Write to Congress Re:Labeling by 8/13/01/edit October 29, 2001

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting on the labeling of food products containing allergens. The
purpose of the meeting is to stimulate discussion and to obtain
information to help FDA determine what additional actions may be
necessary to provide consumers with adequate information on product
labels. The meeting will focus on: Source or plain English labeling;
advisory labeling (e.g., ``May contain [name of food allergen]''); and
labeling of ingredients exempted from declaration (common or usual
names of flavorings, spices, and colors; incidental additives).
DATES: The public meeting will be held on August 13, 2001, from 9 a.m.
to 4 p.m. Please preregister by close of business on August 6, 2001.
Preregistered persons should check in before the meeting between 8:30
a.m. and 9 a.m. Late registration will be accepted contingent on space
availability. Comments must be submitted no later than October 29,
2001.
ADDRESSES: The meeting will be held at the Cohen Bldg., 330
Independence Ave. SW., Washington, DC 20201, 202-619-1299 (Metro:
Federal Center SW.). All attendees must enter the building at the
Independence Ave. entrance.
Submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. You may also send comments to the Dockets Management Branch
at the following e-mail address: [email]FDADOCKETS@oc.fda.gov[/email], or at http://
[url="http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm."]www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.[/url]

babyjakesmom,
I'm running a little behind on these things. Mind if I pretty much copy your letter and email it today?

Here's an e-mail I just received. My head is spinning from all this stuff.
Hi Everyone,
An acquaintance of mine attended the FDA Food Labeling Hearing held last
week in Washington, DC. The following is an edited report she posted on
a Food Allergy Yahoo Group:
Full details of the focus of the meeting can be found at:
[url="http://frwebgate1.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=086023412+0+"]http://frwebgate1.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=086023412+0+[/url]
0+0&WAISaction=retrieve
Information about the FDA's activities focused on food allergies can be
found at:
[url="http://www.cfsan.fda.gov/~dms/wh-alrgy.html"]http://www.cfsan.fda.gov/~dms/wh-alrgy.html[/url]
Essentially, the goal of the meeting was to allow the FDA to obtain
information to help it determine what additional actions the FDA needs to
take to provide consumers with adequate information on product labels.
The meeting was conducted with a discussion panel composed of four
representatives of the FDA and representatives of various groups with
interests in the food labeling issue. The individuals on the panel included
the FDA as well as:
Michael Jacobson, PhD, Center for Science in the Public Interest
([url]http://www.cspinet.org[/url]),
Ann Munoz Furlong, of the Food Allergy and Anaphylaxis Network
Regina Hildwine, Senior Director of Food Labeling and Standards for the
National Food Processors Association
John Hallagan, General Counsel for three organizations: The Flavor and
Extract Manufacturers Association, The International Association of Color
Manufacturers, and the American Spice Trade Association
Lisa Katic, R.D., Director of Scientific and Nutrition Policy for the
Grocery Manufacturers of America
The three topics discussed were:
1. Source or Plain English Labeling
2. Advisory Labeling (such as use of "may contains" types of statements)
3. Labeling of ingredients exempted from regulation (such as flavorings,
spices and incidental additives)
Most of the discussion centered on whether there was a need for regulatory
changes or if these types of labeling improvements could be made on a
voluntary basis by food manufacturers. The weaknesses in the current
labeling laws, and deficiencies in current food labeling, was clearly
recognized and acknowledged by all parties. There was an opportunity for
public comment at the end of the day, and a number of individuals got up to
present their concerns with labels and what they believe needs to be
changed.
Ann Munoz Furlong of the Food Allergy and Anaphylaxis Network did a great
job representing the interests of food allergic individuals. When asked,
she announced that FAAN would support any initiative, either voluntary or
regulatory, that will improve the food labels to assist food allergic
individuals. FAAN's position at this time is that it supports initiatives
focused on the 8 big allergens, and once this is in place, would work for
improvements for other allergens.
Dr. Jacobson of the Center for Science in the Public Interest, represents an
advocacy group that is pushing for better labeling and mandatory regulation
changes for food labels. He presented a model for new labels that would
include a section for declared allergens, and he stated that he believed
that regulations should include declarations for the top 8 allergens as well
as other allergens such as corn and sulfites, which are also known to cause
reaction.
The representatives of the food industry on the panel (unsurprisingly) were
opposed to further regulation of labeling requirements, and instead,
advocated for voluntary compliance.
Even though the meeting is now over, the FDA is still seeking additional
input from interested consumers to help them determine what course of action
they should take on this matter. So if you want to give the FDA your input,
you can submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. You may also send comments to the Dockets Management Branch at the
following e-mail address: [email]FDADOCKETS@oc.fda.gov[/email], or at
[url="http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm"]http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm[/url]
You can submit comments at any time between now and October 29, 2001.
If you are willing to write a letter to the FDA, these are the types of
questions they want you to help them answer:
Source Labeling Questions:
1. What plain English terms would be understandable for the eight most
common food allergens?
2. What source or plain English labeling format or formats would be most
informative to consumers? Are the formats from the Food Allergy Issues
Alliance appropriate and sufficient? Are the recommendations in the petition
from the attorneys general of nine States warranted and beneficial? Are
multiple formats confusing to consumers, and if so, is there a single format
that would be preferable? If so, why?
3. Should source or plain English labeling be voluntary or mandatory for the
eight most common food allergens?
Advisory Labeling ("may contains" "made in a plant that uses peanuts" types
of statements)
1. Under what circumstances, if any, should advisory labeling statements
(e.g., ``May contain [name of allergen]'') be permitted, and what impact
would those circumstances have on manufacturers and on consumers? Should the
recommendations in the petition from the attorneys general of nine States be
adopted? Do the criteria from the Food Allergy Issues Alliance form a
reasonable basis for determining when a manufacturer may use advisory
labeling on a particular product
or should other criteria be used? Why?
2. Are there better alternatives for advisory labeling than the type of
wording that currently exists (e.g., ``May contain [name of specific
allergen],'' ``Made on shared equipment,'' ``Manufactured in a facility that
also processes [name of specific allergen]'')? Do such statements adequately
inform consumers of possible cross-contact with allergenic materials? How do
consumers interpret the wording of such labeling? Should advisory labeling
statements be prescriptive (i.e.,
one or more specific statements) or flexible?
3. Where should advisory labeling statements be located on the food label?
How prominent should advisory labeling statements be on the label? Should
the location and prominence of advisory labeling statements be prescribed?
Commonly used flavors, spices and colorings
Questions for the public meeting relate to the alternatives available to the
agency:
1. Should the agency continue to address the labeling of individual
allergenic flavorings, spices, and colors on a case-by-case basis, or should
there be a generally applicable policy?
2. Should the information on allergenic components of flavorings,
spices, and colors be included in the ingredient list? Is there a better
location or format for this information? Explain.
3. For individual flavorings, spices, or colors that contain one of the
eight most common allergens, should listing the common or usual name of the
individual flavoring, spice, or color on the product labeling be voluntary
or mandatory?
Labeling of Additives
1. What, if any, minor ingredients would manufacturers be unlikely to
recognize as containing food allergens and therefore not include on the
label, and what kinds of manufacturing

Hi,
Individuals were in attendance at the Aug 13 FDA meeting. It was absolutely fascinating, and extremely eye opening. Unfortunately, there were only about 20 food allergic individuals/consumers who spoke up on the issue. Of course, it is very important to remember, that this meeting did not get the proper publicity and press it needed in food allergic lay groups, stressing the importance of such a groundbreaking national meeting. Two groups with a history of representing food allegic individuals were glaringly missing: AAFA (Asthma and Allergy Foundation of America) and MOA/AAN (Asthma and Allergy Network (Mothers of AsthmaticAlso.) While the number of food allergic individuals/families present at the meeting was modest, they were there at their own personal expense,(what industry typically might call "undo finacial hardship"). While, needless to say, food industry was on their geneous "expense accounts."
Food allergy is in a position of greater strength than we have ever been. To know that, one must do their homework, and look at what the FEDERAL GOVERNMENT IS SAYING, and what the research shows:
The FDA has said, " UNDECLARED FOOD ALLERGENS ARE A SERIOUS PUBLIC HEALTH ISSUE..." in the FEDERAL REGISTER announcement of that meeting.
THE FEDERAL GOVERNMENT, in THE public health document for the American People,HEALTHY PEOPLE 2010, has stated as a stated objective to : "reduce food anaphylactic fatalities."
Those statements by the federal government, clearly imply that the Federal government will be implementing actions to achieve those goals.
Also, the recent Food Allergen Partnership Study done by the FDA, showed a 25% incidence of cross contamination and undeclared allergens in ice cream, bakery goods, and candy. What does that mean? it means that 1 in 4 of those products are in violation of FEDERAL LAW, with regard to current food labeling law. MISSION CONTROL...WE HAVE A PROBLEM!
Also, National legislation is being introduced by Sen. Lowey's office on food allergen issues.
In regards to that FDA meeting, I must raise a very important issue, that seems to be escaping the attention of some people.
FAAN was a member of, and signed off with the FOOD ALLERGY ISSUES ALLIANCE, which is composed of food industry representatives, and an undisclosed representative from Academia. That document favors VOLUNTARY vs. MANDATORY LABELING CHANGES. Everyone with food allergy or food allergic child should take the time to read that document. FOR the sake of your food allergic kids, please DO YOUR HOMEWORK and read that document, with EXTREME care. IS THAT WHAT YOU WANT? FAAN SIGNED OFF ON IT. Personally, it frightens me.
While FAAN has publicly stated that they favor ALL initiatives, I remain EXCEEDINGLY confused on EXACTLY where they stand.
THE AAAAI, the American Academy of Allery,Asthma, and Immunology, the professional organization of allergists, strongly, clearly, and very articulately, supported Mandatory labeling changes, and full disclosure of all ingredients.
At that meeting, food industry stated that they oppose mandatory labeling changes because mandatory changes (such as FDA rules/regs) will "slow down implementation" of the measures voluntary steps outline in the FOOD ALLERGY ISSUES ALLIANCE DOCUMENT.
The critical question that one must then ask is: are voluntary and mandatory labeling changes mutually exclusive in the eyes of industry? I asked that of industry representatives, and the reply was yes. THEY are mutually exclusive, (or so they say.) Industry stated and also implied in some pretty blatant panel posturing, that they will not be interested in making voluntary changes if the FDA will be mandating steps. Whether that is simply posturing or fact, one can only guess.
However, statements like that show the lack of GENUINE committment of industry to follow the FDA's 1996 letter to industry on labeling, food allergens, and Good Manufacturing Processes, particularly in light of the FDA Food Allern Partnership study results. It also show that they are not willing to address the needs of the food alleric consumer if they decide to drag their heels like that.
SO, in light of just some of this information, and more, my question to FAAN remains the same as it was at the FDA meeting:
ARE YOU IN FAVOR OF MANDATORY LABELING, INSPECTION, AND ENFORCEMENT regarding food allergens? OR are you in favor or voluntary, like industry is?
THE CENTER FOR SCIENCE IN THE PUBLIC INTEREST (CSPI) is for MANDATORY LABELING CHANGES,AS WELL AS INCREASED INSECTION AND INFORCEMENT BY THE FDA.
FOOD Industry does not favor ANYTHING mandatory.
The AAAAI strongly supports MANDATORY labeling changes and full disclosure of all indgredients. The truly were strong patient/family advocates!
WHERE DO YOU STAND,FAAN, as the you state you represent 23,000 FOOD ALLERGIC PATIENTS AND FAMILIES?
Remember that children and adults are reacting to minute amount of allergenic material in foods. Remember, that you, who have worked very closely with the food industry on food allergens for years, know,as I have just learned by attending this one meeting, that industy, knowingly omits ingredients off the label,at least off the record, which is in direct violation of federal law... That means MANDATORY change are the only acceptable answer. You have done so much for food allergic individuals in the past.
DON'T WAFFLE ON THIS ISSUE, FAAN, or issue MEANINGLESS RHETORIC that states you support all initiatives.
These initiatives are not all the same. They are as different as night and day, or slavery and abolition. Stand up, be counted. Everyone else is, and people are watching. There are enough sheep in Central Park.

Dear Friends,
I attended the FDA meeting along with a representative of the NYS Attorney General's Office and we spoke for our allotted time of three minutes each. As reported by the members that also attended, the primary issue of discussion was whether the FDA should adopt the regulations proposed by the Attorneys General or permit the food industry to "regulate" itself pursuant to the recently adopted FAIA and NFPA guidelines. Yes, Anne Munoz-Furlong was on the panel and did a fairly good job describing the difficulties that consumers face in deciphering food labels. However, I found it very troublesome that Ms. Munoz-Furlong was asked to serve on the panel and not the NYS Attorney General (who wrote the petition). FAAN receives much of its financial support from the food industry and also helped create the FAIA guidelines. It was thus not surprising, though no less appalling, when a representative of the FDA told me that FAAN has been actively lobbying the FDA against the AG's petition in favor of these voluntary standards. We need to make it perfectly clear to the FDA that FAAN does not represent the best interests of consumers. Please take the time to write a letter to the FDA and tell them that you support the AG's proposed regulations.
The AG's petition is available at the following address: [url="http://www.fda.gov/ohrms/dockets/dailys/00/may00/053100/cp001.pdf"]http://www.fda.gov/ohrms/dockets/dailys/00/may00/053100/cp001.pdf[/url]
You may mail your letter to the following address:
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may also send comments to the Dockets Management Branch at the following e-mail addresses: [email]FDADOCKETS@oc.fda.gov[/email] or [url="http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm"]http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm[/url]
[This message has been edited by Colleen's Mom (edited August 21, 2001).]
[This message has been edited by Colleen's Mom (edited August 21, 2001).]
[This message has been edited by Colleen's Mom (edited August 21, 2001).]

Following is a copy of my email to FAAN [img]http://uumor.pair.com/nutalle2/peanutallergy/biggrin.gif[/img]ear FAAN,
I am so very disappointed to have read that you are supportive of voluntary labeling by the food industry. This is a betrayal of the trust we members of FAAN have put in you. The only way to obtain safe information about allergens in food is to require definite labeling guidelines which must be followed by all U.S. manufacturers, with strong penalties for failure to do so.
Without legislation, manufacturers can simply put "may contain" warnings on everything to limit liability, without letting us know whether it's the line or the plant involved. (Already, Nabisco is listing peanuts as the last ingredient in their Ritz Bitz cheese crackers, when, in fact, it is not an ingredient. They're doing that because there could be cross-contamination. That's wrong.) The flavoring people will just avoid any warnings, to protect their secrets. And you will have sold out to the food industry. I'd rather you stopped taking any money from food companies, and asked your members for more money, if that's what it takes for you to work on our behalf instead of theirs.
Please change your position on this issue and speak on behalf of your members.
--- Chris or Diane (Zimmer) Fascione
--- [email]slicendice@earthlink.net[/email]
--- EarthLink: It's your Internet.

It is not too late to write a letter to the FDA regarding this matter. The deadline for writing to them is October 29th, 2001.
You will find more info here:
You will find the email address of where to send this letter, along with other information at:
[url="http://www.cfsan.fda.gov/~dms/alrgltr4.html#comment"]http://www.cfsan.fda.gov/~dms/alrgltr4.html#comment[/url]
NOTE that the deadline for your letter is October 29th, 2001

We must all write letters today if possible to urge mandatory labeling guidelines for allergens in foods. Even a simple one-sentence letter saying that you support mandatory labeling to protect your child's life would help. See above letter for address. cc your senators and representatives if you can.