By Wohlgemuth                                         H.B. No. 3619
         Line and page numbers may not match official copy.
         Bill not drafted by TLC or Senate E&E.
                                A BILL TO BE ENTITLED
 1-1                                   AN ACT
 1-2     related to the requirements for which a dietary supplement
 1-3     containing ephedrine group alkaloids shall be deemed an adulterated
 1-4     food.
 1-5           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
 1-6           SECTION 1.  Section 431.081, Health and Safety Code, is
 1-7     amended by adding a new subsection (e) to read as follows:
 1-8           (e)  if it is a dietary supplement containing ephedrine group
 1-9     alkaloids unless the dietary supplement complies with all of the
1-10     following requirements:
1-11                 (1)  The product label bears an adequate cautionary
1-12     statement, which shall at a minimum include the following language,
1-13     or comparable language:
1-14     "WARNING:  Not intended for use by anyone under the age of 18.  Do
1-15     not use this product if you are pregnant or nursing.  Consult a
1-16     health care professional before using this product if you have
1-17     heart disease, thyroid disease, diabetes, high blood pressure,
1-18     depression or other psychiatric condition, glaucoma, difficulty in
1-19     urinating, prostate enlargement, or seizure disorder, if you are
1-20     using a monoamine oxidase inhibitor (MAOI) or any other
1-21     prescription drug, or you are using an over-the-counter drug
1-22     containing ephedrine, pseudoephedrine or phenylpropanolamine
1-23     (ingredients found in certain allergy, asthma, cough/cold and
 2-1     weight control products).  Exceeding recommended serving will not
 2-2     improve results and may cause serious adverse health effects.
 2-3     Discontinue use and call a health care professional immediately if
 2-4     you experience rapid heartbeat, dizziness, severe headaches,
 2-5     shortness of breath, or other similar symptoms."
 2-6                 (2)  The product label lists the amount of ephedrine
 2-7     group alkaloids and caffeine alkaloids, if present, per serving.
 2-8                 (3)  The product does not contain in excess of 25 mg of
 2-9     total ephedrine group alkaloids per serving, or, if a different
2-10     serving limit is established under federal law, the product does
2-11     not contain in excess of the limit established by such law.
2-12                 (4)  The directions for use on the label specify the
2-13     maximum recommended daily intake of ephedrine group alkaloids,
2-14     which shall not exceed 100 mg per day.
2-15                 (5)  The product label bears a company toll-free number
2-16     for consumer questions regarding the product.
2-17                 (6)  Neither finished product nor raw materials used in
2-18     their manufacture shall contain any synthetically-derived ephedrine
2-19     group alkaloids or their salts (e.g., ephedrine sulfate;
2-20     pseudoephedrine hydrochloride; phenylpropanolamine hydrochloride).
2-21                 (7)  No claims shall be made that the product may be
2-22     useful to achieve an altered state of consciousness, euphoria, or
2-23     as a "legal" alternative for an illicit drug.
2-24           SECTION 2.  This Act takes effect immediately if it receives
2-25     a vote of two-thirds of all the members elected to each house, as
2-26     provided by Section 39, Article III, Texas Constitution.  If this
 3-1     Act does not receive the vote necessary for immediate effect, this
 3-2     Act takes effect September 1, 2001.