HBA-MPM H.B. 3619 77(R)    BILL ANALYSIS


Office of House Bill AnalysisH.B. 3619
By: Wohlgemuth
Public Health
4/12/2001
Introduced



BACKGROUND AND PURPOSE 

Ephedrine group alkaloids contained in some dietary supplements are
amphetamine-like compounds with potentially powerful stimulant effects on
the nervous system and heart.  Studies have shown that this compound can be
safe and effective if consumed in accordance with proven standards.  In
1999, the Texas Department of Health (TDH) adopted rules for the
formulation, sale, and distribution of dietary supplements containing
natural ephedrine group alkaloids.  TDH rules require such dietary
supplements to contain a warning label.  The labels do not include safe
serving or daily intake labeling and do not contain a contact number for
consumer questions.  House Bill 3619 requires dietary supplements
containing ephedrine group alkaloids to bear a label including a warning
statement about possible adverse side effects, servings of certain
ingredients, the company's toll-free number, and other information. 

RULEMAKING AUTHORITY

It is the opinion of the Office of House Bill Analysis that this bill does
not expressly delegate any additional rulemaking authority to a state
officer, department, agency, or institution. 

ANALYSIS

House Bill 3619 amends the Health and Safety Code to provide that food
shall be deemed to be adulterated if it is a dietary supplement containing
ephedrine group alkaloids unless:  

_the supplement's product label bears an adequate cautionary statement that
includes the warning statement set forth in the bill or comparable
language; 

_the product label lists the amount of ephedrine group alkaloids and
caffeine alkaloids, if present, per serving; 

_the product does not contain more than 25 milligrams of total ephedrine
group alkaloids per serving or, if a different serving limit is established
under federal law, the product does not contain in excess of that limit; 

_the directions for use on the label specify the maximum recommended daily
intake of ephedrine group alkaloids, which shall not exceed 100 milligrams
per day; 

_the product label bears a company toll-free number for consumer questions;

_neither finished product or raw materials used in the supplement contain
any syntheticallyderived ephedrine group alkaloids or their salts; and 

_no claims shall be made that the product may be useful to achieve an
altered state of consciousness, euphoria, or as a "legal" alternative for
an illicit drug. 

EFFECTIVE DATE
 
On passage, or if the Act does not receive the necessary vote, the Act
takes effect September 1, 2001.