Congress Unhappy With FDA

Davis Labels Investigation of Steroids Makers as Inadequate

The Food and Drug Administration is investigating five dietary supplements recently found to contain steroids and is considering enforcement action against the companies that produced them, the agency said in a letter delivered Monday to House Government Reform Committee Chairman Thomas M. Davis III (R-Va.). Davis yesterday described the FDA response as inadequate.

The letter said an FDA investigative team is seeking evidence from Don Catlin, the director of the UCLA Olympic Analytical Laboratory in Los Angeles who evaluated the supplements for The Washington Post, which published the findings in an Oct. 18 story. Before the story ran, all of the products were available over the Internet, costing between $50 and $125 per bottle. Catlin said each of the products contained newly created steroids designed to elude detection in standard sport drug screens.

Davis, who requested soon after the story's appearance that the FDA explain its efforts to ensure that steroids are not found in dietary supplements, yesterday demanded more specific information on the investigative effort. In his Oct. 21 letter, Davis asked for details on how the FDA was dealing with the companies mentioned in The Post article and other issues, but the FDA provided mostly general information about how it oversees the industry in its five-page response and 48-page attachment.

"While I appreciate the FDA's compliance to our deadline, I would prefer a late but substantive response as opposed to an inadequate prompt one," Davis said in a statement. "Given the disturbing trend of teenage steroid-use and the apparent increase in designer steroids production, FDA must provide specific answers to help us turn back this rising tide."

The steroids discovered in the dietary supplements also have attracted the attention of the Drug Enforcement Agency, which has turned chemical information about the steroids over to its pharmacologists to determine whether each should be banned, according to Rogene Waite, a DEA spokeswoman. The process could take months. For drugs such as steroids, the DEA does not have the authority to issue emergency bans, Waite said. It must undergo a laborious process that includes publishing its intent to schedule in the Federal Register and allowing for time for comment and review.

Several companies have voluntarily removed products from the market since The Post story appeared, which the FDA noted in its letter. Applied Lifescience Research Industries (ALRI) announced two weeks ago it had discontinued sales of two products mentioned -- Prostanozol and Ergomax LMG -- and all similar products. Anabolic Xtreme discontinued sales of three of the products mentioned (two licensed from ALRI) and Serious Nutrition Solutions announced on its Web site that it was withdrawing two of its dietary supplements -- neither of which was mentioned in the story -- "since finding out about legal issues surrounding these products after the initial first small product run."

"We know that there are several superior supplemental health and performance promoting options for athletes and enthusiasts alike, and that hormone related compounds just seem like a step backwards," said ALRI director Author L. Rea in an e-mail. "The FDA has been very supportive in furthering the types of products that do not call into question an athlete's or company's ethics, that ALRI is focusing solely on providing proof it can be done very well."

Several companies, however, have released dietary supplements that appear to contain steroids in the last few weeks, according to information available about the products, industry sources and chemistry experts.

The FDA "shares your concern about the use of steroids among adolescents and the apparent increase in so-called designer steroid production and use," said Patrick Ronan, FDA Associate Commissioner for Legislation, in Monday's letter to Davis. "We will consider enforcement and other options as part of the agency's investigation of this matter once this evidence has been evaluated."