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Tuesday, April 13, 2004
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Judge allows banoi
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THE ASSOCIATED PRESS
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NEWARK, NJ. — A federal
judge allowed a nationwide ban
on dietary supplements contain
ing ephedra to take effect
Monday, turning aside a request
by two supplement makers.
U.S. District Judge Joel
Pisano refused to grant a tempo
rary restraining order sought by
the two manufacturers that
would have prevented the U.S.
Food and Drug Administration
from banning the products.
NVE Pharmaceuticals Inc. of
Newton, the manufacturer of the
popular diet supplement Stacker
2, had hoped to head off the
nationwide ban on the herbal
stimulant, arguing the main
ingredient in its product is safe
if used as directed.
The company had asked for
the temporary restraining order
pending further scientific tests. On
Monday, a second company had
been allow ed to join the motion —
the National Institute for Clinical
Weight Loss, manufacturer of a
product called Thermalean.
Ephedra, once hugely popu
lar for weight loss and body
building. has been linked to 155
deaths and dozens more heart
attacks and strokes.
After years of fighting manu
facturers over ephedra’s risks,
(Ik* EDA announced in December
that it was banning sales of the
amphetamine-like herb — the first
such ban of a dietary supplement.
The ban takes effect Monday.
Research shows the herb can
speed heart rate and constrict
blood vessels even in seemingly
healthy people, but it’s particular
ly risky for those with heart dis
ease or high blood pressure or
w ho engage in strenuous exercise.
Unlike medications, which
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Ephedra ban
goes into effect
A federal judge allowed 3;
on dietary supplements
containing ephedra to go;
i
effect Monday despite a
temporary restraining orae
sought by two manufaclr.
Ephedra,
also
known as
Ephedrine,
or Ma huang
Properties
and uses:
Used to
prevent
attacks of
bronchial asthma and act;
relieve nasal congestion
common ingredient in wee
loss products; shown to piy
fat-loss and muscle gain
controlled tests
Ephedras-.
Side effects: Raisedbto
pressure, can cause
irregularities in heart rate
insomnia, tremors and
headaches, seizures,!®
attacks, strokes anddea!
SOURCES Food and Drug
Administration; Harvard Schoo’
Public Health
must be proven safeandeffe
before they’re allowed tote,
federal law allows dwavsy
ments to he marketed nittwi
such proof. Tocurbasuppa
the law requires the FDAt
it poses a significanthealii;
NVE Pharmaceutical;
tains that the FDA lads j
that ephedra is dangerous
correctly. Its lawsuit apt
the agency simply reactedi;
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