THG Controversy Spotlights Growing Sports Supplement Concerns

FDA's ban of tetrahydrogestrinone (THG) represents another black eye for sports supplements, coinciding with the highly publicized debate over the safety of ephedra-containing products.

The substance, which previously had been marketed as a dietary supplement, "does not meet the dietary supplement definition" and cannot be legally marketed without FDA approval, according to an Oct. 28 release from the agency.

THG is classified as a "designer" steroid that is derived by chemical modification from an anabolic steroid banned by the U.S. Anti-Doping Agency, the release states.

USADA brought sales of the steroid to light when it informed the International Olympic Committee several months ago that it had obtained a syringe containing THG from a track and field coach. The coach identified the Bay Area Laboratories Co-Operative as the source of the steroid.

A grand jury in San Francisco has since initiated an investigation of the sale of THG, and has subpoenaed several athletes for questioning.

The action follows introduction of a bill (S 1780) by Sen. Joseph Biden (D-Del.) that would prohibit the marketing of androstenedione and other steroid precursors as sports supplements (¹ (Also see "Andro Classified As Controlled Substance In Senate Bill; DHEA Excluded" - Pink Sheet, 27 Oct, 2003.), p. 15).

The marketing of steroids as supplements and related concerns over the growing use of performance-enhancing supplements among young athletes was addressed by the Senate Commerce Committee during an Oct. 28 hearing.

Committee Chairman John McCain (R-Ariz.) said in his opening statement "while it is true that [the Dietary Supplement Health & Education Act] has succeeded in freeing many safe and useful supplements from unnecessary regulation, it is equally true that the Act appears to have provided a safe haven for substances that many experts believe pose potentially serious health risks."

Of "particular concern to many is the heavy use of supplements among teenagers," McCain continued. "Members of school sports teams appear particularly vulnerable to the lure of performance-enhancing dietary supplements."

Based on projections from a recent survey by the Blue Cross & Blue Shield Association, 1.1 mil. young people ages 12 to 17 have taken performance-enhancing drugs or sports supplements, and almost four times as many said they know someone who is taking these substances.

Released Oct. 31, the 2003 survey also found steroids are the most well known performance-enhancing substances among teens and preteens, followed by ephedra and creatine.

In addition, three-quarters of 10 to 17 year olds surveyed could not identify any negative effects that might result from using the substances, "although virtually everyone (99%) agreed those who used them faced the potential for some health damage," according to a summary of results.

The survey involved telephone interviews of 1,000 adults and 803 youths during April 2003. The findings update a 2001 study by the organization on the same topic.

Concerns with the safety of substances marketed as sports supplements have fueled the position that vitamins and minerals should be governed by a different set of rules from those for the more complex and potentially hazardous substances, although all may currently fall under the statutory definition of dietary supplements.

"We need to develop clear lines when it comes to steroids and stimulants," Sen. Richard Durbin (D-Ill.) said, indicating that both should be banned from the market.

When DSHEA "was being debated...we talked about vitamin C and multiple vitamins and garlic, and the basic things that frankly cause no problems to anyone," Durbin said.

Since then, "witches brews of chemicals that no one has ever tested in terms of their safety and efficacy" have been marketed as supplements.

"That's not what we had in mind when we passed DSHEA, but that is what's happened," he remarked. The Illinois Senator expressed concerns that DSHEA is not effective because it leads consumers to assume supplements are as safe as other OTC healthcare products.

"I don't think the average American walking into a drug store understands the different standards of care that are being applied to the products you buy in a drug store," he said.

Durbin is the sponsor of legislation that would require dietary supplements containing stimulants to obtain FDA preapproval before entering the market.

His bill, S 722, has been hotly contested by the supplement industry as an assault on DSHEA and has prompted widespread grassroots lobbying efforts (² (Also see "DSHEA “Defense” To Be Supported By Supplement Industry Lobbying Day" - Pink Sheet, 6 Oct, 2003.), p. 16).

Sen. Orrin Hatch (R-Utah) defended the adequacy of DSHEA, stating it "gives the FDA abundant tools to remove products that are unsafe from the market."

Hatch also asserted "FDA's record has not been as strong" as the Federal Trade Commission's in terms of challenging deceptive advertising.

National Nutritional Foods Association Executive Director & CEO David Seckman agreed with Hatch. "The FDA, under the leadership of Commissioner McClellan, has made progress in implementation of the law," he maintained, but conceded "there is still much more to be done."

Seckman advised the committee to "stop seeking legislative solutions to regulatory problems when it comes to DSHEA" and to consider that FDA "has not fully applied its current powers." He also requested that Congress give FDA "the resources it needs to fully implement the law."

McCain urged Seckman to be more active in combating problems surrounding the marketing of unsafe supplements.

"I think you've got a PR problem right now. And it's in your interest and in the interest of your industry to be part of a solution, and not remain part of the problem," McCain said.

"It is in your interest as well as the nation's interest to be with us and move forward and try to devise remedies for what is a terrible problem for young Americans."