Texas ephedrine rule tabled on 'advice' of Bush administration

WASHINGTON -- Public health officials in Texas, citing "advice" from the
Bush administration, have suspended enforcement of a new state regulation
designed to protect athletes and other users of dietary supplements.

The Texas regulation centers on supplements that contain ephedrine, a
powerful stimulant that is suspected of causing at least 80 deaths
nationally. The new rule requires the labels on those products to provide a
toll-free number for reporting suspected side effects to the U.S. Food and
Drug Administration.

The state would be the first in the nation to impose such a requirement on
the $16.8 billion-a-year dietary supplement industry, exempt from federal
prescription drug regulations. Attempts to enact similar regulations in
other states have failed in the face of strong industry opposition.
Calls for the stricter controls of the supplements in Texas followed
several deaths there. The new rule was supposed to take effect Sept. 1. But
in the last week, noting Bush administration concerns, Texas health
officials have instructed staff to allow the sale of supplements without
the required labeling information for at least 60 days.

The instruction to postpone enforcement of the labeling provision followed
telephone calls to Austin over the last month from a senior aide to U.S.
Health and Human Services Secretary Tommy G. Thompson, according to records
and interviews.

The calls came after Thompson was approached Aug. 1 by a lawyer
representing Metabolife International Inc. of San Diego, a major dietary
supplement manufacturer. The lawyer, Jeff Wentworth, who is also a
Republican Texas state senator, said he voiced the company's concerns to
Thompson after a speech the Cabinet secretary gave to a group at a New York
City hotel.

Wentworth said he raised the suitability of the FDA's toll-free number with
Thompson during a conversation that lasted about "three or four minutes."

"I just told him that I wanted to visit with him about the line and my
belief that it could be improved," Wentworth said.

He said he did not think the FDA's system could deal with the influx of
calls or adequately address the needs of callers.

FDA officials disagree and say they are well prepared to handle calls from
supplement users.
Metabolife spokeswoman Jan Strode said the company is concerned about how
the FDA or public might use information reported to the toll-free number.

"The issue that Metabolife and others are concerned about is the gathering
of bad data," she said.

One of Thompson's aides subsequently called Don A. Gilbert, Texas'
commissioner of health and human services. Gilbert was first appointed in
1998 by then-Gov. George W. Bush and was reappointed this year by Bush's
successor, Rick Perry.

A spokesman for Thompson said Wednesday that the department did not try to
influence Texas regulators. But the calls from Thompson's policy aide, Mary
Kay Mantho, were cited by Texas health officials during staff meetings and
in e-mail as the basis for tempering enforcement of the state's regulation.

One of the e-mail messages, distributed to the Texas Department of Health's
staff on Aug. 28 by Dr. Charles E. Bell, executive deputy commissioner,
said it "seems to be in the best interest of TDH to take the advice of
Secretary Thompson's office and delay either our implementation date or our
enforcement of the rules ... for 60 days."

In a separate e-mail, also distributed last week, officials in the Texas
health department received this instruction: "During this period please DO
NOT detain dietary supplements containing ephedrine that lack the 800
number when performing inspections/investigations."

The instruction was signed by John L. Gower, a TDH director.

The dietary supplement industry remains relatively clear of federal
regulation. The supplements are sold in supermarkets without a doctor's
prescription. And if a manufacturer learns of a death or other suspected
side effect, it is under no legal obligation to report such an event to the
FDA.
On Wednesday, two nationally prominent physicians, Raymond L. Woosley of
the University of Arizona Medical Center and Sidney Wolfe of the consumer
group Public Citizen, called on Thompson and the FDA to ban the production
and sale of ephedrine.

Wolfe and Woosley cited 81 voluntarily reported deaths associated with use
of supplements containing ephedrine, plus other, nonfatal heart attacks,
strokes and seizures.

Strode said Metabolife believes that, when taken as directed, its product
is safe.