I 
108TH CONGRESS 
1ST SESSION 
H. R. 724
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 
FEBRUARY 12, 2003
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’’.
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 wheth-
er—
‘‘(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: 
‘‘(hh) The failure of a person to register, submit re-
ports, or comply with any other requirement under section 
416.’’. 
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 third sentence, by striking ‘‘or 
restricted devices’’ each place such term ap-
pears and inserting ‘‘restricted devices, or die-
tary supplements’’; and 
(B) in the fourth 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 416, section 505(i), 
section 505(k),’’; and
(2) in subsection (e), by striking ‘‘section 519’’ 
and inserting ‘‘section 416, 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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