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FDA attempts to stem sale of andro

3/11/2004

WASHINGTON -- The government will crack down on the
steroidlike supplement taken by Mark McGwire, telling companies
Thursday to quit selling androstenedione unless they can prove it's
not dangerous.

Commonly called andro, the product is a steroid precursor -- the
body uses it to make testosterone.

That means it poses the same health risks as directly using an
anabolic steroid, the Food and Drug Administration says in warnings
telling 23 manufacturers to cease their production.

"Anyone who takes these products in sufficient quantities to
build muscle or improve performance is putting himself or herself
at risk for serious long-term and potentially irreversible health
consequences," FDA Commissioner Mark McClellan said.

The FDA's newest crackdown comes as it is facing a legal
challenge to its pending ban on another dietary supplement,
ephedra. That herbal stimulant, widely used for weight loss, has
been linked to 155 deaths, including Baltimore Orioles pitcher
Steve Bechler during spring training last year.

The maker of the Stacker 2 brand of ephedra supplements, NVE
Pharmaceuticals, filed suit this week in federal court in New
Jersey seeking to block FDA's sales ban, which is set to begin
April 12.

"We're confident that we do have a clear legal basis" for the
ban, FDA spokesman Brad Stone said Thursday.

Anabolic steroids, which build muscle, are controlled
substances. But andro -- because it is a precursor, not the steroid
itself -- has long been marketed as a dietary supplement and been
sold over the counter. U.S. law lets dietary supplements sell with
little oversight to ensure they're safe.

But the FDA is citing a seldom-used provision of that law that
defines as a dietary supplement natural ingredients that were on
the market before 1994 -- and says manufacturers must prove that any
new ingredients are safe before selling them as supplements.

Andro wasn't on the market in 1994 and thus its makers failed to
follow the law's safety provision, the FDA contends.

The FDA expects its action to at least temporarily halt andro
sales. Meanwhile, Congress is considering legislation sponsored by
Sen. Joe Biden, D-Del., that would permanently end over-the-counter
sales of andro, as well as the newly unmasked steroid THG, and
subject them to the same prescription restrictions as apply to
anabolic steroids.

Health and Human Services Secretary Tommy Thompson urged
Congress to pass the legislation, and baseball commissioner Bud
Selig supports it.

Thompson said, "if firms refuse to cease
distributing these products, we may seize products, pursue
injunctions or seek criminal actions."

Thompson had a message for those considering using andro to
boost their athletic prowess: "The best and safest way to get
faster and stronger is to eat well, to exercise and to avoid risky
behaviors."

Andro's use skyrocketed after McGwire said he used it in 1998,
the year he hit a record-setting 70 home runs for the St. Louis
Cardinals. He has said he later quit the supplements.

Medical studies show andro raises testosterone above normal
levels. Side effects of elevated testosterone include acne,
baldness, and a drop in the so-called good cholesterol that could
lead to heart disease.

Federal health officials are particularly concerned about
children who use andro, especially if they're still in puberty.
While they didn't have statistics on preteen use, federal
drug-monitoring surveys suggest one out of 40 high school seniors
and one out of 50 10th graders were using andro in 2001, the latest
data available.