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FDA to Crack Down on Supplement Andro
Fri Mar 12, 3:27 AM ET
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Worried that children still are imitating baseball slugger Mark McGwire's one-time fondness for andro, federal health officials are moving to end sales of the steroid-like supplement.
The body converts andro, known officially as androstenedione, into testosterone and, to some extent, estrogen, the Food and Drug Administration (news - web sites) said Thursday.
That means it poses the same health risks as directly using anabolic steroids, which are controlled substances, the FDA said in warning 23 manufacturers to cease sales or face federal seizure of their products or other penalties.
Among the risks FDA cited are heart and liver damage, and some gender-specific problems: testicular atrophy, impotence and breast enlargement for males, and facial hair, menstrual problems and increased risk of breast and uterine cancer for females. Children can undergo early puberty and stunting of bone growth.
"These are irreversible, irreversible health consequences," said FDA Commissioner Mark McClellan.
One major supplement company, TwinLab Corp., didn't return a call seeking comment. But some smaller distributors said Thursday they'll comply, reluctantly.
"This is a political way of making hay" because of hysteria over athlete steroid use, said Troy Dickerson of LifeLink in Grover Beach, Calif., who said he sells up to 10,000 bottles of andro annually and has never had a health complaint.
Athletic use of performance-enhancing drugs is drawing harsh political scrutiny, and legislation pending in Congress would formally designate andro and more than two dozen other steroid-like substances as controlled substances just like other anabolid steroids ? making them available by prescription only under certain conditions.
The bill also urges tougher sentencing guidelines, so if the legislation passes and athletes take a banned steroid, "we're going to send them to jail," said Sen. Joe Biden, D-Del., a co-sponsor of the bill.
The Bush administration endorsed that legislation Thursday ? but the FDA decided it had enough legal backing to begin ending andro sales without waiting for Congress.
FDA cited a 1994 dietary supplements law that required any dietary ingredient sold after that date to provide reasonable risk of safety to FDA before selling ? something no andro maker ever did, McClellan said.
"In short, it's not a legal product," agreed Sen. Orrin Hatch, R-Utah, who wrote that supplements law.
"Today, we have hit a home run: our top health authorities are making clear that andro should not be on the market," he added. "Kids shouldn't be able to buy it. ... Now they won't be able to."
Andro's use soared after McGwire said he used it in 1998, the year he hit a record-setting 70 home runs for the St. Louis Cardinals. He later said he was quitting andro, citing concern that children copied his use of the pills.
Andro's use has since plummeted, from $55 million in 2001 to $15 million last year, according to the Nutrition Business Journal. But sales of supplement steroid precursors have almost doubled, to $125 million last year.
So why did FDA only now crack down on andro, and not its competitors?
The government is investigating a list of supplements and could take additional action, said Health and Human Services (news - web sites) Secretary Tommy Thompson. But it took several years to clarify andro's risks, McClellan added.
And andro remains popular with kids, said Rep. John Sweeney, R-NY, citing interest among his own children's friends. One government survey found one in 50 high school sophomores and one in 40 seniors had used andro in 2001, the latest data available.
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Fri Mar 12, 3:27 AM ET
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Worried that children still are imitating baseball slugger Mark McGwire's one-time fondness for andro, federal health officials are moving to end sales of the steroid-like supplement.
The body converts andro, known officially as androstenedione, into testosterone and, to some extent, estrogen, the Food and Drug Administration (news - web sites) said Thursday.
That means it poses the same health risks as directly using anabolic steroids, which are controlled substances, the FDA said in warning 23 manufacturers to cease sales or face federal seizure of their products or other penalties.
Among the risks FDA cited are heart and liver damage, and some gender-specific problems: testicular atrophy, impotence and breast enlargement for males, and facial hair, menstrual problems and increased risk of breast and uterine cancer for females. Children can undergo early puberty and stunting of bone growth.
"These are irreversible, irreversible health consequences," said FDA Commissioner Mark McClellan.
One major supplement company, TwinLab Corp., didn't return a call seeking comment. But some smaller distributors said Thursday they'll comply, reluctantly.
"This is a political way of making hay" because of hysteria over athlete steroid use, said Troy Dickerson of LifeLink in Grover Beach, Calif., who said he sells up to 10,000 bottles of andro annually and has never had a health complaint.
Athletic use of performance-enhancing drugs is drawing harsh political scrutiny, and legislation pending in Congress would formally designate andro and more than two dozen other steroid-like substances as controlled substances just like other anabolid steroids ? making them available by prescription only under certain conditions.
The bill also urges tougher sentencing guidelines, so if the legislation passes and athletes take a banned steroid, "we're going to send them to jail," said Sen. Joe Biden, D-Del., a co-sponsor of the bill.
The Bush administration endorsed that legislation Thursday ? but the FDA decided it had enough legal backing to begin ending andro sales without waiting for Congress.
FDA cited a 1994 dietary supplements law that required any dietary ingredient sold after that date to provide reasonable risk of safety to FDA before selling ? something no andro maker ever did, McClellan said.
"In short, it's not a legal product," agreed Sen. Orrin Hatch, R-Utah, who wrote that supplements law.
"Today, we have hit a home run: our top health authorities are making clear that andro should not be on the market," he added. "Kids shouldn't be able to buy it. ... Now they won't be able to."
Andro's use soared after McGwire said he used it in 1998, the year he hit a record-setting 70 home runs for the St. Louis Cardinals. He later said he was quitting andro, citing concern that children copied his use of the pills.
Andro's use has since plummeted, from $55 million in 2001 to $15 million last year, according to the Nutrition Business Journal. But sales of supplement steroid precursors have almost doubled, to $125 million last year.
So why did FDA only now crack down on andro, and not its competitors?
The government is investigating a list of supplements and could take additional action, said Health and Human Services (news - web sites) Secretary Tommy Thompson. But it took several years to clarify andro's risks, McClellan added.
And andro remains popular with kids, said Rep. John Sweeney, R-NY, citing interest among his own children's friends. One government survey found one in 50 high school sophomores and one in 40 seniors had used andro in 2001, the latest data available.
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