[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 784 Enrolled Bill (ENR)]
S.784
One Hundred Third Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twenty-fifth day of January, one thousand nine hundred and ninety-
four
An Act
To amend the Federal Food, Drug, and Cosmetic Act to establish
standards with respect to dietary supplements, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; 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.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.