pro hormones
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FDA to try to stem sales of supplement andro
Thursday, March 11, 2004 Posted: 10:37 AM EST (1537 GMT)
WASHINGTON (AP) -- The government will crack down on the steroid-like supplement made famous by baseball's 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 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.
The FDA expects its action to at least temporarily halt andro sales. Meanwhile, Congress is considering legislation sponsored by Sen. Joe Biden, D-Delaware, 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.
---------------------------------------------
House panel approves bill to limit sales of steroid precursors
By FREDERIC J. FROMMER
Associated Press Writer
WASHINGTON (AP) -- Legislation limiting sales of steroid precursors such as androstenedione, a substance baseball slugger Mark McGwire used in his record-breaking home run year, won approval Wednesday by the House Judiciary Committee.
The measure would ban over-the-counter sales of precursors, which act like steroids in the human body. The Food and Drug Administration said earlier this month it would ban all sales of androstenedione.
"Since steroids were banned under the Control Act of 1990, many new substances have been developed that have essentially the same effect on the body as anabolic steroids," said the bill's sponsor and committee chairman, Rep. Jim Sensenbrenner, R-Wis.
The bill also would double the penalties for manufacturing or distributing anabolic steroids at or near a sports facility, prompting the only real debate at Wednesday's meeting.
Rep. Melvin Watt, D-N.C., questioned the rationale for that provision. "My concern is that we can do things rationally, or we can do things kind of based on sound bite," he said.
"This is a twofer," Sensenbrenner responded to laughter. "It's a rational sound bite." He said that while the provision allows for doubling of penalties, it does not mandate it.
The committee approved the bill on voice vote, sending it to the House floor.
Similar legislation, sponsored by Sen. Joe Biden, D-Del., is pending in the Senate.
Congress has taken an increased interest in the issue this year in the wake of reports of steroid use among athletes, particularly professional baseball players. A federal grand jury in San Francisco has indicted four men on charges of illegally distributing steroids, including the personal trainer of Barry Bonds.
At a Senate Commerce Committee hearing March 10, panel chairman John McCain, R-Ariz., warned the baseball players union he would look for "legislative remedies" if baseball did not adopt a stronger testing policy.
Since then, Commissioner Bud Selig has asked the union to renegotiate a tough steroids policy, and union chief Donald Fehr has left open the possibility of doing that before the players' collective bargaining agreement expires in December 2006.
---------------------------------------
March 31, 2004 -- TOKYO - It is possible that major league officials and their union counterparts will never have to haggle over which substances would be covered by an updated performance-enhancing drug policy. The federal government might do the work for them.
The proposed Anabolic Steroid Control Act of 2003, introduced by Sens. Joe Biden (D-Del.) and Orrin Hatch (R-Utah) last October, is designed to eliminate steroid precursors such as androstenedione, the muscle-building supplement Mark McGwire used when he broke Roger Maris' single-season home run record.
MLB officials are confident the Biden-Hatch bill will be enacted - possibly by June. If so, the vast majority of drugs and supplements the commissioner's office would like to see banned from the sport would become illegal.
"If any substance becomes illegal in the United States, it gets banned by baseball [as part of the collective bargaining agreement], and Biden-Hatch covers all the precursor substances that are steroidal by nature," said MLB VP Rob Manfred.
For now, that issue is a backburner one for Manfred and Gene Orza, the union's No. 2 official. They are in Tokyo trying to finalize a separate drug-testing program that would create an agreement for a World Cup featuring major league players next March. Both Manfred and Orza expressed optimism they were nearing an accord that would satisfy the strict drug policies of the International Baseball Federation, the worldwide ruling body for baseball.
This is where the Biden-Hatch bill becomes more pertinent. The World Cup, which would feature as many as 16 nations, would come on the dawn of next season. Many of the majors' best players might not want to disrupt their current training programs in preparation for the 162-game season by cutting out their use of supplements/drugs that are currently permissible.
But if those drugs were to be outlawed in the United States, players would be breaking the law by taking them.
"If they pass the Hatch-Biden Bill, automatically, we add it to our program [the collective bargaining agreement]," Manfred said. "Once that happens, the gap between the Olympic list and our list would be non-existent."
--------------------------------------
Bill HR HR 3866 states that the folowing substance will be affected:
(i) androstanediol--
(I) 3b,17b-dihydroxy-5a-androstane; and
(II) 3a,17b-dihydroxy-5a-androstane;
(ii) androstanedione (5a-androstan-3,17-dione);
(iii) androstenediol--
(I) 1-androstenediol (3b,17b-dihydroxy-5a-androst-1-ene);
(II) 1-androstenediol (3a,17b-dihydroxy-5a-androst-1-ene);
(III) 4-androstenediol (3b,17b-dihydroxy-androst-4-ene); and
(IV) 5-androstenediol (3b,17b-dihydroxy-androst-5-ene);
(iv) androstenedione--
(I) 1-androstenedione ([5a]-androst-1-en-3,17-dione);
(II) 4-androstenedione (androst-4-en-3,17-dione); and
(III) 5-androstenedione (androst-5-en-3,17-dione);
(v) bolasterone (7a,17a-dimethyl-17b-hydroxyandrost-4-en-3-one);
(vi) boldenone (17b-hydroxyandrost-1,4,-diene-3-one);
(vii) calusterone (7b,17a-dimethyl-17b-hydroxyandrost-4-en-3-one);
(viii) clostebol (4-chloro-17b-hydroxyandrost-4-en-3-one);
(ix) dehydrochlormethyltestosterone (4-chloro-17b-hydroxy-17a-methyl-androst-1,4-dien-3-one);
(x) 4-dihydrotestosterone (17b-hydroxy-androstan-3-one);
(xi) drostanolone (17b-hydroxy-2a-methyl-5a-androstan-3-one);
(xii) ethylestrenol (17a-ethyl-17b-hydroxyestr-4-ene);
(xiii) fluoxymesterone (9-fluoro-17a-methyl-11b,17b-dihydroxyandrost-4-en-3-one);
(xiv) formebolone (2-formyl-17a-methyl-11a,17b-dihydroxyandrost-1,4-dien-3-one);
(xv) furazabol (17a-methyl-17b-hydroxyandrostano[2,3-c]-furazan);
(xvi) 18a-homo-17b-hydroxyestr-4-en-3-one (13b-ethyl-17b-hydroxygon-4-en-3-one);
(xvii) 4-hydroxytestosterone (4,17b-dihydroxy-androst-4-en-3-one);
(xviii) 4-hydroxy-19-nortestosterone (4,17b-dihydroxy-estr-4-en-3-one);
(xix) mestanolone (17a-methyl-17b-hydroxy-5a-androstan-3-one);
(xx) mesterolone (1a-methyl-17b-hydroxy-[5a]-androstan-3-one);
(xxi) methandienone (17a-methyl-17b-hydroxyandrost-1,4-dien-3-one);
(xxii) methandriol (17a-methyl-3b,17b-dihydroxyandrost-5-ene);
(xxiii) methenolone (1-methyl-17b-hydroxy-5a-androst-1-en-3-one);
(xxiv) methyltestosterone (17a-methyl-17b-hydroxyandrost-4-en-3-one);
(xxv) mibolerone (7a,17a-dimethyl-17b-hydroxyestr-4-en-3-one);
(xxvi) nandrolone (17b-hydroxyestr-4-en-3-one);
(xxvii) norandrostenediol--
(I) 19-nor-4-androstenediol (3b, 17b-dihydroxyestr-4-ene);
(II) 19-nor-4-androstenediol (3a, 17b-dihydroxyestr-4-ene);
(III) 19-nor-5-androstenediol (3b, 17b-dihydroxyestr-5-ene); and
(IV) 19-nor-5-androstenediol (3a, 17b-dihydroxyestr-5-ene);
(xxviii) norandrostenedione--
(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and
(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;
(xxix) norbolethone (18a-homo-17b-hydroxypregna-4-en-3-one);
(xxx) norclostebol (4-chloro-17b-hydroxyestr-4-en-3-one);
(xxxi) norethandrolone (17a-ethyl-17b-hydroxyestr-4-en-3-one);
(xxxii) oxandrolone (17a-methyl-17b-hydroxy-2-oxa-[5a]-androstan-3-one);
(xxxiii) oxymesterone (17a-methyl-4,17b-dihydroxyandrost-4-en-3-one);
(xxxiv) oxymetholone (17a-methyl-2-hydroxymethylene-17b-hydroxy-[5a]-androstan-3-one);
(xxxv) stanozolol (17a-methyl-17b-hydroxy-[5a]-androst-2-eno[3,2-c]-pyrazole);
(xxxvi) stenbolone (17b-hydroxy-2-methyl-[5a]-androst-1-en-3-one);
(xxxvii) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(xxxviii) 1-testosterone (17b-hydroxy-5a-androst-1-en-3-one);
(xxxix) testosterone (17b-hydroxyandrost-4-en-3-one);
(xl) tetrahydrogestrinone (13b,17a-diethyl-17b-hydroxygon-4,9,11-trien-3-one);
(xli) trenbolone (17b-hydroxyestr-4,9,11-trien-3-one);
Thursday, March 11, 2004 Posted: 10:37 AM EST (1537 GMT)
WASHINGTON (AP) -- The government will crack down on the steroid-like supplement made famous by baseball's 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 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.
The FDA expects its action to at least temporarily halt andro sales. Meanwhile, Congress is considering legislation sponsored by Sen. Joe Biden, D-Delaware, 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.
---------------------------------------------
House panel approves bill to limit sales of steroid precursors
By FREDERIC J. FROMMER
Associated Press Writer
WASHINGTON (AP) -- Legislation limiting sales of steroid precursors such as androstenedione, a substance baseball slugger Mark McGwire used in his record-breaking home run year, won approval Wednesday by the House Judiciary Committee.
The measure would ban over-the-counter sales of precursors, which act like steroids in the human body. The Food and Drug Administration said earlier this month it would ban all sales of androstenedione.
"Since steroids were banned under the Control Act of 1990, many new substances have been developed that have essentially the same effect on the body as anabolic steroids," said the bill's sponsor and committee chairman, Rep. Jim Sensenbrenner, R-Wis.
The bill also would double the penalties for manufacturing or distributing anabolic steroids at or near a sports facility, prompting the only real debate at Wednesday's meeting.
Rep. Melvin Watt, D-N.C., questioned the rationale for that provision. "My concern is that we can do things rationally, or we can do things kind of based on sound bite," he said.
"This is a twofer," Sensenbrenner responded to laughter. "It's a rational sound bite." He said that while the provision allows for doubling of penalties, it does not mandate it.
The committee approved the bill on voice vote, sending it to the House floor.
Similar legislation, sponsored by Sen. Joe Biden, D-Del., is pending in the Senate.
Congress has taken an increased interest in the issue this year in the wake of reports of steroid use among athletes, particularly professional baseball players. A federal grand jury in San Francisco has indicted four men on charges of illegally distributing steroids, including the personal trainer of Barry Bonds.
At a Senate Commerce Committee hearing March 10, panel chairman John McCain, R-Ariz., warned the baseball players union he would look for "legislative remedies" if baseball did not adopt a stronger testing policy.
Since then, Commissioner Bud Selig has asked the union to renegotiate a tough steroids policy, and union chief Donald Fehr has left open the possibility of doing that before the players' collective bargaining agreement expires in December 2006.
---------------------------------------
March 31, 2004 -- TOKYO - It is possible that major league officials and their union counterparts will never have to haggle over which substances would be covered by an updated performance-enhancing drug policy. The federal government might do the work for them.
The proposed Anabolic Steroid Control Act of 2003, introduced by Sens. Joe Biden (D-Del.) and Orrin Hatch (R-Utah) last October, is designed to eliminate steroid precursors such as androstenedione, the muscle-building supplement Mark McGwire used when he broke Roger Maris' single-season home run record.
MLB officials are confident the Biden-Hatch bill will be enacted - possibly by June. If so, the vast majority of drugs and supplements the commissioner's office would like to see banned from the sport would become illegal.
"If any substance becomes illegal in the United States, it gets banned by baseball [as part of the collective bargaining agreement], and Biden-Hatch covers all the precursor substances that are steroidal by nature," said MLB VP Rob Manfred.
For now, that issue is a backburner one for Manfred and Gene Orza, the union's No. 2 official. They are in Tokyo trying to finalize a separate drug-testing program that would create an agreement for a World Cup featuring major league players next March. Both Manfred and Orza expressed optimism they were nearing an accord that would satisfy the strict drug policies of the International Baseball Federation, the worldwide ruling body for baseball.
This is where the Biden-Hatch bill becomes more pertinent. The World Cup, which would feature as many as 16 nations, would come on the dawn of next season. Many of the majors' best players might not want to disrupt their current training programs in preparation for the 162-game season by cutting out their use of supplements/drugs that are currently permissible.
But if those drugs were to be outlawed in the United States, players would be breaking the law by taking them.
"If they pass the Hatch-Biden Bill, automatically, we add it to our program [the collective bargaining agreement]," Manfred said. "Once that happens, the gap between the Olympic list and our list would be non-existent."
--------------------------------------
Bill HR HR 3866 states that the folowing substance will be affected:
(i) androstanediol--
(I) 3b,17b-dihydroxy-5a-androstane; and
(II) 3a,17b-dihydroxy-5a-androstane;
(ii) androstanedione (5a-androstan-3,17-dione);
(iii) androstenediol--
(I) 1-androstenediol (3b,17b-dihydroxy-5a-androst-1-ene);
(II) 1-androstenediol (3a,17b-dihydroxy-5a-androst-1-ene);
(III) 4-androstenediol (3b,17b-dihydroxy-androst-4-ene); and
(IV) 5-androstenediol (3b,17b-dihydroxy-androst-5-ene);
(iv) androstenedione--
(I) 1-androstenedione ([5a]-androst-1-en-3,17-dione);
(II) 4-androstenedione (androst-4-en-3,17-dione); and
(III) 5-androstenedione (androst-5-en-3,17-dione);
(v) bolasterone (7a,17a-dimethyl-17b-hydroxyandrost-4-en-3-one);
(vi) boldenone (17b-hydroxyandrost-1,4,-diene-3-one);
(vii) calusterone (7b,17a-dimethyl-17b-hydroxyandrost-4-en-3-one);
(viii) clostebol (4-chloro-17b-hydroxyandrost-4-en-3-one);
(ix) dehydrochlormethyltestosterone (4-chloro-17b-hydroxy-17a-methyl-androst-1,4-dien-3-one);
(x) 4-dihydrotestosterone (17b-hydroxy-androstan-3-one);
(xi) drostanolone (17b-hydroxy-2a-methyl-5a-androstan-3-one);
(xii) ethylestrenol (17a-ethyl-17b-hydroxyestr-4-ene);
(xiii) fluoxymesterone (9-fluoro-17a-methyl-11b,17b-dihydroxyandrost-4-en-3-one);
(xiv) formebolone (2-formyl-17a-methyl-11a,17b-dihydroxyandrost-1,4-dien-3-one);
(xv) furazabol (17a-methyl-17b-hydroxyandrostano[2,3-c]-furazan);
(xvi) 18a-homo-17b-hydroxyestr-4-en-3-one (13b-ethyl-17b-hydroxygon-4-en-3-one);
(xvii) 4-hydroxytestosterone (4,17b-dihydroxy-androst-4-en-3-one);
(xviii) 4-hydroxy-19-nortestosterone (4,17b-dihydroxy-estr-4-en-3-one);
(xix) mestanolone (17a-methyl-17b-hydroxy-5a-androstan-3-one);
(xx) mesterolone (1a-methyl-17b-hydroxy-[5a]-androstan-3-one);
(xxi) methandienone (17a-methyl-17b-hydroxyandrost-1,4-dien-3-one);
(xxii) methandriol (17a-methyl-3b,17b-dihydroxyandrost-5-ene);
(xxiii) methenolone (1-methyl-17b-hydroxy-5a-androst-1-en-3-one);
(xxiv) methyltestosterone (17a-methyl-17b-hydroxyandrost-4-en-3-one);
(xxv) mibolerone (7a,17a-dimethyl-17b-hydroxyestr-4-en-3-one);
(xxvi) nandrolone (17b-hydroxyestr-4-en-3-one);
(xxvii) norandrostenediol--
(I) 19-nor-4-androstenediol (3b, 17b-dihydroxyestr-4-ene);
(II) 19-nor-4-androstenediol (3a, 17b-dihydroxyestr-4-ene);
(III) 19-nor-5-androstenediol (3b, 17b-dihydroxyestr-5-ene); and
(IV) 19-nor-5-androstenediol (3a, 17b-dihydroxyestr-5-ene);
(xxviii) norandrostenedione--
(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and
(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;
(xxix) norbolethone (18a-homo-17b-hydroxypregna-4-en-3-one);
(xxx) norclostebol (4-chloro-17b-hydroxyestr-4-en-3-one);
(xxxi) norethandrolone (17a-ethyl-17b-hydroxyestr-4-en-3-one);
(xxxii) oxandrolone (17a-methyl-17b-hydroxy-2-oxa-[5a]-androstan-3-one);
(xxxiii) oxymesterone (17a-methyl-4,17b-dihydroxyandrost-4-en-3-one);
(xxxiv) oxymetholone (17a-methyl-2-hydroxymethylene-17b-hydroxy-[5a]-androstan-3-one);
(xxxv) stanozolol (17a-methyl-17b-hydroxy-[5a]-androst-2-eno[3,2-c]-pyrazole);
(xxxvi) stenbolone (17b-hydroxy-2-methyl-[5a]-androst-1-en-3-one);
(xxxvii) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(xxxviii) 1-testosterone (17b-hydroxy-5a-androst-1-en-3-one);
(xxxix) testosterone (17b-hydroxyandrost-4-en-3-one);
(xl) tetrahydrogestrinone (13b,17a-diethyl-17b-hydroxygon-4,9,11-trien-3-one);
(xli) trenbolone (17b-hydroxyestr-4,9,11-trien-3-one);
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