THE
United States Health and Human Services Sec retary Tommy Thompson
and Food and Drug Administration chief Mark McClellan have announced
the ban on dietary supplements containing ephedra and alkaloids.
Speaking to newsmen, Thompson said that based on
the "best possible scientific evidence" and more than 16,000
incident reports saying ephedra caused adverse effects, the
government deduced the product presents an "unreasonable risk to the
public health."
Ephedra, known as Ma huang, Chinese Ephedra and
epitonin, poses health hazards ranging from high blood pressure,
irregular heart-beat, nerve damage, injury, insomnia, tremors and
headaches to seizures, heart attack, stroke and death, the FDA says.
Ephedra has been linked to as many as 100 deaths, officials have
said.
McClellan said his agency was concerned about
young people and athletes looking to ephedra to boost their
performance. Use of the supplement has led to serious health
effects, he said. The rule will go into effect in 60 days "and have
the practical effect" of banning ephedra, he said.
The ban is likely to be met with litigation from
manufacturers who dispute the agency's assertion that ephedra is a
health risk.
The FDA would issue a consumer alert about
products containing ephedra, "warning everyone of the dangers they
pose," Thompson said.
Ephedra, which has also been used by many
athletes to enhance performance, is believed to have killed the
Baltimore Orioles baseball player Steve Bechler last February.
Bechler died during spring training while trying to lose weight.
Toxicology tests showed ephedra was in his system.
The government ban, one of the first involving a
dietary supplement, comes after Thompson urged Congress this summer
to require manufacturers to acknowledge potential side effects and
to rewrite a law that rolled back dietary-supplement regulations.
However, executives of several companies that
make ephedra-based products said studies have proven that they are
safe when used properly.
"Anyone who has read our label knows that we go
to great lengths to inform our customers about the proper use of our
products," said Russell Schreck, CEO of San Diego-based nutritional
supplement-maker Metabolife International.
Scientists have said it's impossible to prove
whether ephedra is safe, because studies screen out participants who
have health problems -- the people most likely to be hurt by the
products.
"It's a dead product, and unfortunately it has
become a dead product over the backs of a lot of dead people when
the FDA could have acted before," said Dr. Sidney Wolfe of the
consumer advocacy group Public Citizen , which petitioned the
government for a ban in 2001.
The supplement industry's Council for Responsible
Nutrition said it didn't oppose a ban, noting that very few
companies still make the drug.
The FDA had proposed warning labels and dosage
limits for dietary supplements with ephedra back in 1997, but then
withdrew the proposal after complaints from the industry and members
of Congress.