FDA Restricts Performance Booster Andro
The federal government broadened its crackdown on muscle-building dietary supplements Thursday, telling 23 companies to immediately stop the distribution and marketing of the substance made popular by St. Louis Cardinal slugger Mark McGwire.
The government’s top health and drug officials, joined by several lawmakers, said androstenedione, commonly called andro, must be pulled from the market because it causes serious and irreversible side effects.
Just as important, they said, the government, professional athletes and parents must work together to counteract a “cheating” culture in which performance-enhancing supplements are often viewed as an acceptable training tool.
“Young people should understand that there are no short cuts to a stronger body and that the best way to get faster and stronger is through good diet, nutrition and exercise,” said Health and Human Services Secretary Tommy G. Thompson.
In effect, the FDA action means that “these products are going to be off the market,” said Dr. Mark B. McClellan, commissioner of the Food and Drug Administration.
If the companies do not comply with the FDA’s warning, the agency could seize their inventories of andro products and pursue civil and legal action against them, he added.
Small amounts of androstenedione are produced naturally in the adrenal glands, ovaries and testicles and convert into testosterone, a steroid hormone that, among other things, increases muscle mass. The synthetic form of andro in dietary supplements is a steroid precursor, turning into a steroid only after it is absorbed by the body.
Although sales of andro products have declined sharply in recent years, Thompson said his agency’s action was needed to get the substance off the market altogether.
“We’re not stopping here,” he added, indicating that the government was prepared to clamp down on other body-building supplements. Andro is the second supplement targeted by the government in less than three months; on Dec. 30, it announcement a ban on sales of the herbal supplement ephedra.
Scientific studies indicate that the use of andro products increases the body’s production of the hormones testosterone and estrogen, with potentially unwelcome and dangerous effects. Boys and men can develop such female characteristics as enlarged breasts while girls and women can become more masculine, developing male pattern baldness, excessive facial hair and deepened voices.
Other health effects include testicular atrophy and impotence in men, and abnormal menstruation, blood clots and an increased risk of breast and endometrial cancer in women. When taken by children and adolescents, andro products can stunt growth and cause premature onset of puberty.
“These are irreversible health consequences,” said the FDA’s McClellan.
Thursday’s anti-andro enforcement action by the FDA, as well as recent controversies involving so-called designer steroids, also appeared to give new life to legislation pending in Congress that would ban andro, the designer steroid THG and 25 other anabolic steroid precursors.
“This bill has been laying around for two years ... [but] nobody paid attention until all of a sudden ESPN paid attention,” said Sen. Joseph R. Biden Jr. (D-Del.), one of the bill’s sponsors.
Biden joined his Republican co-sponsors, Sen. Orrin G. Hatch of Utah and Rep. John E. Sweeney of New York, in crediting President Bush, who criticized steroid use in his State of the Union address this year, for focusing new attention on the issue. The lawmakers predicted that Congress would pass the legislation overwhelmingly this year.
In its warning letter to 23 andro manufacturers, the FDA cited a rarely used provision of federal drug law that requires dietary ingredients introduced after 1994 to be certified by the government as safe before they are marketed.
Although synthetic andro was not marketed before 1994, the FDA has received no requests from its manufacturers for safety certification. And, because of the scientific information about andro’s health effects, the agency would deny such certification if the manufacturers requested it, officials said.
The FDA’s list of 23 andro manufacturers included five businesses in California, but an employee of Palms Springs-based OSMO Inc. said his company has not sold andro products since late 2001.
The FDA’s warning letter “doesn’t really affect us,” said Stan Antosh, OSMO research and development director. He said many other firms also have stopped selling andro products.
“It’s an election year,” he said of the government’s anti-andro campaign.
There was no telephone listing for another California company on the FDA list, and calls to Hawthorne-based Kaizen Nutrition Inc. were not returned.
Retail sales of supplements containing andro surged to $25 million in 1998 after it was revealed that McGwire, who hit 70 home runs that year to break Roger Maris’ single-season home-run record, had used the substance to increase his muscle strength.
Nationally, andro product sales topped $55 million in 2001, San Diego’s Nutrition Business Journal reported, but fell to $15 million last year as more became known about the side effects.
The government’s most recent figures on andro use by adolescents suggest that 2% of high school sophomores and 2.5% of high school seniors used andro products in 2001.
Thursday’s action also could increase pressure on the Major League Baseball Players Assn. to ban use of andro products by its members. The nation’s other major pro sport leagues -- football, basketball and hockey -- have banned andro and expressed support for legislation to ban other steroid precursors.
“We have supported the [anti-designer steroid] legislation for months,” said Robert Manfred, executive vice president of labor relations for Major League Baseball.
But Greg Bouris, communications director for the players association, said that the union had “no comment at this time” on the government’s crackdown against andro.
