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.
In 1999, however, when the FDA was trying to reduce the recommended dosage of ephedra in response to accumulating evidence of health risks, Hatch was in the vanguard of industry supporters who challenged the agency. He was joined by Harkin, who sits on the Senate subcommittee that controls FDA budget appropriations.
In a letter to the FDA, the two senators questioned the scientific basis for the agency's proposal to reduce the recommended single dosage to 8 milligrams. Some states allowed as much as 25 milligrams.
The FDA said then it had received more than a dozen reports of possible ephedra-related problems, ranging from heart attacks and arrhythmia to strokes, psychotic episodes, dizziness and skin rashes.
It also relied on studies and advice from a range of experts, the agency said.
Hatch and Harkin questioned whether the number of problems reported were sufficient to warrant action, when measured against the billions of doses consumed by users of products containing ephedra.
The pair also decried the incomplete nature of some of the incident reports, which came from users, doctors and other sources.
The kind of detailed scientific data Hatch and Harkin were insisting on is routinely compiled during premarket tests and clinical trials conducted before prescription medicines are allowed on the market.
In the face of those challenges and a lobbying blitz by the industry, the FDA backed down.
At the time, Hatch's son worked for Parry and Romani Associates Inc., the lobbying firm headed by the late Tom Parry, a former senior aide to Sen. Hatch.
Before being hired at Parry and Romani, Scott Hatch, now 41, had finished college and worked as a government clerk in Washington. At Parry and Romani, he worked his way up to lobbyist.
Among others, Parry and Romani had been hired by New York-based Twin Laboratories Inc., a manufacturer of products containing ephedra, to lobby Congress and the FDA "regarding ephedra products."
The firm had also been hired by the National Nutritional Foods Assn., a major trade group representing the diet supplements industry, to lobby on supplement regulation, including ephedra.
Last year, Scott Hatch opened his own lobbying firm with Jack Martin, a veteran of Sen. Hatch's Senate staff and a former diet supplements lobbyist at Parry Romani. Laird Walker, another longtime associate of the senator, became the third partner.
One of the first clients to sign up was the National Nutritional Foods Assn., which paid the fledgling firm $20,000 through the first half of 2002.
The foods association particularly asked the firm to lobby on behalf of ephedra and other supplement issues. The firm lobbied the Senate, the House, the executive office of the president and the FDA on the organization's behalf.
Kim Smith, the association's legislative director, said the Walker Martin Hatch firm was hired because of Martin, not because Scott Hatch was the senator's son.
Twin Laboratories, called Twinlab on its labels, also left Parry and Romani to sign up with the new firm last year. The firm was paid $10,000 for three months of work on ephedra and other issues.
Twinlab was one of 24 companies that received a warning letter from the FDA last week on their products containing ephedra. Those include its Diet Fuel, Ultimate Diet Fuel and Energy Fuel.
Several months ago, as the controversy grew, the company decided to stop making ephedra products.
The payments from Twinlab were reported on the firm's lobbying disclosure forms, covering the first six months of 2002.
It is not known what further payments may have been made because year-end reports have not been released.
Scott Hatch said he does not lobby his father directly, leaving that to his partners. Martin said he has handled the dietary supplement account.
The firm is being paid to monitor regulatory and legislative activity that might affect ephedra and other supplement issues, he said.
Sen. Hatch said in an interview that he has met frequently with Martin to discuss dietary supplements.
"Jack Martin worked with the FDA and has been very active in the dietary supplements area. And of course, I am the author of the dietary supplement authorization act," he said. "Naturally, he has been in and out of the office on those issues. Quite a bit."
Industry payments to Scott Hatch and his partners represent only part of the supplements industry's total lobbying budget.
Hatch may be the foremost defender of the diet supplements industry in Congress.
"I have taken dietary supplements almost my entire adult life and can attest to the benefits they provide," he wrote in his memoirs.
He has received nearly $137,000 in campaign contributions from the supplements industry over the last decade, according to the Center for Responsive Politics. It based its figures on government reports.
In addition to the contributions to the senator and lobbying fees to his son's firms, the supplements industry has given Sen. Hatch its Congressional Champion award and a lifetime achievement citation.
Harkin, another regular supplements user, received $119,242 from the supplements industry from 1993 to 2002.