[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 784 Engrossed Amendment House (EAH)]

                In the House of Representatives, U. S.,

                          October 7 (legislative day, October 6), 1994.
      Resolved, That the bill from the Senate (S. 784) entitled ``An 
Act to amend the Federal Food, Drug, and Cosmetic Act to establish 
standards with respect to dietary supplements, and for other 
purposes'', do pass with the following

                               AMENDMENT:

        Strike out all after the enacting clause and insert:

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.''.

            Attest:






                                                                 Clerk.
103d CONGRESS

  2d Session

                                 S. 784

_______________________________________________________________________

                               AMENDMENT