II 111th CONGRESS 1st Session S. 558 IN THE SENATE OF THE UNITED STATES March 10, 2009 Mr. Carper (for himself, Ms. Murkowski, Mr. Burr, Ms. Landrieu, Mr. Nelson of Florida, and Mr. Voinovich) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to nutrition labeling of food offered for sale in food service establishments.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Labeling Education and Nutrition Act of 2009 or the LEAN Act of 2009. (b)

Table of contents

The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings. Sec. 3. Definitions. Sec. 4. Nutrition labeling exemption. Sec. 5. Voluntary nutrition labeling. Sec. 6. Mandatory nutrition labeling. Sec. 7. National uniformity. Sec. 8. Implementing regulations. Sec. 9. Effective dates. Sec. 10. Technical and conforming amendments.

2.

Findings

Congress finds that— (1)a healthy lifestyle includes a balanced diet as well as physical activity; (2)more than 60 percent of American adults and 30 percent of American children suffer from being overweight and obese, which can lead to many chronic health risks, including diabetes, heart disease, and hypertension; (3)the United States ranks last among nations in reducing the number of preventable deaths resulting from obesity-related chronic illnesses; (4)during the 2-decade period preceding the date of enactment of this Act, there has been a significant increase in the number of meals prepared or eaten outside the home; (5)nutrition labeling pursuant to the Nutrition Labeling and Education Act of 1990 has increased significantly American consumers' access to nutrition information regarding the foods they consume; (6)the Department of Agriculture and leading health groups recognize that many individuals require different information based on individual and specific health needs and risks; (7)the nutrients provided pursuant to the Nutrition Labeling and Education Act of 1990 (Public Law 101–535) provides consumers with all the tools needed to make healthy choices; (8)as of 2008, nutrition information for standard food items is voluntarily provided by various delivery methods at many major chains of food service establishments; (9)the nutrient content of a food offered for sale in a food service establishment can be determined with appropriate accuracy by consulting nutrient databases, cookbooks, laboratory analyses, or other sources that provide a reasonable basis for information regarding the nutrient content of a food, notwithstanding variability in the portion size, formulation, and other characteristics of such food or its preparation method; and (10)public health and welfare are advanced if food service establishment nutrition information is not subject to frivolous litigation.

3.

Definitions

Section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) is amended by adding at the end the following: (6)

Definitions

For purposes of subparagraphs (7) and (8): (A)The term standard food item means a food offered for sale at least 90 days per calendar year, but does not include food not separately offered for sale or food exempt under subparagraph (5)(C). (B)The term menu or menu board means the primary writing on the premises of the food service establishment from which consumers make their order selection. (C)The term reasonable basis means any means of determining nutrition information for a standard food item made without an intent to deceive, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means. (D)The term food service establishment means an establishment that offers for sale food described in subclause (i) or (ii) of subparagraph (5)(A). .

4.

Nutrition labeling exemption

Section 403(q)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(A)) is amended— (1)by adding at the end of subclause (i) the following: except that such food shall not be considered exempt under this subclause for purposes of providing nutrition information under subparagraph (7) or (8),; and (2)by adding at the end of subclause (ii) the following: except that such food shall not be considered exempt under this subclause for purposes of providing nutrition information under subparagraph (7) or (8),.

5.

Voluntary nutrition labeling

Section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)), as amended by section 3, is further amended by adding at the end the following: (7)

Voluntary nutrition labeling of food service establishment food

A food service establishment may provide nutrition information for a food item under this subparagraph by meeting the following requirements: (A)Providing nutrition information for all of the nutrients required by subparagraphs (1)(C) and (1)(D), determined with a reasonable basis. (B)Disclosing such information in written form on the premises of the food service establishment. (C)Making such disclosure available upon request prior to purchase. .

6.

Mandatory nutrition labeling

Section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)), as amended by section 5, is further amended by adding at the end the following: (8)

In general

The labeling of a standard food item served or offered for sale in a food service establishment that is part of a chain that operates 20 or more establishments under the same trade name (regardless of the type of ownership of the establishments) shall, except as provided in clause (E), disclose, in a clear and conspicuous manner in accordance with paragraph (f), the following information, determined with a reasonable basis, as follows: (A)

Disclosure of calories

(i)

Calories on the menu board

The number of calories shall be disclosed prior to the point of purchase by 1 of the following means: (I)On the menu board. (II)On a sign presenting standard food items in a manner similar to the menu board and located on the same wall as the menu board. (III)On a sign at eye level in the consumer queue prior to the point of purchase. (ii)

Calories on the menu

The number of calories shall be disclosed prior to the point of purchase by 1 of the following means: (I)In the menu. (II)In an insert that accompanies the menu. (III)In an appendix that is attached to the back of the menu. (IV)In a supplemental menu that accompanies the menu. (B)

Additional nutrition information

The nutrition information for all nutrients required by subparagraphs (1)(C) and (1)(D) shall be located on the premises of the food service establishment, in writing, and available to the consumer upon request prior to the point of purchase. (C)

Referral statement

A menu, menu board, or other writing prior to the point of purchase shall bear a statement directing the consumer to the availability of additional nutrition information required under clause (B). (D)

Calorie information statement

If calories are not listed directly on a menu or menu board pursuant to subclause (i)(I), (i)(II), or (ii)(I) of clause (A), then the menu or menu board shall state the suggested daily caloric intake as 2000 calories or an alternative statement prescribed by the Secretary through guidance. (E)

Applicability

This subparagraph shall not apply to— (i)food offered for sale in a nonprofit food service establishment; (ii)food that is not food described in subclause (i) or (ii) of subparagraph (5)(A); and (iii)such other food as the Secretary may exempt by regulation. (F)

Violations

A person shall have knowingly or willfully violated the requirements of this paragraph if the person— (i)purposefully failed to make a disclosure required by this paragraph; or (ii)made a disclosure under this paragraph with an intent to deceive. (G)

One determination per item

A reasonable basis determination of nutrition information shall be required only once per standard food item if the portion size is reasonably consistent and the food service establishment follows a standardized recipe and trains to a consistent method of preparation. .

7.

National uniformity

Section 403A(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(4)) is amended to read as follows: (4)any requirement for nutrition labeling of food that is not identical to the requirement of section 403(q), except a requirement for nutrition labeling of food which is exempt under subclause (i) or (ii) of section 403(q)(5)(A), other than food served in an establishment that is not part of a chain that operates 20 or more establishments under the same trade name, or .

8.

Implementing regulations

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall carry out the following: (1)Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate proposed regulations to mandate nutrition labeling of food service establishment food in accordance with section 403(q)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(8)) (as added by section 6). (2)Not later than 2 years after the date of enactment of this Act, the Secretary shall promulgate final regulations to mandate nutrition labeling of food service establishment food in accordance with section 403(q)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(8)) (as added by section 6). (3)If the Secretary determines that a nutrient other than a nutrient required by section 403(q)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(8)) should be included in the labeling of food menu items subject to such section 403(q)(8) for purposes of providing information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices, the Secretary may by regulation require that information relating to such an additional nutrient be included in the labeling of such food items. (4)If the Secretary determines that the information relating to a nutrient required by section 403(q)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(8)) or paragraph (3) of this section to be included in the labeling of food menu items is not necessary to assist consumers in maintaining healthy dietary practices, the Secretary may by regulation strike the requirement to include such information relating to such nutrient. (5)The Secretary may prescribe by regulation alternative clear and conspicuous means of meeting the requirements of section 403(q)(8)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(8)(A)) (as added by section 6).

9.

Effective dates

The amendments made by this Act shall take effect on the date of enactment of this Act, except that the amendment made by section 6 shall take effect 180 days after the Secretary of Health and Human Services promulgates final regulations under section 8(2).

10.

Technical and conforming amendments

(a)Section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)) is amended by striking subparagraphs (3), (4), and (5) and inserting subparagraphs (3), (4), (5), (7), and (8). (b)Section 403(q)(5)(G) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(G)) is amended by striking Subparagraphs (1), (2), (3) and (4) and inserting Subparagraphs (1), (2), (3), (4), (7) and (8).