Feds Move Against Andro Makers

March 11, 2004 -- Federal officials on Thursday announced a crackdown against makers of "andro," saying that they consider the performance-enhancing supplement unsafe.

The FDA has sent letters warning 23 known makers of andro to stop distributing the product as a dietary supplement or risk facing enforcement actions. The agency maintains that andro poses dangerous health effects and that companies have not shown it to be safe.

The FDA threatened companies that do not comply with the order with product seizures, injunctions, and possible criminal sanctions.

"These products are going to be off the market unless and until they are shown to be safe," FDA commissioner Mark McClellan, MD, said at a news conference.

The agency used a federal law requiring dietary supplement makers to file safety information with regulators if the supplement's ingredients were new to the market after 1994. McClellan said that none of the 23 companies has filed safety statements for their andro products, making the products illegal.

"These products are adulterated and their marketing is prohibited under the law," he said.

Americans spent about $15 million on andro last year, says David R. Seckman, CEO of the National Nutritional Foods Association, a dietary supplement trade group. The group supports the FDA's move, Seckman tells WebMD.

"Andro is a new ingredient and it has to go through the FDA submission process," he says.

McClellan would not specify what kinds of criminal sanctions the agency would seek if companies keep selling their andro products.

A Natural Hormone With Dangerous Effects

Andro, formally known as androstenedione, gained popularity in the late 1990s among athletes who saw it as a legal alternative to banned anabolic steroids. Sales peaked in 1998 after St. Louis Cardinals first baseman Mark McGwire acknowledged using it during his successful pursuit of Major League Baseball's single-season home run record.

Androstenedione occurs naturally in the human body as a precursor to sex hormones. Excess doses can help users gain weight, increase muscle mass, and possibly improve their running speed.

But excessive doses like the ones needed to improve athletic performance are associated with a variety of health effects. Men can experience shrinkage of the testes, a drop in sperm counts, and enlargement of breast tissue. In women, it can cause masculinizing effects like increased facial hair and acne, and some women may develop abnormal periods.

Officials said that they were most concerned about andro's popularity among children of high school age and younger. The 2002 federal Monitoring the Future drug survey estimated that one in 40 high school seniors used andro in the past year. Younger children who take it can experience early puberty and stunted growth.

Andro Restriction Gains Support

Administration officials also backed legislation in Congress to reclassify andro and 26 other similar chemicals as controlled substances, giving the Drug Enforcement Administration the authority to police them.

"Kids shouldn't be able to buy it, they shouldn't be able to use it, and now they won't be able to," said Sen. Orrin Hatch (R-Utah), one of the bill's sponsors.

The bill was first introduced two years ago with little notice from most lawmakers. But recent uproar over substance abuse in Major League Baseball -- as well as President Bush's attack on steroid use in his State of the Union Address in January -- helped reignite its popularity.

The bill could pass Congress this spring, lawmakers said. President Bush has pledged to sign the bill.

"Nobody paid attention until all of the sudden ESPN paid attention," said Sen. Joseph Biden (D-Del.), who is sponsoring the Senate bill with Hatch.