I
107TH CONGRESS
1ST SESSION
H. R. 3066
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling
and advertising requirements for dietary supplements containing ephed-
rine alkaloids, to prohibit sales of such supplements to individuals under
the age of 18, 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
establish labeling and advertising requirements for die-
tary supplements containing ephedrine alkaloids, to pro-
hibit sales of such supplements to individuals under the
age of 18, 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 ‘‘Ephedrine Alkaloid
Consumer Protection Act’’.
SEC. 2. REQUIREMENTS REGARDING DIETARY SUPPLE-
MENTS CONTAINING EPHEDRINE ALKALOIDS.
(a) FOOD LABELING
AND ADVERTISING.—Section
403 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343) is amended by adding at the end the fol-
lowing:
‘‘(t) If it is a dietary supplement containing ephed-
rine alkaloids, unless its labeling and advertising are in
accordance with the following, as applicable:
‘‘(1) The label bears, in at least 1⁄16 inch type,
a notice as follows:
‘WARNING: (A) Not for use by individ-
uals under the age of 18. Do not use if preg-
nant or nursing. Consult a physician or licensed
qualified health care professional before using
this product if you have, or have a family his-
tory of, heart disease, thyroid disease, diabetes,
asthma, high blood pressure, recurrent head-
aches, depression or other psychiatric condition,
glaucoma, difficulty in urinating, prostate en-
largement, or seizure disorder, or if you are
using monoamine oxidase inhibitor (MAOI) or
any other dietary supplement, prescription
drug, or over-the-counter drug containing
ephedrine, pseudoephedrine, caffeine, or phenyl-
propanolamine (ingredients found in certain al-
lergy, asthma, cough or cold, and weight control
products).
‘(B) Consuming this product may cause se-
rious adverse health effects, including heart at-
tack, stroke, and death.
‘(C) Discontinue use and call a physician
or licensed qualified health care professional im-
mediately if you experience rapid heartbeat, diz-
ziness, severe headache, shortness of breath, or
other similar symptoms.
‘(D) Individuals who consume additional
caffeine with this product may experience seri-
ous adverse health effects.
‘(E) This product contains ll milli-
grams concentrated ephedrine group alkaloids
per serving in the form of herbal extracts.’.
In lieu of the blank, the number of milligrams shall
be identified.
‘‘(2) The label bears standardized nomenclature
for the ephedrine ingredient such that the ephedrine
group alkaloid name is used when referring to the
active ingredients in place of or in addition to the
botanical name of the ephedrine group alkaloid.
‘‘(3) The label bears the amount in milligrams
of caffeine alkaloids and other ingredients per serv-
ing that have a known stimulant effect (ex yohim-
bine).
‘‘(4) The label bears the toll-free telephone
number, and the address of the Internet site, main-
tained by the Secretary for purposes of the medical
product reporting program (MedWatch or any suc-
cessor program).
‘‘(5) The labeling (other than the label), and all
prerecorded or scripted radio or television adver-
tising, provide a notice as follows: ‘This product con-
tains ephedrine group alkaloids and may cause seri-
ous adverse health effects. Read the label and follow
directions.’’’.
(b) SALES TO MINORS.—Chapter IV of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.)
is amended by inserting after section 403C the following
section:
‘‘SALE OF DIETARY SUPPLEMENTS CONTAINING
EPHEDRINE ALKALOIDS
‘‘SEC. 403D. The sale of a dietary supplement con-
taining ephedrine alkaloids shall be deemed to be an act
that results in such supplement being misbranded while
held for sale if—
‘‘(1) the sale of the supplement is made to an
individual under the age of 18; or
‘‘(2) in the case of a sale at retail, the pur-
chaser has direct access to the supplement at the re-
tail establishment involved, rather than the supple-
ment being held at a portion of the establishment
not intended to be accessible to customers of the es-
tablishment.’’.
Æ