[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.
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