WASHINGTON — For more than a decade, the dietary supplements industry has counted on Sen. Orrin G. Hatch to fend off tighter regulation of products such as ephedra, the controversial stimulant linked to more than 80 deaths -- most recently a young Baltimore Orioles baseball player.
Among other things, the Utah Republican co-wrote the 1994 law that lets supplement makers sell products without the scientific premarket safety testing required for drugs and other food additives. That law has proved a major obstacle to federal control of ephedra.
For its part, the supplements industry has not only showered the senator with campaign money but also paid almost $2 million in lobbying fees to firms that employed his son Scott.
From 1998 to 2001, while Scott Hatch worked for a lobbying firm with close ties to his father, clients in the diet supplements industry paid the company more than $1.96 million, more than $1 million of it from clients involved with ephedra.
Since Scott Hatch opened his own lobbying firm last year in partnership with two of his father's close associates, the firm has received at least $30,000 in retainers from a supplements industry trade group and a major manufacturer of ephedra. Both clients came from the old firm.
Sen. Hatch said the new firm, Walker, Martin & Hatch, was formed with his personal encouragement. He said he sees no conflict of interest in championing issues that benefit his son's clients. Neither Senate rules nor federal laws forbid relatives from lobbying members of Congress.
"I would have no qualms talking to Scott" about his clients, Hatch said in an interview. "I wouldn't do anything for him that wasn't right."
The debt owed to the senator by the makers of diet supplements comes close to being unique. Supplements, like prescription drugs, belong to a relatively small category of products for which federal laws and regulations are the defining factor in a whole industry's business equation.
And since at least 1992, Sen. Hatch -- along with Sen. Tom Harkin (D-Iowa), co-author of the 1994 law -- has played a decisive role in helping the industry fend off restrictive oversight by the Food and Drug Administration.
Indeed, the Hatch-Harkin act defined dietary supplements as a special category outside drugs and other food additives, and did so in a way that has helped supplements mushroom into what the Nutrition Business Journal says is an industry with $17.7 billion in annual U.S. sales. Many of the companies are based in Utah, which describes itself as "the Silicon Valley of the supplements industry."
Before the 1994 legislation, the FDA would classify supplements as either food additives or drugs on a case-by-case basis. It had taken at least four supplements off the market because they had not been proved safe.
The Hatch-Harkin law shifted the burden of proof, requiring the FDA to make the case that each supplement was unsafe -- and preventing the agency from holding the product off the market until tests were completed.
On Friday, federal officials reopened consideration of steps to increase regulation of ephedra -- including a warning label pointing to the possible risk of heart attack, stroke and death, as well as a ban on advertising that suggests ephedra could enhance physical or athletic performance.
The FDA also raised the question of whether it had sufficient authority to regulate diet supplements effectively.
Based on an Asian herb called ma huang, ephedra is sold as an aid to bodybuilding, enhanced physical performance and weight loss. Sometimes called "legalized speed" because of its power as a stimulant, ephedra has been widely used by athletes, despite reports linking it to heart attacks, strokes and other severe medical problems.
Most recently, it has been cited as a possible contributing factor in the death of 23-year-old Orioles pitcher Steve Bechler on Feb. 17. It was also reported as a possible factor in the training camp death of Minnesota Vikings football player Korey Stringer in 2001.
In all, ephedra has been cited as a possible factor in more than 80 deaths nationwide, a contention the supplements industry vigorously disputes.
Yet the history of efforts to rein in ephedra -- which is stringently regulated by the FDA when used in prescription and over-the-counter medicines -- illustrates how difficult that is to do, given the terms of the Hatch-Harkin law.
On Friday, as the government announced its proposed new crackdown, Sen. Hatch issued a statement chiding the FDA for being slow to act against a known hazard.
"It has been obvious to even the most casual observer that problems exist," his statement said, calling the FDA's action "long overdue."
"As one of the lead authors of the law governing the regulation of dietary supplements, I have long been concerned that the agency was not seriously enforcing the Dietary Supplement Health and Education Act," Hatch added, referring to the law commonly known as the Hatch-Harkin act.