FDA warns about supplements with steroids

The Food and Drug Administration issued a public health advisory Tuesday, warning consumers to stop using products touted as containing steroids or steroid-like substances, many of which are labeled as dietary supplements.

The advisory came five days after FDA investigators, led by Jeff Novitzky of the BALCO probe, raided the California offices of American Cellular Labs, looking for evidence the company sells steroids under the guise of a supplement.

The FDA sent a warning letter to the company, saying it was selling unapproved and misbranded drugs and telling the company to explain how it was going to “prevent the recurrence of violations.”

Those products include TREN-Xtreme, MASS Xtreme and six others. Melissa Truffa of the FDA said the administration had received five reports of adverse effects over two years, including serious liver injury, from the American Cellular products and 15 from similar products made by other manufacturers.

Though most high-level athletes in testing programs would test positive for taking these products, they are thought to be popular among athletes in high school, especially football players, most of whom aren’t subjected to as thorough a drug-testing program.

“It’s because they work, they’re relatively cheap and you assume they’re safe because you can buy them at your local shopping center,” said Travis Tygart, CEO of the U.S. Anti-Doping Agency, in explaining the popularity among high schoolers.

Michael Levy of the FDA said consumers should be cautious when they buy any dietary supplements, not just the ones that claim to build muscle.

“They are not proven safe and effective before they get to market and we find that many are contaminated with potentially dangerous” substances, Levy said.

Many of the key regulations governing supplements are written for enforcement after products reach the shelves.

Andrew Shao, a scientist for the Council for Responsible Nutrition, applauded the FDA warning, saying it’s the kind of enforcement the industry needs to see more.

“This isn’t an issue of supplements, it’s an issue of criminals and criminal activity,” Shao said. “They take chances and take risks and perceive there won’t be consequences. The FDA’s recent actions shows that’s not the case.”

Levy said the company’s failure to respond to the FDA warning letter could lead to seizure of the products, an injunction to prevent the company from selling them and possible criminal sanctions that would stem from last week’s Novitzky search warrant.

But Levy could not immediately say what the exact sanctions might be. He said the FDA had no authority to make a mandatory recall of the product, and any recall would have to be voluntarily made by the company.

Tygart also applauded the FDA’s move, but said there are still too many dangerous products out there and not enough teeth in the federal regulations.

“It’s a tsunami of products out there but the law handcuffs both their arms behind their back when they attempt to regulate and stop the tsunami,” he said.

Shao, however, noted that five reports of adverse effects from the Americell products does not indicate a widespread problem in the supplement business.

“While this case is egregious and we’re supportive of the FDA action, it’s an isolated incident and in no way should be perceived as representative of the industry as a whole,” he said.