[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2469 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 2469

To amend the Federal Food, Drug, and Cosmetic Act and other statutes to 
    provide for improvements in the regulation of food ingredients, 
  nutrient content claims, and health claims, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 11, 1997

Mr. Whitfield (for himself, Mr. Towns, Mr. Klug, Mr. Hall of Texas, Mr. 
  Greenwood, Mr. Manton, Mr. Burr of North Carolina, Ms. McCarthy of 
   Missouri, Mr. Barton of Texas, Mr. Coburn, Mr. Upton, Mr. Deal of 
  Georgia, Mr. Bilirakis, Mr. Engel, and Mr. Dingell) introduced the 
    following bill; which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and other statutes to 
    provide for improvements in the regulation of food ingredients, 
  nutrient content claims, and health claims, and for other purposes.

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

SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food and Nutrition 
Information Reform Act''.
    (b) Reference.--Unless otherwise stated, whenever in this Act an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title; reference; table of contents.
         TITLE I--IMPROVING THE REGULATION AND LABELING OF FOOD

Sec. 101. Flexibility for regulations regarding claims.
Sec. 102. Petitions for claims.
Sec. 103. Health claims for food products.
Sec. 104. Nutrient content claims.
Sec. 105. Referral statements.
Sec. 106. Disclosure of irradiation.
Sec. 107. Margarine.
                        TITLE II--EFFECTIVE DATE

Sec. 201. Effective date.

         TITLE I--IMPROVING THE REGULATION AND LABELING OF FOOD

SEC. 101. FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.

    Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended by adding at the 
end the following:
    ``(D) Proposed regulations under this paragraph may be made 
effective upon publication at the discretion of the Secretary, 
notwithstanding the provisions of 5 U.S.C. 553, pending consideration 
of public comment and publication of a final regulation. Such 
regulations shall be effective for a period not to exceed 270 days and 
shall be deemed final agency action for purposes of judicial review.''.

SEC. 102. PETITIONS FOR CLAIMS.

    Section 403(r)(4) (21 U.S.C. 343(r)(4)) is amended as follows:
            (1) By adding after the second sentence the following: ``If 
        the Secretary does not act within such 100 days, the petition 
        shall be deemed to be denied.''.
            (2) In the fourth sentence of subparagraph (A)(i) (as 
        amended by paragraph (1)) by inserting immediately before the 
        comma the following: ``or the petition is deemed to be 
        denied''.
            (3) Subparagraph (A)(i) is amended by adding at the end the 
        following: ``If the Secretary does not act within such 90 days, 
        the petition shall be deemed to be denied. If the Secretary 
        issues a proposed regulation, the rulemaking shall be completed 
        within 540 days of the date the petition is received by the 
        Secretary and the proposed regulation shall be considered a 
        final regulation if the Secretary does not complete the 
        rulemaking within such 540 days.''.

SEC. 103. HEALTH CLAIMS FOR FOOD PRODUCTS.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the 
end thereof the following:
    ``(C) Notwithstanding the provisions of clauses (A)(i) and (B), a 
claim of the type described in subparagraph (1)(B) which is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause (B) shall be authorized and may be made with respect to a 
food if--
            ``(i) a scientific body of the United States Government 
        with official responsibility for public health protection or 
        research directly relating to human nutrition (such as the 
        National Institutes of Health, the Centers for Disease Control 
        and Prevention, or the National Academy of Sciences or 
        subdivisions of such scientific body) has published an 
        authoritative statement, which is currently in effect, about 
        the relationship between a nutrient and a disease or health-
        related condition to which the claim refers;
            ``(ii) a person has submitted to the Secretary, at least 
        120 days before the first introduction into interstate commerce 
        of the food with a label containing the claim, a notice of the 
        claim, including a concise description of the basis upon which 
        such person relied for determining that the requirements of 
        subclause (i) have been satisfied;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clause (A)(ii) and are otherwise in 
compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in clause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an 
authoritative statement of such a scientific body described in 
subclause (i) only if the statement is published by the scientific body 
and shall not include a statement of an employee of the scientific body 
made in the individual capacity of the employee.
    ``(D) A claim submitted under the requirements of clause (C) may be 
made until--
            ``(i) such time as the Secretary issues a regulation under 
        the standard in clause (B) (I) prohibiting or modifying the 
        claim and the regulation has become effective, or (II) finding 
        that the requirements of clause (C) have not been met; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (C) have not been met.''.

SEC. 104. NUTRIENT CONTENT CLAIMS.

    Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding at the 
end the following:
    ``(G) A claim of the type described in subparagraph (1)(A) for a 
nutrient, for which the Secretary has not promulgated a regulation 
under clause (A)(i), shall be authorized and may be made with respect 
to a food if--
            ``(i) a scientific body of the United States Government 
        with official responsibility for public health protection or 
        research directly relating to human nutrition (such as the 
        National Institutes of Health, the Centers for Disease Control 
        and Prevention, or the National Academy of Sciences or 
        subdivisions of such scientific body) has published an 
        authoritative statement, which is currently in effect, which 
        sets forth a basis for such claim;
            ``(ii) a person has submitted to the Secretary, at least 
        120 days before the first introduction into interstate commerce 
        of the food with a label containing the claim, a notice of the 
        claim, including a concise description of the basis upon which 
        such person relied for determining that the requirements of 
        subclause (i) have been satisfied;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clauses (A) and (B), and are otherwise 
        in compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an 
authoritative statement of such a scientific body described in 
subclause (i) only if the statement is published by the scientific body 
and shall not include a statement of an employee of the scientific body 
made in the individual capacity of the employee.
    ``(H) A claim submitted under the requirements of clause (G) may be 
made until--
            ``(i) such time as the Secretary issues a regulation (I) 
        prohibiting or modifying the claim and the regulation has 
        become effective, or (II) finding that the requirements of 
        clause (G) have not been met; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (G) have not been met.''.

SEC. 105. REFERRAL STATEMENTS.

    Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as 
follows:
    ``(B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food, and the Secretary makes a 
determination that the food contains a nutrient at a level that 
increases to persons in the general population the risk of a disease or 
health-related condition that is diet related, then the label or 
labeling of such food shall contain, prominently and in immediate 
proximity to such claim, the following statement: `See nutrition 
information for ____ content.' The blank shall identify the nutrient 
associated with the increased disease or health-related condition risk. 
In making the determination described in this clause, the Secretary 
shall take into account the significance of the food in the total daily 
diet.''.

SEC. 106. DISCLOSURE OF IRRADIATION.

    Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after 
section 403B the following:

                              ``disclosure

    ``Sec. 403C. (a) No provision of section 403(a), 201(n) or 409 
shall be construed to require on the label or labeling of a food a 
separate radiation disclosure statement that is more prominent than the 
declaration of ingredients required by section 403(i)(2).
    ``(b) In this section, the term `radiation disclosure statement' 
means a written statement that discloses that a food or a component of 
the food has been intentionally subject to radiation.''.

SEC. 107. MARGARINE.

    (a) Section 301(m).--Paragraph (m) of section 301 (21 U.S.C. 331) 
is amended by striking ``section 407(b) or 407(c)'' and inserting 
``section 407''.
    (b) Section 407.--Section 407 (21 U.S.C. 347) is amended to read as 
follows:

                     ``oleomargarine and margarine

    ``Sec. 407. No person shall sell, or offer for sale, oleomargarine 
or colored margarine unless the principal display panel of such 
oleomargarine or margarine bears as one of its principal features the 
word ``oleomargarine'' or ``margarine'' which is in--
            ``(1) bold type on such panel;
            ``(2) a size reasonably related to the most prominent 
        printed matter (but no less than one-half the point size of 
        such matter); and
            ``(3) lines generally parallel to the base on which the 
        package rests as it is designed to be displayed.''.
    (c) Act of March 16, 1950.--Sections 3(a) and 6 of the Act of March 
16, 1950 (21 U.S.C. 347a, 347b), are repealed.

                        TITLE II--EFFECTIVE DATE

SEC. 201. EFFECTIVE DATE.

    The amendments made by this Act shall take effect on the date of 
the enactment of this Act. The Secretary of Health and Human Services 
shall not enforce any regulation that is inconsistent with the 
amendment made by section 101 after the date of the enactment of this 
Act.
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