Enhanced FDA enforcement against steroid products sold as dietary supplements is likely reassuring to law-abiding supplement companies.

Even so, high-profile cases of steroids labeled as supplements frequently fuel negative media reports and serve as ammunition to opponents of an industry they consistently attempt to paint as unregulated.

A Sept. 24 FDA raid of a firm marketing steroid products as supplements - Bodybuilding.com of Meridian, Idaho - will likely provide fodder for discussion at an upcoming Senate Judiciary Committee subpanel hearing on "hidden steroids."

In a same-day application and affidavit for search warrant ¹ document, FDA special agent Robert Blenkinsop affirms at the close of a two-year investigation that Bodybuilding.com markets and distributes anabolic steroids, including madol and androstenedione, as dietary supplements.

The retailer "has substantially complied with" five warning letters FDA sent since 2002, Blenkinsop writes, even as it continued illegal marketing behavior. In one 2006 letter, FDA said several steroid products sold by Bodybuilding.com contained uncleared new dietary ingredients (² Also see "Are Designer Steroids Dietary Ingredients? FDA Warning Letter Skirts Issue" - Pink Sheet, 7 August, 2006.).

FDA has ramped up activity against steroids of late, notifying American Cellular Labs in July that its products TREN-Xtreme , MASS Xtreme and others were unapproved, misbranded drugs, ineligible to be sold as supplements (³ Also see "FDA Warning Draws Solid Line Between Steroid Products And Supplements" - Pink Sheet, 3 August, 2009.).

The Judiciary Subcommittee on Crime and Drugs hearing slated for Sept. 29 will be chaired by Sen. Arlen Specter, D-Pa., who faces a tough reelection bid in 2010. Specter may be attempting in part to appeal to baseball fans who saw a Philadelphia Phillies player suspended 50 games this year after a positive drug test, allegedly due to a tainted supplement.

The witness list for "Body Building Products and Hidden Steroids: Enforcement Barriers" includes Michael Levy, director of the Office of Compliance in FDA's drug center; Daniel Fabricant, acting executive director of the Natural Products Association; and Travis Tygart, CEO of the U.S. Anti-Doping Agency, who has criticized the oversight of the supplement industry as lax (⁴ Also see "CRN Stands Up Against U.S. Sports Official's Criticism Of Supplement Quality" - Pink Sheet, 20 July, 2009.).

- Dan Schiff ( ⁵ d.schiff@elsevier.com )

Steroids Sold As Supplements Targeted In FDA Actions, Congressional Hearing

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