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FDA implements crackdown on 'andro'
Companies must prove steroid is not dangerous
The Associated Press
Updated: 12:16 p.m. ET March 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.
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.
© 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Companies must prove steroid is not dangerous
The Associated Press
Updated: 12:16 p.m. ET March 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.
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.
© 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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