[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>