[Congressional Record Volume 140, Number 144 (Thursday, October 6, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: October 6, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
          DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994

  Mr. WAXMAN. Mr. Speaker, I ask unanimous consent that the Committee 
on Energy and Commerce be discharged from further consideration of the 
Senate bill (S. 784) to amend the Federal Food, Drug, and Cosmetic Act 
to establish standards with respect to dietary supplements, and for 
other purposes.
  The Clerk read the title of the Senate bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from California?
  There was no objection.
  The Clerk read the Senate bill as follows:

                                 S. 784

       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 health 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 coronoary 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 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, 1944 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 be 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.''.


     amendment in the nature of a substitute offered by mr. waxman

  Mr. WAXMAN. Mr. Speaker, I offer an amendment in the nature of a 
substitute:
  The Clerk read as follows:

       Amendment in the nature of a substitute offered by Mr. 
     Waxman:
       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Dietary 
     Supplement Health and Education Act of 1994''.
       (b) Reference.--Whenever in this Act an amendment or repeal 
     is expressed in terms of an amendment to, or repeal of, a 
     section or other provision, the reference shall be considered 
     to be made to a section or other provision of the Federal 
     Food, Drug, and Cosmetic Act.
       (c) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Safety of dietary supplements and burden of proof on FDA.
Sec. 5. Dietary supplement claims.
Sec. 6. Statements of nutritional support.
Sec. 7. Dietary supplement ingredient labeling and nutrition 
              information labeling.
Sec. 8. New dietary ingredients.
Sec. 9. Good manufacturing practices.
Sec. 10. Conforming amendments.
Sec. 11. Withdrawal of the regulations and notice.
Sec. 12. Commission on dietary supplement labels.
Sec. 13. Office of dietary supplements.

     SEC. 2. FINDINGS.

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

     SEC. 3. DEFINITIONS.

       (a) Definition of Certain Foods as Dietary Supplements.--
     Section 201 (21 U.S.C. 321) is amended by adding at the end 
     the following:
       ``(ff) The term `dietary supplement'--
       ``(1) means a product (other than tobacco) intended to 
     supplement the diet that bears or contains one or more of the 
     following dietary ingredients:
       ``(A) a vitamin;
       ``(B) a mineral;
       ``(C) an herb or other botanical;
       ``(D) an amino acid;
       ``(E) a dietary substance for use by man to supplement the 
     diet by increasing the total dietary intake; or
       ``(F) a concentrate, metabolite, constituent, extract, or 
     combination of any ingredient described in clause (A), (B), 
     (C), (D), or (E);
       ``(2) means a product that--
       ``(A)(i) is intended for ingestion in a form described in 
     section 411(c)(1)(B)(i); or
       ``(ii) complies with section 411(c)(1)(B)(ii); 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; and
       (3) does--
       ``(A) include an article that is approved as a new drug 
     under section 505, certified as an antibiotic under section 
     507, or licensed as a biologic under section 351 of the 
     Public Health Service Act (42 U.S.C. 262) and was, prior to 
     such approval, certification, or license, marketed as a 
     dietary supplement or as a food unless the Secretary has 
     issued a regulation, after notice and comment, finding that 
     the article, when used as or in a dietary supplement under 
     the conditions of use and dosages set forth in the labeling 
     for such dietary supplement, is unlawful under section 
     402(f); and
       ``(B) not include--
       ``(i) an article that is approved as a new drug under 
     section 505, certified as an antibiotic under section 507, or 
     licensed as a biologic under section 351 of the Public Health 
     Service Act (42 U.S.C. 262), or
       ``(ii) an article authorized for investigation as a new 
     drug, antibiotic, or biological for which substantial 
     clinical investigations have been instituted and for which 
     the existence of such investigations has been made public,

     which was not before such approval, certification, licensing, 
     or authorization marketed as a dietary supplement or as a 
     food unless the Secretary, in the Secretary's discretion, has 
     issued a regulation, after notice and comment, finding that 
     the article would be lawful under this Act.

     Except for purposes of section 201(g), a dietary supplement 
     shall be deemed to be a food within the meaning of this 
     Act.''.
       (b) Exclusion From Definition of Food Additive.--Section 
     201(s) (21 U.S.C. 321(s)) is amended--
       (1) by striking ``or'' at the end of subparagraph (4);
       (2) by striking the period at the end of subparagraph (5) 
     and inserting ``; or''; and
       (3) by adding at the end the following new subparagraph:
       ``(6) an ingredient described in paragraph (ff) in, or 
     intended for use in, a dietary supplement.''.
       (c) Form of Ingestion.--Section 411(c)(1)(B) (21 U.S.C. 
     350(c)(1)(B)) is amended--
       (1) in clause (i), by inserting ``powder, softgel, 
     gelcap,'' after ``capsule,''; and
       (2) in clause (ii), by striking ``does not simulate and''.

     SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON 
                   FDA.

       Section 402 (21 U.S.C. 342) is amended by adding at the end 
     the following:
       ``(f)(1) If it is a dietary supplement or contains a 
     dietary ingredient that--
       ``(A) presents a significant or unreasonable risk of 
     illness or injury under--
       ``(i) conditions of use recommended or suggested in 
     labeling, or
       ``(ii) if no conditions of use are suggested or recommended 
     in the labeling, under ordinary conditions of use;
       ``(B) is a new dietary ingredient for which there is 
     inadequate information to provide reasonable assurance that 
     such ingredient does not present a significant or 
     unreasonable risk of illness or injury;
       ``(C) the Secretary declares to pose an imminent hazard to 
     public health or safety, except that the authority to make 
     such declaration shall not be delegated and the Secretary 
     shall promptly after such a declaration initiate a proceeding 
     in accordance with sections 554 and 556 of title 5, United 
     States Code, to affirm or withdraw the declaration; or
       ``(D) is or contains a dietary ingredient that renders it 
     adulterated under paragraph (a)(1) under the conditions of 
     use recommended or suggested in the labeling of such dietary 
     supplement.

     In any proceeding under this subparagraph, the United States 
     shall bear the burden of proof on each element to show that a 
     dietary supplement is adulterated. The court shall decide any 
     issue under this paragraph on a de novo basis.
       ``(2) Before the Secretary may report to a United States 
     attorney a violation of paragraph (1)(A) for a civil 
     proceeding, the person against whom such proceeding would be 
     initiated shall be given appropriate notice and the 
     opportunity to present views, orally and in writing, at least 
     10 days before such notice, with regard to such 
     proceeding.''.

     SEC. 5. DIETARY SUPPLEMENT CLAIMS.

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


                ``dietary supplement labeling exemptions

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

     SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.

       Section 403(r) (21 U.S.C. 343(r)) is amended by adding at 
     the end the following:
       ``(6) For purposes of paragraph (r)(1)(B), a statement for 
     a dietary supplement may be made if--
       ``(A) the statement claims a benefit related to a classical 
     nutrient deficiency disease and discloses the prevalence of 
     such disease in the United States, describes the role of a 
     nutrient or dietary ingredient intended to affect the 
     structure or function in humans, characterizes the documented 
     mechanism by which a nutrient or dietary ingredient acts to 
     maintain such structure or function, or describes general 
     well-being from consumption of a nutrient or dietary 
     ingredient,
       ``(B) the manufacturer of the dietary supplement has 
     substantiation that such statement is truthful and not 
     misleading, and
       ``(C) the statement contains, prominently displayed and in 
     boldface type, the following: `This statement has not been 
     evaluated by the Food and Drug Administration. This product 
     is not intended to diagnose, treat, cure, or prevent any 
     disease.'.

     A statement under this subparagraph may not claim to 
     diagnose, mitigate, treat, cure, or prevent a specific 
     disease or class of diseases. If the manufacturer of a 
     dietary supplement proposes to make a statement described in 
     the first sentence of this subparagraph in the labeling of 
     the dietary supplement, the manufacturer shall notify the 
     Secretary no later than 30 days after the first marketing of 
     the dietary supplement with such statement that such a 
     statement is being made.''.

     SEC. 7. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRITION 
                   INFORMATION LABELING.

       (a) Misbranded Supplements.--Section 403 (21 U.S.C. 343) is 
     amended by adding at the end the following:
       ``(s) If--
       ``(1) it is a dietary supplement; and
       ``(2)(A) the label or labeling of the supplement fails to 
     list--
       ``(i) the name of each ingredient of the supplement that is 
     described in section 201(ff); and
       ``(ii)(I) the quantity of each such ingredient; or
       ``(II) with respect to a proprietary blend of such 
     ingredients, the total quantity of all ingredients in the 
     blend;
       ``(B) the label or labeling of the dietary supplement fails 
     to identify the product by using the term `dietary 
     supplement', which term may be modified with the name of such 
     an ingredient;
       ``(C) the supplement contains an ingredient described in 
     section 201(ff)(1)(C), and the label or labeling of the 
     supplement fails to identify any part of the plant from which 
     the ingredient is derived;
       ``(D) the supplement--
       ``(i) is covered by the specifications of an official 
     compendium;
       ``(ii) is represented as conforming to the specifications 
     of an official compendium; and
       ``(iii) fails to so conform; or
       ``(E) the supplement--
       ``(i) is not covered by the specifications of an official 
     compendium; and
       ``(ii)(I) fails to have the identity and strength that the 
     supplement is represented to have; or
       ``(II) fails to meet the quality (including tablet or 
     capsule disintegration), purity, or compositional 
     specifications, based on validated assay or other appropriate 
     methods, that the supplement is represented to meet.''.
       (b) Supplement Listing on Nutrition Labeling.--Section 
     403(q)(5)(F) (21 U.S.C. 343(q)(5)(F)) is amended to read as 
     follows:
       ``(F) A dietary supplement product (including a food to 
     which section 411 applies) shall comply with the requirements 
     of subparagraphs (1) and (2) in a manner which is appropriate 
     for the product and which is specified in regulations of the 
     Secretary which shall provide that--
       ``(i) nutrition information shall first list those dietary 
     ingredients that are present in the product in a significant 
     amount and for which a recommendation for daily consumption 
     has been established by the Secretary, except that a dietary 
     ingredient shall not be required to be listed if it is not 
     present in a significant amount, and shall list any other 
     dietary ingredient present and identified as having no such 
     recommendation;
       ``(ii) the listing of dietary ingredients shall include the 
     quantity of each such ingredient (or of a proprietary blend 
     of such ingredients) per serving;
       ``(iii) the listing of dietary ingredients may include the 
     source of a dietary ingredient; and
       ``(iv) the nutrition information shall immediately precede 
     the ingredient information required under subclause (i), 
     except that no ingredient identified pursuant to subclause 
     (i) shall be required to be identified a second time.''.
       (c) Percentage Level Claims.--Section 403(r)(2) (21 U.S.C. 
     343(r)(2)) is amended by adding after clause (E) the 
     following:
       ``(F) Subclause (i) clause (A) does not apply to a 
     statement in the labeling of a dietary supplement that 
     characterizes the percentage level of a dietary ingredient 
     for which the Secretary has not established a reference daily 
     intake, daily recommended value, or other recommendation for 
     daily consumption.''
       (d) Vitamins and Minerals.--Section 411(b)(2) (21 U.S.C. 
     350(b)(2)) is amended--
       (1) by striking ``vitamins or minerals'' and inserting 
     ``dietary supplement ingredients described in section 
     201(ff)'';
       (2) by striking ``(2)(A)'' and inserting ``(2)''; and
       (3) by striking subparagraph (B).
       (e) Effective Date.--Dietary supplements--
       (1) may be labeled after the date of the enactment of this 
     Act in accordance with the amendments made by this section, 
     and
       (2) shall be labeled after December 31, 1996, in accordance 
     with such amendments.

     SEC. 8. NEW DIETARY INGREDIENTS.

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


                       ``new dietary ingredients

       ``Sec. 413. (a) In General.--A dietary supplement which 
     contains a new dietary ingredient shall be deemed adulterated 
     under section 402(f) unless it meets one of the following 
     requirements:
       ``(1) The dietary supplement contains only dietary 
     ingredients which have been present in the food supply as an 
     article used for food in a form in which the food has not 
     been chemically altered.
       ``(2) There is a history of use or other evidence of safety 
     establishing that the dietary ingredient when used under the 
     conditions recommended or suggested in the labeling of the 
     dietary supplement will reasonably be expected to be safe 
     and, at least 75 days before being introduced or delivered 
     for introduction into interstate commerce, the manufacturer 
     or distributor of the dietary ingredient or dietary 
     supplement provides the Secretary with information, including 
     any citation to published articles, which is the basis on 
     which the manufacturer or distributor has concluded that a 
     dietary supplement containing such dietary ingredient will 
     reasonably be expected to be safe.

     The Secretary shall keep confidential any information 
     provided under paragraph (2) for 90 days following its 
     receipt. After the expiration of such 90 days, the Secretary 
     shall place such information on public display, except 
     matters in the information which are trade secrets or 
     otherwise confidential, commercial information.
       ``(b) Petition.--Any person may file with the Secretary a 
     petition proposing the issuance of an order prescribing the 
     conditions under which a new dietary ingredient under its 
     intended conditions of use will reasonably be expected to be 
     safe. The Secretary shall make a decision on such petition 
     within 180 days of the date the petition is filed with the 
     Secretary. For purposes of chapter 7 of title 5, United 
     States Code, the decision of the Secretary shall be 
     considered final agency action.
       ``(c) Definition.--For purposes of this section, the term 
     `new dietary ingredient' means a dietary ingredient that was 
     not marketed in the United States before October 15, 1994 and 
     does not include any dietary ingredient which was marketed in 
     the United States before October 15, 1994.''.

     SEC. 9. GOOD MANUFACTURING PRACTICES.

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

     SEC. 10. CONFORMING AMENDMENTS.

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

     SEC. 11. WITHDRAWAL OF THE REGULATIONS AND NOTICE.

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

     SEC. 12. COMMISSION ON DIETARY SUPPLEMENT LABELS.

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

     SEC. 13. OFFICE OF DIETARY SUPPLEMENTS.

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

               ``Subpart 4--Office of Dietary Supplements

     ``SEC. 485C. DIETARY SUPPLEMENTS.

       ``(a) Establishment.--The Secretary shall establish an 
     Office of Dietary Supplements within the National Institutes 
     of Health.
       ``(b) Purpose.--The purposes of the Office are--
       ``(1) to explore more fully the potential role of dietary 
     supplements as a significant part of the efforts of the 
     United States to improve health care; and
       ``(2) to promote scientific study of the benefits of 
     dietary supplements in maintaining health and preventing 
     chronic disease and other health-related conditions.
       ``(c) Duties.--The Director of the Office of Dietary 
     Supplements shall--
       ``(1) conduct and coordinate scientific research within the 
     National Institutes of Health relating to dietary supplements 
     and the extent to which the use of dietary supplements can 
     limit or reduce the risk of diseases such as heart disease, 
     cancer, birth defects, osteoporosis, cataracts, or 
     prostatism;
       ``(2) collect and compile the results of scientific 
     research relating to dietary supplements, including 
     scientific data from foreign sources or the Office of 
     Alternative Medicine;
       ``(3) serve as the principal advisor to the Secretary and 
     to the Assistant Secretary for Health and provide advice to 
     the Director of the National Institutes of Health, the 
     Director of the Centers for Disease Control and Prevention, 
     and the Commissioner of Food and Drugs on issues relating to 
     dietary supplements including--
       ``(A) dietary intake regulations;
       ``(B) the safety of dietary supplements;
       ``(C) claims characterizing the relationship between--
       ``(i) dietary supplements; and
       ``(ii)(I) prevention of disease or other health-related 
     conditions; and
       ``(II) maintenance of health; and
       ``(D) scientific issues arising in connection with the 
     labeling and composition of dietary supplements;
       ``(4) compile a database of scientific research on dietary 
     supplements and individual nutrients; and
       ``(5) coordinate funding relating to dietary supplements 
     for the National Institutes of Health.
       ``(d) Definition.--As used in this section, the term 
     `dietary supplement' has the meaning given the term in 
     section 201(ff) of the Federal Food, Drug, and Cosmetic Act.
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $5,000,000 for fiscal year 1994 and such sums as may be 
     necessary for each subsequent fiscal year.''.
       (b) Conforming Amendment.--Section 401(b)(2) of the Public 
     Health Service Act (42 U.S.C. 281(b)(2)) is amended by adding 
     at the end the following:
       ``(E) The Office of Dietary Supplements.''.
  Mr. WAXMAN (during the reading). Mr. Speaker, I ask unanimous consent 
that the amendment in the nature of a substitute be considered as read 
and printed in the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from California?
  There was no objection.
  The SPEAKER pro tempore. The gentleman from California [Mr. Waxman] 
is recognized for 1 hour.
  Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume.
  There is no Member who is not aware of the issues addressed by this 
bill. We have all heard from constituents who are concerned about the 
regulation of dietary supplements.
  I am pleased to announce that an agreement has been reached on 
dietary supplement legislation. This legislation will assure consumers 
access to all supplements on the market so long as they are not unsafe. 
It will allow manufacturers to distribute certain scientific 
publications and make certain statements about supplements if those 
publications and statements are not false and misleading.
  The legislation also provides for a Presidential commission that will 
study a number of contentious issues pertaining to claims that can be 
made for supplements and the application of the Nutrition Labeling and 
Education Act to supplements. During the commission's consideration of 
these issues, the NLEA will remain in effect for supplements.
  Mr. Speaker, this bill resolves an extremely contentious issue. Many 
members deserve credit for this compromise. In particular, I would like 
to acknowledge the chairman of my committee, Mr. Dingell, as well as 
the lead sponsor of the House bill, Mr. Richardson, and Mr. Gallegly 
who sponsored a similar bill. Mr. Bliley and Mr. Moorhead were of great 
assistance. Senators Hatch, Harkin, and Kennedy also had enormous 
influence on the bill.
  I would also like to acknowledge the untiring and skillful staff work 
of Kay Holcombe of the committee staff, as well as the important 
contribution made by Mary McGrane, counsel for the minority on our 
committee, and Melody Harned for the minority, as well as John Lewis of 
Mr. Richardson's staff. David Meade, the House Legislative Counsel, 
was, as always, a superb draftsman who was available whenever we needed 
him.
  Finally, the chief sponsors of the bill from both Chambers have 
agreed that the only legislative history for this legislation will be a 
statement of agreement that I ask be included in the Record immediately 
after this statement.
  Mr. Speaker, I know of no opposition to the bill and I urge it be 
adopted by unanimous consent.

                         Statement of Agreement

       This statement comprises the entire legislative history for 
     the Dietary Supplement Health and Education Act of 1994, S. 
     784. It is the intent of the chief sponsors of the bill 
     (Senators Hatch, Harkin and Kennedy, and Congressmen 
     Richardson, Bliley, Moorhead, Gallegly, Dingell, Waxman) that 
     no other reports or statements be considered as legislative 
     history for the bill.
       1. The bill does not affect the Food and Drug 
     Administration's (``FDA's'') existing authority under the 
     Federal Food, Drug and Cosmetic Act to prohibit the import or 
     sale of any product marketed as a drug in a foreign country.
       2. In section 201(ff)(3)(B)(ii), added by section 3 of the 
     bill, the term ``substantial clinical investigations'' does 
     not include compassionate investigational new drug 
     applications or an investigational new drug application 
     submitted by a physical for a single patient.
       3. Section 403B, added by section 5, does not apply to a 
     summary of a publication other than an official abstract of a 
     peer-reviewed scientific publication.
       4. Section 403(r)(6)(A), added by section 6, does not 
     permit premarket approval or require premarket review by the 
     FDA of any statement permitted under that provision.
       5. In section 413(a)(1), added by section 8, the term 
     ``chemically altered'' does not include the following 
     physical modifications: minor loss of volatile components, 
     dehydration, lyophlization, milling, tincture or solution in 
     water, slurry, powder, or solid in suspension.
  Mr. MOORHEAD. Mr. Speaker, will the gentleman yield?
  Mr. WAXMAN. I yield to the gentleman from California.
  Mr. MOORHEAD. Mr. Speaker, I support enactment of this legislation. I 
certainly wish to commend all of the people who the gentleman from 
California has listed, those that have participated.
  This legislation is the result of long hours of negotiations over a 
number of days, and certainly the gentleman from New Mexico has worked 
extremely hard to get this legislation. I know in my own district I 
have gotten hundreds of letters from people badly wanting this bill 
passed.
  I am happy at this late moment in this Congress we are able to be 
successful and bring this bill before the House.
  Mr. RICHARDSON. Mr. Speaker, will the gentleman yield?
  Mr. WAXMAN. Mr. Speaker, no Member has worked more tirelessly for 
this legislation than has the lead sponsor in the House of 
Representatives, the gentleman from New Mexico [Mr. Richardson], and I 
am happy to yield to the gentleman from New Mexico [Mr. Richardson].
  Mr. RICHARDSON. Mr. Speaker, I rise in full support of this 
amendment, which represents a historic agreement on the Dietary 
Supplements Health and Education Act.
  Guaranteeing access to dietary supplements and information about them 
started with the introduction of my bill, H.R. 1709, the Dietary 
Supplement Health and Education Act of 1993.
  Two hundred sixty-two cosponsors in the House and 66 cosponsors in 
the Senate listened intently to the thousands of calls, letters, and 
personal messages urging Congress to act. I want to thank each and 
every one of those cosponsors for their support.
  This agreement is a big victory for consumers of supplements. It 
guarantees access to safe supplements now and in the future.
  This agreement contains a very clear definition of dietary 
supplements.
  It ensures that people who want to learn more about the benefits of 
supplements can do so through literature and labeling.
  This agreement creates a commission to study health claims and other 
means of communicating information to consumers about supplements.
  This agreement will also encourage the advancement of research about 
the relationship between nutrients and diseases through the creation of 
the Office of Dietary Supplements.
  And there are good manufacturing practices included in this amendment 
to ensure high-quality products for consumers.
  This is an agreement that we can all be proud of. This has been a 
long and difficult road to meeting the concerns of all those involved, 
but we have done it.
  I would like to thank Chairman Waxman and Chairman Dingell for all 
the time and energy that they put into this. I appreciate your efforts 
and the work of your staffs.
  My sincere thanks to our ranking minority members, Representatives 
Bliley and Moorhead, and their staffs for their fine work, especially 
John Lewis, my staff, Kay Holcomb, Mr. Dingell's staff, Bill Schultz, 
and Tricia Knight of Senator Hatch's staff, and Mary Magraine of Mr. 
Moorhead's staff.
  I would also like to extend my thanks to Representative Gallegly for 
his work on pushing this issue to the forefront.
  Finally, I would like to extend my great appreciation to Senator 
Orrin Hatch of Utah for championing this cause in the Senate. He is 
truly the king of vitamins. His staff has also done a tremendous job.
  And I would be forgetting something very important if I did not thank 
the grassroots groups for helping to bring us to this resolution. 
Citizens for Health, the Nutrition Health Alliance, and the Natural 
Nutritional Foods Association are just a few of the groups who deserve 
a great deal of credit.
  This is a great victory for the more than 100 million Americans who 
use these products and I am proud to be part of it.
  Mr. WAXMAN. Mr. Speaker, I have no further requests for time, and I 
yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the amendment in the 
nature of a substitute offered by the gentleman from California [Mr. 
Waxman].
  The amendment in the nature of a substitute was agreed to.
  The Senate bill was ordered to be read a third time, and was read the 
third time, and passed.
  A motion to reconsider was laid on the table.

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