I
107TH CONGRESS
1ST SESSION
H. R. 3065
To amend the Federal Food, Drug, and Cosmetic Act to require that manu-
facturers of dietary supplements register with the Food and Drug Admin-
istration, to require the submission to such Administration of reports
on adverse experiences regarding such supplements, and for other pur-
poses.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 9, 2001
Mrs. DAVIS of California introduced the following bill; which was referred to
the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
require that manufacturers of dietary supplements reg-
ister with the Food and Drug Administration, to require
the submission to such Administration of reports on ad-
verse experiences regarding such supplements, 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.
This Act may be cited as the ‘‘Dietary Supplement
Information Act’’.
SEC. 2. REGISTRATION, REPORTING, AND POSTMARKET
SURVEILLANCE REGARDING DIETARY SUP-
PLEMENTS.
(a) IN GENERAL.—Chapter IV of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by adding at the end the following section:
‘‘REGISTRATION, REPORTING, AND POSTMARKET
SURVEILLANCE REGARDING DIETARY SUPPLEMENTS
‘‘SEC. 414. (a) REGISTRATION.—
‘‘(1) ANNUAL
REGISTRATION.—Each calendar
year a person who in any State owns or operates an
establishment engaged in the business of manufac-
turing, packing, or distributing a dietary supplement
shall register with the Secretary the name of the
person, places of business, and all such establish-
ments.
‘‘(2) INITIAL
MANUFACTURING.—A person,
upon first engaging in a business described in para-
graph (1) in an establishment that the person owns
or operates in any State, shall immediately register
with the Secretary the name of the person, place of
business, and such establishment.
‘‘(3) ADDITIONAL ESTABLISHMENTS.—A person
duly registered in accordance with paragraph (1) or
(2), upon engaging in the business involved in any
additional establishment that the person owns or op-
erates in any State, shall immediately register with
the Secretary the additional establishment.
‘‘(4) IMPORTS.—Any establishment within any
foreign country engaged in the manufacture of a die-
tary supplement that is imported or offered for im-
port into the United States shall register with the
Secretary the name and place of business of the es-
tablishment and the name of the United States
agent for the establishment.
‘‘(5) PRODUCT INFORMATION.—
‘‘(A) LABELING; OTHER INFORMATION.—
In addition to information that under any of
paragraphs (1) through (4) is required to be
provided in a registration, the registration shall
provide the labeling of the dietary supplements
involved (except to the extent that another reg-
istration under this subsection provides the la-
beling) and such other information describing
the dietary supplements as the Secretary may
by regulation require.
‘‘(B) CHANGES IN UNDERLYING FACTS.—
With respect to information that pursuant to
subparagraph (A) is submitted in a registra-
tion, if after submitting the registration to the
Secretary any of the underlying facts change,
the person involved shall submit revised infor-
mation to the Secretary in accordance with
such criteria and procedures as the Secretary
may establish, which may include requiring the
submission of a substitute registration. The re-
vised information shall be so submitted not
later than 30 days after the date on which the
factual changes occur.
‘‘(C) PREMARKET SUBMISSION OF LABEL-
ING FOR POSTENACTMENT PRODUCTS.—In the
case of a dietary supplement that was not in
commercial distribution as of the day before the
date of the enactment of the Dietary Supple-
ment Information Act, the manufacturer of
such supplement shall submit the labeling for
the supplement to the Secretary in accordance
with subparagraph (A) before introducing the
supplement into interstate commerce or deliv-
ering the supplement for such introduction.
‘‘(6) FEES.—The Secretary may by regulation
establish a requirement that a registration under
this subsection is subject to a fee to be assessed and
collected by the Secretary. Subject to the extent of
amounts approved in advance by an appropriation
Act for the fiscal year involved, amounts collected by
the Secretary under the preceding sentence are
available to the Secretary for the purpose of car-
rying out the responsibilities of the Secretary under
this subsection and subsection (b). The Secretary
may waive the requirement that a person pay such
a fee if the Secretary determines that the waiver is
justified on the basis that the person is a small busi-
ness.
‘‘(b) REPORTING OF INFORMATION ON ADVERSE EX-
PERIENCES.—
‘‘(1) SERIOUS
EXPERIENCES.—Each person
who is a manufacturer of a dietary supplement, or
a packer or distributor of the supplement whose
name appears on the labeling of the supplement,
shall—
‘‘(A) report to the Secretary in accordance
with paragraph (2) any information received by
such person on serious adverse experiences re-
garding the supplement; and
‘‘(B) develop written procedures regarding
the submission to the Secretary of such reports,
including procedures for surveillance, receipt,
and evaluation of information on such experi-
ences.
‘‘(2) REPORTING OF SERIOUS EXPERIENCES.—
‘‘(A) INITIAL
REPORT.—With respect to
the initial receipt of information on a serious
adverse experience, a person with reporting re-
sponsibility under paragraph (1) shall submit
the report to the Secretary as soon as is pos-
sible, but in no case later than 15 calendar days
after the initial receipt of the information. Such
report shall be accompanied by a copy of the
current labeling for the dietary supplement in-
volved.
‘‘(B) INVESTIGATION AND FOLLOW-UP.—A
person submitting an initial report under sub-
paragraph (A) on a serious adverse experience
shall promptly investigate the experience, and if
additional information is obtained, shall report
the information to the Secretary not later than
15 days after obtaining the information. If no
additional information is obtained, records of
the steps taken to seek additional information
shall be maintained by the person.
‘‘(C) DUPLICATIVE REPORTING.—In order
to avoid duplicative reporting under this para-
graph, the Secretary may provide for proce-
dures under which persons who are packers or
distributors described in paragraph (1) submit
reports under this paragraph to the manufac-
turer involved rather than the Secretary, with
the manufacturers then submitting the required
reports to the Secretary, subject to the Sec-
retary establishing requirements to ensure that
the Secretary receives reports within the appli-
cable period of time specified in subparagraph
(A) or (B).
‘‘(3) CLINICAL EVALUATIONS BY SECRETARY.—
The Secretary shall conduct a clinical evaluation of
each serious adverse experience reported to the Sec-
retary under paragraph (2) (except to the extent
that the patient involved or the next of kin for the
patient, as the case may be, elects not to cooperate
with the Secretary).
‘‘(4) ADDITIONAL REQUIREMENTS FOR MANU-
FACTURERS.—
‘‘(A) GENERAL
REVIEW
REGARDING
AD-
VERSE EXPERIENCES.—A manufacturer of a di-
etary supplement shall promptly review all in-
formation on adverse experiences regarding the
supplement obtained or otherwise received by
the manufacturer. The preceding sentence ap-
plies to information without regard to the
source of the information, foreign or domestic,
and includes information derived from sources
such as commercial marketing experience, post-
marketing investigations, postmarketing surveil-
lance, studies, reports in the scientific lit-
erature, and unpublished scientific papers.
‘‘(B) PERIODIC REPORTS ON NONSERIOUS
EXPERIENCES.—With respect to the receipt of
information on adverse experiences that are not
serious, a manufacturer of the dietary supple-
ment involved shall submit reports to the Sec-
retary annually, or at such shorter intervals as
the Secretary may require. Each such report
shall meet such requirements as the Secretary
may establish.
‘‘(5) AUTHORITY OF SECRETARY.—In addition
to requirements established in this subsection, the
Secretary may establish such requirements regarding
the reporting of information on adverse experiences
as the Secretary determines to be appropriate to
protect the public health. The Secretary may estab-
lish waivers from requirements under this subsection
regarding such information if the Secretary deter-
mines that compliance with the requirement involved
is not necessary to protect the public health regard-
ing such supplements.
‘‘(6) SYSTEM FOR COORDINATING REPORTS RE-
CEIVED BY SECRETARY.—With respect to reports of
adverse health experiences submitted to the Sec-
retary (whether required under this subsection or
otherwise), the Secretary shall establish a system to
receive the reports, refer the reports to the appro-
priate officials within the Food and Drug Adminis-
tration, store and retrieve the reports, store and re-
trieve records of activities carried out in response to
the reports, and carry out such other administrative
functions regarding the reports as the Secretary de-
termines to be appropriate.
‘‘(7) DATA COLLECTION BY SECRETARY.—The
Secretary shall carry out a program to collect data
on serious adverse experiences, in addition to receiv-
ing reports required in this subsection. In carrying
out such program, the Secretary shall seek the co-
operation of appropriate public and private entities,
including entities that respond to medical emer-
gencies.
‘‘(8) DEFINITIONS.—For purposes of this sec-
tion:
‘‘(A) The term ‘adverse experience’ means
an adverse experience regarding a dietary sup-
plement.
‘‘(B) The term ‘adverse experience regard-
ing a dietary supplement’ means any adverse
event associated with the use of such supple-
ment in humans, whether or not such event is
considered to be related to the supplement by a
person referred to in paragraph (1) who obtains
the information.
‘‘(C) The term ‘serious’, with respect to an
adverse experience, means an adverse experi-
ence to which any of clauses (i) through (iii)
applies, as follows:
‘‘(i) The experience is associated with
any of the following outcomes: Death; a
life-threatening condition; inpatient hos-
pitalization or prolongation of existing hos-
pitalization; a persistent or significant dis-
ability or incapacity; or a congenital anom-
aly, birth defect, or other effect regarding
pregnancy, including premature labor or
low birth weight.
‘‘(ii) The experience requires medical
or surgical intervention to prevent one of
the outcomes specified in clause (i).
‘‘(iii) There is reason to believe that a
factor associated with the experience is the
interaction of the dietary supplement in-
volved with a drug, without regard to
whether clause (i) or (ii) applies to the ex-
perience.
‘‘(c) POSTMARKET SURVEILLANCE.—
‘‘(1) 
AUTHORITY
TO
REQUIRE
SURVEIL-
LANCE.—The Secretary may by order require a
manufacturer of a dietary supplement to conduct
postmarket surveillance for such supplement if the
Secretary determines that there is a reasonable pos-
sibility that a use or expected use of the supplement
by a significant number of consumers may have seri-
ous adverse health consequences.
‘‘(2) SURVEILLANCE PLAN.—
‘‘(A) IN
GENERAL.—Not later than 30
days after receiving from the Secretary an
order under paragraph (1) to conduct surveil-
lance for a dietary supplement, the manufac-
turer involved shall submit to the Secretary, for
the approval of the Secretary, a plan for the re-
quired surveillance.
‘‘(B) QUALIFICATIONS
REGARDING
SUR-
VEILLANCE; DATA REGARDING ADVERSE EXPE-
RIENCES.—Not later than 60 days after a plan
is submitted to the Secretary under subpara-
graph (A), the Secretary shall determine
whether—
‘‘(i) the person designated to conduct
the surveillance has appropriate qualifica-
tions and experience to conduct such sur-
veillance; and
‘‘(ii) the plan will result in the collec-
tion of useful data that can reveal adverse
experiences or other information necessary
to protect the public health.
‘‘(3) SURVEILLANCE PERIOD.—In consultation
with a manufacturer of a dietary supplement that is
required to conduct surveillance under paragraph
(1), the Secretary may by order require a prospec-
tive surveillance period for the manufacturer of up
to 36 months. Any determination by the Secretary
that a longer period is necessary shall be made by
mutual agreement between the Secretary and the
manufacturer or, if no agreement can be reached,
after the completion of a dispute resolution process
that is established by the Secretary by regulation.
‘‘(d) REPORTING IN GENERAL.—In addition to re-
quirements otherwise established under this section, a
manufacturer of a dietary supplement shall establish and
maintain such records, make such reports, and provide
such information as the Secretary may by regulation rea-
sonably require to assure that such supplement is not
adulterated or misbranded.’’.
(b) PROHIBITED ACTS.—Section 301 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following:
‘‘(bb) The failure of a person to register, submit re-
ports, or comply with any other requirement under section
414.’’.
SEC. 3. INSPECTION AUTHORITY REGARDING RECORDS ON
DIETARY SUPPLEMENTS.
Section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374) is amended—
(1) in subsection (a)(1)—
(A) in the second sentence, by striking ‘‘or
restricted devices’’ each place such term ap-
pears and inserting ‘‘restricted devices, or die-
tary supplements’’; and
(B) in the third sentence—
(i) by striking ‘‘and devices’’ and in-
serting ‘‘devices, and dietary supplements’’;
and
(ii) by striking ‘‘section 505(i) or (k)’’
and inserting ‘‘section 414, section 505(i),
section 505(k),’’; and
(2) in subsection (e), by striking ‘‘section 519’’
and inserting ‘‘section 414, 519,’’.
SEC. 4. LABELING OF DIETARY SUPPLEMENTS.
Section 403(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343(e)) is amended—
(1) by striking ‘‘and (2)’’ and inserting the fol-
lowing: ‘‘(2) the toll-free telephone number, and the
address of the Internet site, maintained by the Sec-
retary for purposes of the medical product reporting
program (MedWatch or any successor program); and
(3) ’’; and
(2) by striking ‘‘clause (2)’’ and inserting
‘‘clause (3)’’.
SEC. 5. PUBLICATION OF PROPOSED RULE ON CURRENT
GOOD MANUFACTURING PRACTICES FOR DI-
ETARY SUPPLEMENTS.
Not later than 30 days after the date of the enact-
ment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register a proposed
rule for carrying out section 402(g) of the Federal Food,
Drug, and Cosmetic Act.
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