[Congressional Record Volume 140, Number 113 (Saturday, August 13, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: August 13, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                          AMENDMENTS SUBMITTED

                                 ______


          DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994

                                 ______


                 HATCH (AND HARKIN) AMENDMENT NO. 2562

  Mr. HATCH (for himself and Mr. Harkin) proposed an amendment to the 
bill (S. 784) to amend the Federal Food, Drug, and Cosmetic Act to 
establish standards with respect to dietary supplements, and for other 
purposes; as follows:

       Strike out all after the enacting clause and insert the 
     following:

     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.''.

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