U.S. BANS DIET PILL EPHEDRA
The federal government will ban the "fat-burning" and muscle-enhancing herb
ephedra within a few months, after more than six years of study and at
least 155 deaths from heart attacks and strokes linked to it.
In the nation's first-ever ban of a dietary supplement, the U.S. Food and
Drug Administration on Tuesday declared ephedra a hazard even for healthy
adults, in light of more than 16,000 reports of adverse reactions from users.
The FDA urged consumers to stop taking ephedra products immediately and
called on manufacturers and marketers to stop selling it. The ban would
take effect 60 days after the new rule is published, expected in the next
"The time to stop taking this product is now," said Tommy Thompson,
secretary of health and human services. "They are just too risky to use."
The amphetamine-like supplement, derived from the herb ma huang used by
Chinese doctors for centuries, has been found to constrict the blood
vessels, speed the heart rate and raise blood pressure. It has been linked
to 155 deaths, including Baltimore Orioles pitcher Steve Bechler, who
suffered heat stroke after taking Xenedrine during spring training in Fort
Lauderdale on Feb. 16.
Ephedra merchants defended the safety of their products and said they
expected the largest producer, Metabolife, to file a lawsuit to challenge
the FDA ban and tie it up in court for months or years. The legal
wranglings would allow ephedra, which brings in $1.5 billion per year, to
continue being sold in stores and on Web sites.
Consumer groups and attorneys for ephedra victims ripped the FDA for taking
so long to act, despite what they called mountains of evidence dating back
to 1997 indicating it is harmful.
"This ban is trying to wash some of the blood off their hands," said Dr.
Sidney Wolfe of the consumer group Public Citizen, which petitioned the FDA
to ban ephedra in 2001.
"The case was already made by their own staff about six years ago, and they
did nothing. They just waited for a high enough body count and waited for
every major manufacturer to take it off the market for liability reasons,"
Hundreds of ephedra victims have filed lawsuits. Bechler's family sued
Xenedrine maker Cytodyne Technologies of New Jersey for $600 million in
federal court in Fort Lauderdale; the case is pending.
Miami-Dade County police Maj. Charles Nanney sued two companies in 1995
after suffering a stroke he alleged was linked to taking an ephedra
supplement. Nanney was paralyzed and lost some brain function, although he
has recovered, said his Miami attorney, Ervin Gonzalez. He won a settlement
from General Nutrition Corp. and manufacturer Ultimate Nutrition.
In a similar case, Arthur and Carol Halperin of Boyton Beach last year sued
Cytodyne after a severe reaction to Xenedrine. The case is pending,
although the company has filed for bankruptcy protection.
Wolfe said the delay in banning the herb has allowed the largest supplement
makers to make and market "ephedra-free" diet pills and muscle formulas
that have not been proven safe, Wolfe said.
As part of its ban, the FDA sent letters to 65 companies -- six in South
Florida -- warning of legal action against them if they did not stop making
or selling ephedra pills and sports drinks when the ban takes effect.
"This is far from over," said Jack Owoc, chief executive of VPX Sports in
Davie, which makes and sells the ephedra and caffeine mixture Clenbutrx. A
bottle of about 8 ounces sells for $100. He and others in the industry said
the FDA move was prompted by pharmaceutical companies trying to eliminate
the competition to their diet pills.
"I think [ephedra products] provide a significant health benefit," Owoc
said. "Just look at the number of obese people in this country and how many
have been helped by ephedra. They are not as dangerous as people make them
out to be. You take away the right of the consumer to choose."
Rexall Sundown in Boca Raton stopped making ephedra products in March. Carl
Hymans, a spokesman for Rexall's parent, NBTY Inc., said the ban shows the
FDA has the power to take action without changing the nation's laws over
Public Citizen's Wolfe, however, said laws on supplements need an overhaul.
Unlike prescription drugs, which must be proven safe in advance,
supplements can be sold with no studies on safety or effectiveness unless
the FDA can prove they are unsafe.
The Associated Press contributed to this report.