I
106TH CONGRESS
1ST SESSION
H. R. 3001
To amend the Federal Food, Drug, and Cosmetic Act to promote clinical
research and development on dietary supplements and foods for their
health benefits; to establish a new legal classification for dietary supple-
ments and foods with health benefits, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 1, 1999
Mr. PALLONE introduced the following bill; which was referred to the Com-
mittee on Commerce, and in addition to the Committee on the Judiciary,
for a period to be subsequently determined by the Speaker, in each case
for consideration of such provisions as fall within the jurisdiction of the
committee concerned
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
promote clinical research and development on dietary
supplements and foods for their health benefits; to estab-
lish a new legal classification for dietary supplements
and foods with health benefits, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE AND REFERENCE.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Nutraceutical Research and Education Act’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment 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 provi-
sion of the Federal Food, Drug, and Cosmetic Act.
SEC. 2. FINDINGS AND STATEMENT OF PURPOSE.
(a) FINDINGS.—The Congress finds the following:
(1) Consumers spend annually an estimated
$12,000,000,000 on dietary supplements and billions
more on medical and similar foods. Nevertheless, the
health benefits of these products have not, in most
cases, been demonstrated by clinical testing or other
means. In consequence, specific health claims may
not be advanced for them. Consumers are thus left
uncertain as to the value of these products in pro-
moting health and well-being, and preventing or re-
ducing the risk of disease, including the manage-
ment of a disease or condition. The companies that
produce these products desire to provide them to
consumers with specific health claims based on clin-
ical testing. The Federal Government demands
sound scientific evidence of safety and effectiveness
in order to fulfill its statutory mandate to protect
and promote the public health.
(2) Because dietary supplements and similar
foods are natural products widely available without
a strong proprietary position, a person who now fi-
nances the cost of research successfully dem-
onstrating the health benefits of such a product re-
ceives no special economic benefit in the marketplace
to repay that cost. Others, who have not contributed
to those research costs, may nevertheless embrace
the findings of that research to support identical
claims for their own versions of the product. With-
out economic incentive to research and develop new
products, those who would finance the cost of re-
search are presently focusing their efforts on pro-
motional activities to the disservice of the public in-
terest and health.
(3) It is in the national interest to encourage
clinical research into the health benefits of dietary
supplements, medical foods, and other foods.
(4) Current regulatory and epistemological
chaos exists with regard to health claims for foods,
dietary supplement, and medical foods. It is in the
national interest to provide a category of products
that have recognized health benefits but are not
drugs and to recognize that these products are safe
when used as indicated on their labeling.
(5) It is necessary to promote research into the
health benefits of dietary supplements, medical
foods, and other foods and to require that these
health benefits be established by the results of clin-
ical studies.
(6) It is necessary to establish a regulatory sys-
tem within the Food and Drug Administration for
reviewing health claims of health benefits of such
products which is less burdensome than the tradi-
tional regulatory scheme for drugs and to stimulate
the industry to devote resources to proving the
health claims anticipated under this Act since such
claims relate to the possibility of preventing or re-
ducing the risk of disease, including the manage-
ment of a disease or health condition.
(7) It is necessary to update the present regu-
latory scheme to reflect the fact that such products
can safely prevent disease and health conditions,
manage or improve health, or reduce the risk of dis-
ease.
(b) STATEMENT OF PURPOSE.—It is the purpose of
this Act to—
(1) promote research into the health benefits of
dietary supplements, medical foods, and other foods;
(2) establish a simplified process within the
Food and Drug Administration for reviewing, on a
case by case method, health claims of health benefits
of such nutraceutical products made under a petition
under section 403(r)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343(r)(3));
(3) prescribe a period of exclusive marketing
protection for a person that demonstrates the health
benefits of a dietary supplement, medical food, or
other food, and who markets such product in asso-
ciation with approved labeling that describes its con-
tribution to human health; and
(4) confirm the health benefits of these prod-
ucts as determined by clinical trials, and disseminate
this information to the public and the health care
profession, so that the public and the health care
profession may integrate this knowledge into prac-
tice.
SEC. 3. DEFINITIONS.
Section 201 (21 U.S.C 321) is amended by adding
at the end the following:
‘‘(kk) The term ‘nutraceutical’ means a dietary sup-
plement, food, or medical food, as respectively defined in
paragraphs (f) and (ff) and section 5(b)(3) of the Orphan
Drug Act (21 U.S.C. 360ee(b)(3)), that—
‘‘(1) possesses health benefits; and
‘‘(2) is safe for human consumption in
such quantity, and with such frequency, as re-
quired to realize such properties.
‘‘(ll) The term ‘health benefit’, when used with ref-
erence to a nutraceutical, means a benefit which prevents
or reduces the risk of a disease or health condition, includ-
ing the management of a disease or health condition or
the improvement of health.
SEC. 4. HEALTH CLAIMS.
(a) 
NUTRACEUTICAL
HEALTH
CLAIM.—Section
403(r)(5)(D) (21 U.S.C. 343(r)(5)(D)) is amended by in-
serting before the period the following: ‘‘except that in the
case of a claim made with respect to a nutraceutical, the
regulation shall be issued by the Secretary under subpara-
graph (4)(D)’’.
(b) 
PETITION.—Section 
403(r)(4) 
(21 
U.S.C.
343(r)(4)) is amended by adding at the end the following:
‘‘(D)(i) Any person may file a petition with the Sec-
retary to issue a regulation relating to a claim for a
nutraceutical described in subparagraph (5)(D).
‘‘(ii) A petition filed under subclause (i) shall be pre-
pared in such form, and submitted in such manner, as
the Secretary may prescribe, and, with respect to the prod-
uct sought to be introduced as a nutraceutical, shall con-
tain the following:
‘‘(I) A report of at least 1 clinical trial which
has been conducted on the product which is the sub-
ject of the petition. Such clinical trial results shall
address the potential health benefits of the product
and its safety. The results of the clinical trial must
demonstrate and characterize the beneficial relation-
ship or the significance of the relationship of the
nutraceutical in such product to a disease or its af-
fects on a health related condition, health problem,
or health status. The clinical trial must have a suffi-
cient size to prove the benefits and may have as its
endpoints either surrogate markers or clinical
endpoints to support the claim. The application may
also include epidemiological or preclinical studies in
support of the clinical trial. The amount of evidence
necessary to sustain a claim will be determined by
the Secretary on a case by case basis.
‘‘(II) Evidence that it is safe for human con-
sumption in such quantity, and with such frequency,
as required to provide the health benefits.
‘‘(III) A complete description, in the case of a
processed product, as to its ingredients or chemical
composition.
‘‘(IV) Information adequate to enable the Sec-
retary to determine, where pertinent, that the meth-
ods used in, and the facilities and controls used for,
processing and packing the product are sufficient to
preserve its identity, strength, quality, and purity.
‘‘(V) Such samples of the product as the Sec-
retary may require.
‘‘(VI) A specimen of the labeling proposed to be
used with the product, when introduced or delivered
for introduction into commerce as a nutraceutical,
that accurately and completely describes its health
benefits under its stated conditions of use.
‘‘(iii) Within 7 days of the receipt of a petition, the
Secretary shall cause it to be published in the Federal
Register to provide notice to the public that the petition
has been filed. Such notice shall contain the name of the
petitioner, date and time of filing, a summary and descrip-
tion of the proposed product, and the nature of the pro-
posed health claim.
‘‘(iv) When a petition is filed for a nutraceutical claim
under subparagraph (5)(D), no other petition for a prod-
uct which is the same as or similar to the product for
which a petition has been filed and no other petition for
a claim which is the same or similar to the claim for which
a petition has been filed may be filed until final action
has been taken on the first petition.
‘‘(v) A person who files a petition for a claim for a
nutraceutical claim under subparagraph (5)(D) may apply
to the Secretary to amend the petition when the amend-
ment is required by a change in the product due to new
and unexpected findings in research on the product or the
disease or condition for which the product is being pro-
posed.
‘‘(vi) The Secretary shall refer any petition filed for
a nutraceutical claim under subclause (i) to the Advisory
Council on Nutraceuticals established under section 7 of
the Nutraceutical Research and Education Act.
‘‘(vii) The Secretary shall take final action on a peti-
tion which—
‘‘(I) was filed under subclause (i), and
‘‘(II) was determined by such Advisory Council
on Nutraceuticals to be worthy of review,
not later than 6 months after the date the petition is
filed.’’.
SEC. 5. MARKET PROTECTION FOR NUTRACEUTICAL.
(a) IN GENERAL.—Section 403(r) is amended by
adding at the end the following:
‘‘(8) If the Secretary issues a regulation in response
to a petition filed under subparagraph (4) relating to a
claim for a nutraceutical described in subparagraph
(5)(D), the Secretary may not issue another regulation for
an essentially identical nutraceutical claim during the 10-
year period that begins on the date that the Secretary ap-
proved the original petition, except that—
‘‘(A) if a petition is submitted for an essentially
identical nutraceutical claim for a nutraceutical the
intended use of which provides greater effectiveness,
greater safety, or otherwise a major contribution to
patient care, the Secretary may issue a regulation
under subparagraph (4)(D) for such claim; or
‘‘(B) if a petition is subsequently revoked, an-
other petition may be submitted to the Secretary for
an essentially identical nutraceutical claim.’’.
(b) MISBRANDING.—Section 402 (21 U.S.C. 342) is
amended by adding at the end the following:
‘‘(h) If it is a nutraceutical and it has not had a peti-
tion approved under section 403(r)(4)(D).’’.
SEC. 6. GOOD MANUFACTURING PRACTICES.
Section 402(g) (21 U.S.C 342(g)) is amended by—
(1) inserting ‘‘, including a nutraceutical’’ after
‘‘dietary supplement’’ in subparagraph (1); and
(2) inserting ‘‘, including nutraceuticals’’ after
‘‘dietary supplements’’ in subparagraph (2).
SEC. 7. ADVISORY COUNCIL ON NUTRACEUTICALS.
(a) ESTABLISHMENT.—There is established within
the Food and Drug Administration an advisory council to
be known as the ‘‘Advisory Council on Nutraceuticals’’.
(b) DUTIES.—The Advisory Council shall evaluate
the merit of each petition filed for a nutraceutical health
claim under section 403(r)(4)(D) of the Federal Food,
Drug, and Cosmetic Act, including the proposed labeling
of the product that is the subject of the petition, and sub-
mit its evaluation to the Secretary. The evaluation of the
Advisory Council shall determine if a petition is worthy
of review by the Food and Drug Administration and
whether it conflicts with any other petition.
(c) MEMBERSHIP.—
(1) IN GENERAL.—The Advisory Council shall
consist of ex officio members and not more than 6
additional members appointed by the Secretary. The
ex officio members shall be nonvoting members.
(2) EX
OFFICIO
MEMBERS.—The ex officio
members of the Advisory Council shall be the Sec-
retary, the Director of the National Institutes of
Health (hereinafter in this Act referred to as the
‘‘Director of NIH’’), and such additional officers or
employees of the United States as the Secretary de-
termines necessary for the Advisory Council to carry
out its functions.
(3) OTHER
MEMBERS.—The members of the
Advisory Council who are not ex officio members
shall be appointed by the Secretary from among in-
dividuals distinguished in the fields of health, nutri-
tion, or biomedical research.
(d) COMPENSATION.—Members of the Advisory
Council who are officers or employees of the United States
shall serve on the Advisory Council as part of their official
duties, and shall not receive additional compensation
therefor. Other members of the Advisory Council shall re-
ceive, for each day (including traveltime) they are engaged
in the performance of Advisory Council functions, com-
pensation at rates not to exceed the daily equivalent of
the annual rate in effect for grade ES–1 (5 U.S.C. 5382).
Such other members, when performing Advisory Council
functions (including travel to and from Advisory Council
meetings), shall be entitled to travel expenses (including
per diem in lieu of subsistence) as authorized by section
5703 of title 5, United States Code, for persons in the
Government service employed intermittently.
(e) TERM.—The term of office of an appointed mem-
ber of the Advisory Council is 4 years, except that any
member appointed to fill a vacancy for an unexpired term
shall be appointed for the remainder of such term and the
Secretary shall make appointments to the Advisory Coun-
cil in such a manner as to ensure that the terms of the
members do not all expire in the same year. A member
may serve after the expiration of the member’s term for
180 days after the date of such expiration. A member who
has been appointed for a term of 4 years may not be re-
appointed to the Advisory Council before 2 years from the
date of expiration of such term of office. If a vacancy oc-
curs in the Advisory Council among the appointed mem-
bers, the Secretary shall make an appointment to fill the
vacancy within 90 days from the date the vacancy occurs.
(f) CHAIR.—The Secretary shall select the chair of
the Advisory Council from among the appointed members.
The term of office of the chair shall be 2 years.
(g) MEETINGS
AND PROCEDURES.—The Advisory
Council shall meet at the call of the chair, or at the direc-
tion of the Director of the National Institutes of Health,
but with sufficient frequency to ensure prompt evaluation
of every nutraceutical petition referred to it by the Sec-
retary. The Advisory Council shall adopt rules governing
its procedures.
(h) FEDERAL ADVISORY COMMITTEE ACT.—Meet-
ings and proceedings of the Advisory Council shall not be
subject to the Federal Advisory Committee Act (5 U.S.C.
Appendix).
SEC. 8. NUTRACEUTICAL INDEX.
The Secretary shall maintain, and periodically pub-
lish in the Federal Register, an index that shall list—
(1) 
the 
name 
and 
description 
of 
each
nutraceutical for which there is an approved peti-
tion, the name and address of the applicant, and the
date upon which the Secretary approved the petition;
and
(2) each petition pending with the Secretary,
the date upon which it was filed with the Secretary,
the name and address of the applicant, and a de-
scription of the nutraceutical and the claim made for
the nutraceutical that is the subject of that petition.
SEC. 10. SMALL BUSINESS ANTITRUST EXEMPTION.
(a) EXEMPTION.—It shall not be unlawful under the
antitrust laws for 2 or more small businesses to agree to
combine their resources to meet the requirements of sec-
tion 403(r) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(r)) for claims of health benefits of a
nutraceutical.
(b) DEFINITIONS.—
(1) ANTITRUST
LAWS.—The term ‘‘antitrust
laws’’ has the meaning given such term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12(a)), except that such term includes section 5 of
the Federal Trade Commission Act (15 U.S.C. 45)
to the extent such section applies to unfair methods
of competition.
(2) 
NUTRACEUTICAL.—The 
term
‘‘nutraceutical’’ has the meaning given such term in
section 201(k)(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(k)(k)).
(3) SMALL BUSINESS.—The term ‘‘small busi-
ness’’ has the meaning given such term in section
736(d)(3)(A) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379h(d)(3)(A)).
SEC. 11. EFFECTIVE DATE.
This Act and the amendments made by this Act shall
take effect 90 days after the date of its enactment.
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