[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3414 Introduced in Senate (IS)]

111th CONGRESS
  2d Session
                                S. 3414

To ensure that the Dietary Supplement Health and Education Act of 1994 
 and other requirements for dietary supplements under the jurisdiction 
of the Food and Drug Administration are fully implemented and enforced, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 25, 2010

 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 Dietary Supplement Health and Education Act of 1994 
 and other requirements for dietary supplements under the jurisdiction 
of the Food and Drug Administration are fully implemented and enforced, 
                        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 Full 
Implementation and Enforcement Act of 2010''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Each year, more than 150,000,000 Americans regularly 
        consume dietary supplements to maintain and improve their 
        health.
            (2) Consumer expenditures on dietary supplements exceeded 
        $25,000,000,000 in 2008.
            (3) Given the growing awareness of the importance of 
        prevention and wellness in the health care system of the United 
        States, it is vital that laws governing the safety of, and 
        education about, dietary supplements be fully implemented and 
        enforced.
            (4) In 1994, Congress approved, and the President signed 
        into law, the Dietary Supplement Health and Education Act of 
        1994 (Public Law 103-417) (referred to in this Act as 
        ``DSHEA''). DSHEA balanced the importance of continuing 
        consumer access to vitamins, minerals, and other dietary 
        supplements, promoting scientific research on the benefits and 
        risks of dietary supplements, and fostering public education on 
        the benefits and risks of supplement use with the need for 
        regulatory safeguards to protect consumer health, including a 
        new standard for safety, penalties for mislabeled or 
        adulterated dietary supplements, rules to ensure scientific 
        substantiation of the claims made regarding dietary 
        supplements, and a notification requirement to the Food and 
        Drug Administration before dietary supplements that contain 
        certain new dietary ingredients may be marketed.
            (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 requires that dietary supplements comply with 
        good manufacturing practice (referred to in this section as 
        ``GMP'') requirements, and authorizes the Food and Drug 
        Administration to establish such requirements.
            (7) In 2007, after many years of delay, the Food and Drug 
        Administration published regulations detailing the GMP 
        requirements for dietary supplements, including requirements 
        for identity, purity, strength, sanitary conditions, and 
        recordkeeping. The Food and Drug Administration began to 
        enforce those requirements in 2008.
            (8) DSHEA requires that, before marketing a dietary 
        supplement containing certain new dietary ingredients, the 
        manufacturer or distributor must submit notice to the Food and 
        Drug Administration that includes information showing that the 
        dietary supplement will reasonably be expected to be safe. 
        According to the Food and Drug Administration, the Food and 
        Drug Administration has raised objections to more than 70 
        percent of all new dietary ingredient notifications submitted 
        to the agency.
            (9) The Food and Drug Administration has successfully used 
        the adulteration provisions of DSHEA to remove from the 
        marketplace dietary supplements that present an unreasonable 
        risk of injury or illness.
            (10) In 2002, Congress passed the Public Health Security 
        and Bioterrorism Preparedness and Response Act (Public Law 107-
        188). This law requires any facility engaged in manufacturing, 
        processing, packing, or holding food for consumption in the 
        United States, including dietary supplements, to be registered 
        with the Food and Drug Administration.
            (11) In 2006, Congress supplemented DSHEA by approving the 
        Dietary Supplement and Nonprescription Drug Consumer Protection 
        Act (Public Law 109-462). This law requires dietary supplement 
        manufacturers, packers, and distributors to report promptly to 
        the Food and Drug Administration any reports the manufacturer 
        or other responsible person receives of serious adverse events 
        associated with the use of the products of such manufacturer or 
        other responsible person. Information the Food and Drug 
        Administration receives under this reporting requirement may 
        help the agency detect possible safety problems related to 
        dietary supplement products or ingredients.
            (12) 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. The Office of Dietary Supplements has greatly 
        expanded the number of scientific studies of dietary 
        supplements and the availability of reliable information to 
        consumers.
            (13) While the Food and Drug Administration has taken some 
        important steps to implement and enforce DSHEA and the other 
        laws governing the regulation of dietary supplements, the 
        agency has not fully implemented and enforced DSHEA and the 
        other laws governing the regulation of dietary supplements.
            (14) Both the public and regulated industry would benefit 
        from more guidance from the Food and Drug Administration on the 
        procedures and definitions concerning the regulation of new 
        dietary ingredients under section 413 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 350b).
            (15) If the Food and Drug Administration determines that a 
        product labeled as a dietary supplement includes an anabolic 
        steroid or an analogue of an anabolic steroid, the Food and 
        Drug Administration does not systematically notify the Drug 
        Enforcement Administration of that determination.
            (16) The Food and Drug Administration needs adequate 
        resources to implement and enforce DSHEA and other laws 
        governing the regulation of dietary supplements appropriately. 
        Congress has appropriated additional funds over the last 
        several years to implement and enforce DSHEA, reaching more 
        than $14,000,000 for fiscal year 2009.
            (17) According to the Food and Drug Administration, full 
        implementation of DSHEA and the other laws governing the 
        regulation of dietary supplements would require substantial 
        additional resources. In 2002, the Food and Drug Administration 
        reported to Congress in writing that the agency would need 
        between $24,000,000 and $65,000,000 per year to fully implement 
        DSHEA.

SEC. 3. SENSE OF CONGRESS.

    It is the sense of Congress that:
            (1) The Food and Drug Administration should increase 
        efforts to implement DSHEA more fully and effectively, by--
                    (A) providing Congress with a professional judgment 
                estimate of the annual costs during the 5-year period 
                beginning on the date of enactment of this Act to fully 
                implement and enforce DSHEA and other dietary 
                supplement laws and regulations under the jurisdiction 
                of the Food and Drug Administration;
                    (B) conducting inspections, using appropriately 
                trained inspection personnel, of all facilities in 
                which a dietary supplement is manufactured, processed, 
                packed, or held to ensure compliance with the new 
                dietary supplement good manufacturing practices 
                regulations;
                    (C) using the authority under DSHEA to protect the 
                public from unsafe dietary supplement products and 
                ingredients and to ensure that claims made are 
                truthful, non-misleading, and substantiated, with 
                highest regulatory priority given to cases of clear 
                violations of the law (including the intentional 
                adulteration and spiking of products);
                    (D) implementing the recommendations contained in 
                the January 2009 report of the Government 
                Accountability Office, entitled, ``Dietary Supplements: 
                FDA Should Take Further Actions To Improve Oversight 
                and Consumer Understanding'', (GAO 09-250) that the 
                Food and Drug Administration--
                            (i) require all dietary supplement 
                        manufacturers, packers, and distributors to 
                        identify themselves specifically as such under 
                        existing registration requirements and to 
                        update such information annually;
                            (ii) promptly issue guidance to clarify 
                        when a dietary supplement ingredient is a new 
                        dietary ingredient, the evidence needed to 
                        document the safety of new dietary ingredients, 
                        and appropriate methods for establishing the 
                        identity of a new dietary ingredient; and
                            (iii) coordinate with stakeholder groups 
                        involved in consumer outreach to identify, 
                        implement, and evaluate the effectiveness of 
                        additional mechanisms for educating consumers 
                        about the safety, efficacy, and labeling of 
                        dietary supplements; and
                    (E) notifying the Drug Enforcement Administration 
                if the Food and Drug Administration determines that the 
                information in a new dietary ingredient notification 
                submitted under section 413 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 350b) is inadequate to 
                establish that the new dietary ingredient will 
                reasonably be expected to be safe, because the dietary 
                supplement may contain an anabolic steroid or an 
                analogue of an anabolic steroid.
            (2) The manufacturers, packers, retailers, and distributors 
        of dietary supplements and dietary supplement ingredients 
        should increase efforts to--
                    (A) comply fully with all requirements of DSHEA and 
                the Dietary Supplement and Nonprescription Drug 
                Consumer Protection Act;
                    (B) cooperate fully and appropriately with the Food 
                and Drug Administration in implementation and 
                enforcement of Federal laws and regulations; and
                    (C) provide the Food and Drug Administration with 
                appropriate input on known and suspected violations of 
                such laws and regulations.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS AND ALLOCATION OF RESOURCES.

    (a) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out the Dietary Supplement Health and Education 
Act of 1994, the amendments made by such Act, and other provisions 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
that apply to dietary supplements, $30,000,000 for fiscal year 2011 and 
such sums as may be necessary for each of fiscal years 2012 through 
2014.
    (b) Allocation of Funds for Fiscal Year 2010.--From funds 
appropriated to the Food and Drug Administration for fiscal year 2010 
for the purpose of enhancing food safety, not less than $20,000,000 
shall be expended to effectively and fully implement and enforce the 
Dietary Supplement Health and Education Act of 1994, the amendments 
made by such Act, and other provisions under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) that apply to dietary 
supplements.
    (c) Office of Dietary Supplements.--There are authorized to be 
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) $40,000,000 for fiscal year 2010; and
            (2) such sums as may be necessary for each of the fiscal 
        years 2011 through 2014.

SEC. 5. ANNUAL ACCOUNTABILITY REPORT ON THE REGULATION OF DIETARY 
              SUPPLEMENTS.

    (a) In General.--Not later than January 31, 2011, 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 and the amendments made by 
such Act.
    (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 during 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 such systems 
        relate to dietary supplement regulation, during 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 during the prior fiscal year and a brief 
        explanation of the activities of such personnel.
            (4) The total funding and number of full-time equivalent 
        personnel in the Food and Drug Administration dedicated to the 
        review and enforcement of good manufacturing practice 
        requirements with respect to dietary supplements during the 
        prior fiscal year.
            (5) The number of inspections at which the Food and Drug 
        Administration evaluated or reviewed the compliance of a 
        manufacturer with good manufacturing practices for dietary 
        supplements during the prior fiscal year, and the number of 
        times the Food and Drug Administration issued a warning letter 
        because it determined that such manufacturer was not in 
        compliance with some aspect of such requirements.
            (6) The number of new dietary ingredient notification 
        reviews that the Food and Drug Administration performed during 
        the prior fiscal year and the number of times the Food and Drug 
        Administration objected to the marketing of the dietary 
        supplement described in such notification reviews.
            (7) The number of times the Food and Drug Administration 
        issued a warning letter or initiated an enforcement action 
        against a manufacturer or distributor for failure to file a new 
        dietary ingredient notification as required under section 413 
        of the Federal Food, Drug, and Cosmetic Act.
            (8) A brief summary and explanation of all enforcement 
        actions taken by the Food and Drug Administration and the 
        Department of Health and Human Services related to dietary 
        supplements during the prior fiscal year, including the number 
        and type of actions.
            (9) The number of times the Food and Drug Administration 
        requested substantiation of dietary supplement claims from a 
        manufacturer during the prior fiscal year, the number of times 
        a manufacturer refused to provide such information, and the 
        response of the agency in such situations.
            (10) The number of dietary supplement claims determined by 
        the Food and Drug Administration during the prior fiscal year 
        to be false, misleading, or not substantiated, and a 
        description of the follow-up action taken by the agency in such 
        instances.
            (11) The research and consumer education activities 
        supported by the Office of Dietary Supplements of the National 
        Institutes of Health during the prior fiscal year.
            (12) Any recommendations for administrative or legislative 
        actions to improve the regulation of dietary supplements.
            (13) 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.

SEC. 6. NEW DIETARY INGREDIENTS.

    (a) Guidelines for Introducing New Dietary Ingredients.--Section 
413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is 
amended--
            (1) by redesignating subsection (c) as subsection (e); and
            (2) by inserting after subsection (b) the following:
    ``(c) Guidelines.--Not later than 180 days after the date of 
enactment of the Dietary Supplement Full Implementation and Enforcement 
Act of 2010, the Secretary shall publish guidance that clarifies when a 
dietary supplement ingredient is a new dietary ingredient, when the 
manufacturer or distributor of a dietary ingredient or dietary 
supplement should provide the Secretary with information as described 
in subsection (a)(2), the evidence needed to document the safety of new 
dietary ingredients, and appropriate methods for establishing the 
identity of a new dietary ingredient.
    ``(d) Notification to DEA.--
            ``(1) In general.--If the Secretary determines that the 
        information in a new dietary ingredient notification submitted 
        under this section for an article purported to be a new dietary 
        ingredient is inadequate to establish that a dietary supplement 
        containing such article will reasonably be expected to be safe 
        because the article may be, or may contain, an anabolic steroid 
        or an analogue of an anabolic steroid, the Secretary shall 
        notify the Drug Enforcement Administration of such 
        determination. Such notification by the Secretary shall 
        include, at a minimum, the name of the product or article, the 
        name of the person or persons who marketed the product or made 
        the submission of information regarding the article to the 
        Secretary under this section, and any contact information for 
        such person or persons that the Secretary has.
            ``(2) Definitions.--For purposes of this subsection--
                    ``(A) the term `anabolic steroid' has the meaning 
                given such term in section 102(41) of the Controlled 
                Substances Act; and
                    ``(B) the term `analogue of an anabolic steroid' 
                means a substance whose chemical structure is 
                substantially similar to the chemical structure of an 
                anabolic steroid.''.
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