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home » news » testimony July 30, 2003


Testimony

Testimony of:
Lisa Katic
Senior Food & Health Policy Advisor
Grocery Manufacturers of America, Inc.
Food Allergy Issues Alliance Labeling Guidelines

May 31, 2001

Food Allergy Issues Alliance Labeling Guidelines

Introduction

The Food Allergy Issues Alliance is a group of food trade associations and other interested organizations that convene to discuss issues related to food allergy. During 2000 and 2001, the Food Allergy Issues Alliance has been discussing numerous options related to labeling of Major Food Allergens (defined in Section A of this document), focusing on those options that would not require new regulations.

Food allergies affect an estimated six to seven million persons in the United States. Some of these sensitized consumers can develop serious or life-threatening allergic reactions if exposed to the causative proteins. Currently, there is no cure for food allergies. The only successful method to manage food allergies is to avoid foods containing the causative proteins. Food processors must be diligent in informing food allergic consumers about the presence of Major Food Allergens in their products. This information, which is communicated on food labels, is intended to help food allergic consumers make a clear decision about whether or not a food is appropriate for them to eat.

The food industry has taken numerous steps over the past several years to address the needs of food allergic consumers, including changes to manufacturing processes to reduce the potential for cross contact with Major Food Allergens. The food industry recognizes that under existing good manufacturing practice (GMP) regulations, reasonable precautions must be taken to prevent cross contact with major allergenic proteins. In instances when cross contact cannot be avoided, even when complying with GMPs, food and ingredient manufacturers use labeling that informs the food allergic consumer of the possible presence of allergens in the food.

Food manufacturers label the ingredients in their products in accordance with existing regulatory requirements. The Food Allergy Issues Alliance recognizes, however, that consistency in labeling of food allergens could further address the needs of food allergic consumers, and has developed these Food Allergen Labeling Guidelines to address those needs.

The Food Allergen Labeling Guidelines:

A. Identify the Major Food Allergens.

B. Advocate the use of terms commonly understood by consumers (i.e., "plain English"[1]) for Major Food Allergens within, or in immediate proximity to, the ingredient declaration, to provide clear communication with the food allergic consumer.

C. Call for manufacturers to disclose the presence of Major Food Allergens when they are an intentional part of the food, regardless of source. Thus, Major Food Allergens would be disclosed regardless of the fact they may otherwise be exempted from declaration (e.g., as part of a flavor, or as an incidental additive or processing aid).

D. Establish guidelines for conditions when the use of supplemental allergen statements is appropriate.

All companies in the food industry are encouraged to adopt and adhere to the following labeling guidelines for Major Food Allergens.

A. Major Food Allergens

The Food Allergen Labeling Guidelines focus on the Major Food Allergens, which have been estimated to cause more than 90% of all food allergic reactions. For the purposes of this program, the Major Food Allergens are defined[2] as the allergenic proteins from:

1. Crustaceans (such as crab, crayfish, lobster, and shrimp)

2. Eggs;

3. Fish;

4. Milk;

5. Peanuts;

6. Soy;

7. Tree nuts (almonds, Brazil nuts, cashews, chestnuts, filberts/hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts); and,

8. Wheat.

Additional food allergens may be added to this list of Major Food Allergens as their public health importance becomes recognized.

An ingredient that is derived from a Major Food Allergen is not subject to these guidelines when it does not contain the causative allergenic protein. By way of example, highly refined peanut and soybean oils would not be subject to these labeling guidelines to the extent that the allergenic proteins are not present in the oils.

B. Use of Ingredient Terms Commonly Understood by Consumers

Ingredient terms commonly understood by consumers for the Major Food Allergens in the product should appear within, or in immediate proximity to, the ingredient declaration of the food label. Examples of acceptable ingredient terms commonly understood by consumers of Major Food Allergens include "eggs," "fish," "milk," "peanuts," "shrimp," "soy," "walnut," or "wheat."

The ingredient terms commonly understood by consumers should be disclosed by following the label declaration options presented in Section C of these guidelines.

C. Label Declaration of Major Food Allergens

A food that contains a protein of a Major Food Allergen should be labeled in a manner that informs the consumer of the allergen's presence, regardless of its source. Ingredient declarations, which appear on the information panels of food labels, are the primary vehicle for communicating information about food allergens to the at-risk population. Information on Major Food Allergens should appear within, or in immediate proximity to, ingredient declarations.[3]

A Major Food Allergen should be disclosed even where a labeling exemption might otherwise apply (e.g., as a component of a flavor). Food processors should request from their suppliers, and those suppliers should provide, information about the presence of Major Food Allergens in all food ingredients, such as flavors. Food processors should carry this information forward to the ingredient declarations on labels of foods that use those ingredients.

The ingredient terms commonly understood by consumers for Major Food Allergens should be disclosed on the information panel, within, or in immediate proximity to, the ingredient declaration, by using one or more of the following methods:

1) The use of a statement, such as "Contains __________," with the blank filled in with the ingredient term commonly understood by consumers for Major Food Allergens (e.g., Contains soy and milk). This statement may be prefixed by an allergy information statement phrase (e.g., Allergy information: Contains soy and milk"). This statement should be placed at the end of, or in immediate proximity to, the ingredient declaration.

2) The use of an asterisk or other reference mark next to the ingredient name or class name that refers the consumer to a statement that identifies the ingredient term commonly understood by consumers for Major Food Allergens. This statement should be placed at the end of, or in immediate proximity to, the ingredient declaration. For products that contain two or more ingredients that contain the same Major Food Allergen, the same asterisk or other reference mark should be placed after each relevant ingredient in the product. For example, "casein*, whey*, semolina+, natural flavor+" would appear in the ingredient declaration, referring the consumer to a statement such as "*milk, +wheat" following the ingredient declaration.

3) The use within the ingredient declaration of a parenthetical statement following the ingredient name or class name that identifies allergens that are present in the ingredient (e.g., natural flavor (peanuts and soy), whey (milk)).

4) The use within the ingredient declaration of a name that identifies the presence of the allergen such as "natural walnut flavor," or "natural peanut flavor."

5) The use of bolding or other highlighting within the ingredient declaration or in allergy information statements in immediate proximity to the ingredient declaration.

Food companies also should follow FDA's current guidance[4] regarding the labeling of "incidental additives" that contain or are themselves a Major Food Allergen, by declaring the Major Food Allergen in the ingredient list of the food.

D. Supplemental Allergen Statements

Food processors that prepare foods potentially exposed to inadvertent contact with Major Food Allergens acknowledge that labeling is not a substitute for good manufacturing practices (GMP).

Supplemental allergen statements should be used judiciously only when all four of the following criteria are met:

1) The presence of a Major Food Allergen is documented through visual examination or analytical testing of the processing line, equipment, ingredient or product, or other means;

2) The risk of presence of a Major Food Allergen is unavoidable even when current GMPs are followed;

3) A Major Food Allergen is present in some, but not all, of the product; and,

4) The presence of a Major Food Allergen is potentially hazardous.

If some, but not all, of these criteria are met, food and ingredient manufacturers should consider food allergen control and/or labeling strategies other than supplemental allergen statements.

When all four of these criteria are satisfied, the supplemental allergen statement should be placed in close proximity to the ingredient declaration. When using an ingredient that utilizes a supplemental allergen statement, the food processor should carry that supplemental allergen statement forward to the label of its food only when these four criteria are met. Any supplemental allergen statement should be as accurate and conspicuous as possible, to help allergic consumers make a clear decision about whether or not the food is appropriate for them to eat. Any supplemental allergen statement should be placed at the end of, or in immediate proximity to, the ingredient declaration.

Food processors should strive to label the same product consistently, even if it is produced in different locations or in different package sizes. Such label consistency would be useful to food allergic consumers.

May 22, 2001

Appendix A

June 10, 1996

FDA Allergy Warning Letter
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition

NOTICE TO MANUFACTURERS

Label Declaration of Allergenic Substances in Foods

This letter is to make you aware of the Food and Drug Administration's (FDA's) concerns regarding the labeling of foods that contain allergenic substances. Recently, FDA has received a number of reports concerning consumers who experienced adverse reactions following exposure to an allergenic substance in foods. These exposures occurred because the presence of the allergenic substance in the food was not declared on the food label.

The Food, Drug, and Cosmetic Act (the act) requires, in virtually all cases, a complete listing of all the ingredients of a food. Two of the very narrow exemptions from ingredient labeling requirements appear to have been involved in a number of the recent incidents, however. First, section 403(i) of the act provides that spices, flavorings, and colorings may be declared collectively without naming each one. Secondly, FDA regulations (21 CFR 101.100(a)(3)) exempt from ingredient declaration incidental additives, such as processing aids, that are present in a food at insignificant levels and that do not have a technical or functional effect in the finished food.

In some of the instances of adverse reactions, failure to declare an ingredient appears to have been the result of a misinterpretation of the exemption from ingredient declaration provided for incidental additives in 101.100(a)(3). FDA reminds manufacturers that to qualify for the exemption from ingredient declaration provided for incidental additives and processing aids, a substance must meet both of the requirements of 101.100(a)(3), i.e., it must be present in the food at an insignificant level, and it must not have any technical or functional effect in the finished food. Thus, incidental additives may include substances that are present in a food by virtue of their incorporation as an ingredient in another food. However, when an ingredient added to another food continues to have an effect in the finished food (e.g., egg white as a binder in breading used on a breaded fish product), the ingredient is not an incidental additive, and its use must be declared on the label.

The recent adverse reaction reports indicate that some manufacturers have also incorrectly interpreted what constitutes an insignificant level of a substance. Clearly, an amount of a substance that may cause an adverse reaction is not insignificant. Because evidence suggests that some allergenic substances can cause serious allergic responses in some individuals upon ingestion of very small amounts of the substance, it is unlikely that such an allergen, when it is present in a food, can be present at an insignificant level. Thus, it follows that the requirements of 101.100(a)(3) cannot be met under such circumstances.

FDA is considering whether it is necessary to clarify its regulations to ensure that manufacturers fully understand the circumstances in which allergenic food ingredients must be declared and to ensure that sensitive individuals are protected by appropriate labeling.

We have also received reports of adverse reactions to foods in which likely allergenic substances were used as flavors, and not declared by name. Therefore, in addition to the exemption in 101.100(a)(3), the agency is also considering whether an allergenic ingredient in a spice, flavor, or color should be required to be declared, 403(i) not withstanding. On a substance-by-substance basis, the agency has required ingredients covered by the exemption in section 403(i) to be declared when necessary to protect individuals who experience adverse reactions to the substance, e.g., FD&C Yellow No. 5. The agency is open to suggestions on how to best address this problem.

While FDA has not formally defined "allergens," it provided examples of foods that are among the most commonly known to cause serious allergenic responses, i.e., milk, eggs, fish, crustacea, mollusks, tree nuts, wheat, and legumes (particularly peanuts and soybeans), in a policy statement dealing with foods derived from new plant varieties published in the FEDERAL REGISTER of May 29, 1992 (57 FR 22984 at 22987).

FDA advises that the issue of declaring allergenic ingredients in food is being discussed on an international level. Several individual governments and the Codex Alimentarius Commission have begun to formulate policy for the labeling of foods containing allergenic ingredients to ensure that consumers are provided sufficient information to avoid substances to which they are allergic. While packaged foods sold in the U.S. are among the most comprehensively labeled foods in the world (some countries provide broader exemptions from ingredient declaration), FDA is studying its labeling requirements, and considering whether rulemaking is necessary, for the labeling of allergenic ingredients.

While the agency does so, FDA asks manufacturers to examine their product formulations for ingredients and processing aids that contain known allergens that they may have considered to be exempt from declaration as incidental additives under 101.100(a)(3), and to declare the presence of such ingredients in the ingredient statement. Where appropriate, the name of the ingredient may be accompanied by a parenthetical statement such as "(processing aid)" for clarity.

The voluntary declaration of an allergenic ingredient of a color, flavor, or spice could be accomplished by simply naming the allergenic ingredient in the ingredient list. Because such ingredients are normally present at very low levels, the name of the ingredient could generally be placed at the end of the ingredient list and be consistent with its descending order of predominance by weight. Other, non-allergenic ingredients that are exempt from declaration would remain unlisted.

Another area of concern is the potential, inadvertent introduction of an allergenic ingredient to a food (e.g., in a bakery that is manufacturing two food products on one production line, one product with peanuts and one without, where traces of peanuts, or peanut products, may end up in the product that does not normally contain peanuts). FDA is considering options for providing consumers with information about the possible presence of allergens in these foods.

The agency is aware that some manufacturers are voluntarily labeling their products with statements such as "may contain (insert name of allergenic ingredient)." FDA advises that, because adhering to good manufacturing practice (GMP) is essential for effective reduction of adverse reactions, such precautionary labeling should not be used in lieu of adherence to GMP. The agency urges manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of the identified food. The agency is open to suggestions on how best to address this issue.

Sincerely,

Fred R. Shank, Ph.D.
Director, Center for Food Safety and Applied Nutrition

Appendix B

Compliance Policy Guide
Compliance Policy Guidance for FDA Staff

Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens 1

This update to the Compliance Policy Guides Manual (August 2000 edition) is a new CPG. This update will be included in the next printing of the Compliance Policy Guides Manual. The statements made in the CPG are not intended to create or confer any rights for, or obligations on FDA or any private person, but are intended for internal guidance.

BACKGROUND:

Each year the Food & Drug Administration (FDA) receives reports of consumers who experienced adverse reactions following exposure to an allergenic substance in foods. Food allergies are abnormal responses of the immune system, especially involving the production of allergen specific IgE antibodies, to naturally occurring proteins in certain foods that most individuals can eat safely. Frequently such reactions occur because the presence of the allergenic substances in the foods is not declared on the food label.

To combat this problem, the agency issued a letter titled "Notice to Manufacturers," dated June 10, 1996, which addressed labeling issues and Good Manufacturing Practices (GMPs). This letter is available on FDA's website, www.cfsan.fda.gov/~lrd/allerg7.html.

FDA believes there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies. 2, 3, 4

Peanuts
Soybeans
Milk
Eggs
Fish
Crustacea
Tree nuts
Wheat

Note: For other foods that may cause an allergic response in certain individuals, the FDA district office should contact CFSAN/Office of Field Programs for guidance.

Manufacturers are responsible for ensuring that food is not adulterated or misbranded as a result of the presence of undeclared allergens. Therefore, the districts should pay particular attention to situations where these substances are added intentionally to food, but not declared on the label, or may be unintentionally introduced into a food product and consequently not declared on the label. When an allergen, not formulated in the product, is identified as likely to occur in the food due to the firm's practices, (e.g., use of common equipment, production scheduling, rework practices) then the district should determine if a manufacturer has identified and implemented control(s) to prevent potential allergen cross-contact, e.g. dedicated equipment, separation, production scheduling, sanitation, proper rework usage (like into like).

POLICY:
Direct addition as ingredients or sub-ingredients

Products which contain an allergenic ingredient by design must comply with 21 U.S.C. 343(i)(2). Where substances that are, bear, or contain allergens are added as ingredients or sub-ingredients (including rework), the Federal Food, Drug, and Cosmetic Act (the Act) requires a complete listing of the food ingredients (section 403(i)(2); 21 U.S.C. 343(i)(2); 21 C.F.R.101.4) unless a labeling exemption applies.

Exemptions from Ingredient Labeling

Section 403(i)(2) of the Act provides that spices, flavors, and certain colors used in a food may be declared collectively without naming each one. In some instances, these ingredients contain sub-components that are allergens. 5

FDA's regulations (21 CFR 101.100(a)(3)), provide that incidental additives, such as processing aids, which are present in a food at insignificant levels and that do not have a technical or functional effect in the finished food are exempt from ingredient declaration. Some manufacturers have asserted to FDA that some allergens that are used as processing aids qualify for this exemption. FDA, however, has never considered food allergens eligible for this exemption. Evidence indicates that some food allergens can cause serious reactions in sensitive individuals upon ingestion of very small amounts; therefore, the presence of an allergen must be declared in accordance with 21 CFR 101.4. The exemption under 21 CFR 101.100(a)(3) does not apply to allergenic ingredients.

Practices Used to Prevent Potential Allergen Cross-contact

Allergens may be unintentionally added to food as a result of practices such as improper rework addition, product carry-over due to use of common equipment and production sequencing, or the presence of an allergenic product above exposed product lines. Such practices with respect to allergenic substances may be insanitary conditions that may render the food injurious to health and adulterate the product under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)].

REGULATORY ACTION CRITERIA:

The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210):

The FDA district office obtains inspection evidence showing that a food was manufactured to contain an allergenic ingredient as a primary or secondary ingredient, but the food's label does not declare such allergenic ingredient, and

The allergenic ingredient is one of the eight (8) ingredients listed in this guide, and

The allergenic ingredient was not used as a processing aid in the production of the food, and

The inspection of the firm was conducted consistent with the Guide To Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients. The following represents the criteria for recommending legal action to CFSAN/Office of Field Programs/Division of Enforcement and Programs (HFS-605):

The food contains an undeclared allergenic ingredient that is a derivative of one of the eight (8) ingredients listed in this guide.

The food contains an undeclared allergenic ingredient that was used as a processing aid in the manufacture of the product.

The food contains an undeclared allergenic ingredient, but the ingredient is not one of the eight (8) allergens listed in this guide.

The food is not labeled as containing an allergen, but inspection of the firm shows that it was manufactured under conditions whereby the food may have become contaminated with an allergen.

The inspection of the firm was conducted consistent with the Guide To Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients.

Specimen Charges:

Misbranding due to an undeclared allergen:

The article was misbranded when introduced into and while in interstate commerce and is misbranded while held for sale after shipment in interstate commerce, within the meaning of the Act, 21 U.S.C. 343(i)(2), in that it is fabricated from two or more ingredients, and its label fails to bear the common or usual name of each such ingredient, namely (specify the undeclared allergenic ingredient).

Adulteration due to food contamination with an allergen:

The article was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce, within the meaning of the Act, 21 U.S.C. 342(a)(4), in that it has been prepared, packed and held under insanitary conditions whereby it may have been rendered injurious to health.

_____________________________________

1. This update to the Compliance Policy Guides Manual (August 2000 edition) is a new CPG. This update will be included in the next printing of the Compliance Policy Guides Manual. The statements made in the CPG are not intended to create or confer any rights for, or obligations on FDA or any private person, but are intended for internal guidance.

2. Food and Agriculture Organization of the United Nations, Report of the FAO Technical Consultation on Food Allergies. Rome, Italy, November 13 to 14, 1995.

3. Hefle, S.L., et al. Allergenic Foods. Critical Reviews in Food Science and Nutrition, 36(S);S69-S89 (1996).

4. Sampson, H.A. Food Allergy, JAMA (278), pp. 1888-1894, 1997.

5. As noted in the 1996 letter, FDA is exploring whether allergenic ingredients in spices, flavorings, or colors should be declared, 21 U.S.C. 343(i) notwithstanding. In the meantime, FDA strongly encourages the declaration of an allergenic ingredient of a spice, flavor, or color by either:

£declaring the allergenic ingredient by it's common or usual name in the ingredient list as a separate ingredient or parenthetically following the term spice, flavor, or color
or

as a declaration attached at the end of the list of ingredients indicating the presence of a specific allergen.

_____________________________________

Issued: 04/19/2001

--------------------------------------------------------------------------------

[1] The Food Allergy Issues Alliance recognizes "plain English" as a simple term of art for terms commonly understood by consumers. However, "plain English" is not appropriate terminology to reference the names of Major Food Allergens with respect to bilingual or multi-lingual food labels.

[2] FAO. 1995. Report of the FAO Technical Consultation on Food Allergies. Rome: Food and Agriculture Organization.

[3] Some foods that are introduced unlabeled into interstate commerce for final labeling or further processing at a different location (21 CFR 101.100(d)) should include information on the presence of Major Food Allergens in the labeling that accompanies such shipments.

[4] June 10, 1996, FDA Allergy Warning Letter, is attached as Appendix A. April 2001 Compliance Policy Guide, Sec. 555.250 "Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens," is attached as Appendix B.



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