Text: S.784 — 103rd Congress (1993-1994)All Information (Except Text)

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[Congressional Bills 103th Congress]
[From the U.S. Government Printing Office]
[S. 784 Enrolled Bill (ENR)]

        S.784

                       One Hundred Third Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
 the twenty-fifth day of January, one thousand nine hundred and ninety-
                                  four


                                 An Act

  
 
  To amend the Federal Food, Drug, and Cosmetic Act to establish 
standards with respect to dietary supplements, 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 ``Dietary Supplement 
Health and Education Act of 1994''.
    (b) Reference.--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.
    (c) Table of Contents.--The table of contents of this Act is as 
follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Safety of dietary supplements and burden of proof on FDA.
Sec. 5. Dietary supplement claims.
Sec. 6. Statements of nutritional support.
Sec. 7. Dietary supplement ingredient labeling and nutrition information 
          labeling.
Sec. 8. New dietary ingredients.
Sec. 9. Good manufacturing practices.
Sec. 10. Conforming amendments.
Sec. 11. Withdrawal of the regulations and notice.
Sec. 12. Commission on dietary supplement labels.
Sec. 13. Office of dietary supplements.

SEC. 2. FINDINGS.

    Congress finds that--
        (1) improving the health status of United States citizens ranks 
    at the top of the national priorities of the Federal Government;
        (2) the importance of nutrition and the benefits of dietary 
    supplements to health promotion and disease prevention have been 
    documented increasingly in scientific studies;
        (3)(A) there is a link between the ingestion of certain 
    nutrients or dietary supplements and the prevention of chronic 
    diseases such as cancer, heart disease, and osteoporosis; and
        (B) clinical research has shown that several chronic diseases 
    can be prevented simply with a healthful diet, such as a diet that 
    is low in fat, saturated fat, cholesterol, and sodium, with a high 
    proportion of plant-based foods;
        (4) healthful diets may mitigate the need for expensive medical 
    procedures, such as coronary bypass surgery or angioplasty;
        (5) preventive health measures, including education, good 
    nutrition, and appropriate use of safe nutritional supplements will 
    limit the incidence of chronic diseases, and reduce long-term 
    health care expenditures;
        (6)(A) promotion of good health and healthy lifestyles improves 
    and extends lives while reducing health care expenditures; and
        (B) reduction in health care expenditures is of paramount 
    importance to the future of the country and the economic well-being 
    of the country;
        (7) there is a growing need for emphasis on the dissemination 
    of information linking nutrition and long-term good health;
        (8) consumers should be empowered to make choices about 
    preventive health care programs based on data from scientific 
    studies of health benefits related to particular dietary 
    supplements;
        (9) national surveys have revealed that almost 50 percent of 
    the 260,000,000 Americans regularly consume dietary supplements of 
    vitamins, minerals, or herbs as a means of improving their 
    nutrition;
        (10) studies indicate that consumers are placing increased 
    reliance on the use of nontraditional health care providers to 
    avoid the excessive costs of traditional medical services and to 
    obtain more holistic consideration of their needs;
        (11) the United States will spend over $1,000,000,000,000 on 
    health care in 1994, which is about 12 percent of the Gross 
    National Product of the United States, and this amount and 
    percentage will continue to increase unless significant efforts are 
    undertaken to reverse the increase;
        (12)(A) the nutritional supplement industry is an integral part 
    of the economy of the United States;
        (B) the industry consistently projects a positive trade 
    balance; and
        (C) the estimated 600 dietary supplement manufacturers in the 
    United States produce approximately 4,000 products, with total 
    annual sales of such products alone reaching at least 
    $4,000,000,000;
        (13) although the Federal Government should take swift action 
    against products that are unsafe or adulterated, the Federal 
    Government should not take any actions to impose unreasonable 
    regulatory barriers limiting or slowing the flow of safe products 
    and accurate information to consumers;
        (14) dietary supplements are safe within a broad range of 
    intake, and safety problems with the supplements are relatively 
    rare; and
        (15)(A) legislative action that protects the right of access of 
    consumers to safe dietary supplements is necessary in order to 
    promote wellness; and
        (B) a rational Federal framework must be established to 
    supersede the current ad hoc, patchwork regulatory policy on 
    dietary supplements.

SEC. 3. DEFINITIONS.

    (a) Definition of Certain Foods as Dietary Supplements.--Section 
201 (21 U.S.C. 321) is amended by adding at the end the following:
    ``(ff) The term `dietary supplement'--
        ``(1) means a product (other than tobacco) intended to 
    supplement the diet that bears or contains one or more of the 
    following dietary ingredients:
            ``(A) a vitamin;
            ``(B) a mineral;
            ``(C) an herb or other botanical;
            ``(D) an amino acid;
            ``(E) a dietary substance for use by man to supplement the 
        diet by increasing the total dietary intake; or
            ``(F) a concentrate, metabolite, constituent, extract, or 
        combination of any ingredient described in clause (A), (B), 
        (C), (D), or (E);
        ``(2) means a product that--
            ``(A)(i) is intended for ingestion in a form described in 
        section 411(c)(1)(B)(i); or
            ``(ii) complies with section 411(c)(1)(B)(ii);
            ``(B) is not represented for use as a conventional food or 
        as a sole item of a meal or the diet; and
            ``(C) is labeled as a dietary supplement; and
        ``(3) does--
            ``(A) include an article that is approved as a new drug 
        under section 505, certified as an antibiotic under section 
        507, or licensed as a biologic under section 351 of the Public 
        Health Service Act (42 U.S.C. 262) and was, prior to such 
        approval, certification, or license, marketed as a dietary 
        supplement or as a food unless the Secretary has issued a 
        regulation, after notice and comment, finding that the article, 
        when used as or in a dietary supplement under the conditions of 
        use and dosages set forth in the labeling for such dietary 
        supplement, is unlawful under section 402(f); and
            ``(B) not include--
                ``(i) an article that is approved as a new drug under 
            section 505, certified as an antibiotic under section 507, 
            or licensed as a biologic under section 351 of the Public 
            Health Service Act (42 U.S.C. 262), or
                ``(ii) an article authorized for investigation as a new 
            drug, antibiotic, or biological for which substantial 
            clinical investigations have been instituted and for which 
            the existence of such investigations has been made public,
    which was not before such approval, certification, licensing, or 
    authorization marketed as a dietary supplement or as a food unless 
    the Secretary, in the Secretary's discretion, has issued a 
    regulation, after notice and comment, finding that the article 
    would be lawful under this Act.
Except for purposes of section 201(g), a dietary supplement shall be 
deemed to be a food within the meaning of this Act.''.
    (b) Exclusion From Definition of Food Additive.--Section 201(s) (21 
U.S.C. 321(s)) is amended--
        (1) by striking ``or'' at the end of subparagraph (4);
        (2) by striking the period at the end of subparagraph (5) and 
    inserting ``; or''; and
        (3) by adding at the end the following new subparagraph:
        ``(6) an ingredient described in paragraph (ff) in, or intended 
    for use in, a dietary supplement.''.
    (c) Form of Ingestion.--Section 411(c)(1)(B) (21 U.S.C. 
350(c)(1)(B)) is amended--
        (1) in clause (i), by inserting ``powder, softgel, gelcap,'' 
    after ``capsule,''; and
        (2) in clause (ii), by striking ``does not simulate and''.
SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON FDA.
    Section 402 (21 U.S.C. 342) is amended by adding at the end the 
following:
    ``(f)(1) If it is a dietary supplement or contains a dietary 
ingredient that--
        ``(A) presents a significant or unreasonable risk of illness or 
    injury under--
            ``(i) conditions of use recommended or suggested in 
        labeling, or
            ``(ii) if no conditions of use are suggested or recommended 
        in the labeling, under ordinary conditions of use;
        ``(B) is a new dietary ingredient for which there is inadequate 
    information to provide reasonable assurance that such ingredient 
    does not present a significant or unreasonable risk of illness or 
    injury;
        ``(C) the Secretary declares to pose an imminent hazard to 
    public health or safety, except that the authority to make such 
    declaration shall not be delegated and the Secretary shall promptly 
    after such a declaration initiate a proceeding in accordance with 
    sections 554 and 556 of title 5, United States Code, to affirm or 
    withdraw the declaration; or
        ``(D) is or contains a dietary ingredient that renders it 
    adulterated under paragraph (a)(1) under the conditions of use 
    recommended or suggested in the labeling of such dietary 
    supplement.
In any proceeding under this subparagraph, the United States shall bear 
the burden of proof on each element to show that a dietary supplement 
is adulterated. The court shall decide any issue under this paragraph 
on a de novo basis.
    ``(2) Before the Secretary may report to a United States attorney a 
violation of paragraph (1)(A) for a civil proceeding, the person 
against whom such proceeding would be initiated shall be given 
appropriate notice and the opportunity to present views, orally and in 
writing, at least 10 days before such notice, with regard to such 
proceeding.''.

SEC. 5. DIETARY SUPPLEMENT CLAIMS.

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


                 ``dietary supplement labeling exemptions

    ``Sec. 403B. (a) In General.--A publication, including an article, 
a chapter in a book, or an official abstract of a peer-reviewed 
scientific publication that appears in an article and was prepared by 
the author or the editors of the publication, which is reprinted in its 
entirety, shall not be defined as labeling when used in connection with 
the sale of a dietary supplement to consumers when it--
        ``(1) is not false or misleading;
        ``(2) does not promote a particular manufacturer or brand of a 
    dietary supplement;
        ``(3) is displayed or presented, or is displayed or presented 
    with other such items on the same subject matter, so as to present 
    a balanced view of the available scientific information on a 
    dietary supplement;
        ``(4) if displayed in an establishment, is physically separate 
    from the dietary supplements; and
        ``(5) does not have appended to it any information by sticker 
    or any other method.
    ``(b) Application.--Subsection (a) shall not apply to or restrict a 
retailer or wholesaler of dietary supplements in any way whatsoever in 
the sale of books or other publications as a part of the business of 
such retailer or wholesaler.
    ``(c) Burden of Proof.--In any proceeding brought under subsection 
(a), the burden of proof shall be on the United States to establish 
that an article or other such matter is false or misleading.''.

SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.

    Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end 
the following:
    ``(6) For purposes of paragraph (r)(1)(B), a statement for a 
dietary supplement may be made if--
        ``(A) the statement claims a benefit related to a classical 
    nutrient deficiency disease and discloses the prevalence of such 
    disease in the United States, describes the role of a nutrient or 
    dietary ingredient intended to affect the structure or function in 
    humans, characterizes the documented mechanism by which a nutrient 
    or dietary ingredient acts to maintain such structure or function, 
    or describes general well-being from consumption of a nutrient or 
    dietary ingredient,
        ``(B) the manufacturer of the dietary supplement has 
    substantiation that such statement is truthful and not misleading, 
    and
        ``(C) the statement contains, prominently displayed and in 
    boldface type, the following: `This statement has not been 
    evaluated by the Food and Drug Administration. This product is not 
    intended to diagnose, treat, cure, or prevent any disease.'.
A statement under this subparagraph may not claim to diagnose, 
mitigate, treat, cure, or prevent a specific disease or class of 
diseases. If the manufacturer of a dietary supplement proposes to make 
a statement described in the first sentence of this subparagraph in the 
labeling of the dietary supplement, the manufacturer shall notify the 
Secretary no later than 30 days after the first marketing of the 
dietary supplement with such statement that such a statement is being 
made.''.
SEC. 7. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRITION 
INFORMATION LABELING.
    (a) Misbranded Supplements.--Section 403 (21 U.S.C. 343) is amended 
by adding at the end the following:
    ``(s) If--
        ``(1) it is a dietary supplement; and
        ``(2)(A) the label or labeling of the supplement fails to 
    list--
            ``(i) the name of each ingredient of the supplement that is 
        described in section 201(ff); and
            ``(ii)(I) the quantity of each such ingredient; or
            ``(II) with respect to a proprietary blend of such 
        ingredients, the total quantity of all ingredients in the 
        blend;
        ``(B) the label or labeling of the dietary supplement fails to 
    identify the product by using the term `dietary supplement', which 
    term may be modified with the name of such an ingredient;
        ``(C) the supplement contains an ingredient described in 
    section 201(ff)(1)(C), and the label or labeling of the supplement 
    fails to identify any part of the plant from which the ingredient 
    is derived;
        ``(D) the supplement--
            ``(i) is covered by the specifications of an official 
        compendium;
            ``(ii) is represented as conforming to the specifications 
        of an official compendium; and
            ``(iii) fails to so conform; or
        ``(E) the supplement--
            ``(i) is not covered by the specifications of an official 
        compendium; and
            ``(ii)(I) fails to have the identity and strength that the 
        supplement is represented to have; or
            ``(II) fails to meet the quality (including tablet or 
        capsule disintegration), purity, or compositional 
        specifications, based on validated assay or other appropriate 
        methods, that the supplement is represented to meet.''.
    (b) Supplement Listing on Nutrition Labeling.--Section 403(q)(5)(F) 
(21 U.S.C. 343(q)(5)(F)) is amended to read as follows:
    ``(F) A dietary supplement product (including a food to which 
section 411 applies) shall comply with the requirements of 
subparagraphs (1) and (2) in a manner which is appropriate for the 
product and which is specified in regulations of the Secretary which 
shall provide that--
        ``(i) nutrition information shall first list those dietary 
    ingredients that are present in the product in a significant amount 
    and for which a recommendation for daily consumption has been 
    established by the Secretary, except that a dietary ingredient 
    shall not be required to be listed if it is not present in a 
    significant amount, and shall list any other dietary ingredient 
    present and identified as having no such recommendation;
        ``(ii) the listing of dietary ingredients shall include the 
    quantity of each such ingredient (or of a proprietary blend of such 
    ingredients) per serving;
        ``(iii) the listing of dietary ingredients may include the 
    source of a dietary ingredient; and
        ``(iv) the nutrition information shall immediately precede the 
    ingredient information required under subclause (i), except that no 
    ingredient identified pursuant to subclause (i) shall be required 
    to be identified a second time.''.
    (c) Percentage Level Claims.--Section 403(r)(2) (21 U.S.C. 
343(r)(2)) is amended by adding after clause (E) the following:
    ``(F) Subclause (i) clause (A) does not apply to a statement in the 
labeling of a dietary supplement that characterizes the percentage 
level of a dietary ingredient for which the Secretary has not 
established a reference daily intake, daily recommended value, or other 
recommendation for daily consumption.''.
    (d) Vitamins and Minerals.--Section 411(b)(2) (21 U.S.C. 350(b)(2)) 
is amended--
        (1) by striking ``vitamins or minerals'' and inserting 
    ``dietary supplement ingredients described in section 201(ff)'';
        (2) by striking ``(2)(A)'' and inserting ``(2)''; and
        (3) by striking subparagraph (B).
    (e) Effective Date.--Dietary supplements--
        (1) may be labeled after the date of the enactment of this Act 
    in accordance with the amendments made by this section, and
        (2) shall be labeled after December 31, 1996, in accordance 
    with such amendments.

SEC. 8. NEW DIETARY INGREDIENTS.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended 
by adding at the end the following:


                        ``new dietary ingredients

    ``Sec. 413. (a) In General.--A dietary supplement which contains a 
new dietary ingredient shall be deemed adulterated under section 402(f) 
unless it meets one of the following requirements:
        ``(1) The dietary supplement contains only dietary ingredients 
    which have been present in the food supply as an article used for 
    food in a form in which the food has not been chemically altered.
        ``(2) There is a history of use or other evidence of safety 
    establishing that the dietary ingredient when used under the 
    conditions recommended or suggested in the labeling of the dietary 
    supplement will reasonably be expected to be safe and, at least 75 
    days before being introduced or delivered for introduction into 
    interstate commerce, the manufacturer or distributor of the dietary 
    ingredient or dietary supplement provides the Secretary with 
    information, including any citation to published articles, which is 
    the basis on which the manufacturer or distributor has concluded 
    that a dietary supplement containing such dietary ingredient will 
    reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under 
paragraph (2) for 90 days following its receipt. After the expiration 
of such 90 days, the Secretary shall place such information on public 
display, except matters in the information which are trade secrets or 
otherwise confidential, commercial information.
    ``(b) Petition.--Any person may file with the Secretary a petition 
proposing the issuance of an order prescribing the conditions under 
which a new dietary ingredient under its intended conditions of use 
will reasonably be expected to be safe. The Secretary shall make a 
decision on such petition within 180 days of the date the petition is 
filed with the Secretary. For purposes of chapter 7 of title 5, United 
States Code, the decision of the Secretary shall be considered final 
agency action.
    ``(c) Definition.--For purposes of this section, the term `new 
dietary ingredient' means a dietary ingredient that was not marketed in 
the United States before October 15, 1994 and does not include any 
dietary ingredient which was marketed in the United States before 
October 15, 1994.''.

SEC. 9. GOOD MANUFACTURING PRACTICES.

    Section 402 (21 U.S.C. 342), as amended by section 4, is amended by 
adding at the end the following:
    ``(g)(1) If it is a dietary supplement and it has been prepared, 
packed, or held under conditions that do not meet current good 
manufacturing practice regulations, including regulations requiring, 
when necessary, expiration date labeling, issued by the Secretary under 
subparagraph (2).
    ``(2) The Secretary may by regulation prescribe good manufacturing 
practices for dietary supplements. Such regulations shall be modeled 
after current good manufacturing practice regulations for food and may 
not impose standards for which there is no current and generally 
available analytical methodology. No standard of current good 
manufacturing practice may be imposed unless such standard is included 
in a regulation promulgated after notice and opportunity for comment in 
accordance with chapter 5 of title 5, United States Code.''.

SEC. 10. CONFORMING AMENDMENTS.

    (a) Section 201.--The last sentence of section 201(g)(1) (21 U.S.C. 
321(g)(1)) is amended to read as follows: ``A food or dietary 
supplement for which a claim, subject to sections 403(r)(1)(B) and 
403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in 
accordance with the requirements of section 403(r) is not a drug solely 
because the label or the labeling contains such a claim. A food, 
dietary ingredient, or dietary supplement for which a truthful and not 
misleading statement is made in accordance with section 403(r)(6) is 
not a drug under clause (C) solely because the label or the labeling 
contains such a statement.''.
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(u) The introduction or delivery for introduction into interstate 
commerce of a dietary supplement that is unsafe under section 413.''.
    (c) Section 403.--Section 403 (21 U.S.C. 343), as amended by 
section 7, is amended by adding after paragraph (s) the following:
``A dietary supplement shall not be deemed misbranded solely because 
its label or labeling contains directions or conditions of use or 
warnings.''.

SEC. 11. WITHDRAWAL OF THE REGULATIONS AND NOTICE.

    The advance notice of proposed rulemaking concerning dietary 
supplements published in the Federal Register of June 18, 1993 (58 FR 
33690-33700) is null and void and of no force or effect insofar as it 
applies to dietary supplements. The Secretary of Health and Human 
Services shall publish a notice in the Federal Register to revoke the 
item declared to be null and void and of no force or effect under 
subsection (a).

SEC. 12. COMMISSION ON DIETARY SUPPLEMENT LABELS.

    (a) Establishment.--There shall be established as an independent 
agency within the executive branch a commission to be known as the 
Commission on Dietary Supplement Labels (hereafter in this section 
referred to as the ``Commission'').
    (b) Membership.--
        (1) Composition.--The Commission shall be composed of 7 members 
    who shall be appointed by the President.
        (2) Expertise requirement.--The members of the Commission shall 
    consist of individuals with expertise and experience in dietary 
    supplements and in the manufacture, regulation, distribution, and 
    use of such supplements. At least three of the members of the 
    Commission shall be qualified by scientific training and experience 
    to evaluate the benefits to health of the use of dietary 
    supplements and one of such three members shall have experience in 
    pharmacognosy, medical botany, traditional herbal medicine, or 
    other related sciences. Members and staff of the Commission shall 
    be without bias on the issue of dietary supplements.
    (c) Functions of the Commission.--The Commission shall conduct a 
study on, and provide recommendations for, the regulation of label 
claims and statements for dietary supplements, including the use of 
literature in connection with the sale of dietary supplements and 
procedures for the evaluation of such claims. In making such 
recommendations, the Commission shall evaluate how best to provide 
truthful, scientifically valid, and not misleading information to 
consumers so that such consumers may make informed and appropriate 
health care choices for themselves and their families.
    (d) Administrative Powers of the Commission.--
        (1) Hearings.--The Commission may hold hearings, sit and act at 
    such times and places, take such testimony, and receive such 
    evidence as the Commission considers advisable to carry out the 
    purposes of this section.
        (2) Information from federal agencies.--The Commission may 
    secure directly from any Federal department or agency such 
    information as the Commission considers necessary to carry out the 
    provisions of this section.
        (3) Authorization of appropriations.--There are authorized to 
    be appropriated such sums as may be necessary to carry out this 
    section.
    (e) Reports and Recommendations.--
        (1) Final report required.--Not later than 24 months after the 
    date of enactment of this Act, the Commission shall prepare and 
    submit to the President and to the Congress a final report on the 
    study required by this section.
        (2) Recommendations.--The report described in paragraph (1) 
    shall contain such recommendations, including recommendations for 
    legislation, as the Commission deems appropriate.
        (3) Action on recommendations.--Within 90 days of the issuance 
    of the report under paragraph (1), the Secretary of Health and 
    Human Services shall publish in the Federal Register a notice of 
    any recommendation of Commission for changes in regulations of the 
    Secretary for the regulation of dietary supplements and shall 
    include in such notice a notice of proposed rulemaking on such 
    changes together with an opportunity to present views on such 
    changes. Such rulemaking shall be completed not later than 2 years 
    after the date of the issuance of such report. If such rulemaking 
    is not completed on or before the expiration of such 2 years, 
    regulations of the Secretary published in 59 FR 395-426 on January 
    4, 1994, shall not be in effect.

SEC. 13. OFFICE OF DIETARY SUPPLEMENTS.

    (a) In General.--Title IV of the Public Health Service Act is 
amended by inserting after section 485B (42 U.S.C. 287c-3) the 
following:

               ``Subpart 4--Office of Dietary Supplements

``SEC. 485C. DIETARY SUPPLEMENTS.

    ``(a) Establishment.--The Secretary shall establish an Office of 
Dietary Supplements within the National Institutes of Health.
    ``(b) Purpose.--The purposes of the Office are--
        ``(1) to 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
        ``(2) to promote scientific study of the benefits of dietary 
    supplements in maintaining health and preventing chronic disease 
    and other health-related conditions.
    ``(c) Duties.--The Director of the Office of 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 Medicine;
        ``(3) serve as the principal advisor to the Secretary and to 
    the Assistant Secretary for Health and 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; and
        ``(5) coordinate funding relating to dietary supplements for 
    the National Institutes of Health.
    ``(d) Definition.--As used in this section, the term `dietary 
supplement' has the meaning given the term in section 201(ff) of the 
Federal Food, Drug, and Cosmetic Act.
    ``(e) 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 of Dietary Supplements.''.







                               Speaker of the House of Representatives.







                            Vice President of the United States and    
                                               President of the Senate.

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