Lipodrene Ephedra Supplements
2/27/2006-FDA seizes more ephedra supplements
The Food and Drug Administration (FDA) has seized around
$3m worth of dietary supplements containing 25 mg ephedrine alkaloids.
O
n
the request of the FDA, the US Attorney’s Office for the Northern
District of Georgia filed a complaint for Forfeiture against Lipodrene,
Stimerex-ES and Betadrene dietary supplements, manufactured by
Hi-tech Pharmaceuticals.
With the legal position of ephedra containing
products still unclear, the FDA said it continues to warn consumers to
avoid consuming such products.
"We will continue to do all we can to protect the public health against
these dietary supplements that have been found to cause serious illness
and injury," said Andrew von Eschenbach, acting FDA commissioner.
Ephedra has been marketed as a supplement for
weight-loss and sports performance, but a number of recent studies have
linked ephedrine alkaloids with adverse effects on the cardiovascular
and central nervous systems.
And in February 2004 the FDA issued a rule declaring that dietary
supplements containing ephedrine alkaloids present an “unreasonable risk
of illness or injury.” Since this rule became effective in April 2004,
the government has executed six seizures against numerous products.
Last week’s seizure from Hi-Tech Pharmaceutical’s facilities in
Norcross, Georgia, included more than 200 cases of finished product,
more than 200 boxes of bulk tablets and nine 25 kilo drums of ephedrine
alkaloid raw material.
According to the FDA, the supplements in question are labeled as
containing 25mg of ephedrine alkaloids per tablet. The product labels
also state that the maximum recommended dosage of ephedrine for a
healthy adult is 100 mg in a 24 hour period. But in the United States,
dietary supplements containing more than 10mg of ephedrine alkaloids are
outlawed.
However, in April 2005, a Utah judge ruled that the FDA failed to prove
that a daily dosage of 10mg or less of ephedra presents an unreasonable
risk of illness or injury.
Judge Teena Campbell ordered the FDA to carry out a dose-dependent
toxicology study and impose a ban on the herbal's use only at and above
the level at which it is found to produce toxicity. She also enjoined
the government agency from taking any enforcement action to block
Nutraceutical Corp, which brought the action, from selling supplements
containing 10mg or less of ephedrine alkaloids per daily dose.
And Hi-Tech previously filed a lawsuit against FDA seeking to prevent
the agency from enforcing the 2004 rule declaring dietary supplements
containing ephedrine alkaloids to be adulterated. The United States
recently moved to dismiss that lawsuit, which is currently pending in
the United States District Court for the Northern District of Georgia.
The FDA has said that there is little evidence for the herbal's
effectiveness other than for short-term weight loss.
United States Attorney David Nahmias commented on last week’s
enforcement action that "the FDA has advised that these dietary
supplements can be dangerous to the health of the citizens in our
communities. This office and the FDA are taking the legal steps to
safeguard the health and safety of people who may not know or understand
the dangers that they face using ephedrine alkaloid products."
Ephedra supplements are safe when used as part of an overall weight-loss program
In particular, a six-month study by researchers at Harvard and Columbia Universities on Ephedra/caffeine supplements concluded that the products were safe and produced significant weight loss. Nevertheless, critics of Ephedra often cite Adverse Event Reports (AERs), which are anecdotal reports compiled by the Food and Drug Administration, as cause for concern.
Ephedra Weight Loss Supplement Ephedra | Ephedra Products