U.S. to Crack Down on Andro Supplement

Performance enhancer poses significant health risks, officials say

THURSDAY, March 11, 2004 (HealthDayNews) -- U.S. health officials said Thursday that they're cracking down on companies that manufacture, market or distribute the performance-enhancing steroid precursor androstenedione, better known as "andro."

"We are sending letters to 23 companies telling them to stop selling these products as dietary supplements and warning them they could face enforcement options if they don't take appropriate steps," Department of Health and Human Services Secretary Tommy Thompson said at a news conference in Washington, D.C.

The warning letters state that the companies must stop selling any products containing andro unless they can offer proof the substances are safe.

The use of andro took off dramatically after baseball slugger Mark McGwire said he used it in 1998 while hitting a then-record-setting 70 home runs for the St. Louis Cardinals. He has said he later quit the supplements.

U.S. Food and Drug Administration Commissioner Dr. Mark McClellan added Thursday that if companies don't comply with the warning letters, the government would consider taking such actions such seizures or injunctions, as well as civil or criminal court action.

Senators Joseph Biden (D-Del.) and Orrin Hatch (R-Utah) were also present at the news conference as sponsors of the Anabolic Steroid Control Act of 2003. The bill would add andro and other so-called "steroid precursors" to the category of controlled substances. This would give the U.S. Drug Enforcement Agency more flexibility to further crack down on companies that make or sell the substances. The senators said they hoped the legislation would pass both the House and the Senate by the end of the year.

"I think it'll pass like a hot knife through butter," Biden said.

The dual moves received the support of the supplement industry.

"We believe they're quite right to enforce this requirement under DSHEA [the Dietary Supplement Health and Education Act]," said Annette Dickinson, president of the Council for Responsible Nutrition, a trade association in Washington, D.C.

Dickinson was referring to a DSHEA requirement that dietary supplements on the market before 1994 had to come with notifications stating the ingredients were safe. Because andro appeared on the market after that, no notification was required, according to the Associated Press.

Dickinson added that her group also supports the legislation proposed by Biden and Hatch.

The crackdown comes amid a swelling steroid controversy engulfing Major League Baseball. At the start of spring training, a grand jury indicted four men in connection with a San Francisco Bay area lab that provided steroids and other performance-enhancing compounds to what the U.S. Justice Department said were "dozens of elite track and field athletes and professional athletes from Major League Baseball and the National Football League."

Among those charged was the personal trainer of San Francisco Giants star Barry Bonds, who eclipsed McGwire's single-season home run record only three years later, clubbing 73 in 2001. Earlier this month, the San Francisco Chronicle reported that investigators were given information that Bonds -- the National League Most Valuable Player for the last three years -- and two New York Yankees stars, Jason Giambi and Gary Sheffield, received steroids from the lab.

On Wednesday, Sen. John McCain (R-Ariz.) threatened that if Major League Baseball and its players' union don't get serious in efforts to eliminate steroid use, then Congress would.

"There are real consequences to demanding anything less than clean professional and amateur sports," said McCain, chairman of the Senate Commerce Committee, which held a hearing on the matter. "The failure to insist on stringent drug-testing policies damages the integrity of the games, calls into question records set by those suspected of using performance-enhancing drugs, and puts in peril the health of the athletes who play the games."

"But most worrisome," McCain added, "is the poor example set by professional and amateur athletes in the eyes of the kids who idolize and emulate them."

Alluding to Major League Baseball's players' union apparent reluctance to agree to drug testing, Biden said Thursday: "It's bone-headed for labor not to agree for more testing. And [the] leadership of baseball is bone-headed as well. What have we done to our culture based on this notion of meritocracy?"

Andro is a steroid precursor, meaning the body uses it to produce testosterone. This designation has allowed it to slip through federal laws governing steroids, so it can be sold over-the-counter as a dietary supplement.

"It's one of the biochemical building blocks and it has similar side effects to some steroids but it's not technically part of that exact class of drugs," says Scott Swartzwelder, professor of psychiatry and behavioral sciences at Duke University Medical Center. He's also the author of Pumped: Straight Facts for Athletes about Drugs, Supplements, and Training.

"[Steroid precursors] are dangerous," Swartzwelder adds. "They produce effects on the hormonal system, the reproductive system. They may produce central nervous system effects that result in behavioral changes.

Of particular concern are the effects on children who are not yet sexually developed. FDA Commissioner McClellan cited disruption of normal sexual development, deepening of the voice, enlargement of sex organs, acne and infertility as among the irreversible health consequences of taking steroid precursors at that age.

In addition, said DEA Administrator Karen Tandy, children are "also at risk of heart disease, liver cancer, depression, stunted growth, eating disorders and increased hostility and aggression."

"Some may doubt the powerful effect that athletes have on the lives of kids," McCain said during Wednesday's hearing. "Let me remind them of the five-fold increase in the sales of androstenedione -- better known as andro -- that occurred after Mark McGwire admitted to using the substance in 1998 while chasing Roger Maris' home run record. As everyone here knows, the health consequences associated with the use of steroids and other dangerous performance-enhancing substances are dire."

At the end of Thursday's news conference, which at times seemed to attain the peak fervor of a religious revival meeting, Secretary Thompson vowed to continue the crusade.

"[Andro] is the first one we've examined," he said. "I can tell you we're not stopping now."

More information

The FDA has a white paper on andro, as well as the sample warning letter.

SOURCES: March 11, 2004, press conference in Washington, D.C., with Health and Human Services Secretary Tommy G. Thompson; Food and Drug Administration Commissioner Mark B. McClellan, M.D., Ph.D.; Sen. Orrin Hatch, Sen. Joseph Biden Jr., and Drug Enforcement Agency Administrator Karen Tandy; H. Scott Swartzwelder, Ph.D., professor of psychiatry and behavioral sciences, Duke University Medical Center, Durham, N.C.; Annette Dickinson, Ph.D., president, Council for Responsible Nutrition, Washington, D.C.
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