Better Labeling Laws needed in the USA, what you can do

Posted on: Mon, 10/22/2001 - 1:20am
Chris PeanutAllergy Com's picture
Joined: 04/25/2001 - 09:00

Better Labeling Laws needed in the USA, what you can do.

This thread is to help you understand what is going on in regards to the labeling issue the USA. If you have comments or information please add it to this or one of the appropriate linked threads on these discussion boards.

We hope this thread will help to educate you to what is needed, why, AND WHAT YOU CAN DO TO MAKE IT HAPPEN! There are other threads on this "Take Action" forum on this issue, and we will add web links on this thread to help bring it all together, along with threads on the "Labeling" and other forums.

Here is a letter for your information that we hope will inspire you to get involved in this issue. You can help to acquire better labeling for those relying on labels on products in and from the USA.

There is a lot to this issue and we hope you will educate yourself as much as possible so you will see what really is going on, what needs to be done etc.

Here is the text from letter to help you become educated and hopefully involved >>>

Important Request

6, 2001

Re: Food Allergen labeling

Dear Friends:

We have attached a letter dated July 3, 2001 to the Food and
Drug Administration (FDA) urging them to act on the petition submitted
May 26, 2000 by Attorney General Eliot Spitzer of New York and eight
other states to promulgate enforceable regulations to protect consumers
from undeclared food allergens. The petition was filed about one year
ago but has not been acted upon. We do not consider the June 2001
announcements by the FDA and other organizations, while helpful, are an
adequate substitute for the regulations we sought. Your involvement
with this issue in the past has increased the visibility and public
awareness of food allergy hazards and their remedies. A bit more help
could lead to a more concrete resolution of the issues we raised.

We urge that you read the attached letter and prepare your own
letter urging FDA take steps to adopt enforceable regulations and
increase the priority FDA places upon this task. If we can provide
additional information or guidance, please feel free to contact us at
518-474-2432 or 518-474-4819 respectively or at our e-mail address

Thanks in advance for your consideration of this matter.


Peter Skinner, P.E.
Chief Scientist - Albany & Buffalo

Judith S. Schreiber, Ph.D.
Senior Public Health Scientist

Letter is pasted in below for those who cannot open the attachment.

3, 2001

Joseph A. Levitt
Director, Center for Food Safety and Applied Nutrition
United States Food and Drug Administration
Federal Building 8 Room 6815
200 C Street, SW
Mailstop HFS-001
Washington, D.C. 20204

Re: Food Allergen labeling

Dear Dr. Levitt:

We write to reiterate the need for the Food and Drug
Administration (FDA) to act on the petition of the Attorneys General of
New York and eight other states and promulgate enforceable regulations
to protect consumers from food allergens. Recent actions, while
somewhat helpful, are not an adequate substitute for these necessary

It is encouraging that there has been some increased activity to
improve food product labeling to reduce the likelihood that consumers
will be exposed to foods that may cause severe allergic reactions.
Since March 2001, FDA released the results of its Food Allergen
Partnership study, a Guide to Inspections of Firms Producing Food
Products Susceptible to Contamination with Allergenic Ingredients, and
added a Statement of Policy for Labeling and Preventing Cross-contact of
Common Food Allergies to its Compliance Policy Guide (CPG). The
National Food Processors Association (NFPA) issued industry Code of
Practice guidelines (NFPA Guidelines) for managing food allergens in
April, 2001. Most recently, the Food Allergy Issues Alliance (FAIA)
issued food allergen labeling guidelines in May, 2001. (See Reference

While we applaud the FDA and food manufacturers for recognizing
the gravity of the food allergen problem and for taking steps toward
improving industry practices, more comprehensive government oversight is
still needed to protect the public from potentially life-threatening
allergic responses. Most importantly, there must be mandatory
regulations with clear enforcement strategies. The Attorneys General of
nine states (Connecticut, Maryland, Massachusetts, Michigan, New York,
Ohio, Tennessee, Vermont and Wyoming) petitioned the FDA in May 2000 for
regulations mandating comprehensive food product labeling to require
that food manufacturers:

disclose all allergenic ingredients including incidental additives and
natural flavorings;

institute procedures to minimize cross-contamination with allergens;

provide a toll-free telephone number on food labels for consumers
seeking detailed
processing and/or ingredient information; and

include warning label or insignia noting potential allergen content.

Even though more than one year has passed, the FDA has taken no
action on this petition. The FAIA guidelines and the NFPA Guidelines
are helpful documents that reflect a great deal of hard work on the part
of the industry and consumer advocacy groups who contributed to them.
However, they provide inconsistent guidance on certain matters, and are
thus of limited assistance. Moreover, they have no application to
manufacturers that have not aligned themselves with the FAIA or NFPA,
and do not address all necessary issues. Of most significance, however,
they are only voluntary and thus are not enforceable. Therefore, we
believe that the regulations discussed in our petition are still very
much needed.

The inconsistency in the manner in which the FAIA and NFPA
approach the issue of Good Manufacturing Practices (GMP) and cross
contamination is a significant problem. The FAIA guideline includes
the following statement: "The food industry recognizes that under
existing good manufacturing practice (GMP) regulations, reasonable
precautions must be taken to prevent cross contact with major food
allergens." However, in apparent acknowledgment that the current GMP
regulations do not fully address the issue of cross-contamination, the
NFPA Guidelines urge members to not only follow the GMP regulations, but
to employ "other allergen control strategies to manage and minimize the
potential of cross-contact of the major food allergens" as well.

The FDA Guide to Inspections and CPG do little to resolve these
conflicting views on precautions manufacturers are expected to take to
avoid cross-contamination. While both the Guide to Inspections and the
CPG list some strategies for avoiding cross-contact with allergens
(including dedicated equipment, separation, production scheduling,
sanitation and proper rework usage), neither document offers specific
direction as to which of these strategies, if any, are required under
current law. The resulting confusion will not lead to adequate action.

The Guide to Inspections and CPG also fail to address the proper
use, prominence or placement of supplemental allergy statements on
packaging. We are concerned that the absence of clear, comprehensive
guidance from the FDA in the form of enforceable regulations will result
in a proliferation of "may contain" type labels as manufacturers attempt
to protect themselves from product seizure or legal action. Such an
outcome would further limit the choices available to food-allergic
consumers and run counter to the intent of the industry guidelines and
the petition submitted by the Attorneys General.

FDA's recent actions have failed to provide a way for
food-allergic consumers and their families to contact manufacturers to
obtain product information. We realize that in the long term, the
implementation of better production and labeling practices will mitigate
the need for such information for many consumers; in the short term,
however, consumers continue to need quick and easy access to information
exclusively maintained by food manufacturers. Also, for certain food
allergic consumers who are severely afflicted or have allergies to foods
other than the "Big 8," detailed information on production and
ingredients is the only way to protect against exposure to
life-threatening allergens. As proposed in our petition, the inclusion
of a toll-free telephone number on a product label is the only practical
way to ensure that the lines of communication are open to all

The FDA Guide to Inspections and CPG also fail to adequately
address the issue of allergenic flavorings. Rather, manufacturers are
merely "encouraged" to declare spices, flavors or colors derived from
allergenic substances.

The most egregious failing of the current FDA and industry
guidelines is that they are completely voluntary and unenforceable. We
find this approach to be dangerous and unacceptable. It is also
unsupported by FDA practice. For example, with respect to the issue of
undeclared monosodium glutamate (MSG) and protein hydrolysates, the FDA
adopted regulations (21 CFR 101.22(h)(5) and (7)) that required
manufacturers to declare MSG used as an ingredient in food and to
specifically identify the source of protein in the hydrolysates used for
flavor. Food-allergic consumers are entitled no less than the same
remedy with respect to allergenic flavorings.

We recognize that FDA claims, in the Guide to Inspections and
CPG, that existing regulations and laws (specifically 21 CFR
101.100(a)(3) and Section 402(a)(4) of the Food, Drug and Cosmetic Act)
allow the FDA to classify unlabeled allergenic ingredients as food
adulterants and to take enforcement actions against manufacturers that
do not declare the presence of these ingredients in food. FDA contends
that the incidental additives exemption set forth in 21 CFR
100.100(a)(3) has never applied to food allergens, although no explicit
regulations address allergens as incidental additives. In practice,
however, food manufacturers have relied upon this exemption for a number
of years with relative impunity. To our knowledge, the FDA first
communicated to the food industry in 1996 that an allergen may not meet
the definition of an incidental additive. Although the FAIA and NFPA
appear to have accepted this interpretation and structured their
guidelines on its basis, nonmember manufacturers may mount challenges.
In 1985-1986, the FDA faced a similar situation regarding sulfiting
agents which can cause asthmatic reactions in people who are sensitive
to them. In that case, the FDA addressed the issue by adding 21 CFR
101.100(a)(4), and modifying the definition of an incidental additive to
exclude sulfites that are present in a "detectable" amount. We are
concerned that the FDA has not yet offered similar regulatory protection
to consumers with food allergies. Surely, an amendment specifically
excluding allergens from the definition of incidental additives would be
consistent with existing regulatory interpretation and be more
enforceable than a potentially contentious reinterpretation of the
existing regulation.

In conclusion, while we appreciate the efforts that both the
food industry and the FDA have taken thus far to address the needs of
food-allergic consumers, more regulations and strict enforcement are
needed to provide reasonable assurances that the food supply is safe for
people who suffer food allergies. We would welcome an opportunity to
discuss the status of our petition and how the FDA intends to
incorporate our proposals in its continuing efforts to combat the
problem of undeclared food allergens.


Peter Skinner, P.E.
Chief Scientist

Judith S. Schreiber, Ph.D.
Senior Public Health Scientist

cc: Congresswoman Nita Lowey
Senator Edward Kennedy
Secretary Tommy Thompson, Health and Human Services
Dennis E. Baker, Associate Commissioner for Regulatory Affairs,

References Cited:

Food Allergy Issues Alliance (FAIA) May, 2001, Food Allergen Labeling

National Food Processors Association (NFPA), April, 2001, Code of
Practice Guidelines,

U.S. Food and Drug Administration (FDA), March 2001, Food Allergen
Partnership Study.

U.S. Food and Drug Adminstration (FDA), April, 2001, Guide to
Inspections of Firms Producing Food Products Susceptible to
Contamination with Allergenic Ingredients,

U.S. Food and Drug Administration (FDA), April, 2001, Sec. 555.250
Statement of Policy for Labeling and Preventing Cross-contact of Common
Food Allergies, Compliance Policy Guide, Chapter 5-Foods, Colors and

Peter N. Skinner P.E.
Scientist - Albany Office
Environmental Protection Bureau
Justice Building - Room 221
The Capitol
Albany, NY 12224
518-474-2432 (o)
518-473-2534 (f)

>>>end of letter

Here are some links to more information, note that some are to sites that want to leave it "voluntary" and not "mandatory". This is cause for concern for those of us who must rely on others, (such as manufacturers), to keep us safe.





After researching this issue, please feel free to comment on these boards, this helps us all to become more educated (not only the peanut allergy community, but also manufacturers, lawmakers etc.).

Here are some links to other threads on the PeanutAllergy.Com discussion boards

FDA Petition

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

write to your Senators and Congressmen/Please keep me posted

FDA Hosting a Meeting on Food Allergy Labeling on August 13

FDA calling Chris Monday June 18th, if you have labeling concerns please let us know


If you are able, please locate other threads on the PeanutAllergy.Com discussion boards and add links to those thread here, also add any links to other sites you feel are helpful.

Stay Safe,


Peanut Free Store

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