Steroids Stir

December 10, 2009

With steroid issues making serious headlines throughout the year, the September Senate hearing on "hidden steroids" in dietary supplements could prove to be a turning point. On September 29, the Senate Subcommittee on Crime and Drugs convened the hearing, Body-Building Products and Hidden Steroids: Enforcement Barriers.

With steroid issues making serious headlines throughout the year, the September Senate hearing on "hidden steroids" in dietary supplements could prove to be a turning point. On September 29, the Senate Subcommittee on Crime and Drugs convened the hearing, Body-Building Products and Hidden Steroids: Enforcement Barriers.

We tracked the witnesses and speakers from the hearing who are deeply involved in the issue. The Drug Enforcement Administration (DEA; Washington, DC), which had a spokesperson at the hearing, issued no statement. Here's what the other parties shared with us:

Dan Fabricant
The Natural Products Association
(NPA; Washington, DC)

Major changes could be on the way for the supplement industry and its regulatory agencies. But Fabricant believes there are still big concerns that need to be cleared up before anything changes for good. For starters, Fabricant and the industry at large believe that the full extent of legislation under the Dietary Supplement and Health Act of 1994 (DSHEA) is not being exercised.

Doubt still surrounds what exactly Congress plans to change (if anything), but Fabricant still maintains that any changes must not hamper the law-abiding majority of the industry selling trustworthy, healthy supplements. Fabricant stresses that premarket changes (to scare off bad actors) could require added time and costs for the entire industry; again, he says there's language in DSHEA that can already take care of this.

The focus must be on scheduling and increasing enforcement on designer steroids. "There's been follow-up between us and Arlen Specter and Orrin Hatch's office," says Fabricant. "I think what they have in mind-and they made this pretty clear at the hearing-is to give DEA more power to schedule things. As long as they're going to schedule anabolic steroids, we're fine with that." Fabricant also hopes for some outreach from DEA.

Nonetheless, he believes the Senate hearing was positive. "I think the hearing was a good one," says Fabricant. "Anytime we can distance ourselves from the people who are selling illegal steroids, this is beneficial…and I believe we did that."

Travis Tygart
CEO of the United States Anti-Doping Agency
(USADA)

It has become increasingly clear that a deeper commitment from professional athletes and sports organizations is required to help patch up the steroids issues in our country. Tygart was a voice in the hearing to represent this side.

Since the hearing, Tygart has spoken of vital changes he would like to see in premarket clearance for dietary supplement companies, specifically relating to company-and-retailer contracts. While the supplement industry fears any premarket changes, he says such changes would require "no extra cost and no extra burden."

Tygart cites the ease in acquiring steroid-containing products on the Internet as reason to reconsider a premarket fix. "Right now, I can still go to a major Web site and buy Methasterone, which was subject to a raid three months ago-and that's crazy," says Tygart. "When a retailer enters a contract, it should require evidence that the company trying to be retailed has complied with [the rules already in place], so the retailer can't just stick its head in the ground and say, 'I trusted this manufacturer to comply with notification.'"

"The retailers all have contracts anyway, so it's adding nothing to their process," adds Tygart. "Now, there's no notice in this process that a company has either gone through notification requirements or has not. If a retailer is given notice that [a company's product] has not, and the retailer sells it, then [the retailer] is liable criminally and civilly for that product."

Immediately after the Senate hearing, when this article was written, Tygart disclosed an upcoming USADA initiative that he insisted will have a major affect on the state of the issue of tainted supplements. "There's a groundswell of professional and amateur sports [organizations] that are seriously concerned about this issue," said Tygart. "They're going come together to effectuate sensible change to protect the health of our kids and athletes...I can assure you that the groundswell is only getting bigger, not smaller."

Senator Orrin Hatch (R-UT)
Member of the Senate Subcommittee on
Crime and Drugs

Hatch, the "godfather" of DSHEA, provides a key perspective on the supplement industry and what September's hearing could lead to. Like Fabricant, Hatch still maintains confidence in the systems of rules already in place (e.g., DSHEA and the Anabolic Steroid Control Act of 2004).

But it's clear that he thinks the machine can use some more oil. "I will continue advocating for stronger FDA enforcement of the laws currently on the books…and I will also keep pushing for more federal dollars for the FDA to do its job to protect consumers through enforcement of the DSHEA law."

According to Hatch, what's perhaps most lacking, though, is communication on all fronts of the supplement industry and the affiliated agencies. Hatch states that during the hearing, he specifically asked the government agencies (FDA and USADA) about interagency communications, and says that "it appeared to be limited." The more the agencies communicate and coordinate together, the more consumers will benefit.

But making improvements also requires a loud voice from the companies within the industry. "It's extremely important to educate members of Congress and their staff about the dietary supplement industry," urges Hatch. "Industry representatives need to reach out to members of Congress who have dietary supplement plants, facilities, and companies in their home states and invite them to visit these sites."

Senator Arlen Specter (D-PA)
Chairman of the Senate Subcommittee on
Crime and Drugs

Although the chair of the Crime and Drugs subcommittee did not offer comment, it can be noted that Specter is very invested in the hearing and the supplements issue in general.

Throughout the 90-minute discussion, Specter questioned industry regulators about potential flaws in the scheduling of anabolic steroids. Regarding the lengthy scheduling process that accounted for designer steroid Superdrol not yet being on Schedule III, Specter remarked to DEA assistant administrator Joseph Rannazzisi, "Is there any conceivable excuse for why it still isn't listed on Schedule III? Would you like us to change the law to simplify the scheduling process?"

The chairman also inquired about the parties responsible for keeping professional athletes clean of steroidal substances and, most interestingly to the dietary supplement industry, the potential need for new premarket clearance requirements for dietary supplements.

"I agree that more has to be done on the regulators," Specter also added at the hearing.

The Republican-turned-Democrat (as of this spring) is undoubtedly preparing for the upcoming election season, and some speculate that reform of the supplement industry could have an impact. In 2010 elections, he'll have to defend the seat he narrowly won in 2004 against Democratic contenders, and then against a new Republican nominee.

Food and Drug Administration

In as much as a government agency like FDA can provide opinion on the dietary supplement industry, FDA has at least affirmed that there are complications in the current process of cleaning up steroids in the dietary supplement industry.

FDA press officer Christopher Kelly describes the process of dealing with all potentially violative products on the market as "immensely challenging."

"By way of example only, a quick Internet search for 'buy bodybuilding dietary supplements' yields close to 500,000 hits," says Kelly, "indicating that a huge amount of resources would need to be dedicated to seek out all the violative firms and products for this one category of products alone."

Making matters worse, the one-by-one approach FDA uses to tackle illegal products is further time-consuming. Because of these clear obstacles, increased FDA funding remains a key talking point. But Kelly insists that the problem goes beyond funding.

"When a violative product is investigated, FDA must conduct scientific and labeling analyses of the ingredients, conduct a legal review, discover the firms' locations, and, when appropriate, take action," says Kelly. "While additional resources would of course be extremely helpful, the approach FDA must generally take-tackling products one by one-is unsustainable and ineffective in protecting the public from a growing problem, regardless of resources."

Even so, FDA recently saw an increase in federal funding, and various industry experts have noted its proven effectiveness in the form of an increased number of FDA raids this year. At the Council for Responsible Nutrition's (CRN; Washington, DC) annual conference in California this October, FDA principal deputy commissioner Joshua Sharfstein said, "With respect to steroids, we have committeed substantial resources to finding illegal products and taking action."

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