Pro Hormone Ban Link

[einie1]

**broken link removed**

I hope that link works. It looks like more trouble for no reason.

 

[xcelbeyond]

Link doesn't work

xcel

 

[einie1]

I couldn't find the most recent article but...

Supplement sales banned
Long-term health risks of 'andro' cited by FDA
By Alice Dembner, Globe Staff, 3/12/2004

The US Food and Drug Administration yesterday moved to halt sales of androstenedione, a dietary supplement marketed as a muscle enhancer that officials said can stunt growth in children and cause problematic sexual changes in adults.

The agency sent letters to 23 companies that make or market "andro," warning them to stop selling the pills that are converted into steroids in the body or they risk civil or criminal sanctions.

An estimated $15 million worth of the product was sold last year, according to the trade publication Nutrition Business Journal, much of it to athletes and body builders. The supplement became well known in 1998, when baseball slugger Mark McGwire acknowledged using it during the season he hit a then-record 70 home runs. About one in 40 high school seniors in 2002 said they had used andro in the past year, according to a federal survey.

The FDA action follows an announcement from the agency in December that it was banning sales of the dietary supplement ephedra, which had been linked to 155 deaths.

"This is a critical part of the FDA's broad crackdown on unsafe dietary supplements," said Dr. Mark McClellan, the FDA commissioner, at a news conference yesterday. "While andro products may seem to have short-term benefits, the science shows that these same properties create real and significant health risks."

Since December 2002, the FDA has issued 75 additional warning letters to supplement companies that made misleading claims about their products and has confiscated about $9 million worth of the popular substances, according to Tommy Thompson, Health and Human Services secretary and McClellan's boss.

"And we're not stopping now," said Thompson yesterday.

But some criticized the administration for taking too little action too late. Sales of andro products peaked in 2001, according to Nutrition Business Journal, and have been replaced by other "pro-hormones," substances that activate or simulate hormones in the body.

"What have they been doing with their time?" said Patrick Rea, research director for the journal. "Is it just a nice card to play in an election year?"

He said he expected the companies would just switch to similar new products.

Dr. Benjamin Z. Leder, an endocrinologist at Massachusetts General Hospital who has studied andro, called the FDA action "a good start," but said he'd like to see andro banned entirely, along with the entire class of pro-hormones.

Health and Human Services spokesman Bill Pierce denied that politics were involved in the FDA's action. He said the administration focused on ephedra first because of the danger, then began looking at pro-hormones. "This is the fastest action we could take to get a dangerous product off the market," he said.

The FDA didn't seek to ban andro, he said, because of the evidence and time required to build a case that the substance is dangerous. Under federal law passed in 1994, supplements can be marketed without safety tests unless the government proves they pose an unreasonable risk. Instead, the government is using a rule that requires any company marketing a dietary ingredient that wasn't on the market in 1994 to file a "premarket safety notification" with the FDA. The agency has no record of any such notice, officials said, so they consider the products adulterated and therefore prohibited.

The administration also made public yesterday its support for legislation pending in Congress that would classify products containing andro and other pro-hormones as controlled substances and make them subject to regulation by the US Drug Enforcement Agency.

Officials said andro is converted into testosterone and estrogen in the body, raising the levels of these hormones. Although increases in testosterone can strengthen muscles, some studies have shown little or no effect from andro. However, long-term use of the pills can harm the heart and liver, and can cause impotence and breast enlargement in men and baldness and facial hair in women. Children who use andro, the FDA said, are at risk of early puberty and stunted bone growth. McGwire, now retired from baseball, said he stopped using andro in the late 1990s because he didn't want to set a bad example for children.

But one supplement maker said that andro products are safe and that the FDA was just trying to create a monopoly for pharmaceutical companies, which sell steroids by prescription.

"These products will return," said James Riggs, president of Schwartz Laboratories in Cincinnati, who received one of the warning letters. "These pro-hormone, testosterone precursors won't be 20 cents a pill, they will be $20 a pill."

Riggs said Schwartz no longer sold the product that the FDA asked it to take off the market, but that it makes and market similar pills.

Another company, NVE Pharmaceuticals, this week filed suit challenging the FDA's ban on ephedra, which is scheduled to begin April 12. According to the Associated Press, the suit alleges that the FDA hasn't proved that ephedra is dangerous.

Alice Dembner can be reached at [email protected].

© Copyright 2004 Globe Newspaper Company.