S. 1538Senate108th Congress (2003-2005)In Committee

DSHEA Full Implementation and Enforcement Act of 2003

Sponsored by Tom HarkinSen. Tom Harkin (D-IA)
Introduced July 31, 2003

Legislative Activity

Stay on top of the latest movement without scrolling through every action

1 earlier action
SenateIntro Referral Latest Action

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

July 31, 2003

View full timeline
SenateIntro Referral

Introduced in Senate

July 31, 2003

SenateIntro Referral

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

July 31, 2003

Floor Debate

24 members

What members said about S. 1538 on the floor

12 Republicans12 Democrats
Robert F. Bennett
Sen. Robert F. BennettR-UT · Nov 5, 2003

Mr. President, it is our intention to move next to the amendment of the Senator from Hawaii, Mr. Akaka; and, after that, to the amendment of Senator Cantwell. However, Senator Specter from…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Nov 5, 2003

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. I ask the chairman if this is an appropriate time for me to make a 10- or 15-minute statement relative to an…

Maria Cantwell
Sen. Maria CantwellD-WA · Nov 5, 2003

Mr. President, I call up my amendment and I send it to the desk. Mr. President, I ask unanimous consent that reading of the amendment be dispensed with. I ask unanimous consent that Senators…

Orrin G. Hatch
Sen. Orrin G. HatchR-UT · Nov 5, 2003

Mr. President, I thank the managers, Chairman Bennett and Senator Kohl, for agreeing to the amendment that Senators Harkin, Durbin and I offer today. The purpose of our amendment is simple. The Food…

Ben Nelson
Sen. Ben NelsonD-NE · Nov 5, 2003

Madam President, thank you very much for this opportunity to speak on an issue important not only to my State but also to other States in my country as it continues to plague agricultural producers…

Show 8 more
Daniel K. Akaka
Sen. Daniel K. AkakaD-HI · Nov 5, 2003

Mr. President, I rise today to offer an amendment to H.R. 2673, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for fiscal year 2004, that…

Mark Dayton
Sen. Mark DaytonD-MN · Nov 5, 2003

Mr. President, responding to the distinguished manager of the bill, I myself will take less than 10 minutes. It is my understanding there may be one or two other Senators who wish to speak on this…

Susan M. Collins
Sen. Susan M. CollinsR-ME · Nov 5, 2003

Mr. President, I am pleased to join my colleague, Senator Olympia Snowe, in offering an amendment that will expand the borders of the Aroostook County Empowerment Zone to include the entire county,…

Olympia J. Snowe
Sen. Olympia J. SnoweR-ME · Nov 5, 2003

Mr. President, I rise today to engage in a colloquy with the distinguished chairman of the Agriculture Appropriations Subcommittee. As the chairman of this subcommittee, my good friend from Utah is…

Thad Cochran
Sen. Thad CochranR-MS · Nov 5, 2003

Mr. President, I would like to thank my distinguished colleague, the chairman of the Appropriations Subcommittee on Agriculture, Rural Development and Related Agencies, Senator Bennett, for his…

Max Baucus
Sen. Max BaucusD-MT · Nov 5, 2003

Mr. President, I would like to thank Senator Dayton for offering this amendment to secure emergency agricultural disaster assistance for our drought stricken agricultural producers. I worked the past…

Byron L. Dorgan
Sen. Byron L. DorganD-ND · Nov 5, 2003

I wonder if the Senator from Utah will yield for a question. I am not certain exactly what the status of the bill is. I know we have been working on it all day. My understanding is that we have had…

Arlen Specter
Sen. Arlen SpecterR-PA · Nov 5, 2003

Mr. President, I thank the distinguished Senator from Utah. Amendment No. 2080 Mr. President, I call up amendment No. 2080, which is at the desk. Mr. President, I ask unanimous consent that reading…

Show 11 more
Conrad R. Burns
Sen. Conrad R. BurnsR-MT · Nov 5, 2003

Mr. President, the Farm Security and Rural Investment Act of 2002 added new a new provision of the Rural Electrification Act giving the Rural Utilities Service, (RUS), Administrator the authority to…

Thomas A. Daschle
Sen. Thomas A. DaschleD-SD · Nov 5, 2003

Mr. President, today Senator Frist and I are offering an amendment to authorize a new program that we call the Sun Grant Initiative. The Sun Grant Initiative--or SGI--is an effort to provide an…

Larry E. Craig
Sen. Larry E. CraigR-ID · Nov 5, 2003

Mr. President, I would like to engage in a colloquy with the chairman and ranking member of the Appropriations Subcommittee on Agriculture, Rural Development, and Related Agencies regarding the…

Hillary Rodham Clinton
Sen. Hillary Rodham ClintonD-NY · Nov 5, 2003

I am pleased to join the Senator from Montana in this initiative. Last week the Federal Communications Commission held a two day meeting on their E-911 Initiative. One issue that requires both…

Herb Kohl
Sen. Herb KohlD-WI · Nov 5, 2003

Yes. I agree with what Chairman Bennett has said regarding the committee's intentions, and will work with him to make sure this is clear in the final bill. I would like to engage in a brief colloquy…

Wayne Allard
Sen. Wayne AllardR-CO · Nov 5, 2003

Mr. Chairman, I appreciate your help addressing a long- standing concern of mine--the need for greater enforcement by USDA of the Federal law regarding animal fighting. Earlier this year, I and many…

Harry Reid
Sen. Harry ReidD-NV · Nov 5, 2003

I object. Mr. President, I have always been a great admirer of the Senator from the State of Washington. She always steps forward with amendments that are extremely important. I am happy to yield for…

Pat Roberts
Sen. Pat RobertsR-KS · Nov 5, 2003

Mr. President, I would like to engage my good friend and colleague Senator Bennett, the distinguished chairman of the Senate Agriculture Appropriations Subcommittee, in a colloquy regarding funding…

Pete V. Domenici
Sen. Pete V. DomeniciR-NM · Nov 5, 2003

Mr. President, I appreciate the work that you have done in regard to funding for Chronic Wasting Disease (CWD). As you know, this is a fatal neurological disease of farmed and wild elk and deer that…

Saxby Chambliss
Sen. Saxby ChamblissR-GA · Nov 5, 2003

I thank the Chairman for your hard work on this appropriations bill. I would like to bring to your attention a Cooperative State Research, Education and Extension Service project that is funded in…

Jeff Bingaman
Sen. Jeff BingamanD-NM · Nov 5, 2003

Mr. President, I defer to the manager of the bill. If he would like time to review the amendment that I have given him, I have no problem with that course of action. Mr. President, I ask unanimous…

Bill Text

Latest available legislative text

Reading Mode
Latest
Introduced in SenateIssued July 31, 2003
        [Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1538 Introduced in Senate (IS)]

1st Session
S. 1538

To ensure that the goals of the Dietary Supplement Health and Education
Act of 1994 are met by authorizing appropriations to fully enforce and
implement such Act and the amendments made by such Act, and for other
purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

July 31 (legislative day, July 21), 2003

Mr. Harkin (for himself and Mr. Hatch) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions

_______________________________________________________________________

A BILL

To ensure that the goals of the Dietary Supplement Health and Education
Act of 1994 are met by authorizing appropriations to fully enforce and
implement such Act and the amendments made by such Act, 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 ``DSHEA Full Implementation and
Enforcement Act of 2003''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) Over 158,000,000 Americans regularly consume dietary
supplements to maintain and improve their health.
(2) Consumer expenditures on dietary supplements reached a
reported $17,100,000,000 in 2000, double the amount spent in
1994.
(3) According to a recent report issued by the Food and
Drug Administration (in this Act referred to as the ``FDA'')
the use of dietary supplements is likely to grow due to factors
such as the aging of the baby boom generation, increased
interest in self-sufficiency, and advances in science that are
uncovering new relationships between diet and disease.
(4) In 1994, the Dietary Supplement Health and Education
Act of 1994 (Public Law 103-417) (in this Act referred to as
``DSHEA'') was enacted. This Act balanced continued consumer
access to vitamins, minerals, and other dietary supplements,
increased scientific research on the benefits and risks of
dietary supplements, public education on dietary supplements,
and needed consumer protections.
(5) DSHEA requires that claims made on dietary supplement
labels, packaging, and accompanying material be truthful, non-
misleading, and substantiated. Manufacturers are prohibited
from making claims that products are intended to diagnose,
treat, mitigate, cure, or prevent a disease.
(6) DSHEA provides for good manufacturing practice
standards setting requirements for potency, purity, sanitary
conditions, and recordkeeping for dietary supplements.
(7) DSHEA requires that manufacturers submit adequate
information as to the safety of any new ingredients contained
in dietary supplements before those products can be sold.
(8) The FDA has updated and expanded its system for the
reporting, collection, and analysis of dietary supplement
adverse events reports.
(9) DSHEA provides the FDA with a number of authoritites to
remove unsafe dietary supplements from the marketplace.
(10) DSHEA created the Office of Dietary Supplements within
the National Institutes of Health to expand research and
consumer information about the health effects of dietary
supplements.
(11) The FDA has not adequately used its authority to
enforce DSHEA.
(12) The FDA needs adequate resources to appropriately
implement and enforce DSHEA. Congress has appropriated
additional funds over the last several years beyond those
requested in the President's budget to implement and enforce
DSHEA, reaching $9,700,000 in fiscal year 2003.
(13) However, according to the FDA, full implementation of
DSHEA would require substantial additional resources. The FDA
asserts that between $24,000,000 and $65,000,000 per year will
be needed to fully implement DSHEA.

SEC. 3. AUTHORIZATION AND APPROPRIATION OF RESOURCES.

(a) Authorization of Appropriations.--There are authorized to be
appropriated to carry out the Dietary Supplement Health and Education
Act of 1994 (Public Law 103-417), the amendments made by such Act, and
all applicable regulatory requirements for dietary supplements under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)--
(1) $20,000,000 for fiscal year 2004;
(2) $30,000,000 for fiscal year 2005;
(3) $40,000,000 for fiscal year 2006;
(4) $50,000,000 for fiscal year 2007; and
(5) $65,000,000 for fiscal year 2008.
(b) Appropriation of Funds for Fiscal Year 2004.--There are
appropriated, out of any money in the Treasury not otherwise
appropriated, to carry out the Dietary Supplement Health and Education
Act of 1994 (Public Law 103-417), the amendments made by such Act, and
all applicable regulatory requirements for dietary supplements under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
$20,000,000 for fiscal year 2004.
(c) Office of Dietary Supplements.--There are authorized to be
appropriated and there are appropriated, out of any money in the
Treasury not otherwise appropriated, for expanded research and
development of consumer information on dietary supplements by the
Office of Dietary Supplements at the National Institutes of Health--
(1) $30,000,000 for fiscal year 2004; and
(2) such sums as may be necessary for each of the fiscal
years 2005 through 2008.
(d) Use of Funds.--The Food and Drug Administration shall fully and
appropriately use the funds appropriated in subsections (b) and (c) and
pursuant to subsection (a) to regulate dietary supplements.

SEC. 4. ANNUAL ACCOUNTABILITY REPORT ON THE REGULATION OF DIETARY
SUPPLEMENTS.

(a) In General.--Not later than January 31, 2004, and annually
thereafter, the Secretary of Health and Human Services shall submit a
report to Congress on the implementation and enforcement of the Dietary
Supplement Health and Education Act of 1994 (Public Law 103-417).
(b) Contents.--The report under subsection (a) shall include the
following:
(1) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to
dietary supplement regulation over the prior fiscal year.
(2) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to
administering adverse event reporting systems as they relate to
dietary supplement regulation over the prior fiscal year.
(3) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to
enforcement of dietary supplement labeling and claims
requirements over the prior fiscal year and an explanation of
their activities.
(4) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to good
manufacturing practices inspections of dietary supplement
manufacturers over the prior fiscal year and an explanation of
their activities.
(5) The number of good manufacturing practices inspections
of dietary supplement manufacturers by the Food and Drug
Administration over the prior fiscal year and a summary of the
results.
(6) The number of new ingredient reviews and safety reviews
related to dietary supplements and the results of those
reviews.
(7) An explanation of all enforcement actions taken by the
Food and Drug Administration and the Department of Health and
Human Services related to dietary supplements over the prior
fiscal year, including the number and type of actions.
(8) The number of dietary supplement claims for which the
Food and Drug Administration requested substantiation from the
manufacturer over the prior fiscal year, and the agency's
response.
(9) The number of dietary supplement claims determined to
be false, misleading, or nonsubstantiated by the Food and Drug
Administration over the prior fiscal year.
(10) The research and consumer education activities
supported by the Office of Dietary Supplements of the National
Institutes of Health.
(11) Any recommendations for administrative or legislative
actions regarding the regulation of dietary supplements.
(12) Any other information regarding the regulation of
dietary supplements determined appropriate by the Secretary of
Health and Human Services or the Commissioner of Food and
Drugs.
<all>