[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3575 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 3575

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
      nutrition labeling of food offered for sale in food service 
                            establishments.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

           September 25 (legislative day, September 17), 2008

  Mr. Carper (for himself and Ms. Murkowski) 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.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Labeling Education 
and Nutrition Act of 2008'' or the ``LEAN Act of 2008''.
    (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.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) a healthy lifestyle includes a balanced diet as well as 
        physical activity;
            (2) approximately 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 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 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.

SEC. 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).''.

SEC. 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).''.

SEC. 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.''.

SEC. 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.''.

SEC. 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''.

SEC. 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).

SEC. 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).

SEC. 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).''
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