Andro Ban's Effect May Be Small
Manufacturers Say More Potent Products Have Replaced Supplement
By Amy Shipley
Washington Post Staff Writer
Thursday, March 18, 2004; Page D03
Supplement companies notified of last week's Food and Drug Administration ban of androstenedione said the action will have little effect as andro has been surpassed by far more potent products and is virtually obsolete.
At least eight of the 23 manufacturers that received warning letters say they stopped making the androstenedione products for which they were cited months or years ago.
William Llewellyn, the president and chief executive officer of Molecular Nutrition, called androstenedione "an antiquated old product." Derek Cornelius, the owner of Syntrax Innovations, estimated that it represents 0.25 percent of the current dietary supplement market.
"I don't know anyone selling it, I don't know anyone manufacturing it and I sure don't know anyone buying it," said Cornelius, whose company discontinued production of its andro product Libidione more than three years ago.
In what it described as a "crackdown" against androstenedione, the FDA last week banned the substance, which became widely known in 1998 when slugger Mark McGwire admitted using it. The FDA said the action represented the most recent step by the U.S. Department of Health and Human Services to ensure the safety of dietary supplements, an industry that has been largely unregulated since the passage of a 1994 law. In December, the FDA announced a ban on the sale of products containing ephedrine.
FDA spokeswoman Kim Rawlings said the organization decided to ban androstenedione after reviewing scientific evidence that showed health risks associated with its use.
"There are firms continuing to make it and because it is a public health issue, the FDA felt it was prudent to take these actions to stop the distribution and marketing of these products." Rawlings said.
But supplement makers say androstenedione, which reached the market in 1996, was merely the first generation of a category of dietary supplements known as steroid precursors -- substances that convert to steroids in the body.
They say dozens of products available in nutrition stores or online have supplanted andro because they convert more efficiently to steroids or, in some cases, don't even require a conversion since they are already full-blown steroids.
Several manufacturers said the most revolutionary products (such as Methyldienolone from Gaspari Nutrition) closely resemble powerful -- and illegal -- oral steroids like Dianabol because they are synthetically modified so the liver can't break them down. The result is a potency and liver toxicity that is believed to be orders of magnitude greater than for androstenedione.
"It's like a brand new Porsche with two turbo chargers versus a broken down Volkswagen on cement blocks with no tires," said Stan Antosh, senior director of research and development for OSMO, which stopped manufacturing andro products two years ago. "There's no comparison between androstenedione and the new stuff."
Said Jim Riggs, president of Schwartz Laboratories in Cincinnati: "The FDA is so behind the game. . . . The technology is so far advanced past androstenedione."
The companies notified of the andro ban by the FDA did not include all of the current or former androstenedione manufacturers but did target at least one (Genetic Evolutionary Nutrition) that has been out of business for months. The FDA also did not include many steroid precursor manufacturers selling more modern products.
But Rawlings said further action was likely.
"I can't show you a road map to say who we are going after next; however, we are looking into other precursors," Rawlings said. ". . . We do intend to continue to examine and take further action as appropriate."
Manufacturers noted that they could avert the andro ban if they chose. The letters sent to the companies instructed them not to sell androstenedione unless they could prove its safety or that it contains dietary ingredients present in the food supply that have not been chemically altered.
"Andro is found in the food supply," Llewellyn said. "Everybody knows that. I could send you a five-inch folder that shows it occurs in nature. It's everywhere. If that's the criteria, it's easily met."
Several manufacturers called the ban a publicity stunt designed to make the government look tough on drugs.
"It's terrible that the FDA isn't up to speed on what companies are producing," said Ron McAfee, the owner of ISS Research in Charlotte. "We found it comical that we received a certified letter on a product that was discontinued two years ago."
Rawlings said that FDA Commissioner Mark McClellan is "very much on board and has everyone pursuing . . . these products."