[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4747 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 4747

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 HOUSE OF REPRESENTATIVES

                             June 25, 2004

 Mr. Pallone introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 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 ``Dietary Supplement Regulatory 
Implementation Act of 2004''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (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 (``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) (``DSHEA'') was enacted. That 
        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 provides that dietary supplements are to be 
        regulated like foods and not drugs or food additives.
            (8) 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.
            (9) DSHEA provides the FDA with a number of powers 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) $30,000,000 for fiscal year 2006;
            (2) $40,000,000 for fiscal year 2007;
            (3) $50,000,000 for fiscal year 2008; and
            (4) $65,000,000 for fiscal year 2009.
    (b) Appropriation of Funds for Fiscal Year 2005.--There is 
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 2005.
    (c) Office of Dietary Supplements.--
            (1) Authorization of appropriations.--There are authorized 
        to be appropriated for expanded research and development of 
        consumer information, including information on safety and 
        beneficial effects, of dietary supplements by the Office of 
        Dietary Supplements at the National Institutes of Health such 
        sums as may be necessary for each of the fiscal years 2006 
        through 2009.
            (2) Appropriation of funds for fiscal year 2005.--There is 
        appropriated, out of any money in the Treasury not otherwise 
        appropriated, for expanded research and development of consumer 
        information, including information on safety and beneficial 
        effects, of dietary supplements by the Office of Dietary 
        Supplements at the National Institutes of Health $30,000,000 
        for fiscal year 2005.
    (d) Use of Funds.--The Secretary of Health and Human Services 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, 2006, and annually 
thereafter, the Secretary 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 unsubstantiated 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.

SEC. 5. DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS.

    (a) Findings.--The Congress finds that--
            (1) dietary supplements containing ephedrine alkaloids may 
        present a significant or unreasonable risk of illness or 
        injury; and
            (2) through section 402(f) of the Federal Food, Drug, and 
        Cosmetic Act (established by the Dietary Supplement Health and 
        Education Act of 1994), the Congress has granted the Secretary 
        the authority to remove from the market dietary supplements 
        that present such a risk.
    (b) Sense of Congress Regarding Risk of Illness or Injury.--It is 
the sense of the Congress that, in the event the Secretary determines 
under section 402(f) of the Federal Food, Drug, and Cosmetic Act that a 
dietary supplement containing ephedrine alkaloids presents a 
significant or unreasonable risk of illness or injury--
            (1) all dietary supplements containing such alkaloids 
        should be declared to be adulterated in accordance with such 
        section; and
            (2) the Secretary should take all necessary actions to 
        remove all such supplements from the market.
    (c) Sense of Congress Regarding Botanical Sources.--It is the sense 
of the Congress that the Secretary should take steps to assure the 
continued availability of botanical sources of ephedrine alkaloids 
that--
            (1) are in forms that have not been manipulated or 
        chemically altered to increase their ephedrine alkaloid 
        concentration or content;
            (2) are marketed at dosages that are substantiated to be at 
        levels used in traditional herbal formulas; and
            (3) are labeled only for traditional uses and not for 
        weight loss or energy.

SEC. 6. EDUCATION PROGRAMS REGARDING DIETARY SUPPLEMENTS.

    (a) Health Care Professionals.--
            (1) In general.--The Secretary shall carry out a program to 
        educate health professionals on the safety and health benefits 
        of dietary supplements, including the potential for dietary 
        supplement/drug interactions.
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $5,000,000 for fiscal year 2005, in addition to 
        any other authorization of appropriations that is available 
        with respect to such purpose.
    (b) Consumers.--
            (1) In general.--The Secretary shall carry out a program to 
        educate consumers of dietary supplements on the safety and 
        health benefits of the dietary supplements, including the 
        potential for dietary supplement/drug interactions through 
        public education forums, advertisements, and the Internet.
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $5,000,000 for fiscal year 2005, in addition to 
        any other authorization of appropriations that is available 
        with respect to such purpose.

SEC. 7. ADVERSE EVENT REPORTING SYSTEM.

    The Secretary shall establish a system for the requirements for the 
reporting of serious adverse experiences associated with the use of a 
dietary supplement received by the manufacturer, packer, or distributor 
whose name appears on the label of the product.

SEC. 8. DEFINITION.

    For purposes of this Act, the term ``Secretary'' means the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs.
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