Trade Groups To Rep. Davis: FDA Should Pull Steroids Sold As Supplements

FDA should take swift action to remove from the market dietary supplements adulterated with steroids such as PharmaGenX's FiniGenX Magnum Liquid , the Council for Responsible Nutrition stated Oct 24.

Companies marketing steroids as supplements should face prompt, robust enforcement action by the agency so that an example is set and other firms are prevented from selling similar products, CRN said.

CRN's comments came in response to an Oct. 21 letter to FDA Acting Commissioner Andrew von Eschenbach written by Government Reform Committee Chairman Rep. Tom Davis (R-Va.).

Davis' letter points to steroids currently marketed as dietary supplements, noting that "while FDA does not approve dietary supplements for safety and effectiveness, FDA still has the responsibility to ensure that manufacturers do not mislead the consumer about dietary supplement contents."

Davis' letter was prompted by a Washington Post article published Oct. 18 which investigated five muscle-building products marketed over the Internet as dietary supplements that were found to contain "designer" steroids.

The congressman poses several questions, including: "What specific steps is FDA taking to ensure that dietary supplements found to contain anabolic steroids are not available for purchase by consumers?"

Davis also inquires about current good manufacturing practices for dietary supplement manufacturers and asks when FDA will begin implementing the measures. In addition, he asks about enforcement actions that would be taken for violators of labeling requirements mandated by the Dietary Supplement Health & Education Act.

Rep. Davis also brought up the topic of adverse event reports associated with the adulterated products.

"Has FDA received complaints through the MedWatch adverse event reporting system of illnesses or injuries due to dietary supplements containing anabolic steroids?" If adverse events have been reported, Davis requests a list of the illnesses or injuries related to the products as well as specific actions taken by FDA.

The congressman asks von Eschenbach to provide the Government Reform Committee with answers to the questions listed in the letter by Nov. 7.

The products cited in the Washington Post article were tested by Don Catlin, director of the U.S. Olympic drugs testing lab at the University of California, Los Angeles. All five products contained some form of steroid. The World Anti-Doping Agency plans to have several of those forms on the 2006 ban list.

In addition to FiniGenX Magnum Liquid, products tested were: Superdol , marketed by Anabolic Xtreme of San Diego; Prostanozol and Ergomax LMG , both marketed by Applied Lifescience Research Industries of Las Vegas; and Methyl 1-P , sold by Legal Gear of Brighton, Mich.

CRN offered FDA's handling of the BALCO case as a model for enforcement actions against misbranded steroids.

The agency banned terahydrogestrinone (THG) in October 2003, several months after the U.S. Anti-Doping Agency brought the BALCO manufactured "designer" steroid to FDA's attention (¹ (Also see "THG Controversy Spotlights Growing Sports Supplement Concerns" - Pink Sheet, 3 Nov, 2003.), p. 14).

In February 2004, four defendants including BALCO President Victor Comte were indicated by a San Francisco grand jury on 42 counts including incorrect product labeling and misbranding THG as a supplement (² 'The Tan Sheet' Feb. 16, 2004, In Brief).

In addition to the presence of steroids in the tested products, the fact that Davis "keeps on referring to the products as supplements" is equally disconcerting, National Nutritional Foods Association Executive Director & CEO David Seckman stated.

Seckman pointed out that the goods in question are not dietary supplements, but illegal products because they are adulterated with steroids.

However, NNFA also would like to hear von Eschenbach's answers to Davis' questions, especially on the topic of GMPs, Seckman noted.

The Office of Management & Budget received the dietary supplements final GMP regulation Oct. 25..

- Jessica Lake