Senate Steroid Hearing Explores DSHEA Value, Enforcement

<p>Senators Arlen Spector and Orrin Hatch heard testimony from several witneses, including FDA, DEA, USADA and NPA, on the effectiveness of current regulations for dietary supplements, especially bodybuilding products, as well as on the histroical and curretn enforcement efforts by federal authorities.</p>

The Senate Judiciarys 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 testimonySen. Chuck Grassley (D-Iowa) filed testimony for hearing but did not present this testimonyand 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 legislationincluding DSHEA and its mandated regulationsthat 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 DSHEAs 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 FDAs 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 Kinghams reported statistics of 150 million Americans regularly using legitimate dietary supplements, and bodybuilding products 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.

The hearing was focused on the need to overhaul laws regulating supplements, including possibly requiring some sort of preclearance, as Specter continuously called it. He asked Michael Levy, who testified on behalf of FDA, if the agency could handle this problem in the absence of preclearance. Levy, director of the Division of New Drugs and Labeling Compliance at FDA, said, This is a very challenging area in which to regulate, because it is difficult to find violative products and can be difficult to act on those products. In his testimony, Levy noted, After products enter the market, we must undertake a painstaking investigative and analytical process to show they are violative. Currently, the agency struggles to provide effective civil and criminal deterrents to prevent unscrupulous firms from fraudulently marketing these products, and we are unable to effectively prevent the importation of many violative products.

Hatch noted since the passage of DSHEA, almost every FDA commissioner is on record stating the regulations were adequate to enforce DSHEA. He further said the current FDA Commissioner, Margaret Hamburg, has noted the problems with quality, adulteration, labeling and misleading ads in the supplement marketplace, but has said the regulations for enforcement actions against anabolic steroids are adequate. He quoted her as saying, These are unapproved drugs, not supplements.

In fact, Levy reported on a recent flurry of FDA action in this area of illegal steroid products, including 28 warning letters to firms illegally marketing products containing steroids, as well as recent actions specifically against American Cellular and BodyBuilding.com. However, Levy had no answers for some of Specters probing questions into the agencys lack of action on several supplement fronts, including why it took the agency 10 years after its first advisory and more than 1,000s of adverse event reports (AERs)including deathsto ban ephedra. Hatch suggested the agency is underfunded, for which he primarily blamed Congress, and requested the agency to let Congress know what it needs, be it regulatory tweaks or funding.

Travis Tygart, CEO of USADA, had quick answers to the panels questions, including a pointed query from Specter on whether Taggart felt existing laws were sufficient to protect athletes from steroids in supplements. Taggart said, Clearly, no. Tygart brought along former college athlete Jareem Gunter, who experienced life-threatening liver failure after taking the supplement Superdrol, which contains methasterone, an example of what Tygart called designer steroids that are created to circumvent the Steroid Act. Tygart called for premarket approval for supplements, saying it is too easy for bad actors to come to market with products containing designer steroids or similarly dangerous compounds. It is too easy for someone with a credit card to buy raw materials from China and sell millions of [units] before FDA has a chance to take it off the market.

Daniel Fabricant, Ph.D., interim executive director and CEO of NPA, responded to Specters query on bad actors, saying it is a matter of resources, adding the recent FDA actions in this area of the market were welcomed by industry and its critics. In his testimony, Fabricant argued criminal activity is nothing new, but the industry has fought hard to get DSHEA mandates in placesuch as serious AER reporting and GMPs (good manufacturing practices)and called for more funding for continued FDA enforcement actions. However, he also pointed out the issuance of 28 warning letters on steroid adulteration was only a good start, but it is not nearly enough. He recommended the agency use its full authority to bring court actions, which have thus far been rare. Kingham agreed on the need for more advanced action, saying warning letters and seizures are great, but perhaps criminal prosecution would also be appropriate.

Specter also asked Levy about these bad actors, to which Levy responded there are quite a few bad actors in the supplement marketplace, and it is not realistic for FDA to follow all of them. So what weve tried to do is be strategic in how we approach this and try to get the biggest bang for our buck, he said, to which Specter replied, The biggest bang for a few bucks might not be a very big bang, as far as big bangs go.

Further exploring the idea that enforcement has been lacking, Specter and Hatch grilled DEA on its own efforts. Hatch noted the Anabolic Steroid Control Act of 2004 added 36 steroids and prohormones to the schedule III list of 27 anabolic steroids created by the Anabolic Steroid Control Act of 1990, and gave DEA the authority to move steroid or steroid-like compounds to the schedule III controlled drug status if the agency found the compound was being abused by teens or athletes. He reasoned DEA should not have to take such action against DHEA, which is not considered or used as a performance-enhancing substance.

In his verbal testimony, Joseph Rannazzisi, deputy asst. administrator of the Office of Diversion Control at DEA, lamented about the arduous and lengthy process his agency must undertake to schedule new steroids and prohormones, as well as little regulatory authority under DSHEA. While he acknowledged DEA does have the authority to investigate illegal sales of steroids, including those in products marketed as supplements, and make them schedule III controlled substances, the agency has only identified and investigated three new such compounds. The agency moved them to schedule III status in April 2008. He said this shows that the time to schedule such offending steroid compounds is lengthy, taking nearly four years from the 2004 passage of the Steroid Act to schedule any new steroids. In that time, several new steroids were created that can take the place of the ones we scheduled, he said, adding DEA is looking at three more such compounds, two of which are considered more potent than testosterone.

Specter asked Rannazzisi if there was an affidavit filed by DEA stating Superdrolthe product taken by Gunteris a steroid, why hasnt DEA scheduled it as a controlled substance? Its one of the products we are looking at, Rannazzisi said. It still has to go through the scheduling process. I dont have the authority to just say I want this on schedule III. Annoyed that the DEA would not schedule the steroid after its own affidavit stated it is clearly a steroid, Specter asked, Would you like us to change to change the law to simplify the scheduling process?  

Tygart then told the panel that after the affidavit was filed and certain products in the resultant search warrant were seized, you can still find that particular designer steroid over the internet and on Amazon.com. Its the same compound that should be controlled, he said.

Hatch also questioned DEAs commitment to utilizing its authority under the Steroid Act.  In that bill, we followed the recommendations of DEA, he said. The purpose of amending the definition was to allow classification of additional compounds. He then referenced Rannazzisis March 2004 testimony to the Judiciary Committee, when DEA expressed support for the act. You appealed to Congress to provide a legislative remedy to refine the definition of a steroid, Hatch reminded, noting Rannazzisis testimony said this change would give DEA new tools to more quickly and effectively classify new steroids as controlled substances. Congress did what you basically asked for, Hatch confirmed. Referencing Rannazzisis current testimony that DEA is reviewing several compounds, Hatch then asked him, Can you tell me, five years after Congress expanded DEAs authority, why only three substances have been scheduled?

Rannazzisi said the agency looked at androstenedione for five years and could not prove it caused muscle growth, which was the prior definition of steroid under the 1990 act. He said while the changes made to the definition in the 2004 acta steroid is now defined as a substance that is chemically and pharmacologically related to testosterone, but not estrogen, progestin, corticosteroid or DHEAmade the agencys job easier, scheduling new controlled steroids is still a difficult task. This is not process done over night, he concluded, saying the studies and public comment procedures take time.

Both Senators questioned DEAs partnership with FDA, asking if they have a memorandum or understanding and work together to get these new steroid compounds scheduled and off the market. While he said DEA does work with FDA, when asked if DEA checks to see if FDA is working on an NDI a new steroid-type ingredient that DEA is investigating, Rannazzisi said there is no such partnership on anabolic steroids.

Hatch also wondered why if DEA has identified new steroids or similar compounds on the market as supplements, why isnt FDA doing anything about it. We are doing what we can, Levy replied.

Despite the Committees exposure of serious delays and insufficiencies in enforcement of the existing regulations under DSHEA and the Anabolic Steroid Control Act, Specter still expressed interest in looking at some sort of preclearance for bodybuilding supplements, while Hatch continued his stance that the laws he and others created were well-crafted and provide adequate federal authority and safeguards of the public. To this end, he will continue to fight for more resources and any legislative changes that can help FDA, DEA and other agencies remove delays in enforcement.

 

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