I 

108TH CONGRESS 

1ST SESSION H. R. 725

To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 

and advertising requirements for dietary supplements containing ephedrine alkaloids, to prohibit sales of such supplements to individuals under 

the age of 18, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 12, 2003

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 dietary supplements containing ephedrine alkaloids, to prohibit sales of such supplements to individuals under the 

age of 18, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ephedrine Alkaloid 

5 Consumer Protection Act’’. 
2

•HR 725 IH 

1 SEC. 2. REQUIREMENTS REGARDING DIETARY SUPPLE2 MENTS CONTAINING EPHEDRINE ALKALOIDS. 

3 (a) FOOD LABELING AND ADVERTISING.—Section 

4 403 of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 343) is amended by adding at the end the fol6 lowing: 

7 ‘‘(w) If it is a dietary supplement containing ephed8 rine alkaloids, unless its labeling and advertising are in 

9 accordance with the following, as applicable: 

‘‘(1) The label bears, in at least 1 10 ⁄16 inch type, 

11 a notice as follows: 

12 ‘‘ ‘WARNING: (A) Not for use by individ13 uals under the age of 18. Do not use if preg14 nant or nursing. Consult a physician or licensed 

15 qualified health care professional before using 

16 this product if you have, or have a family his17 tory of, heart disease, thyroid disease, diabetes, 

18 asthma, high blood pressure, recurrent head19 aches, depression or other psychiatric condition, 

20 glaucoma, difficulty in urinating, prostate en21 largement, or seizure disorder, or if you are 

22 using monoamine oxidase inhibitor (MAOI) or 

23 any other dietary supplement, prescription 

24 drug, or over-the-counter drug containing 

25 ephedrine, pseudoephedrine, caffeine, or phenyl26 propanolamine (ingredients found in certain al-
3

•HR 725 IH 

1 lergy, asthma, cough or cold, and weight control 

2 products). 

3 ‘‘ ‘(B) Consuming this product may cause 

4 serious adverse health effects, including heart 

5 attack, stroke, and death. 

6 ‘‘ ‘(C) Discontinue use and call a physician 

7 or licensed qualified health care professional im8 mediately if you experience rapid heartbeat, diz9 ziness, severe headache, shortness of breath, or 

10 other similar symptoms. 

11 ‘‘ ‘(D) Individuals who consume additional 

12 caffeine with this product may experience seri13 ous adverse health effects. 

14 ‘‘ ‘(E) This product contains ll milli15 grams concentrated ephedrine group alkaloids 

16 per serving in the form of herbal extracts.’. 

17 In lieu of the blank, the number of milligrams shall 

18 be identified. 

19 ‘‘(2) The label bears standardized nomenclature 

20 for the ephedrine ingredient such that the ephedrine 

21 group alkaloid name is used when referring to the 

22 active ingredients in place of or in addition to the 

23 botanical name of the ephedrine group alkaloid. 

24 ‘‘(3) The label bears the amount in milligrams 

25 of caffeine alkaloids and other ingredients per serv-
4

•HR 725 IH 

1 ing that have a known stimulant effect (ex yohim2 bine). 

3 ‘‘(4) The label bears the toll-free telephone 

4 number, and the address of the Internet site, main5 tained by the Secretary for purposes of the medical 

6 product reporting program (MedWatch or any suc7 cessor program). 

8 ‘‘(5) The labeling (other than the label), and all 

9 prerecorded or scripted radio or television adver10 tising, provide a notice as follows: ‘This product con11 tains ephedrine group alkaloids and may cause seri12 ous adverse health effects. Read the label and follow 

13 directions.’ ’’. 

14 (b) SALES TO MINORS.—Chapter IV of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) 

16 is amended by inserting after section 403C the following 

17 section: 

18 ‘‘SALE OF DIETARY SUPPLEMENTS CONTAINING

19 EPHEDRINE ALKALOIDS

20 ‘‘SEC. 403D. The sale of a dietary supplement con21 taining ephedrine alkaloids shall be deemed to be an act 

22 that results in such supplement being misbranded while 

23 held for sale if—

24 ‘‘(1) the sale of the supplement is made to an 

25 individual under the age of 18; or 
5

•HR 725 IH 

1 ‘‘(2) in the case of a sale at retail, the pur2 chaser has direct access to the supplement at the re3 tail establishment involved, rather than the supple4 ment being held at a portion of the establishment 

5 not intended to be accessible to customers of the es6 tablishment.’’.

Æ