I 

108TH CONGRESS 

1ST SESSION H. R. 3684

To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 

requirements with respect to allergenic substances in foods, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 8, 2003

Mrs. LOWEY (for herself, Mr. GREENWOOD, Mr. LATOURETTE, Ms. WOOLSEY, Mr. SERRANO, Mr. PALLONE, Mr. HOEFFEL, Ms. SLAUGHTER, Mr. 

HINCHEY, Ms. NORTON, Ms. DELAURO, Mr. GEORGE MILLER of California, Mr. BROWN of Ohio, Ms. ROYBAL-ALLARD, and Mr. WAXMAN) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to 

establish labeling requirements with respect to allergenic 

substances in foods, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Allergen Label5 ing and Consumer Protection Act of 2003’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that—
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1 (1) it is estimated that—

2 (A) approximately 2 percent of adults and 

3 about 5 percent of infants and young children 

4 in the United States suffer from food allergies; 

5 and 

6 (B) each year, roughly 30,000 individuals 

7 require emergency room treatment and 150 in8 dividuals die because of allergic reactions to 

9 food; 

10 (2)(A) eight major foods or food groups—milk, 

11 eggs, fish, Crustacean shellfish, tree nuts, peanuts, 

12 wheat, and soybeans—account for 90 percent of 

13 food allergies; 

14 (B) at present, there is no cure for food aller15 gies; and 

16 (C) a food allergic consumer must avoid the 

17 food to which the consumer is allergic; 

18 (3)(A) in a review of the foods of randomly se19 lected manufacturers of baked goods, ice cream, and 

20 candy in Minnesota and Wisconsin in 1999, the 

21 Food and Drug Administration found that 25 per22 cent of sampled foods failed to list peanuts or eggs 

23 as ingredients on the food labels; and 
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1 (B) nationally, the number of recalls because of 

2 unlabeled allergens rose to 121 in 2000 from about 

3 35 a decade earlier; 

4 (4) a recent study shows that many parents of 

5 children with a food allergy were unable to correctly 

6 identify in each of several food labels the ingredients 

7 derived from major food allergens; 

8 (5)(A) ingredients in foods must be listed by 

9 their ‘‘common or usual name’’; 

10 (B) in some cases, the common or usual name 

11 of an ingredient may be unfamiliar to consumers, 

12 and many consumers may not realize the ingredient 

13 is derived from, or contains, a major food allergen; 

14 and 

15 (C) in other cases, the ingredients may be de16 clared as a class, including spices, flavorings, and 

17 certain colorings, or are exempt from the ingredient 

18 labeling requirements, such as incidental additives; 

19 and 

20 (6)(A) celiac disease is an immune-mediated 

21 disease that causes damage to the gastrointestinal 

22 tract, central nervous system, and other organs; 

23 (B) the current recommended treatment is 

24 avoidance of glutens in foods that are associated 

25 with celiac disease; and 
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1 (C) a multicenter, multiyear study estimated 

2 that the prevalence of celiac disease in the United 

3 States is 0.5 to 1 percent of the general population. 

4 SEC. 3. FOOD LABELING; REQUIREMENT OF INFORMATION 

5 REGARDING ALLERGENIC SUBSTANCES. 

6 (a) IN GENERAL.—Section 403 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 

8 adding at the end the following: 

9 ‘‘(w)(1) If it is not a raw agricultural commodity and 

10 it is, or it contains an ingredient that bears or contains, 

11 a major food allergen, unless either—

12 ‘‘(A) the word ‘Contains’, followed by the name 

13 of the food source from which the major food aller14 gen is derived, is printed immediately after or is ad15 jacent to the list of ingredients (in a type size no 

16 smaller than the type size used in the list of ingredi17 ents) required under subsections (g) and (i); or 

18 ‘‘(B) the common or usual name of the major 

19 food allergen in the list of ingredients required 

20 under subsections (g) and (i) is followed in paren21 theses by the name of the food source from which

22 the major food allergen is derived, except that the 

23 name of the food source is not required when—
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1 ‘‘(i) the common or usual name of the in2 gredient uses the name of the food source from 

3 which the major food allergen is derived; or 

4 ‘‘(ii) the name of the food source from 

5 which the major food allergen is derived ap6 pears elsewhere in the ingredient list, unless the 

7 name of the food source appears elsewhere in 

8 the ingredient list only in the common or usual 

9 name of foods that are food ingredients that are 

10 not major food allergens under section 

11 201(qq)(2)(A) or (B). 

12 ‘‘(2) As used in this subsection, the term ‘name of 

13 the food source from which the major food allergen is de14 rived’ means the name described in section 201(qq)(1); 

15 provided that in the case of a tree nut, fish, or Crustacean 

16 shellfish, the term ‘name of the food source from which 

17 the major food allergen is derived’ means the name of the 

18 specific type of nut or species of fish or Crustacean shell19 fish. 

20 ‘‘(3) The information required under this subsection 

21 may appear in labeling in lieu of appearing on the label 

22 only if the Secretary finds that such other labeling is suffi23 cient to protect the public health. A finding by the Sec24 retary under this paragraph (including any change in an 
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1 earlier finding under this paragraph) is effective upon 

2 publication in the Federal Register as a notice. 

3 ‘‘(4) Notwithstanding subsection (g), (i), or (k), or 

4 any other law, a flavoring, coloring, or incidental additive 

5 that is, or that bears or contains, a major food allergen 

6 shall be subject to the labeling requirements of this sub7 section. 

8 ‘‘(5) The Secretary may by regulation modify the re9 quirements of subparagraph (A) or (B) of paragraph (1), 

10 or eliminate either the requirement of subparagraph (A) 

11 or the requirements of subparagraph (B) of paragraph 

12 (1), if the Secretary determines that the modification or 

13 elimination of the requirement of subparagraph (A) or the 

14 requirements of subparagraph (B) is necessary to protect 

15 the public health. 

16 ‘‘(6)(A) Any person may petition the Secretary to ex17 empt a food ingredient described in section 201(qq)(2) 

18 from the allergen labeling requirements of this subsection. 

19 ‘‘(B) The Secretary shall approve or deny such peti20 tion within 180 days of receipt of the petition or the peti21 tion shall be deemed denied, unless an extension of time 

22 is mutually agreed upon by the Secretary and the peti23 tioner. 

24 ‘‘(C) The burden shall be on the petitioner to provide 

25 scientific evidence (including the analytical method used 
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1 to produce the evidence) that demonstrates that such food 

2 ingredient, as derived by the method specified in the peti3 tion, does not cause an allergic response that poses a risk 

4 to human health. 

5 ‘‘(D) A determination regarding a petition under this 

6 paragraph shall constitute final agency action. 

7 ‘‘(E) The Secretary shall promptly post to a public 

8 site all petitions received under this paragraph within 14 

9 days of receipt and the Secretary shall promptly post the 

10 Secretary’s response to each. 

11 ‘‘(7)(A) A person need not file a petition under para12 graph (6) to exempt a food ingredient described in section 

13 201(qq)(2) from the allergen labeling requirements of this 

14 subsection, if the person files with the Secretary a notifica15 tion containing—

16 ‘‘(i) scientific evidence (including the analytical 

17 method used) that demonstrates that the food ingre18 dient (as derived by the method specified in the noti19 fication, where applicable) does not contain aller20 genic protein; or 

21 ‘‘(ii) a determination by the Secretary that the 

22 ingredient does not cause an allergic response that 

23 poses a risk to human health under a premarket ap24 proval or notification program under section 409. 
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1 ‘‘(B) The food ingredient may be introduced or deliv2 ered for introduction into interstate commerce as a food 

3 ingredient that is not a major food allergen 90 days after 

4 the date of receipt of the notification by the Secretary, 

5 unless the Secretary determines within the 90-day period 

6 that the notification does not meet the requirements of 

7 this paragraph, or there is insufficient scientific evidence 

8 to determine that the food ingredient does not contain al9 lergenic protein or does not cause an allergenic response 

10 that poses a risk to human health. 

11 ‘‘(C) The Secretary shall promptly post to a public 

12 site a list of all notifications received under this subpara13 graph within 14 days of receipt and promptly post any 

14 objections thereto by the Secretary. 

15 ‘‘(x) Notwithstanding subsection (g), (i), or (k), or 

16 any other law, a spice, flavoring, coloring, or incidental 

17 additive that is, or that bears or contains, a food allergen 

18 (other than a major food allergen), as determined by the 

19 Secretary by regulation, shall be disclosed in a manner 

20 specified by the Secretary by regulation.’’. 

21 (b) EFFECT ON OTHER AUTHORITY.—The amend22 ments made by this section that require a label or labeling 

23 for major food allergens do not alter the authority of the 

24 Secretary of Health and Human Services under the Fed-
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1 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

2 seq.) to require a label or labeling for other food allergens. 

3 (c) CONFORMING AMENDMENTS.—

4 (1) Section 201 of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 321) (as amended by sec6 tion 2(b)) is amended by adding at the end the fol7 lowing: 

8 ‘‘(qq) The term ‘major food allergen’ means any of 

9 the following: 

10 ‘‘(1) Milk, egg, fish (e.g., bass, flounder, or 

11 cod), Crustacean shellfish (e.g., crab, lobster, or 

12 shrimp), tree nuts (e.g., almonds, pecans, or wal13 nuts), wheat, peanuts, and soybeans. 

14 ‘‘(2) A food ingredient that contains protein de15 rived from a food specified in paragraph (1), except 

16 the following: 

17 ‘‘(A) Any highly refined oil derived from a 

18 food specified in paragraph (1) and any ingre19 dient derived from such highly refined oil. 

20 ‘‘(B) A food ingredient that is exempt 

21 under paragraph (6) or (7) of section 403(w).’’. 

22 (2) Section 403A(a)(2) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(2)) is

24 amended by striking ‘‘or 403(i)(2)’’ and inserting 

25 ‘‘403(i)(2), 403(w), or 403(x)’’. 
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1 (d) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to any food that is labeled on or 

3 after January 1, 2006. 

4 SEC. 4. REPORT ON FOOD ALLERGENS. 

5 Not later than 18 months after the date of enactment 

6 of this Act, the Secretary of Health and Human Services 

7 (in this section referred to as the ‘‘Secretary’’) shall sub8 mit to the Committee on Health, Education, Labor, and 

9 Pensions of the Senate and the Committee on Energy and 

10 Commerce of the House of Representatives a report 

11 that—

12 (1)(A) analyzes—

13 (i) the ways in which foods, during manu14 facturing and processing, are unintentionally 

15 contaminated with major food allergens, includ16 ing contamination caused by the use by manu17 facturers of the same production line to produce 

18 both products for which major food allergens 

19 are intentional ingredients and products for 

20 which major food allergens are not intentional 

21 ingredients; and 

22 (ii) the ways in which foods produced on 

23 dedicated production lines are unintentionally 

24 contaminated with major food allergens; and 
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1 (B) estimates how common the practices de2 scribed in subparagraph (A) are in the food indus3 try, with breakdowns by food type as appropriate; 

4 (2) advises whether good manufacturing prac5 tices or other methods can be used to reduce or 

6 eliminate cross-contact of foods with the major food 

7 allergens; 

8 (3) describes—

9 (A) the various types of advisory labeling 

10 (such as labeling that uses the words ‘‘may con11 tain’’) used by food producers; 

12 (B) the conditions of manufacture of food 

13 that are associated with the various types of ad14 visory labeling; and 

15 (C) the extent to which advisory labels are 

16 being used on food products; 

17 (4) describes how consumers with food allergies 

18 or the caretakers of consumers would prefer that in19 formation about the risk of cross-contact be commu20 nicated on food labels as determined by using appro21 priate survey mechanisms; 

22 (5) states the number of inspections of food 

23 manufacturing and processing facilities conducted in 

24 the previous 2 years and describes—
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1 (A) the number of facilities and food labels 

2 that were found to be in compliance or out of 

3 compliance with respect to cross-contact of 

4 foods with residues of major food allergens and 

5 the proper labeling of major food allergens; 

6 (B) the nature of the violations found; and 

7 (C) the number of voluntary recalls, and 

8 their classifications, of foods containing 

9 undeclared major food allergens; and 

10 (6) assesses the extent to which the Secretary 

11 and the food industry have effectively addressed 

12 cross-contact issues. 

13 SEC. 5. INSPECTIONS RELATING TO FOOD ALLERGENS. 

14 The Secretary of Health and Human Services shall 

15 conduct inspections consistent with the authority under 

16 section 704 of the Federal Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 374) of facilities in which foods are manufac18 tured, processed, packed, or held—

19 (1) to ensure that the entities operating the fa20 cilities comply with practices to reduce or eliminate 

21 cross-contact of a food with residues of major food 

22 allergens that are not intentional ingredients of the 

23 food; and 

24 (2) to ensure that major food allergens are 

25 properly labeled on foods. 
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1 SEC. 6. GLUTEN LABELING. 

2 Not later than 2 years after the date of enactment 

3 of this Act, the Secretary of Health and Human Services, 

4 in consultation with appropriate experts and stakeholders, 

5 shall issue a proposed rule to define, and permit use of, 

6 the term ‘‘gluten-free’’ on the labeling of foods. Not later 

7 than 4 years after the date of enactment of this Act, the 

8 Secretary shall issue a final rule to define, and permit use 

9 of, the term ‘‘gluten-free’’ on the labeling of foods. 

10 SEC. 7. IMPROVEMENT AND PUBLICATION OF DATA ON 

11 FOOD-RELATED ALLERGIC RESPONSES. 

12 (a) IN GENERAL.—The Secretary of Health and 

13 Human Services, acting through the Director of the Cen14 ters for Disease Control and Prevention and in consulta15 tion with the Commissioner of Food and Drugs, shall im16 prove (including by educating physicians and other health 

17 care providers) the collection of, and publish as it becomes 

18 available, national data on—

19 (1) the prevalence of food allergies; 

20 (2) the incidence of clinically significant or seri21 ous adverse events related to food allergies; and 

22 (3) the use of different modes of treatment for 

23 and prevention of allergic responses to foods. 

24 (b) AUTHORIZATION OF APPROPRIATIONS.—For the 

25 purpose of carrying out this section, there are authorized 

26 to be appropriated such sums as may be necessary. 
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1 SEC. 8. FOOD ALLERGIES RESEARCH. 

2 (a) IN GENERAL.—The Secretary of Health and 

3 Human Services, acting through the Director of the Na4 tional Institutes of Health, shall convene an ad hoc panel 

5 of nationally recognized experts in allergy and immunology 

6 to review current basic and clinical research efforts related 

7 to food allergies. 

8 (b) RECOMMENDATIONS.—Not later than 1 year 

9 after the date of enactment of this Act, the panel shall 

10 make recommendations to the Secretary for enhancing 

11 and coordinating research activities concerning food aller12 gies, which the Secretary shall make public. 

13 SEC. 9. FOOD ALLERGENS IN THE FOOD CODE. 

14 The Secretary of Health and Human Services shall, 

15 in the Conference for Food Protection, as part of its ef16 forts to encourage cooperative activities between the 

17 States under section 311 of the Public Health Service Act 

18 (42 U.S.C. 243), pursue revision of the Food Code to pro19 vide guidelines for preparing allergen-free foods in food 

20 establishments, including in restaurants, grocery store 

21 delicatessens and bakeries, and elementary and secondary 

22 school cafeterias. The Secretary shall consider guidelines 

23 and recommendations developed by public and private en24 tities for public and private food establishments for pre25 paring allergen-free foods in pursuing this revision. 
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1 SEC. 10. RECOMMENDATIONS REGARDING RESPONDING TO 

2 FOOD-RELATED ALLERGIC RESPONSES 

3 The Secretary of Health and Human Services shall, 

4 in providing technical assistance relating to trauma care 

5 and emergency medical services to State and local agencies 

6 under section 1202(b)(3) of the Public Health Service Act 

7 (42 U.S.C. 300d–2(b)(3)), include technical assistance re8 lating to the use of different modes of treatment for and 

9 prevention of allergic responses to foods.

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