FDA Global by Dr. Cheng
美國加州大學(UCSF)藥學博士鄭慧文的FDA
global,
是一個提供保健養生資訊的全球網路通訊站,
包括藥品、健康食品、化妝品、隱形眼鏡、體重控制等主題。
前言:
本法案全文資料以美國政府公佈之書面資料為準。
因無法尋獲網路上的DSHEA檔案位置,筆者只好根據書面資料打字彙編。
若您能夠提供網路上可供連結的DSHEA檔案網址,祈請來信告知。
謝謝您的協助。e-mail:dhwcheng@mail.tmc.edu.tw
Dietary Supplement
Health and Education Act of 1994
美國DSHEA法案全文
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4326
Public Law 103-417
103rd Congress
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.
Dietary Supplement
Health and Education
Act of 1994.
21 USC 301 note.
(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 dis-
ease 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;
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4326
(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 regu-
larly 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 per-
centage 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 reg-
ulatory barriers limiting or slowing the flow of safe products and
accurate information to con-
sumers;
(14) dietary supplements are safe within a broad range of uptake, 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
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4327
"(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;
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4328
"(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 I 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
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4329
"(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
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4330
"(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 supple-
ment 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.
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4331
"(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) 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 supple-
ments. 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 accor-
dance 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.
Federal Register, publication.
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.
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4332
(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 recommenda-
tions, including recommendations for legislation, as the Commission
deems appropriate.
Federal Register, publication.
(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 Secre-
tary for the regulation of dietary supplements and shall include in
such notice a notice of pro-
posed 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-
Public Law 103-417(S.784); October 25, 1994
108 STAT. 4332
"(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 pro-
vide advice to the Director of the National Institutes of Health, the
Director of the Centers for Dis-
ease 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 he 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.'.
Approved October 25, 1994.
LEGISLATIVE HISTORY - S. 784.
CONGRESSIONAL RECORD. Vol. 140 (1994):
Aug. 13, considered and passed Senate.
Oct. 6, considered and passed House, amended.
Oct. 7, Senate concurred in House amendments.
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