The Senate Judiciary’s Subcommittee on Crime and Drugs held a hearing on Sept. 29 concerning hidden steroids in bodybuilding supplements, presided over by the subcommittee chairman Sen. Arlen Specter (D-PA) and ranking member Sen. Orrin Hatch (R-Utah). Testimony at the hearing came from several witnesses, including FDA, Drug Enforcement Agency (DEA), USADA (U.S. Anti-Doping Agency), the Natural Products Association (NPA) and the law firm Covington &Burling LLP. Each witness had a few minutes to present parts of their written testimony—Sen. Chuck Grassley (D-Iowa) filed testimony for hearing but did not present this testimony—and then the two Senators on the hearing panel engaged the witnesses in some Q&A.
Specter opened the hearing with remarks on how complex the federal laws are that regulate bodybuilding supplements, noting these products may contain steroids or steroid-like compounds that can damage the liver and kidneys, as well as cause other health problems for those who ingest the adulterated products. “We, as a nation, are addicted to sports,” he said. “We are anxious to build-up our bodies to excel or at least do better.” He cited past cases involving Major league baseball players Mark McGwire and JC Romero as examples of steroid-containing products marketed as supplements that drew Congressional interest.
Specter put the bodybuilding supplement market at around $2.5 billion per year, warning problems with steroid adulteration could potentially affect millions of Americans, including young athletes. He added bodybuilding supplements are sold without preclearance by FDA , under DSHEA (Dietary Supplement Health and Education Act of 1994).
While Specter opened with a critical tone towards DSHEA and the supplement industry, Hatch delivered his opening remarks with more confidence in the existing laws, saying he wants to “clear up the abundance of confusion” that currently persists on the regulation of dietary supplements. Acknowledging that his state of Utah is home to many of the biggest supplement companies, Hatch also reminded how much time and energy he and others spent creating and passing legislation—including DSHEA and its mandated regulations—that provided FDA and other federal agencies the authority and power to regulate the supplement market and safeguard the American public.”This was not controversial legislation,” he reminded. “It passed unanimously in the Senate, twice.” He further emphasized the fact that the sale of products containing steroids or a number of precursors is already illegal.
Under questioning from Specter, Richard Kingham, partner at Covington & Burling, reiterated the notion that the sale of products containing any new steroid marketed as either a drug or supplement is already required to undergo premarket approval, including DSHEA’s new dietary ingredient (NDI) 75-day notification provision or a new drug application (NDA). He pointedly asked the panel, “If people violate existing requirements for NDAs or NDIs, why would we believe that they would comply with some new premarket approval requirement?”
Echoing what Hatch had called an “overburdened” FDA, Kingham repeatedly testified the existing laws for regulating dietary supplements provide adequate authority to FDA and other agencies, and there is no need for a broad premarket approval requirement for dietary supplements. “Premarket approval would add significant expense to bringing a supplement to market and would increase FDA’s responsibilities,” he noted. Hatch later chimed in, “The cost and time involved in premarket approval would sign the death knell for this industry.”
However, Specter belabored on Kingham’s reported statistics of 150 million Americans regularly using legitimate dietary supplements, and bodybuilding product’s only representing a 10-percent sliver of supplement sales. “That means 15 million Americans are at risk,” he concluded. However, Kingham emphasized under redirect from Hatch that only a small portion of this 10 percent bodybuilding supplement segment is thought to be susceptible to steroid adulteration.
