Dietary Supplement Health and Education Act of 1994
PL 103-417 (S.784), enacted 10/25/1994

PUBLIC LAW 103-417—OCT. 25, 1994 
108 STAT. 4325 
Public Law 103-417 
103d 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. 
(a) SHORT TITLE.—This Act may be cited as the "Dietary Supple-
ment 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 Govern-
ment; 
(2) the importance of nutrition smd 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 dis-
eases 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; 
Oct. 25, 1994 
[S. 784] 
Dietary 
Supplement 
Health and 
Education Act 
of 1994. 
21 u s e 301 
note. 
21 u s e 321 
note. 
108 STAT. 4326 
PUBLIC LAW 103-417—OCT. 25, 1994 
(4) healthful diets may mitigate the need for expensive 
medical procedures, jsi^ch 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 expendi-
tures; 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 dissemina-
tion 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 supple-
ments; 
(9) national surveys have revealed that almost 50 percent 
of the 260,000,000 Americans regularly consume dietary supple-
ments 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 bal-
ance; 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 rel-
atively 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. 
PUBLIC LAW 103-417—OCT. 25, 1994 
108 STAT. 4327 
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: 
"(f^ 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 dietsiry intake; or 
"(F) a concentrate, metaboHte, 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)(l)(B)(i); or 
"(ii) complies with section 411(c)(l)(B)(u); 
"(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 
PubUc 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 imlawfiil under section 
402(f); and 
"(B) not include— 
"(i) an article that is approved as a new drug 
imder section 505, certified as an antibiotic under sec-
tion 507, or licensed as a biologic imder 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); 
108 STAT. 4328 
PUBLIC LAW 103-417—OCT. 25, 1994 
(2) by striking the period at the end of subparagraph (5) 
and inserting "; or"; an4 
(3) by adding at th^ end the following new subparagraph: 
"(6) an ingredient described in paragraph (fiO 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 BUKDEN 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 ingredi-
ent 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 rec-
ommended in the labeling, under ordinary conditions of 
use; 
"(B) is a new dietary ingredient for which there is inad-
equate information to provide reasonable assurguice 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 af&rm or withdraw the declaration; or 
"(D) is or contains a dietary ingredient that renders it 
adulterated under paragraph (a)(1) imder 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. 
Notification. 
«(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, orjQly 
and in writing, at least 10 days before such notice, with regard 
to such proceeding.". 
SEC. 6. 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 
21 use 343-2. 
«SEC. 403B. (a) IN GENERAL.—A pubUcation, including an arti-
cle, a chapter in a book, or an ofl[icial abstract of a peer-reviewed 
scientific publication that appears in an article and was prepared 
PUBLIC LAW 103-417—OCT. 25, 1994 
108 STAT. 4329 
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 consiuners 
when it— 
"(1) is not false or misleading; 
"(2) does not promote a particular msinufacturer 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 
fi-om 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 whatso-
ever 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 sub-
section (a), the burden of proof shall be on the United States 
to establish that an article or other such matter is false or mislead-
ing.". 
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)(l)(B), a statement for a 
dietary supplement may be made if— 
"(A) the statement claims a benefit related to a classicgd 
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 
J 
a nutrient or dietary ingredient acts to maintain such structure 
or function, or describes general well-being fi-om consumption 
of a nutrient or dietary ingredient, 
"(B) the manufacturer of the dietary supplement has 
substantiation that such statement is truthful £uid not mislead-
ing, and 
"(C) the statement contains, j)rominently 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 dis-
eases. If the manufacturer of a dietary supplement proposes to 
make a statement described in the first sentence of this subpara-
graph in the labeling of the dietary supplement, the manufacturer 
shall notify the Secretary no later than 30 days after the first 
marketing of tiie dietary supplement with such statement that 
such a statement is being made.". 
SEC. 7. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRI-
TION INFORMATION LABELING. 
(a) MiSBRANDED SUPPLEMENTS.—Section 403 (21 U.S.C. 343) 
is amended by adding at the end the following: 
"(s)If— 
108 STAT. 4330 
PUBLIC LAW 103-417—OCT. 25, 1994 
"(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(fD; and 
"(ii)(I) the quantity of each such ingredient; or 
"(II) with respect to a proprietary blend of such ingredi-
ents, 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 ingredi-
ent; 
"(C) the supplement contains an ingredient described in 
section 201(fO(l)(C), and the label or labeling of the supplement 
fails to identify any part of the plant firom which the ingredient 
is derived; 
"(D) the supplement— 
"(i) is covered by the specifications of an ofiicial 
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 £in 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 cap-
sule 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 dietgiry supplement product (including a food to which 
section 411 applies) shall comply with the requirements of subpara-
graphs (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 ingredi-
ent present and identified as having no such recommendation; 
"(ii) the listing of dietsiry ingredients shall include the 
quantity of each such ingrechent (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: 
PUBLIC LAW 103-417—OCT. 25, 1994 
108 STAT. 4331 
"(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(fO"; 
(2) by striking "(2)(A)" and inserting "(2)"; and 
(3) by striking subparagraph (B). 
(e) EFFECTIVE DATE.—Dietary supplements— 
21 use 343 
(1) may be labeled after the date of the enactment of note, 
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 con- 21 USC 350b. 
tains 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 ingredi-
ents which have been present in the food supply as an ^ i c l e 
used for food in a form in which the food has not been chemi-
cally 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 pro-
vides the Secretary with information, including any citation 
to published articles, which is the basis on which the manufac-
turer 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 Classified 
under paragraph (2) for 90 days following its receipt. After the ^formation, 
expiration of such 90 days, the Secretary shall place such informa-
tion 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 peti-
tion 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 seife. 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 mar-
108 STAT. 4332 
PUBLIC LAW 103-417—OCT. 25, 1994 
keted 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 amend-
ed 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 manufac-
turing 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 smalytical methodology. No stand-
ard 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)(l)(B) and 
403(r)(3) or sections 403(r)(l)(B) and 403(r)(5)(D), is made in accord-
ance 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 Federsd Register of June 18, 1993 
(58 FR 33690-33700) is null and void and of no force or effect 
Federal 
insofar as it applies to dietary supplements. The Secretary of Health 
wuWication 
^^^ 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). 
21 use 343 
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 (here-
after in this section referred to as the "Commission"). 
PUBLIC LAW 103-417—OCT. 25, 1994 
108 STAT. 4333 
(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, medi-
cal botany, traditional herbal medicine, or other related 
sciences. Members £ind 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 supple-
ments 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 informa-
tion to consumers so that such consumers may make informed 
and appropriate health care choices for themselves and their fami-
lies. 
(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 Commis-
sion may secure directly fi-om 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 author-
ized 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 recommenda-
tions for legislation, as the Commission deems appropriate. 
(3) ACTION ON RECOMMENDATIONS.—Within 90 days of the 
issuance of the report imder paragraph (1), the Secretary of 
Health and Human Services shall publish in the Federal Reg-
ister a notice of £iny 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 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 Sec-
retary published in 59 FR 395-426 on January 4, 1994, shall 
not be in effect. 
President. 
Federal 
Register, 
publication. 
108 STAT. 4334 
PUBLIC LAW 103-417—OCT. 25, 1994 
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 
42 use 287C-11. 
"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 dis-
ease 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 fi*om 
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 inteike 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) mainten£ince 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, guid 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.". 
PUBLIC LAW 103-417—OCT. 25, 1994 
108 STAT. 4335 
(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 amendment. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 30 (1994): 
Oct. 25, Presidential statement.