[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1709 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 1709

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
     provisions regarding the composition and labeling of dietary 
                              supplements.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 7, 1993

 Mr. Richardson (for himself, Mr. Inhofe, Mr. Towns, Mr. Boehlert, Mr. 
 Schiff, Mr. Frost, Ms. Norton, Mr. Boucher, Mr. Boehner, Mr. Peterson 
    of Minnesota, Ms. Pelosi, Mr. Hall of Texas, Mr. Upton, and Mr. 
   Pallone) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

                              June 8, 1993

 Additional sponsors: Mr. LaRocco, Mr. Olver, Mr. Kreidler, Mr. Inglis 
 of South Carolina, Mr. Doolittle, Mr. Pastor, Mr. Burton of Indiana, 
   Mr. Hochbrueckner, Mr. Parker, Mr. Sensenbrenner, Mr. Spence, Ms. 
                Velazquez, Mrs. Unsoeld, and Mr. Inslee

                             July 28, 1993

 Additional sponsors: Mr. Skaggs, Mr. Jefferson, Mr. Lewis of Florida, 
   Mr. Combest, Mr. Herger, Mr. Orton, Mr. Manzullo, Mr. Rangel, Mr. 
Shays, Mr. DeFazio, Mr. Barcia of Michigan, Mr. Swett, Mr. Zeliff, Mr. 
  Canady, Mr. Lipinski, Mr. Callahan, Mr. Frank of Massachusetts, Mr. 
Farr of California, Mr. Neal of Massachusetts, Mr. Tauzin, Mr. Meehan, 
                       Mr. Bevill, and Mr. McHale

                            August 23, 1993

 Additional sponsors: Mr. Blute, Mr. Cox, Mr. Yates, Mr. Hastert, and 
                              Mr. Kingston

                           September 9, 1993

  Additional sponsors: Mr. Reynolds, Mr. Applegate, Mr. Linder, Mrs. 
  Kennelly, Mr. Stearns, Mr. Murphy, Ms. Furse, Mr. Knollenberg, Mr. 
Mica, Mr. Sarpalius, Mrs. Fowler, Mr. Roth, Mr. Thomas of Wyoming, Mr. 
Bonilla, Ms. Woolsey, Mr. Greenwood, Mr. Coyne, Mr. Deal, Mr. King, Ms. 
                  Shepherd, Mr. Barlow, and Ms. Eshoo

                            October 7, 1993

    Additional sponsors: Mr. Allard, Mr. Regula, Mr. Goodlatte, Ms. 
 Molinari, Mr. Condit, Mr. Schaefer, Mr. Hamburg, Mr. Camp, Mr. Armey, 
  Mr. Baker of California, Mr. Dickey, Mr. Bilbray, Mr. McCollum, Mr. 
 McCrery, Mr. Talent, Mr. Machtley, Mrs. Vucanovich, Mr. Clement, Mr. 
Jacobs, Mr. Lewis of Georgia, Mr. Brooks, Mr. Kopetski, Mr. Gordon, Mr. 
    Portman, Mr. Brown of Ohio, Mr. Miller of Florida, Mr. Brown of 
California, Mr. Hall of Ohio, Mr. Hinchey, Mr. Darden, Mr. Kildee, Mr. 
Kasich, Mr. McInnis, Mr. Dornan, Mr. Franks of Connecticut, Ms. Danner, 
  Mr. Fish, Ms. McKinney, Mr. Reed, Mr. Diaz-Balart, Mr. Deutsch, Mr. 
  Royce, Ms. Kaptur, Mr. Gilman, Mr. Ewing, Mr. Sharp, Ms. Dunn, Mr. 
  Levy, Mr. Gutierrez, Mr. Fawell, Mr. Calvert, Mr. de la Garza, Mr. 
   Andrews of New Jersey, Mr. Gejdenson, Mr. Hastings, Mr. Taylor of 
  Mississippi, Mr. Quillen, Ms. Byrne, Mr. Montgomery, Mr. Johnson of 
                      Georgia, and Mr. Washington

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to establish 
     provisions regarding the composition and labeling of dietary 
                              supplements.

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

SECTION 1. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Dietary Supplement 
Health and Education Act of 1993''.
    (b) Reference.--Whenever in this Act (other than section 7) 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.

SEC. 2. DEFINITIONS.

    (a) Dietary Supplement.--Section 201 (21 U.S.C. 321) is amended by 
adding at the end the following new paragraph:
    ``(gg) The term `dietary supplement' means a food for special 
dietary use, as defined in section 411(c)(3), that--
            ``(1) includes one or more--
                    ``(A) vitamins;
                    ``(B) minerals;
                    ``(C) herbs;
                    ``(D) amino acids; or
                    ``(E) other ingredients for use by man to 
                supplement the diet by increasing the total dietary 
                intake, including a concentrate or extract of any 
                article listed in this paragraph; and
            ``(2) is intended for use in tablet, capsule, powder, 
        softgel, or any other form (including liquid form) that is not 
        represented for use as conventional food or as a sole item of a 
        meal or of the diet.''.
    (b) Food Additive.--Section 201(s) (21 U.S.C. 321(s)) is amended--
            (1) by striking out the period at the end of subparagraph 
        (5) and inserting in lieu thereof ``; or''; and
            (2) by adding after subparagraph (5) the following:
            ``(6) any dietary ingredients of the kind specified in 
        paragraph (gg)(1) in, or intended for use in, a dietary 
        supplement.
For purposes of subparagraph (6) the term `dietary ingredient' means an 
ingredient that is in, or intended for use in, a dietary supplement.''.

SEC. 3. DIETARY SUPPLEMENT LABELING AND COMPOSITION.

    (a) Adulteration.--Section 402 (21 U.S.C. 342) is amended by adding 
at the end the following:
    ``(f) If it is a dietary supplement and--
            ``(1) it contains an unsafe dietary ingredient which is a 
        substance that is intended to be consumed for its dietary 
        properties but which the Secretary has found through rulemaking 
        to present a substantial and unreasonable risk of illness or 
        injury; or
            ``(2) it contains a dietary ingredient that has not been 
        adequately substantiated for safety by the person identified 
        under section 403(e)(1) or by the raw material manufacturer 
        through--
                    ``(A) evidence of a history of safe use (as part of 
                any prior intended use) and the absence of substantial 
                information that brings the safety of the ingredient 
                into question; or
                    ``(B) by well-designed scientific studies conducted 
                in a manner that is consistent with generally 
                recognized scientific procedures and principles; or
                    ``(C) by other appropriate means.
A dietary ingredient that is found to be safe for use in a dietary 
supplement or as a nutrient by the Secretary or by the National Academy 
of Sciences through the establishment of a recommended dietary 
allowance or an estimated safe and adequate dietary intake shall be 
deemed to have met the requirements of this paragraph within the scope 
of the determination by the Secretary or the National Academy of 
Sciences.
    ``(g)(1) If it is a dietary supplement and the Secretary was not 
notified, in accordance with regulations issued under subparagraph (2), 
about a significant change in the manufacturing practice which produced 
the supplement or of potential problems of safety or contamination 
affecting such practice.
    ``(2) The Secretary shall promulgate regulations within 18 months 
of the date of the enactment of this subparagraph to require 
notification to the Secretary by manufacturers of raw materials 
utilized in dietary supplements of significant changes in manufacturing 
practices of such materials or of any potential problems of safety or 
contamination arising from any such changes to ensure the safety of 
such materials.
    ``(3) Subparagraphs (1) and (2) apply only to manufacturing changes 
that are substantial and have been shown to present adverse safety 
consequences. These sections do not apply to routine changes in the 
formulating and manufacturing of dietary supplements by dietary 
supplement manufacturers that utilize good manufacturing practices.''.
    (b) Misbranding.--Section 403 (21 U.S.C. 343) is amended by adding 
at the end the following:
    ``(s) If it is a dietary supplement and--
            ``(1) its label fails to list the name and quantity or 
        proportion of each dietary ingredient included in section 
        201(gg), except that proprietary blends of ingredients may 
        declare the quantity of the total blend;
            ``(2) its label fails to identify the product as a 
        supplement, as a supplement modified with the name of the 
        ingredient of the kind specified in section 201(gg)(1), or as a 
        dietary supplement;
            ``(3) it contains an ingredient of the kind specified in 
        section 201(gg)(1)(C) and the labeling fails to identify the 
        part of the plant from which the ingredient is derived;
            ``(4) if it purports to be or is represented as a dietary 
        supplement the name of which is listed in a compendium for 
        foods recognized in regulations issued by the Secretary and its 
        composition or strength differs from, or its quality or purity 
        (including tablet or capsule disintegration or dissolution) 
        falls below, the standards set forth in such compendium unless 
        such difference in composition, strength, quality, or purity 
        from the applicable compendium standards is plainly stated on 
        the label; or
            ``(5) it is not subject to subparagraph (4) and its 
        composition or strength differs from, or its purity or quality 
        (including tablet or capsule disintegration or dissolution) 
        falls below, that which it purports or is represented to have.
Subparagraph (4) is not to be construed as prohibiting a dietary 
supplement from representing that it meets U.S. Pharmacopeia standards 
for dietary supplements if it meets such standards. Such a supplement 
shall not be deemed a drug because of such a representation.''.
    (c) Compositional Limits.--Section 411 (21 U.S.C. 350) is amended 
by adding at the end the following:
    ``(d)(1) Except as provided in paragraph (2), the Secretary may 
not--
            ``(A) establish under section 201(n), 401, or 403 maximum 
        limits on the potency of any dietary supplement or any dietary 
        ingredient of the kind specified in section 201(gg);
            ``(B) classify any dietary supplement or any ingredient of 
        the kind specified in section 201(gg) as a drug solely because 
        it exceeds the level of potency that the Secretary determines 
        is nutritionally rational or useful; or
            ``(C) limit, under section 201(n), 401, or 403, in a 
        dietary supplement the combination or number of ingredients of 
        the kind specified in section 201(gg).
    ``(2) Paragraph (1) does not apply in the case of a dietary 
supplement represented (other than in conformity with section 
403(r)(5)(D)) for use by individuals in the treatment or management of 
specific diseases or disorders, by children, or by pregnant or 
lactating women. For purposes of this paragraph, the term `children' 
means individuals who are under the age of 12 years.''.

SEC. 4. CLAIMS.

    Section 403(r)(5)(D) (21 U.S.C. 343(r)(5)(D)) is amended to read as 
follows:
    ``(D)(i) A subparagraph (1)(B) claim made with respect to a dietary 
supplement shall not be subject to subparagraph (3).
    ``(ii) Labeling of a dietary supplement may characterize the 
relationship between the supplement and a disease or other condition of 
the body if--
            ``(I) the supplement contains one or more nutrients for 
        which a claim of the type described in subparagraph (1)(B) has 
        been authorized by the Secretary pursuant to subparagraph 
        (3)(B) and such characterization is consistent with the claim 
        authorized by the Secretary, unless the Secretary determines, 
        through rulemaking based upon the totality of publicly 
        available scientific evidence, that consumption of the nutrient 
        in a dietary supplement would not tend to reduce the risk of 
        disease or other health-related condition in a manner similar 
        to the consumption of such nutrient in conventional foods; or
            ``(II) such characterization accurately represents the 
        current state of scientific evidence concerning the 
        relationship between the supplement or dietary ingredient of 
        the supplement and a disease or other health-related condition, 
        taking into account the totality of scientific evidence 
        (including evidence from well-designed studies conducted in a 
        manner consistent with generally recognized scientific 
        principles).
This clause does not prohibit the labeling of a dietary supplement from 
providing truthful and non-misleading information, measured by the 
standard set forth in subclause (II), concerning its vitamin, mineral, 
or other dietary properties, including nutritional information about 
the manner in which those dietary properties affect physiological 
processes of the body or prevent or repair damage caused by diet or 
other environmental factors and does not authorize the Secretary to 
establish a prior restraint on the use of any labeling that is subject 
to subclause (II).
    ``(iii) At least 30 days before the introduction into interstate 
commerce of any label, consumer package, or literature in the package 
containing a claim described in subclause (ii), or before the making of 
such a claim through any other means, a person responsible for 
marketing the dietary supplement to which such claim refers shall 
provide notification to the Secretary of the wording of such claim if 
such claim has not previously been made for such dietary supplement by 
such person. Documentation that is intended to support such claim may 
be submitted with such notice. The Secretary may not impose any 
additional pre-market requirement, including requirements or requests 
for further documentation.''.

SEC. 5. DIETARY INTAKE STANDARDS.

    (a) Nutrition Information.--Section 403(q)(1) (21 U.S.C. 343(q)(1)) 
is amended by striking the period at the end of subparagraph (E) and 
inserting in lieu thereof ``, or'' and by adding after that 
subparagraph the following:
            ``(F) a declaration of the percent of a daily reference 
        amount for each nutrient specified in subparagraphs (D) and 
        (E), stated as a `Percent Daily Value' provided by a serving of 
        that food.''.
    (b) Regulations.--
            (1) In general.--
                    (A) Daily value.--Subject to subparagraph (B), the 
                Secretary of Health and Human Services shall, by 
                regulation, determine, based on the dietary guidance 
                provided by the Department of Agriculture, the 
                Department of Health and Human Services, the Centers 
                for Disease Control, the National Institutes of Health, 
                and other authoritative public health organizations, a 
                daily value for each nutrient specified in 
                subparagraphs (1)(D) and (1)(E) of section 403(q) of 
                the Federal Food, Drug, and Cosmetic Act which shall 
                reflect the daily intake of each such nutrient that 
                will promote optimal health and minimize the risk of 
                disease or other health-related condition.
                    (B) Limitation.--The daily value determined by the 
                Secretary under subparagraph (A) shall be no less than 
                the Recommended Daily Allowances established by the 
                Food and Nutrition Board of the National Academy of 
                Sciences for the age and sex group most at risk of 
                nutritional deficiencies of any particular nutrient.
            (2) Timing.--Except as provided in paragraph (4), the 
        Secretary of Health and Human Services shall issue proposed 
        regulations under paragraph (1) no later than 12 months from 
        the date of the enactment of this Act and shall issue final 
        regulations no later than 24 months from such date.
            (3) Pending daily values.--Pending the issuance of final 
        regulations under paragraph (1), the daily values for the 
        nutrients declared under section 403(q)(1)(F) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)(F)) shall be 
        those specified in sections 101.9(8) and 101.9(9) of 
        regulations published in title 21 of the Code of Federal 
        Regulations, as in effect on the date of the enactment of this 
        Act.
            (4) Assistance.--To assist the Secretary of Health and 
        Human Services in issuing regulations under paragraph (1), the 
        Director of the Congressional Research Office, in consultation 
        with the Director of the Office of Technology Assessment, shall 
        arrange for that office to review existing scientific data and 
        conduct one or more studies, if necessary, to be completed no 
        later than 9 months from the date of the enactment of this Act, 
        to determine what amount of each nutrient specified in 
        subparagraphs (1)(D) and (1)(E) of section 403(q) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q) would be 
        provided by the diets recommended by the Department of 
        Agriculture, the Department of Health and Human Services, the 
        Centers for Disease Control, the National Institutes of Health, 
        and other authoritative public health organizations to minimize 
        the risk of disease and other health-related conditions and to 
        promote optimal health. If the Office of Technology Assessment 
        does not complete the studies determined to be necessary within 
        9 months from the date of the enactment of this Act, the time 
        prescribed by paragraph (2) for the issuance of proposed and 
        final regulations shall be extended by a period equal to the 
        additional time required by such Office to complete such 
        studies.

SEC. 6. APPEAL.

    Section 411 (21 U.S.C. 350), as amended by section 3(c), is amended 
by adding at the end the following:
    ``(e)(1) If the Secretary asserts that a dietary supplement is in 
violation of any provision of this Act, whether the assertion is made 
in a warning letter issued by an officer or employee of the Department 
of Health and Human Services or in any other manner, the manufacturer, 
processor, packer, distributor, or retailer of the dietary supplement 
or any other person to whom the assertion is addressed may, within 60 
days, appeal to the Secretary or to an officer or employee of the 
Department of Health and Human Services assigned by the Secretary to 
hear such an appeal showing that the assertion is incorrect and should 
be withdrawn. During the 60-day period after such assertion is made by 
the Secretary and during pendency of such an appeal, the United States 
shall not initiate litigation on the matter unless the Secretary 
concludes that such litigation is required because of an imminent 
hazard to health. If such an appeal is not resolved to the satisfaction 
of the appellant, the appellant may--
            ``(A) bring an action in a United States district court in 
        any appropriate judicial district under section 1391 of title 
        28, United States Code, to secure a declaratory judgment in 
        which all factual determinations regarding the validity of the 
        assertion in question shall be made de novo; or
            ``(B) obtain any other means of judicial review authorized 
        by law.
The absence of an action described in subparagraph (A) or (B) shall not 
establish any inference that an assertion is valid.
    ``(2) The institution by the United States of a libel of 
information to condemn a dietary supplement shall constitute final 
agency action on the part of the Secretary.''.

SEC. 7. OFFICE FOR DIETARY SUPPLEMENTS.

    (a) In General.--Title IV of the Public Health Service Act is 
amended by inserting after section 486 (42 U.S.C. 287c-3) the 
following:

              ``Subpart 4--Office for Dietary Supplements

``SEC. 486E. OFFICE OF DIETARY SUPPLEMENTS.

    ``(a) Establishment.--The Secretary shall establish an Office of 
Dietary Supplements within the National Institutes of Health.
    ``(b) Duties.--The Office for Dietary Supplements shall--
            ``(1) conduct and coordinate scientific research within the 
        National Institutes of Health relating to dietary supplements 
        and the extent to which the use of dietary supplements can 
        limit or reduce the risk of diseases such as heart disease, 
        cancer, birth defects, osteoporosis, cataracts, or prostatism;
            ``(2) collect and compile the results of scientific 
        research relating to dietary supplements, including scientific 
        data from foreign sources or the Office of Alternative Medical 
        Practice;
            ``(3) serve as the principal advisor to the Secretary and 
        to the Assistant Secretary for Health, and to provide advice to 
        the Director of the National Institutes of Health, the Director 
        of the Centers for Disease Control and Prevention, and the 
        Commissioner of Food and Drugs, on issues relating to dietary 
        supplements including--
                    ``(A) dietary intake regulations;
                    ``(B) the safety of dietary supplements;
                    ``(C) claims characterizing the relationship 
                between--
                            ``(i) dietary supplements; and
                            ``(ii)(I) prevention of disease or other 
                        health-related conditions; and
                            ``(II) maintenance of health; and
                    ``(D) scientific issues arising in connection with 
                the labeling and composition of dietary supplements;
            ``(4) compile a database of scientific research on dietary 
        supplements and individual nutrients;
            ``(5) coordinate funding relating to dietary supplements 
        for the National Institutes of Health;
            ``(6) explore more fully the potential role of dietary 
        supplements as a significant part of the efforts of the United 
        States to improve health care; and
            ``(7) promote scientific study of the benefits of dietary 
        supplements in maintaining health and preventing chronic 
        disease and other health-related conditions.
    ``(c) Definition.--As used in this section, the term `dietary 
supplement' has the meaning given the term in section 201(gg) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(gg)).
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $5,000,000 for fiscal year 1994 
and such sums as may be necessary for each subsequent fiscal year.''.
    (b) Conforming Amendment.--Section 401(b)(2) of the Public Health 
Service Act (42 U.S.C. 281(b)(2)) is amended by adding at the end the 
following:
            ``(E) The Office for Dietary Supplements.''.

SEC. 8. EFFECTIVE DATE.

    The amendments made by this Act shall take effect on the date of 
the enactment of this Act, except that the amendments made by section 3 
shall take effect 18 months after such date with respect to products 
labeled after such date.

                                 <all>

HR 1709 SC6----2