A Senate Judiciary subcommittee hearing on "hidden steroids" in bodybuilding products sold as supplements took the Drug Enforcement Administration to task for a delay on restricting access to anabolic steroids.

Supplement firms escaped relatively unscathed from the Sept. 29 hearing.

Additionally, despite news reports suggesting otherwise, it remains questionable whether Crime and Drugs Subcommittee Chairman Sen. Arlen Specter has any real intention or latitude to amend the Dietary Supplement Health and Education Act to crack down on steroids masquerading as supplements.

"We need to take a look at what we're going to do here with the exemption, which allows these bodybuilding steroids to be sold without pre-clearance under" DSHEA, the Pennsylvania Democrat said in his opening remarks.

U.S. Anti-Doping Agency CEO Travis Tygart advocated amending DSHEA with tougher pre-market hurdles and post-market responsibilities.

His written ¹ testimony suggests legislative changes including requiring supplement firms to submit pre-market notices to FDA for steroid-containing supplements, register as "dietary supplement companies" and report all levels of adverse events to the agency.

"Legitimate dietary supplement companies truly concerned about the health and safety of our consumers have nothing to fear about the proposals," said Tygart, a critic of current supplement regulation (² Also see "CRN Stands Up Against U.S. Sports Official's Criticism Of Supplement Quality" - Pink Sheet, 20 July, 2009.).

Industry stakeholders, however, view the recommendations as burdensome to firms and FDA, and as ineffectual at deterring criminals.

Another witness, Natural Products Association acting Executive Director Daniel Fabricant, noted after the hearing that the steroid products Tygart singles out for pre-market approval already are illegal. Instead, he said, FDA should put resources and muscle into its new dietary ingredient notification program, for which guidance has not been issued (³ Also see "NDI Notification Guidance To Assist Puzzled Industry Could Emerge In 2009" - Pink Sheet, 12 January, 2009.).

Michael McGuffin, president of the American Herbal Products Association, said firms already register as supplement facilities under bioterrorism laws - a point the supplement industry argued in the wake of a March Government Accountability Office ⁴ report that made suggestions similar to Tygart's (⁵ Also see "Congress Says GAO Report Supports Increasing Supplement Oversight" - Pink Sheet, 9 March, 2009.).

Attorney Richard Kingham, another witness at the hearing, said in an interview that requiring non-serious AERs would be overkill for FDA's Center for Food Safety and Applied Nutrition.

"I doubt very much that CFSAN is able to do very much with the reports that it currently gets, and I can't imagine what they would do if they got literally tens of thousands of rashes, upset stomachs and things like that," said Kingham, a partner with Covington & Burling in Washington.

Playing Hardball With DEA

Specter avoided pointing his finger at the supplement industry as a whole, and instead aggressively questioned a DEA witness on why the agency has been slow to classify anabolic steroids as schedule III controlled substances.

Joseph Rannazzisi, deputy assistant administrator for Office of Diversion Control, ⁶ testified that DEA is in the final stages of scheduling three substances, which would be the first steroids added to schedule III since the agency was given scheduling authority under the Anabolic Steroid Control Act of 2004.

As schedule III substances, anabolic steroids are subject to strict production and recordkeeping requirements that help prevent their use in so-called supplements sold to consumers. Traffickers of such substances additionally face stiff penalties.

Specter asked if DEA needed Congress to legislate a simpler scheduling process, to which Rannazzisi did not respond.

"If you need some revision on your listing, let us know," Specter added. "Don't wait for us to come to you."

Tygart's testimony recommends Congress amend the Controlled Substances Act to add several designer steroids to schedule III.

Kingham said after the hearing he supports legislative action against steroids, but lamented the need for Congress to commandeer DEA's scheduling function.

"If DEA can't do it, perhaps Congress can," he said. "I think it's a little bit ironic that the Congress can act faster than an administrative agency. It's not supposed to be that way."

Challenges To Changing DSHEA

Specter admitted his interest in steroids and steroid-like substances marketed as supplements was piqued when a pitcher for the Philadelphia Phillies was suspended 50 games this season after testing positive for a banned substance. The player, J.C. Romero, blamed a tainted supplement (⁷ Also see "Steroids Sold As Supplements Targeted In FDA Actions, Congressional Hearing" - Pink Sheet, 28 September, 2009.).

Indeed, Specter's interest in supplements appears "parochial," said McGuffin.

While the hearing gave Specter a forum to show Pennsylvania voters he is responding to Romero's complaint, McGuffin said he does not expect it will yield any proposed DSHEA legislation.

The ranking member at the hearing, Sen. Orrin Hatch, backed both the supplement industry and DSHEA, as expected.

The steroid problem stems from a persistent lack of FDA resources and enforcement, said the Utah Republican and principal DSHEA author.

A staffer said in an e-mail that Specter is considering possible legislation in this area but offered no details.

Should Specter pursue changes to DSHEA, he likely would be hampered by not sitting on the Health, Education, Labor and Pensions Committee, which has jurisdiction over FDA and laws affecting supplement products.

Hatch also serves on the HELP Committee, whose chairman, Sen. Tom Harkin, D-Iowa, is another supplement industry ally and fierce defender of DSHEA (⁸ Also see "With Harkin As HELP Chair, Long-Time Supplement Ally Gains Ground" - Pink Sheet, 14 September, 2009.).

- Dan Schiff ( ⁹ d.schiff@elsevier.com )

Specter Spares Supplements, Hammers DEA Over Illegal Steroid Products

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