[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 784 Engrossed Amendment House (EAH)]
In the House of Representatives, U. S.,
October 7 (legislative day, October 6), 1994.
Resolved, That the bill from the Senate (S. 784) entitled ``An
Act to amend the Federal Food, Drug, and Cosmetic Act to establish
standards with respect to dietary supplements, and for other
purposes'', do pass with the following
AMENDMENT:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Dietary Supplement
Health and Education Act of 1994''.
(b) Reference.--Whenever in this Act an amendment or repeal is
expressed in terms of an amendment to, or repeal of, a section or other
provision, the reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act.
(c) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Safety of dietary supplements and burden of proof on FDA.
Sec. 5. Dietary supplement claims.
Sec. 6. Statements of nutritional support.
Sec. 7. Dietary supplement ingredient labeling and nutrition
information labeling.
Sec. 8. New dietary ingredients.
Sec. 9. Good manufacturing practices.
Sec. 10. Conforming amendments.
Sec. 11. Withdrawal of the regulations and notice.
Sec. 12. Commission on dietary supplement labels.
Sec. 13. Office of dietary supplements.
SEC. 2. FINDINGS.
Congress finds that--
(1) improving the health status of United States citizens
ranks at the top of the national priorities of the Federal
Government;
(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have
been documented increasingly in scientific studies;
(3)(A) there is a link between the ingestion of certain
nutrients or dietary supplements and the prevention of chronic
diseases such as cancer, heart disease, and osteoporosis; and
(B) clinical research has shown that several chronic
diseases can be prevented simply with a healthful diet, such as
a diet that is low in fat, saturated fat, cholesterol, and
sodium, with a high proportion of plant-based foods;
(4) healthful diets may mitigate the need for expensive
medical procedures, such as coronary bypass surgery or
angioplasty;
(5) preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements
will limit the incidence of chronic diseases, and reduce long-
term health care expenditures;
(6)(A) promotion of good health and healthy lifestyles
improves and extends lives while reducing health care
expenditures; and
(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-
being of the country;
(7) there is a growing need for emphasis on the
dissemination of information linking nutrition and long-term
good health;
(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements;
(9) national surveys have revealed that almost 50 percent
of the 260,000,000 Americans regularly consume dietary
supplements of vitamins, minerals, or herbs as a means of
improving their nutrition;
(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to
avoid the excessive costs of traditional medical services and
to obtain more holistic consideration of their needs;
(11) the United States will spend over $1,000,000,000,000
on health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage will continue to increase unless significant efforts
are undertaken to reverse the increase;
(12)(A) the nutritional supplement industry is an integral
part of the economy of the United States;
(B) the industry consistently projects a positive trade
balance; and
(C) the estimated 600 dietary supplement manufacturers in
the United States produce approximately 4,000 products, with
total annual sales of such products alone reaching at least
$4,000,000,000;
(13) although the Federal Government should take swift
action against products that are unsafe or adulterated, the
Federal Government should not take any actions to impose
unreasonable regulatory barriers limiting or slowing the flow
of safe products and accurate information to consumers;
(14) dietary supplements are safe within a broad range of
intake, and safety problems with the supplements are relatively
rare; and
(15)(A) legislative action that protects the right of
access of consumers to safe dietary supplements is necessary in
order to promote wellness; and
(B) a rational Federal framework must be established to
supersede the current ad hoc, patchwork regulatory policy on
dietary supplements.
SEC. 3. DEFINITIONS.
(a) Definition of Certain Foods as Dietary Supplements.--Section
201 (21 U.S.C. 321) is amended by adding at the end the following:
``(ff) The term `dietary supplement'--
``(1) means a product (other than tobacco) intended to
supplement the diet that bears or contains one or more of the
following dietary ingredients:
``(A) a vitamin;
``(B) a mineral;
``(C) an herb or other botanical;
``(D) an amino acid;
``(E) a dietary substance for use by man to
supplement the diet by increasing the total dietary
intake; or
``(F) a concentrate, metabolite, constituent,
extract, or combination of any ingredient described in
clause (A), (B), (C), (D), or (E);
``(2) means a product that--
``(A)(i) is intended for ingestion in a form
described in section 411(c)(1)(B)(i); or
``(ii) complies with section 411(c)(1)(B)(ii);
``(B) is not represented for use as a conventional
food or as a sole item of a meal or the diet; and
``(C) is labeled as a dietary supplement; and
``(3) does--
``(A) include an article that is approved as a new
drug under section 505, certified as an antibiotic
under section 507, or licensed as a biologic under
section 351 of the Public Health Service Act (42 U.S.C.
262) and was, prior to such approval, certification, or
license, marketed as a dietary supplement or as a food
unless the Secretary has issued a regulation, after
notice and comment, finding that the article, when used
as or in a dietary supplement under the conditions of
use and dosages set forth in the labeling for such
dietary supplement, is unlawful under section 402(f);
and
``(B) not include--
``(i) an article that is approved as a new
drug under section 505, certified as an
antibiotic under section 507, or licensed as a
biologic under section 351 of the Public Health
Service Act (42 U.S.C. 262), or
``(ii) an article authorized for
investigation as a new drug, antibiotic, or
biological for which substantial clinical
investigations have been instituted and for
which the existence of such investigations has
been made public,
which was not before such approval, certification, licensing,
or authorization marketed as a dietary supplement or as a food
unless the Secretary, in the Secretary's discretion, has issued
a regulation, after notice and comment, finding that the
article would be lawful under this Act.
Except for purposes of section 201(g), a dietary supplement shall be
deemed to be a food within the meaning of this Act.''.
(b) Exclusion From Definition of Food Additive.--Section 201(s) (21
U.S.C. 321(s)) is amended--
(1) by striking ``or'' at the end of subparagraph (4);
(2) by striking the period at the end of subparagraph (5)
and inserting ``; or''; and
(3) by adding at the end the following new subparagraph:
``(6) an ingredient described in paragraph (ff) in, or
intended for use in, a dietary supplement.''.
(c) Form of Ingestion.--Section 411(c)(1)(B) (21 U.S.C.
350(c)(1)(B)) is amended--
(1) in clause (i), by inserting ``powder, softgel,
gelcap,'' after ``capsule,''; and
(2) in clause (ii), by striking ``does not simulate and''.
SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON FDA.
Section 402 (21 U.S.C. 342) is amended by adding at the end the
following:
``(f)(1) If it is a dietary supplement or contains a dietary
ingredient that--
``(A) presents a significant or unreasonable risk of
illness or injury under--
``(i) conditions of use recommended or suggested in
labeling, or
``(ii) if no conditions of use are suggested or
recommended in the labeling, under ordinary conditions
of use;
``(B) is a new dietary ingredient for which there is
inadequate information to provide reasonable assurance that
such ingredient does not present a significant or unreasonable
risk of illness or injury;
``(C) the Secretary declares to pose an imminent hazard to
public health or safety, except that the authority to make such
declaration shall not be delegated and the Secretary shall
promptly after such a declaration initiate a proceeding in
accordance with sections 554 and 556 of title 5, United States
Code, to affirm or withdraw the declaration; or
``(D) is or contains a dietary ingredient that renders it
adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary
supplement.
In any proceeding under this subparagraph, the United States shall bear
the burden of proof on each element to show that a dietary supplement
is adulterated. The court shall decide any issue under this paragraph
on a de novo basis.
``(2) Before the Secretary may report to a United States attorney a
violation of paragraph (1)(A) for a civil proceeding, the person
against whom such proceeding would be initiated shall be given
appropriate notice and the opportunity to present views, orally and in
writing, at least 10 days before such notice, with regard to such
proceeding.''.
SEC. 5. DIETARY SUPPLEMENT CLAIMS.
Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after
section 403A the following new section:
``dietary supplement labeling exemptions
``Sec. 403B. (a) In General.--A publication, including an article,
a chapter in a book, or an official abstract of a peer-reviewed
scientific publication that appears in an article and was prepared by
the author or the editors of the publication, which is reprinted in its
entirety, shall not be defined as labeling when used in connection with
the sale of a dietary supplement to consumers when it--
``(1) is not false or misleading;
``(2) does not promote a particular manufacturer or brand
of a dietary supplement;
``(3) is displayed or presented, or is displayed or
presented with other such items on the same subject matter, so
as to present a balanced view of the available scientific
information on a dietary supplement;
``(4) if displayed in an establishment, is physically
separate from the dietary supplements; and
``(5) does not have appended to it any information by
sticker or any other method.
``(b) Application.--Subsection (a) shall not apply to or restrict a
retailer or wholesaler of dietary supplements in any way whatsoever in
the sale of books or other publications as a part of the business of
such retailer or wholesaler.
``(c) Burden of Proof.--In any proceeding brought under subsection
(a), the burden of proof shall be on the United States to establish
that an article or other such matter is false or misleading.''.
SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.
Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end
the following:
``(6) For purposes of paragraph (r)(1)(B), a statement for a
dietary supplement may be made if--
``(A) the statement claims a benefit related to a classical
nutrient deficiency disease and discloses the prevalence of
such disease in the United States, describes the role of a
nutrient or dietary ingredient intended to affect the structure
or function in humans, characterizes the documented mechanism
by which a nutrient or dietary ingredient acts to maintain such
structure or function, or describes general well-being from
consumption of a nutrient or dietary ingredient,
``(B) the manufacturer of the dietary supplement has
substantiation that such statement is truthful and not
misleading, and
``(C) the statement contains, prominently displayed and in
boldface type, the following: `This statement has not been
evaluated by the Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent any
disease.'.
A statement under this subparagraph may not claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class of
diseases. If the manufacturer of a dietary supplement proposes to make
a statement described in the first sentence of this subparagraph in the
labeling of the dietary supplement, the manufacturer shall notify the
Secretary no later than 30 days after the first marketing of the
dietary supplement with such statement that such a statement is being
made.''.
SEC. 7. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRITION
INFORMATION LABELING.
(a) Misbranded Supplements.--Section 403 (21 U.S.C. 343) is amended
by adding at the end the following:
``(s) If--
``(1) it is a dietary supplement; and
``(2)(A) the label or labeling of the supplement fails to
list--
``(i) the name of each ingredient of the supplement
that is described in section 201(ff); and
``(ii)(I) the quantity of each such ingredient; or
``(II) with respect to a proprietary blend of such
ingredients, the total quantity of all ingredients in
the blend;
``(B) the label or labeling of the dietary supplement fails
to identify the product by using the term `dietary supplement',
which term may be modified with the name of such an ingredient;
``(C) the supplement contains an ingredient described in
section 201(ff)(1)(C), and the label or labeling of the
supplement fails to identify any part of the plant from which
the ingredient is derived;
``(D) the supplement--
``(i) is covered by the specifications of an
official compendium;
``(ii) is represented as conforming to the
specifications of an official compendium; and
``(iii) fails to so conform; or
``(E) the supplement--
``(i) is not covered by the specifications of an
official compendium; and
``(ii)(I) fails to have the identity and strength
that the supplement is represented to have; or
``(II) fails to meet the quality (including tablet
or capsule disintegration), purity, or compositional
specifications, based on validated assay or other
appropriate methods, that the supplement is represented
to meet.''.
(b) Supplement Listing on Nutrition Labeling.--Section 403(q)(5)(F)
(21 U.S.C. 343(q)(5)(F)) is amended to read as follows:
``(F) A dietary supplement product (including a food to which
section 411 applies) shall comply with the requirements of
subparagraphs (1) and (2) in a manner which is appropriate for the
product and which is specified in regulations of the Secretary which
shall provide that--
``(i) nutrition information shall first list those dietary
ingredients that are present in the product in a significant
amount and for which a recommendation for daily consumption has
been established by the Secretary, except that a dietary
ingredient shall not be required to be listed if it is not
present in a significant amount, and shall list any other
dietary ingredient present and identified as having no such
recommendation;
``(ii) the listing of dietary ingredients shall include the
quantity of each such ingredient (or of a proprietary blend of
such ingredients) per serving;
``(iii) the listing of dietary ingredients may include the
source of a dietary ingredient; and
``(iv) the nutrition information shall immediately precede
the ingredient information required under subclause (i), except
that no ingredient identified pursuant to subclause (i) shall
be required to be identified a second time.''.
(c) Percentage Level Claims.--Section 403(r)(2) (21 U.S.C.
343(r)(2)) is amended by adding after clause (E) the following:
``(F) Subclause (i) clause (A) does not apply to a statement in the
labeling of a dietary supplement that characterizes the percentage
level of a dietary ingredient for which the Secretary has not
established a reference daily intake, daily recommended value, or other
recommendation for daily consumption.''
(d) Vitamins and Minerals.--Section 411(b)(2) (21 U.S.C. 350(b)(2))
is amended--
(1) by striking ``vitamins or minerals'' and inserting
``dietary supplement ingredients described in section
201(ff)'';
(2) by striking ``(2)(A)'' and inserting ``(2)''; and
(3) by striking subparagraph (B).
(e) Effective Date.--Dietary supplements--
(1) may be labeled after the date of the enactment of this
Act in accordance with the amendments made by this section, and
(2) shall be labeled after December 31, 1996, in accordance
with such amendments.
SEC. 8. NEW DIETARY INGREDIENTS.
Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended
by adding at the end the following:
``new dietary ingredients
``Sec. 413. (a) In General.--A dietary supplement which contains a
new dietary ingredient shall be deemed adulterated under section 402(f)
unless it meets one of the following requirements:
``(1) The dietary supplement contains only dietary
ingredients which have been present in the food supply as an
article used for food in a form in which the food has not been
chemically altered.
``(2) There is a history of use or other evidence of safety
establishing that the dietary ingredient when used under the
conditions recommended or suggested in the labeling of the
dietary supplement will reasonably be expected to be safe and,
at least 75 days before being introduced or delivered for
introduction into interstate commerce, the manufacturer or
distributor of the dietary ingredient or dietary supplement
provides the Secretary with information, including any citation
to published articles, which is the basis on which the
manufacturer or distributor has concluded that a dietary
supplement containing such dietary ingredient will reasonably
be expected to be safe.
The Secretary shall keep confidential any information provided under
paragraph (2) for 90 days following its receipt. After the expiration
of such 90 days, the Secretary shall place such information on public
display, except matters in the information which are trade secrets or
otherwise confidential, commercial information.
``(b) Petition.--Any person may file with the Secretary a petition
proposing the issuance of an order prescribing the conditions under
which a new dietary ingredient under its intended conditions of use
will reasonably be expected to be safe. The Secretary shall make a
decision on such petition within 180 days of the date the petition is
filed with the Secretary. For purposes of chapter 7 of title 5, United
States Code, the decision of the Secretary shall be considered final
agency action.
``(c) Definition.--For purposes of this section, the term `new
dietary ingredient' means a dietary ingredient that was not marketed in
the United States before October 15, 1994 and does not include any
dietary ingredient which was marketed in the United States before
October 15, 1994.''.
SEC. 9. GOOD MANUFACTURING PRACTICES.
Section 402 (21 U.S.C. 342), as amended by section 4, is amended by
adding at the end the following:
``(g)(1) If it is a dietary supplement and it has been prepared,
packed, or held under conditions that do not meet current good
manufacturing practice regulations, including regulations requiring,
when necessary, expiration date labeling, issued by the Secretary under
subparagraph (2).
``(2) The Secretary may by regulation prescribe good manufacturing
practices for dietary supplements. Such regulations shall be modeled
after current good manufacturing practice regulations for food and may
not impose standards for which there is no current and generally
available analytical methodology. No standard of current good
manufacturing practice may be imposed unless such standard is included
in a regulation promulgated after notice and opportunity for comment in
accordance with chapter 5 of title 5, United States Code.''.
SEC. 10. CONFORMING AMENDMENTS.
(a) Section 201.--The last sentence of section 201(g)(1) (21 U.S.C.
321(g)(1)) is amended to read as follows: ``A food or dietary
supplement for which a claim, subject to sections 403(r)(1)(B) and
403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in
accordance with the requirements of section 403(r) is not a drug solely
because the label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and not
misleading statement is made in accordance with section 403(r)(6) is
not a drug under clause (C) solely because the label or the labeling
contains such a statement.''.
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding
at the end the following:
``(u) The introduction or delivery for introduction into interstate
commerce of a dietary supplement that is unsafe under section 413.''.
(c) Section 403.--Section 403 (21 U.S.C. 343), as amended by
section 7, is amended by adding after paragraph (s) the following:
``A dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings.''.
SEC. 11. WITHDRAWAL OF THE REGULATIONS AND NOTICE.
The advance notice of proposed rulemaking concerning dietary
supplements published in the Federal Register of June 18, 1993 (58 FR
33690-33700) is null and void and of no force or effect insofar as it
applies to dietary supplements. The Secretary of Health and Human
Services shall publish a notice in the Federal Register to revoke the
item declared to be null and void and of no force or effect under
subsection (a).
SEC. 12. COMMISSION ON DIETARY SUPPLEMENT LABELS.
(a) Establishment.--There shall be established as an independent
agency within the executive branch a commission to be known as the
Commission on Dietary Supplement Labels (hereafter in this section
referred to as the ``Commission'').
(b) Membership.--
(1) Composition.--The Commission shall be composed of 7
members who shall be appointed by the President.
(2) Expertise requirement.--The members of the Commission
shall consist of individuals with expertise and experience in
dietary supplements and in the manufacture, regulation,
distribution, and use of such supplements. At least three of
the members of the Commission shall be qualified by scientific
training and experience to evaluate the benefits to health of
the use of dietary supplements and one of such three members
shall have experience in pharmacognosy, medical botany,
traditional herbal medicine, or other related sciences. Members
and staff of the Commission shall be without bias on the issue
of dietary supplements.
(c) Functions of the Commission.--The Commission shall conduct a
study on, and provide recommendations for, the regulation of label
claims and statements for dietary supplements, including the use of
literature in connection with the sale of dietary supplements and
procedures for the evaluation of such claims. In making such
recommendations, the Commission shall evaluate how best to provide
truthful, scientifically valid, and not misleading information to
consumers so that such consumers may make informed and appropriate
health care choices for themselves and their families.
(d) Administrative Powers of the Commission.--
(1) Hearings.--The Commission may hold hearings, sit and
act at such times and places, take such testimony, and receive
such evidence as the Commission considers advisable to carry
out the purposes of this section.
(2) Information from federal agencies.--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section.
(3) Authorization of appropriations.--There are authorized
to be appropriated such sums as may be necessary to carry out
this section.
(e) Reports and Recommendations.--
(1) Final report required.--Not later than 24 months after
the date of enactment of this Act, the Commission shall prepare
and submit to the President and to the Congress a final report
on the study required by this section.
(2) Recommendations.--The report described in paragraph (1)
shall contain such recommendations, including recommendations
for legislation, as the Commission deems appropriate.
(3) Action on recommendations.--Within 90 days of the
issuance of the report under paragraph (1), the Secretary of
Health and Human Services shall publish in the Federal Register
a notice of any recommendation of Commission for changes in
regulations of the Secretary for the regulation of dietary
supplements and shall include in such notice a notice of
proposed rulemaking on such changes together with an
opportunity to present views on such changes. Such rulemaking
shall be completed not later than 2 years after the date of the
issuance of such report. If such rulemaking is not completed on
or before the expiration of such 2 years, regulations of the
Secretary published in 59 FR 395-426 on January 4, 1994, shall
not be in effect.
SEC. 13. OFFICE OF DIETARY SUPPLEMENTS.
(a) In General.--Title IV of the Public Health Service Act is
amended by inserting after section 485B (42 U.S.C. 287c-3) the
following:
``Subpart 4--Office of Dietary Supplements
``SEC. 485C. DIETARY SUPPLEMENTS.
``(a) Establishment.--The Secretary shall establish an Office of
Dietary Supplements within the National Institutes of Health.
``(b) Purpose.--The purposes of the Office are--
``(1) to explore more fully the potential role of dietary
supplements as a significant part of the efforts of the United
States to improve health care; and
``(2) to promote scientific study of the benefits of
dietary supplements in maintaining health and preventing
chronic disease and other health-related conditions.
``(c) Duties.--The Director of the Office of Dietary Supplements
shall--
``(1) conduct and coordinate scientific research within the
National Institutes of Health relating to dietary supplements
and the extent to which the use of dietary supplements can
limit or reduce the risk of diseases such as heart disease,
cancer, birth defects, osteoporosis, cataracts, or prostatism;
``(2) collect and compile the results of scientific
research relating to dietary supplements, including scientific
data from foreign sources or the Office of Alternative
Medicine;
``(3) serve as the principal advisor to the Secretary and
to the Assistant Secretary for Health and provide advice to the
Director of the National Institutes of Health, the Director of
the Centers for Disease Control and Prevention, and the
Commissioner of Food and Drugs on issues relating to dietary
supplements including--
``(A) dietary intake regulations;
``(B) the safety of dietary supplements;
``(C) claims characterizing the relationship
between--
``(i) dietary supplements; and
``(ii)(I) prevention of disease or other
health-related conditions; and
``(II) maintenance of health; and
``(D) scientific issues arising in connection with
the labeling and composition of dietary supplements;
``(4) compile a database of scientific research on dietary
supplements and individual nutrients; and
``(5) coordinate funding relating to dietary supplements
for the National Institutes of Health.
``(d) Definition.--As used in this section, the term `dietary
supplement' has the meaning given the term in section 201(ff) of the
Federal Food, Drug, and Cosmetic Act.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $5,000,000 for fiscal year 1994
and such sums as may be necessary for each subsequent fiscal year.''.
(b) Conforming Amendment.--Section 401(b)(2) of the Public Health
Service Act (42 U.S.C. 281(b)(2)) is amended by adding at the end the
following:
``(E) The Office of Dietary Supplements.''.
Attest:
Clerk.
103d CONGRESS
2d Session
S. 784
_______________________________________________________________________
AMENDMENT