LABELING RULES PROPOSED ON SALES OF EPHEDRINE PRODUCTS IN TEXAS

After failing for five years to ban the sale of nonprescription drugs
and diet supplements containing ephedrine, the Texas Board of Health
will propose a compromise with the herbal products industry today
that will keep the products legal but require standard doses,
recommended daily limits and warning labels.

The rules, which were worked out during negotiations last year between
Health Commissioner Reyn Archer and representatives of companies such
as Metabolife International and Nature's Sunshine, are less
restrictive than rules the same board proposed last May and twice
before in 1995 and 1996.

Amid vocal criticism from the industry, the board never adopted those
rules, despite having the blessing of medical experts shocked by
reports of people abusing products containing ephedrine. Fifteen
states require a prescription for products containing ephedrine.

"Prohibition doesn't seem to work in most things," Archer said. "We
wanted to have a open dialogue with the industry, and we knew if we
moved towards prescription, that would break down communication. The
fact is that . . . there are also a lot of individuals that use these
products and believe in them, and they would not be able to get them."

The warning labels would be required to state the danger of taking
ephedrine with caffeine and the need to seek a doctor's approval if
you have diabetes, high blood pressure, heart disease, depression or
several other medical conditions. Over-the-counter medications
containing ephedrine would be labeled as dangerous drugs.

Archer also will ask the Legislature to pass a law banning the sale of
dietary supplements containing ephedrine to anyone under 18 - -
something the Board of Health cannot do.

The proposed rules cannot be adopted until after a 60-day period of
public comment. A public hearing will be Feb. 25.

Ephedrine is a key ingredient in both dietary supplements sold through
independent distributors and in diet and energy pills sold over the
counter in drugstores and convenience stores. The chemical is used in
small doses in cold and asthma remedies and in herbs prescribed in
Chinese medicine. But when taken in elevated doses or in combination
with caffeine, ephedrine can overstimulate the nervous system, causing
symp-toms from headaches to heart attacks.

The Texas Department of Health first voiced concern about ephedrine in
1994, when a woman who had regularly used a weight-loss pill
containing ephedrine suffered a heart attack on a tennis court at the
Austin Country Club and later died. Around the same time, students in
several Texas cities were hospitalized after taking pep pills
containing ephedrine, and then-Commissioner of Health David Smith
banned selling products containing the chemical to anyone younger
than 19.

The ban was quickly thrown out in court, but the department continued
to investigate adverse reactions to the products. Since then, it has
received reports of more than 1,200 injuries and at least eight deaths
in Texas.

Smith, who is now president of Texas Tech Health Sciences Center,
convened two panels of medical experts -- one inside the department
and one outside -- to investigate the growing log of bad reactions to
ephedrine. Both groups recommended requiring a prescription for all
but a few products containing ephedrine.

"I think there was really good consensus that ephedrine is a drug, and
it needs to be regulated, and it has some serious side effects," said
Smith, who left office in 1997. "I think the bigger problem has been
some of the lack of clear direction" from the U.S. Food and Drug
Administration. An advisory panel to the federal agency also has
recommended banning the sale of most ephedrine products, but the
agency has yet to enact any restrictions.

Archer said Monday that he would ask for more guidance, not just on
ephedrine but on other nondrug dietary supplements .

In drafting the compromise, Archer said the board also wanted to
consider concerns from herbal producers and their distributors, many
of whom work out their homes. They had voiced their concerted
opposition not only to the board, but also to legislators, Lt. Gov.
Bob Bullock and U.S. Sen. Kay Bailey Hutchison.

The outside doctors who had advised the department, picked by the
Texas Medical Association, preferred the prescription option, last
considered in May.

"We were disheartened when the rules were allowed to expire," said
Robert Emmick, a Bryan emergency medical physician who headed the
panel. "When the question was raised again that they may be looking at
the ephedrine issue, we did offer . . . to be of assistance . . . .
Other than through the formal rules process, it was not asked for."

You may contact Andrew Park at apark@statesman.com or
912-2506.

(FROM BOX)

(FROM BOX)

Ephedrine on trial in Texas

When the Texas Board of Health proposes requiring restrictions on
nonprescription products containing ephedrine, it will be the latest
chapter in a long-running saga.

May 1994: Following the death of an Austin woman who had taken diet
pills that contained ephedrine, Texas Commissioner of Health David
Smith bans the sale of over-the-counter products containing the drug
to people under 19. The ban was later thrown out in court.

Fall 1994: Advisory panel to the U.S. Food and Drug Administration
recommends that ephedrine in any form be removed from over-the-
counter status.

March 1995: Texas Board of Health proposes requiring a prescription
for most over-the-counter drugs that contain ephedrine. The rules are
never adopted.

July 1996: Board of Health again proposes making products containing
ephedrine available only by prescription. The proposal was later
tabled for further investigation.

May 1998: Board of Health again proposes rules requiring a
prescription for most products that contain ephedrine. The proposal
expired when it was not acted on.

January 1999: Board of Health proposes rules that would require
warning labels on all over-the-counter products containing ephedrine.

(FROM BOX)

Ephedrine on trial in Texas

When the Texas Board of Health proposes requiring restrictions on
nonprescription products containing ephedrine, it will be the latest
chapter in a long-running saga.

May 1994: Following the death of an Austin woman who had taken diet
pills that contained ephedrine, Texas Commissioner of Health David
Smith bans the sale of over-the-counter products containing the drug
to people under 19. The ban was later thrown out in court.

Fall 1994: Advisory panel to the U.S. Food and Drug Administration
recommends that ephedrine in any form be removed from over-the-
counter status.

March 1995: Texas Board of Health proposes requiring a prescription
for most over-the-counter drugs that contain ephedrine. The rules are
never adopted.

July 1996: Board of Health again proposes making products containing
ephedrine available only by prescription. The proposal was later
tabled for further investigation.

May 1998: Board of Health again proposes rules requiring a
prescription for most products that contain ephedrine. The proposal
expired when it was not acted on.

January 1999: Board of Health proposes rules that would require
warning labels on all over-the-counter products containing ephedrine.

(from box)

Ephedrine on trial in Texas

When the Texas Board of Health proposes requiring restrictions on
nonprescription products containing ephedrine, it will be the latest
chapter in a long-running saga. May 1994: Following the death of an
Austin woman who had taken diet pills that contained ephedrine, Texas
Commissioner of Health David Smith bans the sale of over-the-counter
products containing the drug to people under 19. The ban was later
thrown out in court. Fall 1994: Advisory panel to the U.S. Food and
Drug Administration recommends that ephedrine in any form be removed
from over-the-counter status. March 1995: Texas Board of Health
proposes requiring a prescription for most over-the-counter drugs
that contain ephedrine. The rules are never adopted. July 1996: Board
of Health again proposes making products containing ephedrine
available only by prescription. The proposal was later tabled for
further investigation. May 1998: Board of Health again proposes rules
requiring a prescription for most products that contain ephedrine.
The proposal expired when it was not acted on. January 1999: Board of
Health proposes rules that would require warning labels on all over-
the-counter products containing ephedrine.

(from box)

Controling ephedrine

After three tries at banning over-the-counter sale of drugs and
dietary supplements that contain ephedrine, the Texas Board of Health
will today propose warning labels for the products that state their
health risks. The labeling requirement would not apply to drugs that
contain a small amount of ephedrine, such as cold and asthma
medications.

What is ephedrine: An amphetamine-like stimulant found in many dietary
supplements, diet pills and energy-boosters

Injuries: more than 1,200

Deaths: at least 8

What the products promise:

Increased energy and stamina

Weight loss

Natural high

Enhanced athletic performance

Heightened awareness

Increased sexual sensation

What can happen:

difficulty breathing

headache

irregular heartbeat

psychosis

hypertension

seizure

heart attack

stroke

death

Sold as:

Ripped Fuel

Thermajetics

Formula One

Herbal Ecstasy

ThermoChrome 5000

Cloud 9

MaxBrand

Mini Two-Way Action

Source: Texas Department of Health, FDA