Post by Tim Wescott on Mar 11, 2004 16:14:25 GMT -5
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 (news - web sites) is expected to say in warnings telling 23 manufacturers to cease their production.
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, selling 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, said a spokesman for the Department of Health and Human Services (news - web sites).
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 a new steroid named 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 does raise 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.
Critics are especially concerned about andro's effects if taken by children while they're undergoing puberty.
That means it poses the same health risks as directly using an anabolic steroid, the Food and Drug Administration (news - web sites) is expected to say in warnings telling 23 manufacturers to cease their production.
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, selling 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, said a spokesman for the Department of Health and Human Services (news - web sites).
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 a new steroid named 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 does raise 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.
Critics are especially concerned about andro's effects if taken by children while they're undergoing puberty.
