S. 722Senate108th Congress (2003-2005)In Committee

Dietary Supplement Safety Act of 2003

Introduced March 26, 2003

Legislative Activity

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2 earlier actions
SenateIntro Referral Latest Action

Sponsor introductory remarks on measure. (CR S3547-3548)

April 1, 2004

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SenateIntro Referral

Introduced in Senate

March 26, 2003

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

March 26, 2003

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S3547-3548)

April 1, 2004

Floor Debate

22 members

What members said about S. 722 on the floor

8 Republicans14 Democrats
John McCain
Sen. John McCainR-AZ · May 22, 2003

Mr. President, I rise today to strongly support S. 1050, the fiscal year 2004 Defense Authorization bill. This legislation funds $400.5 billion for defense programs, which is 3.2 percent or $17.9…

Mark Dayton
Sen. Mark DaytonD-MN · Jun 21, 2004

Mr. President, I thank the distinguished chairman of the committee and others for setting aside their amendments, and I call up amendment No. 3197. Mr. President, I ask unanimous consent that reading…

John Warner
Sen. John WarnerR-VA · Jun 21, 2004

Mr. President, I concur in the observation of our distinguished colleague. All I am saying is we should look at each one individually rather than establishing a policy at this point--certainly with…

Byron L. Dorgan
Sen. Byron L. DorganD-ND · Jun 21, 2004

Mr. President, I want to mention in the context of the discussion which has been held between the Senator from Virginia and the Senator from Nevada that I believe the second-degree amendment which I…

James M. Inhofe
Sen. James M. InhofeR-OK · May 22, 2003

If the distinguished Senator from Virginia would yield, Mr. Chairman, I also have concerns about this provision and the effects it would have on our ability to meet production needs to get necessary…

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Olympia J. Snowe
Sen. Olympia J. SnoweR-ME · May 22, 2003

Mr. President, I rise to speak on the Senate version of the fiscal year 2004 national Defense authorization bill. First, I would like to thank the chairman and the ranking member of the Senate Armed…

Robert C. Byrd
Sen. Robert C. ByrdD-WV · May 22, 2003

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I wish to make a brief speech on the bill. Are we under a time limit? I thank the Chair. Mine…

Jeff Bingaman
Sen. Jeff BingamanD-NM · Jun 21, 2004

Mr. President, I ask unanimous consent the order for the quorum call be rescinded. Mr. President, I send an amendment to the desk and ask for its immediate consideration. I ask unanimous consent the…

John Warner
Sen. John WarnerR-VA · May 22, 2003

Mr. President, I ask unanimous consent that the Senate return to the underlying bill. Mr. President, as is so often the case here in the Senate during the course of deliberations, colleagues find a…

Carl Levin
Sen. Carl LevinD-MI · Jun 21, 2004

Mr. President, it is very important to keep in focus what Senator DeWine spoke about. There has been much too little focus by all of us on this subject. The leadership of Senator DeWine in reminding…

John F. Kerry
Sen. John F. KerryD-MA · May 22, 2003

Mr. President, military planning is about balancing risk and cost. Resources will always be limited. And actions will always incur costs, whether financial or political. In the fiscal year 2004…

Christopher J. Dodd
Sen. Christopher J. DoddD-CT · May 22, 2003

Mr. President, today I will join my colleagues in voting to approve the 2004 Defense authorization bill. This legislation provides a significant increase to our defense budget, a total of $400.5…

Russell D. Feingold
Sen. Russell D. FeingoldD-WI · May 22, 2003

Mr. President, I rise to add my thoughts to the debate on the defense budget for fiscal year 2004. First and foremost, I want to thank the members of the United States Armed Forces for the excellent…

Show 11 more
Frank R. Lautenberg
Sen. Frank R. LautenbergD-NJ · May 22, 2003

Further than we can remember. Mr. President, will the manager yield a moment? Just a minute, because I want to second what we just heard from the Senator from California about my friend and colleague…

Harry Reid
Sen. Harry ReidD-NV · Jun 21, 2004

Mr. President, the reason we have considered these side by side on a number of occasions is the person offering the amendment initially wants a vote on his amendment. The second degree usually wipes…

Carl Levin
Sen. Carl LevinD-MI · May 22, 2003

Mr. President, I understand the yeas and nays are going to be requested. I thank my good friend from California for her kind words and, as always, the Senator from Virginia for his willingness to…

Mike DeWine
Sen. Mike DeWineR-OH · Jun 21, 2004

I thank the Chair, and I thank my colleague from Virginia. Update on Darfur Mr. President, several weeks ago, I came to the floor to talk about the crisis in Darfur, Sudan, where it is estimated at…

Susan M. Collins
Sen. Susan M. CollinsR-ME · May 22, 2003

Mr. President, I rise today to discuss an amendment to the Defense Authorization bill which Senator Voinovich and I have submitted. Our amendment would, among other things, provide for the creation…

Barbara Boxer
Sen. Barbara BoxerD-CA · May 22, 2003

Reserving the right to object, I would like to say, I am very supportive of this. I just want to ask if it is the right thing for me to withdraw my amendment, or is that not necessary? I have no…

Pat Roberts
Sen. Pat RobertsR-KS · May 22, 2003

Mr. President, I rise in support of the National Defense Authorization Act for fiscal year 2004. I commend Chairman Warner and Ranking Member Levin for their skillful stewardship. I believe the…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · May 22, 2003

Mr. President, I thank my colleagues for their comments and add my own. Last November, the Office of Management and Budget proposed the most sweeping changes to the rules on outsourcing of Government…

Mary L. Landrieu
Sen. Mary L. LandrieuD-LA · May 22, 2003

Mr. President, on June 6, 2000, the National D-Day opened in New Orleans, LA. This museum was the culmination of a vision of the late Stephen Ambrose. Dr. Ambrose dedicated his life to chronicling…

Tom Harkin
Sen. Tom HarkinD-IA · May 22, 2003

Mr. President, I am pleased to join Senator Wyden and other colleagues in sponsoring this amendment on contracting in Iraq and in support of the Warner-Boxer amendment No. 826. One of our key…

Saxby Chambliss
Sen. Saxby ChamblissR-GA · May 22, 2003

Mr. President, I rise today to express my concern with the administration's approach to competitive sourcing and the revisions to Circular A-76 currently under consideration by the Office of…

Bill Text

Latest available legislative text

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Latest
Introduced in SenateIssued March 26, 2003
        [Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 722 Introduced in Senate (IS)]

108th CONGRESS
1st Session
S. 722

To amend the Federal Food, Drug, and Cosmetic Act to require that
manufacturers of dietary supplements submit to the Food and Drug
Administration reports on adverse experiences with dietary supplements,
and for other purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

March 26, 2003

Mr. Durbin introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to require that
manufacturers of dietary supplements submit to the Food and Drug
Administration reports on adverse experiences with 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.

This Act may be cited as the ``Dietary Supplement Safety Act of
2003''.

SEC. 2. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.

(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:

``SEC. 416. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.

``(a) Definitions.--In this section:
``(1) Adverse dietary supplement experience.--The term
`adverse dietary supplement experience' means an adverse event
that is associated with the use of a dietary supplement in a
human, without regard to whether the event is known to be
causally related to the dietary supplement.
``(2) Serious adverse dietary supplement experience.--The
term `serious adverse dietary supplement experience' means an
adverse dietary supplement experience that--
``(A) results in--
``(i) death;
``(ii) a life-threatening condition;
``(iii) inpatient hospitalization or
prolongation of hospitalization;
``(iv) a persistent or significant
disability or incapacity; or
``(v) a congenital anomaly, birth defect,
or other effect regarding pregnancy, including
premature labor or low birth weight; or
``(B) requires medical or surgical intervention to
prevent 1 of the outcomes described in subparagraph
(A).
``(b) Reporting and Review.--
``(1) Serious adverse dietary supplement experiences.--
``(A) In general.--Each manufacturer of a dietary
supplement, and each packer or distributor of a dietary
supplement the name of which appears on the labeling of
the dietary supplement--
``(i) shall develop written procedures
for--
``(I) surveillance, receipt, and
evaluation of information on adverse
dietary supplement experiences
associated with use of the dietary
supplement; and
``(II) submission to the Secretary
of reports under this subsection;
``(ii) as soon as practicable after, but in
no event later than 15 calendar days after,
initial receipt of information with respect to
a serious adverse dietary supplement
experience, shall submit to the Secretary--
``(I) the information; and
``(II) a copy of the current
labeling for the dietary supplement;
``(iii)(I) shall promptly investigate the
adverse dietary supplement experience; and
``(II)(aa) if additional information is
obtained, shall submit to the Secretary a
report describing the information--
``(AA) not later than 15 days after
obtaining the information; or
``(BB) at the request of the
Secretary; or
``(bb) if no additional information is
obtained, shall maintain records of the steps
taken to seek additional information.
``(B) Elimination of duplicative reporting.--
``(i) In general.--To avoid duplicative
reporting under this subsection, the Secretary
may establish a procedure under which--
``(I) a packer or distributor of a
dietary supplement may submit a report
to the manufacturer of the dietary
supplement; and
``(II) the manufacturer shall
transmit the report to the Secretary.
``(ii) Requirement.--A procedure under
clause (i) shall ensure that the Secretary
receives reports within the applicable period
of time specified in subparagraph (A).
``(C) Clinical evaluations by the secretary.--
``(i) In general.--The Secretary shall
conduct a clinical evaluation of each serious
adverse dietary supplement experience with a
patient that is reported to the Secretary under
subparagraph (A).
``(ii) Unwilling patient.--The Secretary is
not required to conduct a clinical evaluation
under clause (i) to the extent that any
unwillingness of the patient (or the next of
kin for the patient, as the case may be) to
cooperate with the evaluation makes it impracticable to conduct the
evaluation.
``(2) Periodic adverse dietary supplement experience
reporting.--A manufacturer of a dietary supplement shall
annually (or at such shorter intervals as the Secretary may
require), in accordance with such requirements as the Secretary
may establish, submit to the Secretary a report that discloses
all information received with respect to adverse dietary
supplement experiences not previously reported under paragraph
(1).
``(3) Review regarding adverse dietary supplement
experiences.--
``(A) In general.--Promptly after a manufacturer of
a dietary supplement receives from a consumer, or
obtains by any other means, any information on an
adverse dietary supplement experience, the manufacturer
shall review the information.
``(B) Applicability.--Subparagraph (A)--
``(i) applies to information without regard
to the source of the information, foreign or
domestic; and
``(ii) includes information derived from
sources such as--
``(I) commercial marketing
experience;
``(II) postmarketing
investigations;
``(III) postmarketing surveillance;
``(IV) studies;
``(V) reports in the scientific
literature; and
``(VI) unpublished scientific
papers.
``(4) Additional reporting requirements.--In addition to
the requirements of paragraphs (1) and (2), the Secretary may
establish such requirements regarding the reporting of
information on adverse dietary supplement experiences as the
Secretary determines to be appropriate to protect the public
health.
``(5) Waivers.--The Secretary may grant a waiver from the
requirement of paragraph (1), (2), or (3) with respect to a
dietary supplement if the Secretary determines that compliance
with the requirement is not necessary to protect the public
health.
``(6) System for coordination of reports received by the
secretary.--With respect to reports of adverse dietary
supplement experiences submitted to the Secretary (whether
required under this subsection or otherwise), the Secretary
shall establish a system to--
``(A) receive the reports;
``(B) refer the reports to the appropriate
officials within the Food and Drug Administration;
``(C) store and retrieve the reports;
``(D) store and retrieve records of activities
carried out in response to the reports; and
``(E) carry out such other administrative functions
regarding the reports as the Secretary determines to be
appropriate.
``(7) Data collection by secretary.--
``(A) In general.--The Secretary shall carry out a
program to collect data on serious adverse dietary
supplement experiences, in addition to receiving
reports required in this subsection.
``(B) Cooperation.--In carrying out the program,
the Secretary shall seek the cooperation of appropriate
public and private entities, including entities that
respond to medical emergencies.
``(8) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $10,000,000 for
fiscal year 2003 and each fiscal year thereafter.
``(c) Postmarket Surveillance.--
``(1) Authority to require surveillance.--The Secretary may
by order require a manufacturer of a dietary supplement to
conduct postmarket surveillance for the dietary supplement if
the Secretary determines that there is a reasonable possibility
that a use or expected use of the dietary supplement by a
significant number of consumers may result in serious adverse
experiences.
``(2) Surveillance plan.--
``(A) In general.--Not later than 30 days after
receiving from the Secretary an order under paragraph
(1) to conduct surveillance for a dietary supplement, a
manufacturer shall submit to the Secretary, for the
approval of the Secretary, a plan for the required
surveillance.
``(B) Qualifications regarding surveillance; data
regarding adverse dietary supplement experiences.--Not
later than 60 days after a plan is submitted to the
Secretary under subparagraph (A), the Secretary shall
determine whether--
``(i) the person designated to conduct the
surveillance has appropriate qualifications and
experience to conduct the surveillance; and
``(ii) the plan will result in the
collection of useful data that will disclose
adverse dietary supplement 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 prospective surveillance period for the
manufacturer of not more than--
``(A) 3 years; or
``(B) such longer period as may be determined--
``(i) by agreement between the Secretary
and the manufacturer; or
``(ii) if the Secretary and the
manufacturer cannot agree, through a dispute
resolution process established by the Secretary
by regulation.
``(d) Safety Review for Possibly Dangerous Dietary Supplements.--
``(1) In general.--If a clinical evaluation by the
Secretary of 1 or more serious adverse events indicates that a
dietary supplement or a dietary ingredient contained in a
dietary supplement appears to present a significant or
unreasonable risk of illness, the Secretary may require the
manufacturers of the dietary supplement, or of a dietary
ingredient contained in a dietary supplement, to submit to the
Secretary data demonstrating that the dietary supplement
containing the dietary ingredient is safe.
``(2) Approval or disapproval of continued marketing.--As
soon as practicable after receiving data required under
paragraph (1), the Secretary shall review the data and issue a
determination that--
``(A)(i) the dietary supplement is safe; and
``(ii) the continued marketing of the dietary
supplement is approved; or
``(B)(i) the dietary supplement is not safe or has
not been shown to be safe under ordinary or frequent
conditions of use; and
``(ii) the continued marketing of the dietary
supplement is disapproved.''.
(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(hh) Adverse Dietary Supplement Experiences.--
``(1) Failure to comply.--The failure of a person to submit
a report or comply with any other requirement under section
416.
``(2) Disapproval of continued marketing.--The continued
marketing of a dietary supplement by any person after the
Secretary issues a determination under section 416(d)(2)(B)
that--
``(A) the dietary supplement is not safe or has not
been shown to be safe under ordinary conditions of use;
and
``(B) the continued marketing of the dietary
supplement is disapproved.''.

SEC. 3. STIMULANTS.

(a) Definition of Stimulant.--Section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end
the following:
``(nn) Stimulant.--The term `stimulant' means a dietary ingredient
that has a stimulant effect on the cardiovascular system or the central
nervous system of a human by any means, including--
``(1) speeding metabolism;
``(2) increasing heart rate;
``(3) constricting blood vessels; or
``(4) causing the body to release adrenaline.''.
(b) Premarket Approval.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) (as amended by section 2(a)) is
amended by adding at the end the following:

``SEC. 417. STIMULANTS.

``(a) In General.--No person shall introduce or deliver for
introduction into interstate commerce a dietary supplement containing a
stimulant unless an approval of the dietary supplement under this
section is in effect.
``(b) Approval.--The Secretary shall approve an application for
premarket approval of a dietary supplement containing a stimulant if
the manufacturer of the stimulant demonstrates that the dietary
supplement is safe under ordinary or frequent conditions of use.
``(c) Combinations of Stimulants.--In the case of a dietary
supplement that contains a combination of stimulants, the Secretary, in
determining the safety of the dietary supplement, shall consider the
interaction of the various stimulants contained in the dietary
supplement.
``(d) Action on Application.--The Secretary shall approve or
disapprove an application for premarket approval of a dietary
supplement containing a stimulant not later than 180 days after
receiving the application.''.
(c) Adulterated Food.--Section 402 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the
following:
``(i) Dietary Supplements Containing a Stimulant.--If the food is a
dietary supplement containing a stimulant for which the Secretary has
not granted premarket approval under section 417.
``(j) Effect of Section.--Nothing in this section affects any other
law (including a regulation) applicable to caffeine used as a food or
drug.''.
(d) Regulations.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services shall issue
guidance for implementing the amendments made by this section.
(e) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this section--
(A) apply to dietary supplements manufactured
before, on, or after the date of enactment of this Act;
and
(B) take effect on the date that is 180 days after
the date of enactment of this Act.
(2) Already-marketed dietary supplements.--The amendments
made by this section do not apply to a dietary supplement that
has been marketed before the date of enactment of this Act
until the date that is 2 years after the date of enactment of
this Act.

SEC. 4. STEROID PRECURSORS.

(a) Federal Food, Drug, and Cosmetic Act.--Section 201(ff)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)) is
amended by striking ``(other than tobacco)'' and inserting ``(other
than tobacco or a product that bears or contains an anabolic steroid
(including a substance that is chemically and pharmacologically related
to testosterone but not including an estrogen, progestin, or
corticosteroid))''.
(b) Controlled Substances Act.--
(1) Definition of anabolic steroid.--Section 102(41)(A) of
the Controlled Substances Act (21 U.S.C. 802(41)(A)) is
amended--
(A) by striking ``that promotes muscle growth, and
includes--'' and inserting ``that promotes muscle
growth or is advertised or used to promote muscle
growth.
``(B) The term `anabolic steroid' includes--''; and
(B) by striking ``(B)(i)'' and inserting
``(C)(i)''.
(2) Exclusion from schedule.--Section 201(g)(1) of the
Controlled Substances Act (21 U.S.C. 811(g)(1)) is amended by
striking ``if such substance'' and all that follows and
inserting ``if the substance--
``(A) is approved as being safe and effective for its
intended use under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355); or
``(B) is lawfully marketed under an over-the-counter
monograph issued by the Food and Drug Administration.''.

SEC. 5. AGENCY EXPERTISE AND AUTHORITY.

Section 402(f)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342(f)(1)) is amended by striking the matter following
subparagraph (D).
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