TRENTON
– Attorney General Peter C. Harvey
and Commissioner of Health and Senior
Services Clifton R. Lacy, M.D., commended
today’s announcement by the U.S.
Food and Drug Administration (FDA) that
it will ban all products containing ephedra,
a potentially dangerous stimulant that
has been widely marketed in recent years
for weight loss and enhancing sports performance.
On
April 11, 2003, Attorney General Harvey
and Commissioner Lacy sent a letter to
FDA Commissioner Mark B. McClellan urging
that dietary supplements containing ephedra
or ephedrine alkaloids be banned until
further studies were completed into the
dangerous effects of such supplements
on the nervous system and the heart.
Attorney
General Harvey filed two lawsuits this
year against companies that market and
sell dietary supplements containing ephedra,
contending their advertising practices
misled consumers into believing the products
were safe and effective, despite mounting
evidence of the dangers of ephedra.
In
July, the Attorney General’s Office
sued Cytodyne Technologies of Manasquan,
alleging it misrepresented the efficacy
of two dietary supplements and withheld
information about the potentially life-threatening
side effects of the products, one of which,
Xenadrine RFA-1, contained ephedra.
In
October, the Attorney General sued the
founder of Goen weight-loss and smoking-cessation
seminars, alleging he and other defendants
intentionally misled consumers through
a series of false and deceptive claims
that extolled the benefits of hypnosis
as a drug-free alternative to other weight-loss
and smoking-cessation programs. The suit
alleges the seminars were nothing more
than a ploy to sell dietary supplements,
including ephedra-based TrimSpa.
“Dietary
supplements are not subjected to the stringent
pre-marketing screening required of drugs,”
said Attorney General Harvey. “That’s
why we’re taking a hard look at
this industry and, where necessary, taking
legal action. Our lawsuits target companies
that made baseless claims about their
products, convincing vulnerable consumers
that they offered a magic pill for weight
loss while failing to adequately warn
of the very real health threats posed
by their ephedra-based supplements.”
“Because
of the risk of illness or injury, New
Jerseyans should stop using products containing
ephedrine alkaloids immediately, even
though the proposed regulations will not
take effect for a few months,” said
Commissioner Lacy.
McClellan
said the new rule banning products containing
ephedra will be published within a few
weeks and will take effect 60 days after
publication. Federal officials also issued
a consumer alert today warning of the
dangers of ephedra-based products.
Ephedra
is an herbal supplement derived from the
Chinese herb ma huang, with the principal
active ingredient ephedrine, an adrenaline-like
stimulant that increases blood pressure
and heart rate. In announcing the ban
today, McClellan and U.S. Secretary of
Health and Human Services Tommy Thompson
said careful studies that looked at more
than 16,000 adverse incident reports showed
that products containing ephedrine alkaloids
pose “an unreasonable risk”
to persons who take them. The adverse
effects have included heart attacks, strokes,
cardiac arrhythmia, hypertension and seizures
Ephedrine,
when chemically synthesized, is regulated
as a drug. But herbal ephedra is classified
as a dietary supplement, like vitamins,
minerals, amino acids, enzymes and other
herbs and botanicals. Dietary supplements
are regulated under the Dietary Supplement
Health and Education Act, which does not
demand the strict pre-market testing required
of drugs. The burden is placed on the
FDA to prove the harmfulness of a dietary
supplement.
