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.

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).

Summary: Amends the Federal Food, Drug, and Cosmetic Act to require each manufacturer of a dietary supplement (supplement), and each packer or distributor of a supplement the name of which appears on the labeling, to report serious adverse experiences to the Secretary of Health and Human Services and to investigate such occurrences. Defines a serious adverse experience as an adverse event associated with the use of a supplement in a human that involves death or one of other serious calamities. Directs the Secretary to conduct a clinical evaluation of each such reported experience. Requires the manufacturer of a dietary supplement to report periodically on other adverse experiences and to review such occurrences. Allows the Secretary to grant a waiver from the above reporting, reviewing, and investigating requirements with respect to a dietary supplement upon determination that compliance is not necessary to protect the public health. Authorizes the Secretary to require a manufacturer to conduct postmarket surveillance for a supplement under specified circumstances. Permits the Secretary to require a manufacturer of a supplement or of an ingredient in a supplement to demonstrate that its product is safe under specified circumstances. Directs the Secretary to approve the continued marketing of such a supplement or ingredient or to disapprove it. Prohibits any introduction into interstate commerce of a supplement containing a stimulant unless it is approved by the Secretary under this Act. Amends the Act to exclude a product that bears or contains an anabolic steroid from the definition of a dietary supplement for a specified chapter of the Act. Eliminates a provision of the Act requiring the United States to bear the burden of proof to show a supplement or an ingredient in a supplement is adulterated due to a safety violation.