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

103d CONGRESS

  2d Session

                                 S. 784

_______________________________________________________________________

                                 AN ACT

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
 standards with respect to dietary supplements, and for other purposes.
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
103d CONGRESS
  2d Session
                                 S. 784

_______________________________________________________________________

                                 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.

    This Act may be cited as the ``Dietary Supplement Health and 
Education Act of 1994''.

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) 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 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 
        regulatory barriers limiting or slowing the flow of safe 
        products and needed 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.
    (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;
                    (C) regulations relating to food additives are not 
                applicable to dietary supplements and their ingredients 
                used for food additive purposes, including stabilizers, 
                processing agents, or preservatives; and
                    (D) the burden of proof is on the Food and Drug 
                Administration to prove that a product is unsafe before 
                it can be removed from the marketplace;
            (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) provide new administrative and judicial review 
        procedures to affected parties if the Food and Drug 
        Administration takes certain actions to enforce dietary 
        supplement requirements; and
            (7) establish a Commission on Dietary Supplement Labels 
        within the executive branch to develop recommendations on a 
        procedure to evaluate health claims for dietary supplements and 
        provide recommendations to the President and the Congress.

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:
    ``(ff) The term `dietary supplement' means--
            ``(1) a product intended to supplement the diet by 
        increasing the total dietary intake 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) another 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), (E) or (F);
            ``(2) 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); and
                    ``(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.''.
    (b) Exclusion From Definition of Drug.--Section 201(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by 
adding at the end the following new subparagraph:
    ``(3) The term `drug' does not include a dietary supplement as 
defined in paragraph (ff), except that--
            ``(A) an article that is approved as a new drug, certified 
        as an antibiotic (under section 355 or 357), or licensed as a 
        biologic (under section 351 of the Public Health Service Act 
        (42 U.S.C. 262 et seq.)) and was, prior to such approval, 
        certification or license, marketed as a dietary supplement or 
        as a food, may continue to be offered for sale as a dietary 
        supplement 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) an article that is approved as a new drug, certified 
        as an antibiotic (under section 355 or 357), or licensed as a 
        biologic (under section 351 of the Public Health Service Act 
        (42 U.S.C. 262 et seq.)) and was not prior thereto marketed as 
        a dietary supplement or as a food, may not be considered as a 
        dietary ingredient or dietary supplement unless the Secretary 
        has issued a regulation, after notice and comment, finding that 
        the article would be lawful under section 402(f) under the 
        conditions of use and dosages set forth in the recommended 
        labeling for such article.''.
    (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 new subparagraph:
            ``(6) an ingredient described in paragraph (ff) 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, 
        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 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--
            ``(1) the Secretary finds, after rulemaking, presents a 
        substantial and unreasonable risk of illness or injury under 
        conditions of use recommended or suggested in labeling;
            ``(2) the Secretary declares to pose an imminent and 
        substantial hazard to public health or safety, except that the 
        authority to make such declaration shall not be delegated and 
        the Secretary shall promptly thereafter convene rulemaking 
        pursuant to section 701(e), (f), and (g) to affirm or withdraw 
        the declaration; or
            ``(3) 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 section, the United States bears the 
burden of proof on each element to show that a dietary supplement is 
adulterated.''.

SEC. 5. DIETARY SUPPLEMENT CLAIMS.

    (a) Supplement Claims.--Chapter IV of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by inserting after 
section 403A the following new section:

                ``dietary supplement labeling exemptions

    ``Sec. 403B. An article, another publication, a chapter in books, 
or the official abstract of a peer-reviewed scientific publication that 
appears in the article and was prepared by the author or the editors of 
the publication, reprinted in its entirety, shall not be defined as 
labeling when used in connection with the sale of dietary supplements 
to consumers when it--
            ``(1) is not false or misleading;
            ``(2) does not promote a particular 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; and
            ``(4) if displayed in an establishment, is physically 
        separate from the dietary supplements.
This section 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. 
In any proceeding under this section, 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)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(r)(1)) is amended by adding the following new sentence at 
the end:``For purposes of this subparagraph, a statement for a dietary 
supplement shall not be considered a claim of the relationship of a 
nutrient or dietary ingredient to a disease or health-related condition 
if the statement does not claim to diagnose, prevent, mitigate, treat, 
or cure a specific disease or class of diseases. A statement for a 
dietary supplement may be made if 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.''.

SEC. 7. CONFORMING AMENDMENTS.

    (a) Section 201.--The next to the last sentence of section 
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(g)(1)) (as amended by section 3(b)) is amended to read as follows: 
``A food or dietary supplement for which a claim, subject to section 
403(r)(1)(B) and 403(r)(3) or section 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 nonmisleading statement is made in accordance with section 
403(r)(1) is not a drug solely because the label or the labeling 
contains such a statement.''.
    (b) Section 403.--Section 403 (21 U.S.C. 343) is amended by adding 
at the end 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. 8. 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 new 
section:

``SEC. 311. WARNING LETTERS.

    ``Any warning letter or similar written threat of enforcement under 
the Federal Food, Drug, and Cosmetic Act constitutes final agency 
action for the purpose of obtaining judicial review under chapter 7 of 
title 5, United States Code, if the matter with respect to such letter 
or threat is not resolved within 60 days from the date such letter or 
threat is delivered to any person subject to this Act. In any 
proceeding for judicial review of a warning letter or similar written 
threat of enforcement under the Act, the United States bears the burden 
of proof on each element of each alleged violation of law described.''.

SEC. 9. WITHDRAWAL OF THE REGULATIONS AND NOTICE.

    (a) In General.--The advance notice of proposed rulemaking 
concerning dietary supplements published in the Federal Register of 
June 18, 1993 (58 FR 33690-33700), the notices of proposed rulemaking 
concerning nutrition labeling for dietary supplements and nutrient 
content claims for dietary supplements published in the Federal 
Register of June 18, 1993 (58 FR 33715-33731 and 58 FR 33731-33751), 
and the final rules and notices published in the Federal Register of 
January 4, 1994 concerning nutrition labeling for dietary supplements 
and nutrient content claims for dietary supplements (59 FR 354-378 and 
378-395) are null and void and of no force or effect insofar as they 
apply to dietary supplements. Final regulations and notices published 
in the Federal Register of January 4, 1994 concerning health claims for 
dietary supplements under the Nutrition Labeling and Education Act of 
1990 (59 FR 395-426) shall not be affected by this section and shall 
remain in effect until 120 days after the date of the submission of the 
final report of the Commission established under section 11 to the 
President and to Congress, or 28 months after the date of enactment of 
this Act, whichever is earlier.
    (b) Notice of Revocation.--The Secretary of Health and Human 
Services shall publish notices in the Federal Register to revoke all of 
the items declared to be null and void and of no force or effect under 
subsection (a).
    (c) Issuance of Regulations.--Notwithstanding any provision of the 
Nutrition Labeling and Education Act of 1990--
            (1) no regulation is required to be issued pursuant to such 
        Act with respect to dietary supplements of vitamins, minerals, 
        herbs, amino acids, or other similar nutritional substances; 
        and
            (2) no regulation that is issued in whole or in part 
        pursuant to such Act shall have any force or effect with 
        respect to any dietary supplement of vitamins, minerals, herbs, 
        amino acids, or other similar nutritional substances unless 
        such regulation is issued pursuant to rulemaking proceedings 
        that are initiated by an advance notice of proposed rulemaking 
        that is published no earlier than 2 years after the date of 
        enactment of this Act, and followed by, at least, a notice of 
        proposed rulemaking prior to issuance of the final regulation, 
        except insofar as the regulation authorizes the use of labeling 
        about calcium, folic acid, or other matters and does not 
        prohibit the use of any labeling.

SEC. 10. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRITION 
              INFORMATION LABELING.

    (a) Misbranded Supplements.--Section 403 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following new paragraph:
    ``(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)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)) is 
amended by adding at the end the following: ``A dietary supplement may 
bear on the nutrition label or in labeling a listing and quantity of 
ingredients that have not been deemed essential nutrients by the 
Secretary if such ingredients are prominently identified as not having 
been shown to be essential or not having an established daily value.''.
    (c) Dietary Supplement Labeling Exemptions.--Section 403(q)(5) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is 
amended by adding at the end the following new clause:
    ``(H) The labels of dietary supplements shall not be required to 
bear the nutrition information under subparagraph (1), but shall be 
required to list immediately above the ingredient listing the amount of 
nutrients required by the Secretary to be listed pursuant to clause 
(C), (D) or (E) of subparagraph (1) or clause (A) of subparagraph (2) 
that are present in significant amounts in the supplement.''.
    (d) Vitamins and Minerals.--Section 411(b)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350(b)(2)) is amended--
            (1) by striking ``vitamins and 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).

SEC. 11. 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. No 
        member of the Commission shall be biased against dietary 
        supplements.
    (c) Functions of the Commission.--The Commission shall conduct a 
study on, and provide recommendations for, the regulation of label 
claims for dietary supplements, including procedures for the evaluation 
of such claims. In making such recommendations, the Commission shall 
evaluate how best to provide truthful and nonmisleading information to 
consumers so that such consumers may make informed health care choices 
for themselves and their families.
    (d) 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.
    (e) 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 necessary to carry out the 
        provisions of this section.

SEC. 12. GOOD MANUFACTURING PRACTICES.

    Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342) (as amended by section 4) is further 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 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 the Administrative Procedure Act.''.

SEC. 13. 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(ff) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
    ``(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.''.

            Passed the Senate August 13 (legislative day, August 11), 
      1994.

            Attest:






                                                             Secretary.

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