[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1075 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 1075

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
  dietary supplements containing natural or synthetic ephedrine group 
                   alkaloids, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 4, 2003

   Mr. Sweeney (for himself and Mr. Walden of Oregon) 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 with respect to 
  dietary supplements containing natural or synthetic ephedrine group 
                   alkaloids, 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 ``Ephedra Public Protection Act''.

SEC. 2. REQUIREMENT OF PREMARKET APPROVAL FOR DIETARY SUPPLEMENTS 
              CONTAINING EPHEDRINE GROUP ALKALOIDS; REPORTING OF 
              SERIOUS ADVERSE EXPERIENCES.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended--
            (1) in section 402(a)(2), by inserting after ``section 512; 
        or'' the following: ``(D) if it is a dietary supplement that 
        contains any ephedrine group alkaloids and is unsafe within the 
        meaning of section 416; or''; and
            (2) by adding at the end the following section:

``SEC. 416. EPHEDRINE GROUP ALKALOIDS.

    ``(a) Requirement of Premarket Approval.--A new ephedrine 
supplement shall be deemed unsafe for purposes of section 402(a)(2)(D) 
unless an approval of an application filed under subsection (b) is 
effective with respect to such supplement.
    ``(b) Application.--Any person may file with the Secretary an 
application with respect to a new ephedrine supplement. Not later than 
180 days after the filing of the application, or such additional period 
as may be agreed upon by the Secretary and the applicant, the Secretary 
shall either--
            ``(1) issue an order under subsection (c) approving the 
        application; or
            ``(2) issue an order refusing to approve the application, 
        after providing the applicant notice of an opportunity for a 
        hearing before the Secretary.
    ``(c) Standards.--The Secretary shall approve an application under 
subsection (b) for a new ephedrine supplement if the application meets 
the criteria of the Secretary for demonstrating to the Secretary that 
the supplement does not present a significant or unreasonable risk of 
illness or injury--
            ``(1) under the conditions of use recommended or suggested 
        in the labeling for the supplement; or
            ``(2) if no conditions of use are suggested or recommended 
        in the labeling, under ordinary conditions of use.
    ``(d) Reporting of Serious Adverse Experiences.--
            ``(1) In general.--Each person who is a manufacturer of 
        ephedrine supplements, or a packer or distributor of the 
        supplements whose name appears on the labeling of the 
        supplement, shall (with respect to such supplements 
        manufactured, packed, or distributed by that person)--
                    ``(A) investigate each claim of a serious adverse 
                experience of which the person is aware in order to 
                determine whether the claim is a documented incident;
                    ``(B) investigate each documented incident of such 
                an experience;
                    ``(C) develop and implement written procedures for 
                investigations of such claims and incidents; and
                    ``(D) submit to the Secretary in accordance with 
                paragraph (2) notifications and reports regarding such 
                claims and incidents.
            ``(2) Certain requirements.--
                    ``(A) Notification of secretary regarding 
                documented incident.--As soon as possible but not later 
                than 30 days after becoming aware of a claim of a 
                serious adverse experience with respect to an ephedrine 
                supplement, the applicable person under paragraph (1) 
                shall determine whether the claim is a documented 
                incident, and if the claim is such an incident, shall 
                submit to the Secretary a notification of  such fact. 
The notification shall include a copy of the current labeling for the 
supplement.
                    ``(B) Report regarding results of investigation.--
                As soon as possible but not later than 60 days after 
                identifying a documented incident of a serious adverse 
                experience, the applicable person under paragraph (1) 
                shall complete an investigation of the experience and 
                submit to the Secretary a report describing the 
                findings of the investigation, including a finding on 
                whether the ephedrine supplement involved is a causal 
                factor in such experience.
            ``(3) Duplicative reports.--The Secretary may establish 
        procedures to avoid duplicative reporting under paragraph (1) 
        on an ephedrine supplement by the persons referred to in such 
        paragraph with respect to such supplement, subject to the 
        Secretary establishing requirements to ensure that the 
        Secretary receives notifications and reports within the period 
        of time specified in paragraph (2).
    ``(e) Applicability of Certain Provisions.--In the case of new 
ephedrine supplements, this section applies in lieu of sections 
402(f)(1)(A) and 402(f)(1)(B). In the case of any ephedrine supplement, 
the two sentences immediately following section 402(f)(1)(D) do not 
apply, and section 402(f)(2) does not apply.
    ``(f) Definitions.--
            ``(1) Ephedrine supplements.--For purposes of this section:
                    ``(A) The term `ephedrine supplement' means a 
                dietary supplement containing any ephedrine group 
                alkaloids (as defined in section 201(nn)).
                    ``(B) The term `new ephedrine supplement' means a 
                dietary supplement containing any new ephedrine group 
                alkaloids (as defined in section 201(nn)).
            ``(2) Serious adverse experiences.--For purpose of this 
        section:
                    ``(A)(i) The term `adverse experience', with 
                respect to an ephedrine supplement, means an adverse 
                health-related experience of an individual who ingested 
                the supplement, which experience is alleged by the 
                individual, a family member of the individual, or a 
                treating health professional to be associated with the 
                supplement, whether or not such experience is 
                considered to be related, casually or otherwise, to the 
                supplement by a person referred to in paragraph (1) 
                with respect to the supplement .
                    ``(ii) The term `serious', with respect to an 
                adverse experience, means any of the following 
                outcomes: Death, a life-threatening condition, 
                inpatient hospitalization, a persistent or significant 
                disability or incapacity, or a congenital anomaly or 
                birth defect.
                    ``(B) The term `documented incident', with respect 
                to an ephedrine supplement, means a claim of a serious 
                adverse experience that the applicable person under 
                subsection (d)(1) has investigated to the extent of 
                verifying that such an experience did occur, but 
                without investigating the allegation that the 
                experience is associated with the supplement.''.
    (b) Prohibited Act Regarding Reporting on Serious Adverse 
Experiences.--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) The failure of a person to comply with any requirement under 
section 416(d).''.
    (c) Definitions.--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)(1)(A) The term `ephedrine group alkaloids', with respect to 
a dietary supplement, includes natural ephedrine group alkaloids and 
synthetic ephedrine group alkaloids.
    ``(B) The term `natural ephedrine group alkaloids' means ephedrine 
group alkaloids present in or extracted from the herb ephedra or any 
other herb that contains ephedrine group alkaloids.
    ``(C) The term `synthetic ephedrine group alkaloids' means 
ephedrine group alkaloids not present in or extracted from the herb 
ephedra or any other herb that contains ephedrine group alkaloids.
    ``(2)(A) The term `new ephedrine group alkaloids' means ephedrine 
group alkaloids that are not generally recognized, among experts 
described in clause (B), as having been adequately shown through 
scientific procedures to present no significant or unreasonable risk of 
illness or injury under the conditions of use recommended or suggested 
in labeling, or if no conditions of use are suggested or recommended in 
the labeling, under ordinary conditions of use.
    ``(B) The experts referred to in clause (A) are experts qualified 
by scientific training and experience to evaluate whether ephedrine 
group alkaloids present no significant or unreasonable risk of illness 
or injury for purposes of such clause.''.
    (d) Effective Dates.--With respect to section 416 of the Federal 
Food, Drug, and Cosmetic Act (as added by this section):
            (1) Subsection (a) of such section takes effect upon the 
        expiration of 30 days after the date of the enactment of this 
        Act. With respect to dietary supplements containing any 
        ephedrine group alkaloids, shipments in commercial distribution 
        as of the date of the enactment of this Act are subject to such 
        subsection (a) to the extent determined appropriate by the 
        Secretary of Health and Human Services.
            (2) Subsection (d) of such section applies with respect to 
        serious adverse experiences occurring on or after the date of 
        the enactment of this Act, except to the extent that the person 
        involved notifies the Secretary of Health and Human Services in 
        writing that the person will not submit an application under 
        subsection (a) of such section and will not be a packer or 
        distributor of dietary supplements containing any ephedrine 
        group alkaloids.

SEC. 3. PROVISIONS REGARDING ADULTERATED OR MISBRANDED SUPPLEMENTS.

    (a) Adulterated Supplements.--
            (1) Dietary supplements generally; regulations on good 
        manufacturing practice.--
                    (A) In general.--Not later than 120 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 good manufacturing 
                practice regulations under section 402(g) of the 
                Federal Food, Drug, and Cosmetic Act.
                    (B) Conforming amendment.--Section 402(g)(2) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                342(g)(2)) is amended in the first sentence by striking 
                ``may'' and inserting ``shall'';
            (2) Ephedrine group alkaloids.--Section 402(g)(2) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2)) is 
        amended--
                    (A) by striking ``(2)'' and inserting ``(2)(A)''; 
                and
                    (B) by adding at the end the following:
    ``(B) In the case of dietary supplements containing ephedrine group 
alkaloids, regulations under clause (A) shall require the following:
            ``(i) The testing of each production lot or batch to ensure 
        the accuracy of the label in stating the total amount of 
        ephedrine group alkaloids contained in the supplement. Such 
        tests shall be made using high performance liquid 
        chromatography testing or other testing approved by the 
        Secretary for purposes of this subclause.
            ``(ii) A determination of the expiration date of the 
        supplements.
            ``(iii) The retention of reserve samples from each lot 
        produced, stored under conditions consistent with the labeling 
        of the supplements, until at least one year after the 
        expiration date of the supplements.
            ``(iv) The implementation of distribution tracking 
        procedures, including the use of lot numbers.''.
    (b) Misbranded Supplements Containing Ephedrine Group Alkaloids.--
            (1) In general.--Section 403 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343) is amended by adding at the end 
        the following:
    ``(w) If it is a dietary supplement containing any ephedrine group 
alkaloids, unless its label bears an expiration date.''.
            (2) Effective date.--The amendment made by paragraph (1) 
        takes effect upon the effective date of the final rule for good 
        manufacturing practice regulations under section 402(g) of the 
        Federal Food, Drug, and Cosmetic Act.
                                 <all>