[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 725 Introduced in House (IH)]







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.

    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 ``Ephedrine Alkaloid Consumer 
Protection Act''.

SEC. 2. REQUIREMENTS REGARDING DIETARY SUPPLEMENTS 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 following:
    ``(w) If it is a dietary supplement containing ephedrine 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 individuals under 
                the age of 18. Do not use if pregnant or nursing. 
                Consult a physician or licensed qualified health care 
                professional before using this product if you have, or 
                have a family history of, heart disease, thyroid 
                disease, diabetes, asthma, high blood pressure, 
                recurrent headaches, depression or other psychiatric 
                condition, glaucoma, difficulty in urinating, prostate 
                enlargement, 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 
                phenylpropanolamine (ingredients found in certain 
                allergy, asthma, cough or cold, and weight control 
                products).
                    ```(B) Consuming this product may cause serious 
                adverse health effects, including heart attack, stroke, 
                and death.
                    ```(C) Discontinue use and call a physician or 
                licensed qualified health care professional immediately 
                if you experience rapid heartbeat, dizziness, severe 
                headache, shortness of breath, or other similar 
                symptoms.
                    ```(D) Individuals who consume additional caffeine 
                with this product may experience serious adverse health 
                effects.
                    ```(E) This product contains ____ milligrams 
                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 serving that have a known 
        stimulant effect (ex yohimbine).
            ``(4) The label bears the toll-free telephone number, and 
        the address of the Internet site, maintained by the Secretary 
        for purposes of the medical product reporting program (MedWatch 
        or any successor program).
            ``(5) The labeling (other than the label), and all 
        prerecorded or scripted radio or television advertising, 
        provide a notice as follows: `This product contains ephedrine 
        group alkaloids and may cause serious 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 containing 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 purchaser has 
        direct access to the supplement at the retail establishment 
        involved, rather than the supplement being held at a portion of 
        the establishment not intended to be accessible to customers of 
        the establishment.''.
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