even think that in

  25   packaging that it may be dusted with flour, but 
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   1   that does happen, and in terms of--I mean I have a

   2   sheet right here telling me that.  You know I came

   3   in.  I was just so shocked, and I had been with CSA

   4   for a long time, and this was even surprising to me

   5   that, you know, just buying frozen vegetables that

   6   I have to be cautious about that.

   7             So I, you know, mandatory labeling,

   8   please.  And, you know, "may contain," even though

   9   it may eliminate many products that may or may not

  10   contain it is very helpful for people who are on

  11   such a sensitive gluten-free diet.  Thank you.

  12             [Applause.]

  13             DR. LEWIS:  Thank you.  Next would be Lise

  14   Borel.  And if Lise Borel is not here, I understand

  15   Wendy Reinhardt will be substituting for Dave

  16   Schmidt.

  17             MS. REINHARDT:  Hi.  My name is Wendy

  18   Reinhardt.  I'm with the International Food

  19   Information Council Foundation, and just a quick

  20   note, as we consider many ways to try to make food

  21   allergy more understandable for consumers.  The

  22   International Food Information Council would like

  23   to make everyone aware of our foundation resources

  24   which are informational resources on food allergy.

  25   Particularly outside you can get a copy of our 
                                                                215

   1   latest IFIC Review: Understanding Food Allergy,

   2   which is a reference white paper for opinion

   3   leaders.

   4             And you can also get a copy of our

   5   consumer brochure, Understanding Food Allergy,

   6   outside.  These resources as well as many other

   7   resources related to food allergy are available

   8   outside and then also on our website, ific.org.

   9   Thanks.

  10             [Applause.]

  11             DR. LEWIS:  Thank you.  Next on our list

  12   is Jerry Shier.  And following Jerry Shier would be

  13   Kimberly Scott.

  14             DR. SHIER:  Good afternoon.  I'm Jerry

  15   Shier.  I'm a board certified allergist

  16   immunologist in private practice in Rockville and

  17   Silver Spring, Maryland, as well as an Assistant

  18   Clinical Professor at George Washington University

  19   School of Medicine.

  20             Today, I'm representing the American

  21   Academy of Allergy, Asthma and Immunology.  This is

  22   the largest academic organization in the United

  23   States representing physicians who care for

  24   individuals with allergic diseases.  Food allergy

  25   is of great concern to the Academy, so much so 
                                                                216

   1   there's a special academic section within the

   2   organization to further its members' education,

   3   monitor research, and create treatment guidelines.

   4             There are approximately six to seven

   5   million Americans with true food allergy, with

   6   children being the largest group.  Food allergy is

   7   the leading cause of anaphylaxis outside the

   8   hospital.  Anaphylaxis is a full-bodied allergic

   9   reaction that can occur in minutes.  Symptoms

  10   including hives, welts on the skin, asthma like

  11   symptoms, gastrointestinal symptoms, cramping,

  12   diarrhea, bloody stools, swelling of the lips, eyes

  13   and tongue.

  14             An estimated 200 deaths occur each year

  15   from anaphylaxis from foods.  There are

  16   approximately 30,000 emergency room visits from

  17   food allergic reactions.  In my practice, I hear

  18   about food allergic reactions on a daily basis.

  19   Since there is no cure, the physician's goal is to

  20   teach the patient how to recognize and manage an

  21   allergic reaction.

  22             But more important is preaching strict

  23   food avoidance.  Part of the avoidance is vigilant

  24   label reading.  The subject of label reading is why

  25   we're all here today.  I have no other treatment 
                                                                217

   1   recommendations other than avoidance.  In the case

   2   of asthma, another common allergic disease, I can

   3   preach avoidance of airborne allergens, but I also

   4   have numerous medicines to prevent the symptoms,

   5   medicines to treat active symptoms, and a method

   6   to desensitize patients to allergens that

   7   precipitate their symptoms.

   8             It's clear from this comparison to other

   9   allergic diseases that the consumer's ability to

  10   identify food allergens is their only treatment

  11   because the use of medicine is not the treatment of

  12   food allergy, it is the treatment of either an

  13   accidental or unknowing exposure that led to an

  14   acute, potentially life threatening allergic

  15   reaction.

  16             Our goal should be to prevent this from

  17   occurring.  The American Academy of Allergy,

  18   Asthma, Immunology is in full support of the easy

  19   identification of the most common food allergens on

  20   all labels.  These include milk, egg, wheat, soy,

  21   tree nuts, peanuts, fish and shellfish.

  22             What do I mean by easy identification?

  23   Let consumers know that these allergens are in the

  24   products they are purchasing by using the real name

  25   of the food: milk, egg or wheat, not casein, 
                                                                218

   1   ovalbumin or farina.  This should not be Russian

   2   Roulette.  The FDA must make it mandatory that

   3   major food allergens appear on labels if they are

   4   used as an ingredient in a way that our food

   5   allergic patients can easily identify the allergen.

   6             What does "ingredient exempted from

   7   declaration" mean?  If the food allergen is in a

   8   processed food, what's labeled as such.  Major

   9   allergens are found in ingredients labeled as

  10   flavoring or spices or colors.  Low levels of

  11   allergens can be responsible for an allergic

  12   reaction which sometimes can be life threatening.

  13             Please just let me finish.  The FDA needs

  14   to require food manufacturers to place the names of

  15   major food allergens on labels regardless of the

  16   amount.

  17             Finally, I applaud the companies that have

  18   voluntarily instituted labeling that a major food

  19   allergen may be present, even though it's not a

  20   known ingredient.  This is usually due to the use

  21   of shared equipment to produce a food that does and

  22   one that does not have a food allergen.

  23             Unfortunately, there are companies now

  24   that have been begun labeling foods as having major

  25   allergens, purely on a liability basis, versus a 
                                                                219

   1   true risk.  In addition, there is no uniformity on

   2   how the information is presented.

   3             The American Academy looks to the FDA to

   4   create standards for the food industry's proper use

   5   of these statements and consistent verbiage of

   6   these statements so that we can educate our

   7   patients.

   8             In conclusion, although I sit here today

   9   representing a large body of health care providers,

  10   I can tell you first hand that labeling systems

  11   need fixing, and that there are many Americans,

  12   especially parents of children, that have a fear

  13   that is indescribable, a fear of food that can be

  14   paralyzing.

  15             The solution appears simple.  If the major

  16   food allergen is present, label it so we can all

  17   understand it.  If there is a real contamination,

  18   then label it in a uniform way.  The food allergic

  19   individual is already restricted from eating

  20   outside the home because it's so difficult to

  21   identify all the ingredients and the potential for

  22   cross-contamination in restaurant foods.  So let's

  23   make eating at home safe for those with potentially

  24   life threatening conditions.  Thank you.

  25             [Applause.] 
                                                                220

   1             DR. LEWIS:  Next is Kimberly Scott, to be

   2   followed by Sarah Gitlin.

   3             MS. SCOTT:  Good afternoon.  My name is

   4   Kimberly Johnson Scott, and I appreciate this

   5   opportunity to provide oral comments on allergen

   6   related labeling issues.  Today I am speaking both

   7   as a mother of Sidney Scott, our energetic 21 month

   8   old, and as the co-founder of the SOS Foundation.

   9             On March 27 of this year, my husband and I

  10   were shocked to learn that our daughter Sidney had

  11   a life-threatening allergy to peanuts, tree nuts

  12   and eggs.  In a moment, the security we had

  13   previously felt in selecting food for our family

  14   evaporated into thin air.

  15             The exact same labels upon which we had

  16   previously relied and which as parents we found

  17   reassuring suddenly took on a potentially life or

  18   death prominence in our household.  Questions

  19   replaced confidence.

  20             What does it mean when "contains peanuts"

  21   isn't on the label, but "natural flavorings" is?

  22   Did I read over those ingredients with 15 syllables

  23   in it and did not recognize that it was an egg

  24   protein because I didn't see the word "egg"?  Why

  25   would the label say "may contain nuts" when I read 
                                                                221

   1   the label ten times and I didn't see nuts anywhere?

   2             While devoting time to reading food labels

   3   clearly and deliberately is a small sacrifice to

   4   make for those we care about, we need the FDA to

   5   help empower parents by requiring clear and

   6   comprehensive labeling of products.  Through our

   7   desire to help our daughter and other similarly

   8   situated families, my husband Stuart and I have

   9   co-founded the SOS Foundation, a not-for-profit

  10   organization which has pledged financial, emotional

  11   and practical support to those who struggle to meet

  12   the challenges of living with a chronic condition.

  13             In order to help improve the lives of

  14   individuals with food allergies, SOS will serve as

  15   an additional vehicle to advocate for accurate food

  16   labeling, practical food labeling legislation,

  17   effective research and increased awareness.  In the

  18   coming year, the SOS Foundation will join forces

  19   with organizations and individuals who have long

  20   dedicated themselves to this effort.  We hope to

  21   work in partnership with the FDA in bringing

  22   together industry, consumer, medical and scientific

  23   groups for the purpose of better educating the food

  24   industry and enhancing the level of public

  25   awareness of the public health risk of incomplete, 
                                                                222

   1   inaccurate, inconsistent, and incomprehensible

   2   labeling of food products.

   3             I would like to briefly comment on the

   4   specific matters under consideration at this

   5   meeting.  A condition such as anaphylaxis is

   6   unpredictable enough without the added stress of

   7   trying to decipher food labels.  Plain English in

   8   the labeling of food ingredients is critical to

   9   empowering individuals to take control of their

  10   condition, restoring a certain amount of

  11   independence and equally as important is the power

  12   and freedom it gives to friends and relatives of

  13   non-food allergic individuals to make responsible

  14   selection of food items to share with or entertain

  15   their food allergic friends and relatives as will

  16   responsible use of advisory labeling.

  17             When a food company manufactures five

  18   products without nuts but also manufactures one

  19   with nuts, and places advisory labels on all six

  20   products, this greatly reduces the already limited

  21   choices of those who are searching for a list of

  22   can haves in a world of cannot haves.

  23             Finally, we must realize that listing the

  24   major food allergens must not be limited to those

  25   found in significant amounts, but also extend to 
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   1   those found in trace amounts.  This boils down to

   2   an issue of trust.  Can I trust what is on the food

   3   label is actually what's in the product?

   4             With that trust comes the opportunity to

   5   regain the power to monitor and maintain one's

   6   health to the best of their ability until the day a

   7   cure is found.  This is a chance to be free of the

   8   agonizing choice of whether to risk an anaphylactic

   9   reaction every time you take a bite.

  10             With the FDA's help, we have before us the

  11   opportunity to release those who suffer from this

  12   condition from a food prison so that they may not

  13   just eat to live, but that they may also eat and

  14   live.  I thank you for this opportunity.

  15             [Applause.]

  16             DR. LEWIS:  Next will have Carol Schrager.

  17   Sarah Gitlin, first.  Sarah Gitlin is here.

  18             MS. GITLIN:  Good afternoon.  My name is

  19   Sarah Gitlin.  I am ten years old.  I am deathly

  20   allergic to peanuts, tree nuts and fish.  When I

  21   learned to read, five years ago, in kindergarten, I

  22   started with Dr. Seuss, Mother Goose, and

  23   ingredients labels.

  24             [Laughter.]

  25             MS. GITLIN:  I knew that Dr. Seuss and 
                                                                224

   1   Mother Goose wouldn't lie to me, but ingredients

   2   labels, I couldn't be so sure.  I have to be able

   3   to trust these labels.  For if I eat something I'm

   4   allergic to, even a tiny trace of it, and couldn't

   5   get proper treatment, I could die within minutes.

   6             I try very hard only to eat what I know is

   7   safe, not to risk it if the food might contain

   8   anything I'm allergic to.  But who would guess that

   9   a common popcorn brand would use the words "natural

  10   flavors" to mean peanuts?  And who would guess that

  11   the words "vegetable protein" and "plant protein"

  12   would be food companies' code words for tree nuts.

  13             These words as well as incomplete

  14   ingredients labels are life threatening for food

  15   allergic children.  That is why I am here today to

  16   urge the FDA to enact regulations that require

  17   ingredients labels with an accurate list of every

  18   ingredient in the product.

  19             Some food companies already do this

  20   voluntarily.  And that's great.  But I need 100

  21   percent to do it.  My life depends upon it.  I'm

  22   not asking you to tell food manufacturers to change

  23   their recipes.  I'm not asking you to tell them

  24   what they can or can't add to their products.  I'm

  25   not asking you to tell them that they have to 
                                                                225

   1   change their manufacturing processes.

   2             All I'm asking you to do is to make them

   3   tell me what recipes they're using, tell me what

   4   they already add to their products, tell me whether

   5   they're manufacturing processes result in adding

   6   even traces of the food I am so deathly allergic

   7   to.

   8             Reading ingredients is a large part of

   9   food allergic children's lives.  So large that the

  10   Food Allergy and Anaphylaxis Network published this

  11   story:

  12             A mother was trying to teach her food

  13   allergic child not to talk to strangers.  So, she

  14   asked her daughter, if a stranger in a car pulled

  15   up and offered you a candy bar, what would you do?

  16   Without missing a beat, the little girl responded I

  17   would ask them to read me the ingredients.

  18             [Laughter.]

  19             MS. GITLIN:  That girl knew what was

  20   really dangerous.  Because food allergies are so

  21   dangerous, food allergic kids and their families

  22   around the country urge you to protect our lives by

  23   requiring ingredients labels to be complete,

  24   accurate and in plain English so that we can really

  25   know what's in the food we are eating.  Thank you. 
                                                                226

   1             [Applause.]

   2             DR. LEWIS:  Thank you, Sarah.  I now

   3   believe it's Carol Schrager.

   4             MS. SCHRAGER:  Good afternoon.  I'm

   5   Sarah's Mom, and I'm a member of the Food Allergy

   6   Initiative and the Food Allergy and Anaphylaxis

   7   Network.

   8             Raising a food allergic child without

   9   complete and accurate ingredients labeling is like

  10   walking through a mine field.  No matter how

  11   carefully you watch your step, you never know when

  12   there will be an unexpected explosion.  It's hard

  13   enough to avoid the dangers that we know about, but

  14   it's impossible to rest easy when we know that

  15   there are dangers hidden in foods that Sarah might

  16   eat, but we don't know which foods and we don't

  17   know which dangers.

  18             So we turn to you, the Food and Drug

  19   Administration, the agency charged with protecting

  20   American lives by regulating the practices of food

  21   and drug manufacturers.

  22             We need you to help us protect the lives

  23   and health of the seven million Americans with food

  24   allergies by enacting regulations that are

  25   stunningly simple, the kind of regulations that 
                                                                227

   1   most Americans assume already exist, the kind of

   2   regulations that most people are shocked to find

   3   out do not already exist.

   4             What we urge you to require is merely

   5   this: that every packaged food has a label that

   6   states in plain English every ingredient that is in

   7   the product, both ingredients that are part of the

   8   recipe, including spices and natural flavors, and

   9   ingredients that are unavoidably present because of

  10   cross-contamination with other foods.

  11             These regulations would save lives with

  12   virtually no downside for food manufacturers.  Yes,

  13   it may cost the manufacturers a little bit more to

  14   assure that their labeling is accurate, but such

  15   costs are trivial when balanced against the

  16   precious irreplaceable lives of our children.  And

  17   remember, the number of Americans with food

  18   allergies is growing exponentially.  So

  19   manufacturers actually have a lot to gain from

  20   these regulations because the market for their

  21   products will expand.

  22             As food allergic consumers and their

  23   families and friends who now will not buy products

  24   that are said to contain, for example, natural

  25   flavors will feel safe consuming them once they are 
                                                                228

   1   assured that the allergens are not present.

   2             Under the regulations we support, food

   3   manufacturers would not have to change a single

   4   thing that they do.  They could include any or all

   5   allergens in any or all of their products.  They

   6   could process foods on shared equipment without

   7   cleaning the production line in between runs.  They

   8   could do anything they want to do, anyway they want

   9   to do it.  All that we ask you to require them to

  10   do is tell us what they're doing and tell us how

  11   they're doing it, so that we can make intelligent

  12   choices to protect our children's lives, so that we

  13   can walk through a field with our children without

  14   fear of an explosion.

  15             Thank you very much for listening to our

  16   concerns and to giving my daughter a close-up and

  17   personal lesson in participatory democracy.  We

  18   appreciate it very much.

  19             [Applause.]

  20             DR. LEWIS:  Thank you.  Next we have

  21   listed Barbara Solan.  And following Barbara Solan,

  22   we have Ben Wilson.

  23             MS. SOLAN:  Thank you for the opportunity

  24   to speak.  I don't usually do podiums.  I think

  25   democracy is a wonderful opportunity and to stand 
                                                                229

   1   here and say what I think that I've waited a long

   2   time to say is very, very gratifying.

   3             First of all, I'm the mother of an

   4   asthmatic food anaphylactic daughter.  I've been

   5   reading labels for 11 years and I do that probably

   6   about five times a day, 365 days a year, many, many

   7   labels.  Prior to becoming a professional label

   8   reader, I was a nurse in the U.S. Public Health

   9   Service, and I worked in the Indian Health Service

  10   and at the National Institutes of Health, and I've

  11   been involved in quality assurance.

  12             Two of the things that I tried to bring

  13   with me to this meeting are my common sense and my

  14   creative problem solving.  And as I listened today

  15   and as I have read every article I have found on

  16   the topic, I have some comments to make.

  17             First of all, we need to do something

  18   because the 2001 Healthy People statement says that

  19   we're going to reduce food anaphylactic deaths in

  20   the next decade so we need to address that issue.

  21   It's out there.  It's a goal.  It's a national

  22   priority.

  23             Second of all, the FDA is a public health

  24   agency and it is charged with protecting American

  25   consumers by enforcing the FDCA and other related 
                                                                230

   1   public health laws.  It's a charge.

   2             The other thing that is very gratifying to

   3   me is--and the first time that I have heard in all

   4   my years--is that someone has finally declared food

   5   allergens as a serious public health issue, and I

   6   can't thank you enough for that.

   7             I think it's important to look at the

   8   demographics of what's going on in our society as

   9   we address these issues and not just look at

  10   today's issues.  We've got a growing immigrant

  11   population.  We've got a growing allergy issue, and

  12   I think we shouldn't just look at what's right on

  13   the table, but where we're headed.

  14             And to specifically the comments about the

  15   questions you all asked.  I favor plain labeling

  16   with the eight allergens.  I want it bolded.  It's

  17   like reading the newspaper, The Washington Post

  18   with no headlines, and that's what we do all the

  19   time.  If you give us some headlines, it helps us.

  20   It's very tedious.  It's also not safe.

  21             I think that certain font size should be

  22   addressed, and I think we need to pay attention to

  23   the contrast background and materials used in

  24   products for labeling.  Some things are pretty

  25   difficult to read.  I do not like asterisks.  I 
                                                                231

   1   find them confusing.  And I think they will only

   2   muddle the issue.

   3             I like the General Motors--General

   4   Motors--I come from the Detroit area--General Mills

   5   model that says food allergy consumer or allergy

   6   information: contains nuts, soy.  That helps me.

   7   And I'll go very quickly on this.  I think we need

   8   to set priorities.  There's a lot of issues about

   9   food allergies.  I've lived with them for 11 years.

  10   Some are bigger than others.  And we should grab

  11   the big ones.  We should think out of the box and

  12   we should be creative in our problem solving.

  13             Thank you.

  14             [Applause.]

  15             DR. LEWIS:  Thank you.  Next we have

  16   listed Ben Wilson, who will be followed by C.

  17   Gordon Brown.

  18             MR. WILSON:  I'm Ben Wilson and I'm

  19   Director of Regulatory Compliance for Sensient

  20   Flavors, a food flavor company.  I'm feeling a

  21   little at risk on this side of the audience this

  22   afternoon.

  23             [Laughter.]

  24             MR. WILSON:  But we need some help from

  25   FDA as well.  I answer the questions from our 
                                                                232

   1   customers and from their customers, the consumers,

   2   about allergens and what's contained in a food, but

   3   the questions I get go much beyond the simple

   4   allergens.  Today people want to know about GMO,

   5   they want to know about organic, they want to know

   6   about consumer interests in different things, they

   7   want to know about specific issue products.

   8             They're very important to these people

   9   that ask them.  In some cases, they're

  10   significantly life threatening like allergens, but

  11   the responses that we give and when trying to

  12   provide the information seem to confuse the food

  13   companies.  They will ask us does this product

  14   contain soy?  And we will answer yes, but the soy

  15   that's in it may be a partially hydrogenated

  16   soybean oil, has no protein, has no allergen issue.

  17   It's been highly refined, it's been modified, the

  18   proteins are gone.

  19             That may be of interest to a specific few

  20   who have a different type of soy reaction.  It may

  21   be of interest to our customer because he's looking

  22   at a GMO issue for soy.  He may be looking for

  23   Europe.  We need some clarification from FDA as

  24   they look into these products and allergen and

  25   either guidelines or rules or whatever, but what 
                                                                233

   1   are the allergens, what are the things that we need

   2   to talk about?

   3             Are we going to talk about the big eight

   4   in general as allergens, not the big eight of soy,

   5   which contains a lot of things that aren't

   6   allergens, or of corn, which is an issue, but for

   7   most people not an allergen?  Wheat--is that an

   8   allergen issue to wheat or is that an issue of

   9   sprue celiac where it includes the glutens, the

  10   spelt, the rye, the barley?

  11             Does this include different extracts which

  12   may or may not have allergen potential?  We need to

  13   make that clear.  That needs to be very clear in

  14   what we're doing of whether we're addressing

  15   allergens, whether we're addressing big groups, and

  16   that's it.  And that's what I want to say for

  17   today.  Help us help the food manufacturer put the

  18   correct information on the label by giving us some

  19   clear guidelines of what we're talking about and

  20   what the things are of concern.  Thank you.

  21             [Applause.]

  22             DR. LEWIS:  Thank you.  Next, we have C.

  23   Gordon Brown, who would be followed by Carolyn

  24   Garrett.

  25             MR. BROWN:  Thank you very much.  I'm 
                                                                234

   1   Gordon Brown, Senior Vice President of Scientific

   2   and Regulatory Affairs for the International Dairy

   3   Foods Association.  We thank you very much for

   4   providing this forum and for providing an

   5   opportunity for us to get our positions out there.

   6             The following comments are made on behalf

   7   of the International Dairy Foods Association.  IDFA

   8   is the nation's leading trade association

   9   representing the dairy industry.  Our member

  10   companies manufacture the entire range of dairy

  11   products and include processors, manufacturers,

  12   marketers, distributors and suppliers.

  13             IDFA consists of three constituent

  14   organizations: the Milk Industry Foundation, the

  15   International Ice Cream Association, and the

  16   National Cheese Institute.

  17             Member companies in these groups account

  18   for 85 percent of the dairy products consumed in

  19   the United States.  IDFA is a member of the Allergy

  20   Issues Alliance, the coalition of food trade

  21   associations and a leading food allergy consumer

  22   group.  IDFA helped develop new guidelines for

  23   clear labeling of allergenic compounds.

  24             IDFA strongly supports implementation of

  25   these guidelines, encourages disclosure of 
                                                                235

   1   allergenic ingredients in clear and simple language

   2   and is dedicated to assisting dairy processors to

   3   prevent cross-contamination.

   4             Our commitment to the allergen initiative

   5   is demonstrated through our member outreach.

   6   Although dairy processors are conscientious about

   7   compliance with labeling requirements for

   8   allergenic ingredients, IDFA still urges all

   9   members to review their policies and verify that

  10   they are operating within the new allergen

  11   guidelines and we provide a whole lot of one on one

  12   contact and information to our members who request

  13   information.

  14             Further, we recommend that member

  15   companies follow the following recommendations:

  16             (1) Review formulations to identify the

  17   presence if any of the eight major allergens;

  18             (2) Contact ingredient suppliers to

  19   determine if ingredients they supply contain any

  20   allergens including components of flavors, colors,

  21   incidental additives and processing aids that may

  22   not be required to be labeled.

  23             We also suggest they review their current

  24   labels to ensure that if any allergens are present,

  25   they are included in the ingredient declaration in 
                                                                236

   1   terms that are easily understood by consumers.

   2             Number four, advisory statements should

   3   not be used as a substitute for good manufacturing

   4   practices.  Only use advisory label statements such

   5   as "may contain" blank when all of the criteria

   6   established in the allergen guidelines are met, and

   7   I won't go into those now, but they are available.

   8             The dairy industry has a good track record

   9   on the allergen issue.  Recalls for undeclared

  10   allergens and dairy products are rare.  However, we

  11   are committed to continuous improvement and this is

  12   demonstrated by our efforts to educate our members

  13   on the important issues through a variety of

  14   outreach programs.

  15             These programs include (1) providing

  16   publications to member companies on implementation

  17   of the voluntary food allergen labeling guidelines;

  18   (2) instructions for labeling manuals for milk,

  19   cheese and ice cream; (3) we provide workshops on

  20   allergens and proper food labeling on a periodic

  21   base.  These are open to the entire dairy industry

  22   as well as ingredient suppliers.  (4) We provide

  23   education for ice cream manufacturers through a

  24   workshop entitled "Ice Cream Best Practices" to

  25   explain the allergen issues and industry's labeling 
                                                                237

   1   requirements.

   2             In summary, the dairy industry is

   3   committed to maintaining the safety of its products

   4   and is currently engaged in this effort to make

   5   sure that we protect the health of allergenic

   6   consumers.  Thank you.

   7             [Applause.]

   8             DR. LEWIS:  We now have Carolyn Garrett on

   9   our list.  Carolyn Garrett is not here.  That

  10   completes my list of registered speakers.  So I

  11   believe that the meeting is now coming to an end.

  12             My closing comments are quite succinct.  I

  13   think this was an extremely useful meeting for the

  14   agency.  I felt a lot of important information was

  15   obtained by us.

  16             Again, the docket is open so comments are

  17   still possible to this particular series of

  18   questions by the agency.  I do want to thank all

  19   the members of the panel who provided some very

  20   useful discussion points for us, as well as the FDA

  21   support staff who made this meeting possible.

  22             So thank you very much.  The transcript

  23   will be available in about a month and information

  24   on obtaining that is in your Federal Register

  25   documents.  Thank you. 
                                                                238

   1             [Applause.]

   2             [Whereupon, at 3:20 p.m., the meeting was

   3   adjourned.]

   4                              - - - 