[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 784 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 784

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
 standards with respect to dietary supplements, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                April 7 (legislative day, March 3), 1993

  Mr. Hatch (for himself, Mr. Reid, and Mr. Murkowski) introduced the 
 following bill; which was read twice and referred to the Committee on 
                       Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
    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.

    This Act may be cited as the ``Dietary Supplement Health and 
Education Act of 1993''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) 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 definitive 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)(A) recent 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; and
            (B) nearly all consumers indicate that dietary supplements 
        should not be regulated as drugs;
            (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 treatment of patients;
            (11) the United States will spend over $900,000,000,000 on 
        health care in 1993, which is about 12 percent of the Gross 
        National Product of the United States, and this amount and 
        percent 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 3,400 products, with 
        total annual sales of such products alone reaching 
        $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 
        regulatory barriers limiting or slowing the flow of safe 
        products and needed information to the marketplace and 
        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.
    (b) Purpose.--It is the purpose of this Act to--
            (1) improve the health status of the people of the United 
        States and help constrain runaway health care spending by 
        ensuring that the Federal Government erects no regulatory 
        barriers that impede the ability of consumers to improve their 
        nutrition through the free choice of safe dietary supplements;
            (2) clarify that--
                    (A) dietary supplements are not drugs or food 
                additives;
                    (B) dietary supplements should not be regulated as 
                drugs; and
                    (C) regulations relating to food additives should 
                only be applied to dietary supplement ingredients used 
                for food additive purposes, such as stabilizers, 
                processing agents or preservatives;
            (3) establish a new definition of a dietary supplement that 
        differentiates dietary supplements from conventional foods, 
        while recognizing the broad range of food ingredients used to 
        supplement the diet;
            (4) strengthen the current enforcement authority of the 
        Food and Drug Administration by providing to the Administration 
        additional mechanisms to take enforcement action against unsafe 
        or fraudulent products;
            (5) establish a series of labeling requirements that will 
        provide consumers with greater information and assurance about 
        the quality and content of dietary supplements, while at the 
        same time assuring the consumers the freedom to use the 
        supplements of their choice;
            (6) establish dietary intake standards based on the amount 
        of nutrients needed to prevent disease;
            (7) provide new administrative and judicial review 
        procedures to affected parties if the Administration takes 
        certain actions to enforce dietary supplement requirements;
            (8) specify the standards applicable to disease and other 
        health-related claims for dietary supplements;
            (9) reaffirm that dietary supplement labeling may bear 
        information, other than health claims, about the vitamin, 
        mineral, or other dietary properties of the supplement; and
            (10) establish a new Office of Dietary Supplements within 
        the National Institutes of Health to initiate and coordinate 
        research on dietary supplements and advise the Secretary and 
        other officials of the Department of Health and Human Services 
        on dietary supplement issues.

SEC. 3. DEFINITIONS.

    (a) Definition of Certain Foods as Dietary Supplements.--Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is 
amended by adding at the end the following:
    ``(gg) The term `dietary supplement' means a food for special 
dietary use, as defined in section 411(c)(3), that--
            ``(1) includes--
                    ``(A) a vitamin;
                    ``(B) a mineral;
                    ``(C) an herb;
                    ``(D) an amino acid;
                    ``(E) another ingredient for use by man to 
                supplement the diet by increasing the total dietary 
                intake; or
                    ``(F) a concentrate or extract of any ingredient 
                described in clause (A), (B), (C), (D), or (E); and
            ``(2)(A) is intended for ingestion in a form described in 
        section 411(c)(1)(B)(i); or
            ``(B) complies with section 411(c)(1)(B)(ii).''.
    (b) Exclusion From Definition of Drug.--Section 201(g)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by 
adding at the end the following new sentence: ``The term `drug' does 
not include a dietary supplement or an ingredient described in clause 
(A), (B), (C), (D), (E), or (F) of paragraph (gg)(1) in, or intended 
for use in, a dietary supplement.''.
    (c) Exclusion From Definition of Food Additive.--Section 201(s) of 
the Federal Food, Drug, and Cosmetic Act (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:
            ``(6) an ingredient described in clause (A), (B), (C), (D), 
        (E), or (F) of paragraph (gg)(1) in, or intended for use in, a 
        dietary supplement.''.
    (d) Form of Ingestion.--Section 411(c)(1)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350(c)(1)(B)) is amended--
            (1) in clause (i), by inserting ``powder, softgel,'' after 
        ``capsule,''; and
            (2) in clause (ii), by striking ``does not simulate and''.

SEC. 4. SAFETY OF DIETARY SUPPLEMENTS.

    Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342) is amended by adding at the end the following:
    ``(f) If it is a dietary supplement that contains an ingredient 
that is intended to be consumed for its dietary properties and--
            ``(1) the Secretary finds, after rulemaking, that the 
        ingredient presents a substantial and unreasonable risk of 
        illness or injury; or
            ``(2) no manufacturer of the supplement, or manufacturer of 
        the raw material comprising the ingredient, has adequately 
        substantiated the safety of the ingredient--
                    ``(A) through evidence of a history of safe use of 
                the ingredient (as part of any intended use prior to 
                the use of the ingredient in such dietary supplement), 
                and through the absence of substantial information that 
                brings the safety of the ingredient into question;
                    ``(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,
unless--
            ``(i) the Secretary has established, in consultation with 
        the Director of the Centers for Disease Control and Prevention, 
        the Director of the National Institutes of Health, and the 
        National Academy of Sciences, a recommended dietary allowance, 
        or an estimated safe and adequate dietary intake level, with 
        respect to the ingredient;
            ``(ii) the Secretary has determined, prior to the date of 
        enactment of this paragraph, that the ingredient has been 
        generally recognized as safe; or
            ``(iii) the ingredient is used in conformity with a 
        regulation relating to food additives that is described in 
        section 409(a)(2) and is issued prior to the date of enactment 
        of this paragraph.''.

SEC. 5. REPORT ON IMPACT OF SIGNIFICANT CHANGES IN MANUFACTURING 
              PRACTICES.

    (a) Study.--The Director of the Office of Dietary Supplements shall 
conduct a study relating to significant changes in the manufacturing 
practices of manufacturers of raw materials utilized in dietary 
supplements. In conducting the study, the Director shall analyze the 
extent to which such changes pose a risk to public safety.
    (b) Report.--Not later than 3 years after the date of enactment of 
this Act, the Director of the Office of Dietary Supplements shall 
prepare and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Labor and Human Resources of 
the Senate a report containing--
            (1) the results of the study described in subsection (a); 
        and
            (2) any recommendations for legislative reform.

SEC. 6. DIETARY INTAKE STANDARDS.

    (a) Nutrition Information.--Section 403(q)(1) (21 U.S.C. 343(q)(1)) 
is amended--
            (1) by striking the period at the end of clause (E) and 
        inserting ``, or''; and
            (2) by adding after clause (E) the following:
            ``(F) a declaration of the percent of a daily reference 
        amount for each nutrient specified in clauses (D) and (E), 
        stated as a `Percent Daily Value' provided by a serving of the 
        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 and Prevention, the National 
                Institutes of Health, and other authoritative public 
                health organizations, a daily value for each nutrient 
                specified in clauses (D) and (E) of section 403(q)(1) 
                of the Federal Food, Drug, and Cosmetic Act. The daily 
                value shall reflect the daily intake of each such 
                nutrient that will promote optimal health and minimize 
                the risk of disease or other health-related conditions.
                    (B) Limitation.--The daily value determined by the 
                Secretary under subparagraph (A) shall, in every 
                appropriate case, be no less than the United States 
                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 after 
        the date of the enactment of this Act and shall issue final 
        regulations no later than 24 months after 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 shall be the values specified in 
        sections 101.9(c)(8) and 101.9(c)(9) of title 21, Code of 
        Federal Regulations, as in effect on the date of the enactment 
        of this Act.
            (4) Assistance.--
                    (A) Review and studies.--To assist the Secretary of 
                Health and Human Services in issuing regulations under 
                paragraph (1), the Director of the Congressional 
                Research Service, in consultation with the Director of 
                the Office of Technology Assessment, shall review 
                existing scientific data and conduct any necessary 
                studies.
                    (B) Purpose.--Such review and studies shall 
                determine the amount of each nutrient specified in 
                clauses (D) and (E) of section 403(q)(1) of the Federal 
                Food, Drug, and Cosmetic Act that would be provided by 
                the diets recommended by the Department of Agriculture, 
                the Department of Health and Human Services, the 
                Centers for Disease Control and Prevention, 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.
                    (C) Timing.--Such review and studies shall be 
                completed no later than 9 months after the date of the 
                enactment of this Act. If the Congressional Research 
                Service does not complete such review and studies 
                within 9 months after the date of 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 review and 
                studies.

SEC. 7. DIETARY SUPPLEMENT CLAIMS.

    Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(r)) is amended by striking subparagraph (5)(D) and inserting 
the following:
    ``(D) A subparagraph (1)(B) claim made with respect to a dietary 
supplement shall not be subject to subparagraph (3).
    ``(6)(A) A claim made in the label or labeling of a dietary 
supplement may characterize the relationship between the supplement and 
a disease or other health-related condition if--
            ``(i)(I) the Secretary has authorized, under subparagraph 
        (3)(B), a claim of the type described in subparagraph (1)(B) 
        for any nutrient contained in the supplement, with respect to 
        the disease or other health-related condition;
            ``(II) such characterization is consistent with the claim 
        authorized by the Secretary; and
            ``(III) the Secretary has not determined, after rulemaking 
        based on the totality of scientific evidence (including 
        evidence from well-designed studies conducted in a manner 
        consistent with generally recognized scientific principles), 
        that consumption of the nutrient in a dietary supplement would 
        not tend to reduce the risk of the disease or other health-
        related condition in a similar manner as would consumption of 
        the nutrient in conventional foods; or
            ``(ii) such characterization accurately represents the 
        state of scientific evidence, as of the date of the evaluation 
        of the claim, concerning the relationship between the 
        supplement or ingredient of the supplement and the 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).
    ``(B) Nothing in this subparagraph shall--
            ``(i) prohibit the inclusion, in the label or labeling of a 
        dietary supplement, of truthful and nonmisleading information 
        concerning the vitamin, mineral, or other dietary properties of 
        the supplement (including nutritional information about the 
        manner in which the dietary properties affect processes of the 
        body, or prevent or repair damage caused by diet or other 
        environmental factors); or
            ``(ii) permit the Secretary to establish any requirement 
        that such a claim made in the label or labeling of a dietary 
        supplement be approved by the Secretary before the claim may be 
        used.''.

SEC. 8. REPORT ON NOTIFICATION REGARDING NEW CLAIMS.

    (a) Study.--
            (1) In general.--The Director of the Office of Dietary 
        Supplements shall conduct a study regarding the desirability of 
        a notification requirement relating to new claims about dietary 
        supplements.
            (2) Content.--Such study shall examine--
                    (A) the need for a requirement that a person 
                responsible for marketing a dietary supplement provide 
                notification to the Secretary of Health and Human 
                Services before making such a claim;
                    (B) the feasibility of such a requirement;
                    (C) the effect of such a requirement on the 
                marketing of dietary supplements and on the ability of 
                consumers to purchase dietary supplements; and
                    (D) such other issues related to the desirability 
                of such a requirement as the Director of the Office of 
                Dietary Supplements may determine to be appropriate.
    (b) Report.--Not later than 3 years after the date of enactment of 
this Act, the Director of the Office of Dietary Supplements shall 
prepare and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Labor and Human Resources of 
the Senate a report containing--
            (1) the results of the study described in subsection (a); 
        and
            (2) any recommendations for legislative reform.

SEC. 9. DIETARY SUPPLEMENT LABELING.

    Section 403 of the Federal Food, Drug, and Cosmetic Act (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 clause (A), (B), (C), (D), (E), or 
                (F) of section 201(gg)(1); 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 supplement fails to 
        identify the product by using the term `supplement', which term 
        may be modified with--
                    ``(i) the name of such an ingredient; or
                    ``(ii) by a general term such as the term 
                `dietary';
            ``(C) the supplement contains an ingredient described in 
        section 201(gg)(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.''.

SEC. 10. PROHIBITION ON CERTAIN REGULATORY ACTIONS.

    Section 411 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350) is amended--
            (1) in the title, by striking ``vitamins and minerals'' and 
        inserting ``vitamins, minerals, and dietary supplements''; and
            (2) by adding at the end the following:
    ``(d)(1) Except as provided in paragraph (2)--
            ``(A) the Secretary may not establish, under section 
        201(n), 401, or 403, maximum limits on the potency of any 
        dietary supplement, or any ingredient that is described in 
        clause (A), (B), (C), (D), (E), or (F) of section 201(gg)(1) 
        within such a supplement;
            ``(B) the Secretary may not classify any dietary supplement 
        or any such ingredient as a drug; and
            ``(C) the Secretary may not limit, under section 201(n), 
        401, or 403, the combination or number of such ingredients 
        within a dietary supplement.
    ``(2)(A) Subparagraphs (A) and (C) of paragraph (1) shall not apply 
in the case of such a dietary supplement or such an ingredient that is 
represented for use by--
            ``(i) individuals in the treatment or management of 
        specific diseases or disorders;
            ``(ii) children; or
            ``(iii) pregnant or lactating women.
    ``(B) For purposes of this paragraph, the term `children' means 
individuals who are under the age of 12 years.''.

SEC. 11. ADMINISTRATIVE AND JUDICIAL REVIEW.

    The Federal Food, Drug, and Cosmetic Act is amended by adding at 
the end of chapter III (21 U.S.C. 331 et seq.) the following:

``SEC. 311. ADMINISTRATIVE AND JUDICIAL REVIEW.

    ``(a) Definition.--As used in this subsection, the term `affected 
party' means a manufacturer, processor, packer, distributor, or 
retailer, of a dietary supplement, or another appropriate person.
    ``(b) Review of Violations.--
            ``(1) Determination of violation.--
                    ``(A) Informal hearing.--If the Secretary 
                determines that an affected party has violated a 
                provision of this Act with respect to a dietary 
                supplement, whether the Secretary makes the 
                determination in a warning letter issued by an officer 
                or employee of the Department or in connection with 
                another action to enforce a provision of this Act, the 
                Secretary shall provide notice to the affected party of 
                the opportunity to obtain a determination on the record 
                after opportunity for an agency hearing regarding the 
                alleged violation. The affected party may request such 
                a hearing not later than 60 days after receiving the 
                notice.
                    ``(B) Notification.--Not later than 30 days after 
                the date on which the hearing is held, the Secretary 
                shall notify the affected party whether the 
                determination of the violation has been affirmed, 
                modified, or revoked. Such notification shall 
                constitute final agency action.
                    ``(C) Prohibition on action.--The United States may 
                not bring an action in any Federal court relating to 
                the matter that is the subject of the determination 
                until 60 days after the Secretary provides notification 
                under subparagraph (B), unless the Secretary 
                demonstrates that the dietary supplement involved in 
                the matter poses an imminent hazard to health.
                    ``(D) Right of action.--Not later than 60 days 
                after receipt of the notification under subparagraph 
                (B), an affected party who receives notification of an 
                adverse decision under subparagraph (B) may--
                            ``(i) bring an action in a district court 
                        of the United States in any appropriate 
                        judicial district under section 1391 of title 
                        28, United States Code, seeking de novo review 
                        of the final agency action regarding the 
                        validity of the determination; or
                            ``(ii) bring any other action authorized by 
                        law seeking judicial review of the final agency 
                        action.
                    ``(E) Inference.--The absence of any request for a 
                hearing under subparagraph (A), or of an action 
                described in subparagraph (D), with respect to such a 
                determination shall not establish any inference that 
                the determination is valid.
            ``(2) Seizures.--
                    ``(A) Institution of libel of information.--The 
                institution by the United States of a libel of 
                information for condemnation of a dietary supplement, 
                on the basis of a determination that an affected party 
                has violated a provision of this Act with respect to 
                the supplement, shall constitute final agency action by 
                the Secretary or the delegate of the Secretary.
                    ``(B) Right of action.--Not later than 60 days 
                after the United States institutes such a libel of 
                information with respect to a dietary supplement, the 
                affected party may--
                            ``(i) bring an action described in 
                        paragraph (1)(D)(i) seeking de novo review of 
                        the final agency action regarding the validity 
                        of the determination; or
                            ``(ii) obtain any other means authorized by 
                        law of judicial review of the final agency 
                        action.''.

SEC. 12. OFFICE OF 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 of Dietary Supplements

``SEC. 486E. 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 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; 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(gg) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(gg)).
    ``(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.''.

                                 <all>

S 784 IS----2
S 784 IS----3