I 
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 syn-
thetic ephedrine group alkaloids, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ephedra Public Pro-
tection Act’’.
SEC. 2. REQUIREMENT OF PREMARKET APPROVAL FOR DI-
ETARY SUPPLEMENTS CONTAINING EPHED-
RINE GROUP ALKALOIDS; REPORTING OF SE-
RIOUS ADVERSE EXPERIENCES. 
(a) IN GENERAL.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed—
(1) in section 402(a)(2), by inserting after ‘‘sec-
tion 512; or’’ the following: ‘‘(D) if it is a dietary 
supplement that contains any ephedrine group alka-
loids 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 pur-
poses of section 402(a)(2)(D) unless an approval of an ap-
plication 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) ap-
proving the application; or 
‘‘(2) issue an order refusing to approve the ap-
plication, 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 sup-
plement if the application meets the criteria of the Sec-
retary for demonstrating to the Secretary that the supple-
ment 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 condi-
tions of use. 
‘‘(d) REPORTING
OF SERIOUS ADVERSE EXPERI-
ENCES.—
‘‘(1) IN GENERAL.—Each person who is a man-
ufacturer 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 dis-
tributed by that person)—
‘‘(A) investigate each claim of a serious ad-
verse experience of which the person is aware in 
order to determine whether the claim is a docu-
mented incident; 
‘‘(B) investigate each documented incident 
of such an experience; 
‘‘(C) develop and implement written proce-
dures for investigations of such claims and inci-
dents; and 
‘‘(D) submit to the Secretary in accord-
ance with paragraph (2) notifications and re-
ports regarding such claims and incidents. 
‘‘(2) CERTAIN REQUIREMENTS.—
‘‘(A) NOTIFICATION
OF
SECRETARY
RE-
GARDING DOCUMENTED INCIDENT.—As soon as 
possible but not later than 30 days after becom-
ing aware of a claim of a serious adverse expe-
rience 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 IN-
VESTIGATION.—As soon as possible but not 
later than 60 days after identifying a docu-
mented 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 report-
ing under paragraph (1) on an ephedrine supple-
ment by the persons referred to in such paragraph 
with respect to such supplement, subject to the Sec-
retary 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 im-
mediately following section 402(f)(1)(D) do not apply, and 
section 402(f)(2) does not apply. 
‘‘(f) DEFINITIONS.—
‘‘(1) EPHEDRINE
SUPPLEMENTS.—For pur-
poses 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 indi-
vidual who ingested the supplement, which ex-
perience is alleged by the individual, a family 
member of the individual, or a treating health 
professional to be associated with the supple-
ment, whether or not such experience is consid-
ered to be related, casually or otherwise, to the 
supplement by a person referred to in para-
graph (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 signifi-
cant 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 inves-
tigating the allegation that the experience is as-
sociated 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 re-
quirement 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 ex-
tracted from the herb ephedra or any other herb that con-
tains 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 hav-
ing been adequately shown through scientific procedures 
to present no significant or unreasonable risk of illness 
or injury under the conditions of use recommended or sug-
gested 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 sup-
plements containing any ephedrine group alkaloids, 
shipments in commercial distribution as of the date 
of the enactment of this Act are subject to such sub-
section (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 con-
taining any ephedrine group alkaloids. 
SEC. 3. PROVISIONS REGARDING ADULTERATED OR MIS-
BRANDED SUPPLEMENTS. 
(a) ADULTERATED SUPPLEMENTS.—
(1) DIETARY SUPPLEMENTS GENERALLY; REG-
ULATIONS 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 Serv-
ices shall publish in the Federal Register a pro-
posed rule for good manufacturing practice reg-
ulations 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 Cos-
metic Act (21 U.S.C. 342(g)(2)) is amended in 
the first sentence by striking ‘‘may’’ and insert-
ing ‘‘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 supple-
ments. 
‘‘(iv) The implementation of distribution track-
ing 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 expira-
tion 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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