The Food Labeling and Consumer Protection Act

On August 2, 2004, President George W. Bush signed into law
The Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Senate Bill S.741.

Summary of the bill's provisions by CSA Executive Director Mary Schluckebier

1) GLUTEN LABELING
"Not later than two years after the date of enactment, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall is-sue a proposed rule to define, and permit use of, the term 'gluten-free' on the labeling of foods. Not later than four years after the date of enactment, the Secretary shall issue a rule to define, and permit use of, 'gluten-free' on the labeling of foods." Section 206.

2) ALLERGENS
The list of major allergens contains milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soy-beans or ingredients containing the protein from any of the above. Wheat, as one of the major aller-gens, is included in ALL stipulations of Title II of the bill. In this article, only Wheat will be identified. Sec-tion 203 (7)(qq)(1-2).

3) COMMON NAME
Food products labeled after Janu-ary 1, 2006 are required to include the presence of any of the eight major allergens by the common and usual name. Some items will be excluded. Section 202 (5)(A); Section 203 (w); (1)(B)(i)(ii); (7)(C)(d). The common name wheat is to be used (Section 202(5)(A) for any variety or derivative of wheat in all food items except when the grain or derivative is in the unprocessed state of the raw agricultural com-modity. There is a provision to allow wheat derived ingredients to be exempted from source label-ing. Section 203 (a), (w)(1); Section 203(6)(A)(C), (7)(A)(i)(ii).

4) FLAVORS, COLORS, ADDI-TIVES
Food labels will be required to include the presence of wheat in flavoring, coloring or incidental addi-tives for products labeled after Janu-ary 1, 2006. The Secretary of Health and Human Services may develop a regulation for labeling the presence of non-major food allergens. Section 203 (7)(C)(x).

5) CROSS CONTAMINATION
A "Cross Contact" Report on Food Allergens is to be prepared by the Secretary of Health and Hu-man Services and reported to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Repre-sentatives. The report is to:

  • constitute an analysis of US manufacturing processes related to cross contamina- tion, Section 204 (1)(A).
  • advise on good practices to eliminate cross-contact, Sec- tion 204(2).
  • describe the sample of situations reviewed, number of inspections, nature of vio- lations, voluntary recalls, Section 204 (3)-(5) .
  • assess the extent to which the food industry has effectively addressed the cross-contact issues, Section 204 (6).

6) CAUTION STATEMENTS
The Secretary of HHS is to:

  • determine use of cautionary phrases such as "may contain."
  • survey consumers to deter- mine how consumers with food allergies or caretakers prefer the risk of cross- contact to be communicated on food labels. Section 204 (1-6). Terms such as "contains wheat" are to be printed after or adja-cent to the list of ingredients, Section 203 (a),(w)(1)(A) , unless the ingredient uses the common name or appears at least one other time in the list, Section 203 (a),(w)(1)(B)(i),(ii) , or as deter-mined by the Secretary of HHS and published in Federal Register as a notice, Section 203 (a)(w)(3) .

7) EXCEPTIONS
Wheat will not appear on the label if an ingredient is derived from or is a highly refined wheat-based oil. Section 203 (a)(w)(1)(B)(i),(ii),(7)(C)(qq)(A),(B).

8) EXEMPTIONS
Any person may petition the Secretary of HHS to exempt a food ingredient. It must be dem-onstrated that the ingredient does not cause an allergic response or contain the allergic protein that poses a risk to human health. Both the petition and Secretary's decision on that ingredient will be posted to a public site. Section 203 (a)(6)(A)-(E);Section 203 (a), (w)(6)(A)(C),(7)(A). CSA 3 2004 Summer . CSA Lifeline . www.csaceliacs.org . 877-CSA-4-CSA

9) INSPECTIONS
Inspections of facilities in which foods are manufactured, pro-cessed, packed or held will be conducted:

  • to ensure those practices reduce or eliminate cross- contact of a food with resi- dues of wheat not intentional ingredients of the food; and
  • to ensure the presence of wheat is properly labeled on foods. Inspection criteria is described in Section 205 , "Inspections Relating to Food Allergens" and completed by authority under Section 704 of the Federal Food, Drug, and Cosmetic Act (CFR 21 U.S.C. 374). Section 205 (1)-(2). Other aspects of the law include Improvement and Publication of Data on Food-Related Allergic Responses, Section 207 , Food Allergies Research, Section 208 , Food Allergens in the Food Code, Section 209 , Recommenda-tions Regarding Responding to Food-Related Allergic Re-sponses, Section 210 .

Labeling does not become mandatory for several years, but voluntary labeling by manufacturers of source ingre-dients is expected to increase before then. Encourage mean-ingful, consistent and verifi-able labeling by sending thank you letters, e-mails or calls to manufacturers. An additional idea is to compose and send an edited ingredient label including the additional infor-mation you require to make an informed food choice.