[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3065 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 3065

   To amend the Federal Food, Drug, and Cosmetic Act to require that 
 manufacturers of dietary supplements register with the Food and Drug 
  Administration, to require the submission to such Administration of 
  reports on adverse experiences regarding such supplements, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 9, 2001

   Mrs. Davis of California introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to require that 
 manufacturers of dietary supplements register with the Food and Drug 
  Administration, to require the submission to such Administration of 
  reports on adverse experiences regarding such supplements, 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 Information 
Act''.

SEC. 2. REGISTRATION, REPORTING, AND POSTMARKET SURVEILLANCE REGARDING 
              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 section:

   ``registration, reporting, and postmarket surveillance regarding 
                          dietary supplements

    ``Sec. 414. (a) Registration.--
            ``(1) Annual registration.--Each calendar year a person who 
        in any State owns or operates an establishment engaged in the 
        business of manufacturing, packing, or distributing a dietary 
        supplement shall register with the Secretary the name of the 
        person, places of business, and all such establishments.
            ``(2) Initial manufacturing.--A person, upon first engaging 
        in a business described in paragraph (1) in an establishment 
        that the person owns or operates in any State, shall 
        immediately register with the Secretary the name of the person, 
        place of business, and such establishment.
            ``(3) Additional establishments.--A person duly registered 
        in accordance with paragraph (1) or (2), upon engaging in the 
        business involved in any additional establishment that the 
        person owns or operates in any State, shall immediately 
        register with the Secretary the additional establishment.
            ``(4) Imports.--Any establishment within any foreign 
        country engaged in the manufacture of a dietary supplement that 
        is imported or offered for import into the United States shall 
        register with the Secretary the name and place of business of 
        the establishment and the name of the United States agent for 
        the establishment.
            ``(5) Product information.--
                    ``(A) Labeling; other information.--In addition to 
                information that under any of paragraphs (1) through 
                (4) is required to be provided in a registration, the 
                registration shall provide the labeling of the dietary 
                supplements involved (except to the extent that another 
                registration under this subsection provides the 
                labeling) and such other information describing the 
                dietary supplements as the Secretary may by regulation 
                require.
                    ``(B) Changes in underlying facts.-- With respect 
                to information that pursuant to subparagraph (A) is 
                submitted in a registration, if after submitting the 
                registration to the Secretary any of the underlying 
                facts change, the person involved shall submit revised 
                information to the Secretary in accordance with such 
                criteria and procedures as the Secretary may establish, 
                which may include requiring the submission of a 
                substitute registration. The revised information shall 
                be so submitted not later than 30 days after the date 
                on which the factual changes occur.
                    ``(C) Premarket submission of labeling for 
                postenactment products.--In the case of a dietary 
                supplement that was not in commercial distribution as 
                of the day before the date of the enactment of the 
                Dietary Supplement Information Act, the manufacturer of 
                such supplement shall submit the labeling for the 
                supplement to the Secretary in accordance with 
                subparagraph (A) before introducing the supplement into 
                interstate commerce or delivering the supplement for 
                such introduction.
            ``(6) Fees.--The Secretary may by regulation establish a 
        requirement that a registration under this subsection is 
        subject to a fee to be assessed and collected by the Secretary. 
        Subject to the extent of amounts approved in advance by an 
        appropriation Act for the fiscal year involved, amounts 
        collected by the Secretary under the preceding sentence are 
        available to the Secretary for the purpose of carrying out the 
        responsibilities of the Secretary under this subsection and 
        subsection (b). The Secretary may waive the requirement that a 
        person pay such a fee if the Secretary determines that the 
        waiver is justified on the basis that the person is a small 
        business.
    ``(b) Reporting of Information on Adverse Experiences.--
            ``(1) Serious experiences.--Each person who is a 
        manufacturer of a dietary supplement, or a packer or 
        distributor of the supplement whose name appears on the 
        labeling of the supplement, shall--
                    ``(A) report to the Secretary in accordance with 
                paragraph (2) any information received by such person 
                on serious adverse experiences regarding the 
                supplement; and
                    ``(B) develop written procedures regarding the 
                submission to the Secretary of such reports, including 
procedures for surveillance, receipt, and evaluation of information on 
such experiences.
            ``(2) Reporting of serious experiences.--
                    ``(A) Initial report.--With respect to the initial 
                receipt of information on a serious adverse experience, 
                a person with reporting responsibility under paragraph 
                (1) shall submit the report to the Secretary as soon as 
                is possible, but in no case later than 15 calendar days 
                after the initial receipt of the information. Such 
                report shall be accompanied by a copy of the current 
                labeling for the dietary supplement involved.
                    ``(B) Investigation and follow-up.--A person 
                submitting an initial report under subparagraph (A) on 
                a serious adverse experience shall promptly investigate 
                the experience, and if additional information is 
                obtained, shall report the information to the Secretary 
                not later than 15 days after obtaining the information. 
                If no additional information is obtained, records of 
                the steps taken to seek additional information shall be 
                maintained by the person.
                    ``(C) Duplicative reporting.--In order to avoid 
                duplicative reporting under this paragraph, the 
                Secretary may provide for procedures under which 
                persons who are packers or distributors described in 
                paragraph (1) submit reports under this paragraph to 
                the manufacturer involved rather than the Secretary, 
                with the manufacturers then submitting the required 
                reports to the Secretary, subject to the Secretary 
                establishing requirements to ensure that the Secretary 
                receives reports within the applicable period of time 
                specified in subparagraph (A) or (B).
            ``(3) Clinical evaluations by secretary.--The Secretary 
        shall conduct a clinical evaluation of each serious adverse 
        experience reported to the Secretary under paragraph (2) 
        (except to the extent that the patient involved or the next of 
        kin for the patient, as the case may be, elects not to 
        cooperate with the Secretary).
            ``(4) Additional requirements for manufacturers.--
                    ``(A) General review regarding adverse 
                experiences.--A manufacturer of a dietary supplement 
                shall promptly review all information on adverse 
                experiences regarding the supplement obtained or 
                otherwise received by the manufacturer. The preceding 
                sentence applies to information without regard to the 
                source of the information, foreign or domestic, and 
                includes information derived from sources such as 
                commercial marketing experience, postmarketing 
                investigations, postmarketing surveillance, studies, 
                reports in the scientific literature, and unpublished 
                scientific papers.
                    ``(B) Periodic reports on nonserious experiences.--
                With respect to the receipt of information on adverse 
                experiences that are not serious, a manufacturer of the 
                dietary supplement involved shall submit reports to the 
                Secretary annually, or at such shorter intervals as the 
                Secretary may require. Each such report shall meet such 
                requirements as the Secretary may establish.
            ``(5) Authority of secretary.--In addition to requirements 
        established in this subsection, the Secretary may establish 
        such requirements regarding the reporting of information on 
        adverse experiences as the Secretary determines to be 
        appropriate to protect the public health. The Secretary may 
        establish waivers from requirements under this subsection 
        regarding such information if the Secretary determines that 
        compliance with the requirement involved is not necessary to 
        protect the public health regarding such supplements.
            ``(6) System for coordinating reports received by 
        secretary.--With respect to reports of adverse health 
        experiences submitted to the Secretary (whether required under 
        this subsection or otherwise), the Secretary shall establish a 
        system to receive the reports, refer the reports to the 
        appropriate officials within the Food and Drug Administration, 
        store and retrieve the reports, store and retrieve records of 
        activities carried out in response to the reports, and carry 
        out such other administrative functions regarding the reports 
        as the Secretary determines to be appropriate.
            ``(7) Data collection by secretary.--The Secretary shall 
        carry out a program to collect data on serious adverse 
        experiences, in addition to receiving reports required in this 
        subsection. In carrying out such program, the Secretary shall 
        seek the cooperation of appropriate public and private 
        entities, including entities that respond to medical 
        emergencies.
            ``(8) Definitions.--For purposes of this section:
                    ``(A) The term `adverse experience' means an 
                adverse experience regarding a dietary supplement.
                    ``(B) The term `adverse experience regarding a 
                dietary supplement' means any adverse event associated 
                with the use of such supplement in humans, whether or 
                not such event is considered to be related to the 
                supplement by a person referred to in paragraph (1) who 
                obtains the information.
                    ``(C) The term `serious', with respect to an 
                adverse experience, means an adverse experience to 
                which any of clauses (i) through (iii) applies, as 
                follows:
                            ``(i) The experience is associated with any 
                        of the following outcomes: Death; a life-
                        threatening condition; inpatient 
                        hospitalization or prolongation of existing 
                        hospitalization; a persistent or significant 
                        disability or incapacity; or a congenital 
                        anomaly, birth defect, or other effect 
                        regarding pregnancy, including premature labor 
                        or low birth weight.
                            ``(ii) The experience requires medical or 
                        surgical intervention to prevent one of the 
                        outcomes specified in clause (i).
                            ``(iii) There is reason to believe that a 
                        factor associated with the experience is the 
                        interaction of the dietary supplement involved 
                        with a drug, without regard to whether clause 
                        (i) or (ii) applies to the experience.
    ``(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 such supplement if the 
        Secretary determines that there is a reasonable possibility 
        that a use or expected use of the supplement by a significant 
        number of consumers may have serious adverse health 
        consequences.
            ``(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, 
                the manufacturer involved shall submit to the 
                Secretary, for the approval of the Secretary, a plan 
                for the required surveillance.
                    ``(B) Qualifications regarding surveillance; data 
                regarding adverse 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 such surveillance; and
                            ``(ii) the plan will result in the 
                        collection of useful data that can reveal 
                        adverse 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 up to 36 months. Any determination by the 
        Secretary that a longer period is necessary shall be made by 
        mutual agreement between the Secretary and the manufacturer or, 
        if no agreement can be reached, after the completion of a 
        dispute resolution process that is established by the Secretary 
        by regulation.
    ``(d) Reporting in General.--In addition to requirements otherwise 
established under this section, a manufacturer of a dietary supplement 
shall establish and maintain such records, make such reports, and 
provide such information as the Secretary may by regulation reasonably 
require to assure that such supplement is not adulterated or 
misbranded.''.
    (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:
    ``(bb) The failure of a person to register, submit reports, or 
comply with any other requirement under section 414.''.

SEC. 3. INSPECTION AUTHORITY REGARDING RECORDS ON DIETARY SUPPLEMENTS.

    Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374) is amended--
            (1) in subsection (a)(1)--
                    (A) in the second sentence, by striking ``or 
                restricted devices'' each place such term appears and 
                inserting ``restricted devices, or dietary 
                supplements''; and
                    (B) in the third sentence--
                            (i) by striking ``and devices'' and 
                        inserting ``devices, and dietary supplements''; 
                        and
                            (ii) by striking ``section 505(i) or (k)'' 
                        and inserting ``section 414, section 505(i), 
                        section 505(k),''; and
            (2) in subsection (e), by striking ``section 519'' and 
        inserting ``section 414, 519,''.

SEC. 4. LABELING OF DIETARY SUPPLEMENTS.

    Section 403(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(e)) is amended--
            (1) by striking ``and (2)'' and inserting the following: 
        ``(2) the toll-free telephone number, and the address of the 
        Internet site, maintained by the Secretary for purposes of the 
        medical product reporting program (MedWatch or any successor 
        program); and (3) ''; and
            (2) by striking ``clause (2)'' and inserting ``clause 
        (3)''.

SEC. 5. PUBLICATION OF PROPOSED RULE ON CURRENT GOOD MANUFACTURING 
              PRACTICES FOR DIETARY SUPPLEMENTS.

    Not later than 30 days after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall publish in the Federal 
Register a proposed rule for carrying out section 402(g) of the Federal 
Food, Drug, and Cosmetic Act.
                                 <all>