Waxman’s Dose of Regulation Angers Makers of Supplements : Health: Congressman says safety is his priority, but consumers fear restrictions. Legislative session ends with last-minute maneuvering.

A proposal to regulate claims made on behalf of vitamins and dietary supplements has pitted two old adversaries against each other in a battle that has aroused intense public interest--and indignation.

On one side is the $4-billion vitamin and supplement industry, which counts among its customers about 60 million Americans who take their products daily and 100 million who use them occasionally.

On the other side is Rep. Henry A. Waxman (D-Los Angeles), whom the industry has long regarded as a potent adversary whose penchant for regulation is a threat to its economic well-being.

Tensions escalated recently to the point when a prominent advocate asserted that Waxman “has declared war on the dietary supplement industry” and suggested that the lawmaker wants to cripple it.

For his part, Waxman maintains that the industry has, in effect, declared war on the truth by falsely warning legions of health-minded consumers that the government is trying to ban vitamins, minerals and herbal products or require a prescription to obtain them.

Waxman, one of Capitol Hill’s most influential figures on health care issues, says his intent is simply to ensure that manufacturers cannot promote “snake oil” as a cure for cancer or make other unfounded claims about supplements’ curative powers or other beneficial effects--not reduce the availability of safe products.

Some manufacturers, Waxman said, “are really pushing for the opportunity to market their products with claims they can’t sustain under scrutiny and are using the fear tactics that their products won’t be available” to achieve that goal.

The public reaction has been extraordinary.

Waxman’s office reported 1,500 to 2,000 calls and letters in recent months opposing new restrictions on supplements. Those who have encouraged the campaign say the figure is low. Many callers were responding to printed and verbal exhortations in health food stores and other places where supplements are sold.

For its part, the federal Food and Drug Administration insists that regulation of unsupportable claims is badly needed.

“Thousands of unsubstantiated claims are being made about hundreds of dietary supplements,” the FDA said in a July report that the industry maintains overstates the problem.

“Some ingredients marketed as dietary supplements have demonstrated serious or even life-threatening hazards,” the report continued. “As a result, millions of Americans are spending billions of dollars every year on dietary supplement products, many of which have shown little or no evidence of either safety or effectiveness.”

Industry pressure resulted in a moratorium on FDA action under a 1990 food-labeling law authored by Waxman while Congress sought to devise regulations. The law requires that health claims for food and supplements be supported by “significant scientific agreement.”

But the moratorium is set to expire Dec. 15; Waxman torpedoed a last-minute effort in late November to extend it four months when pro-industry legislators refused to accept his counterproposal.

The FDA insists that it is not seeking to ban products unless they are unsafe. Supplement advocates say the proposed rules under the 1990 law would have that effect by shifting the onus onto manufacturers to prove that products were not harmful or by driving costs so high as to put some smaller purveyors out of business. They say the FDA should have to prove that products are unsafe.

The vehicles for addressing the industry’s concerns are similar bills sponsored by Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N. M.) that would create a less rigid regulatory system for vitamins and other supplements. The measures have broad bipartisan support. Hatch has 63 co-sponsors and Richardson 211.

In the final hours before Congress adjourned in late November, it became clear that the primary negotiations between Hatch and Sen. Edward M. Kennedy (D-Mass.), chairman of the Labor and Human Resources Committee, were not going to be concluded before lawmakers went home. Hence, the Senate voted to extend the moratorium on FDA action until the spring.

The bill was sent to the House, where Waxman balked. As an alternative, he produced legislation that proposed a six-month extension and, among other things, a clause that the “FDA may not require prescriptions for dietary supplements.”

Waxman, who chairs the Energy and Commerce subcommittee on health and environment, said he sought the longer extension because Congress was about to depart for two months and six months was “more realistic.” Opponents suggested that he was trying to buy more time to build support for his own legislation to compete with Richardson’s widely supported measure.

Waxman said his bill sought to address the flood of communications to Congress from “scared and angry” consumers who had been misled by manufacturers and industry activists into thinking that their supplements would become unavailable. Beyond quelling these concerns, Waxman sought to remove a powerful political weapon the industry has used to pressure Congress.

Said Waxman: “We were, in effect, calling their bluff.”

He contends that the industry’s advocates blinked: They showed that they were unwilling to lose the ability to mobilize a grass-roots outpouring by playing on their fears.

“We should not have left without assuring people they would have access to their food supplements,” Waxman said in a floor statement in the early morning hours of Nov. 23. “The experience of this evening demonstrates the total irrationality that pervades the debate.”

Waxman said later, “We aren’t going to extend that moratorium when people are being told that their ability to buy these products without a prescription or without any interference from FDA is in jeopardy.”

Richardson and industry advocates tell a different story. They say Waxman clouded the straightforward question of extending the moratorium by unexpectedly introducing a measure that had not been vetted or negotiated through hearings or previous consultation. Under House rules, its passage would have required unanimous agreement without debate.

Richardson and Rep. Elton Gallegly (R-Simi Valley), another key industry advocate, rejected Waxman’s counteroffer. “Henry wanted a short-term guise of flexibility on his part on the access issue but (his proposal) is extremely unworkable,” Richardson said. “It’s too weak. It’s unacceptable. Henry wanted to show some progress because I think he’s feeling pressure.”

At one point, Richardson said that Waxman sought his consent without even having a completed bill to show him. The two Democrats engaged in a heated exchange on the House floor during which Richardson reportedly expressed distrust of Waxman’s intent.

Gallegly said he told Waxman that night: “ ‘I’d love to work with you,’ but here it is 10 minutes to 12 at night and he has this bill he wants me to support under unanimous consent without any debate.”

Some of those familiar with the midnight maneuvering say that Waxman, a renowned legislative strategist, was trying to counter the momentum of the Hatch-Richardson bill without appearing to be obstructionist. Others say that, mindful of the industry’s desire for a moratorium extension, he tried to slip through a bill that might not survive close scrutiny.

Congressional and industry advocates say they have had an opportunity to study Waxman’s measure and have found problems.

They say the measure defines dietary supplements too narrowly and fails to include products developed in the future. It does not protect products that make nutritional support and health claims. And it is not clear that the burden of proof for showing that a product is unsafe would be on the FDA rather than the manufacturer.

“One thing that troubled me a great deal was (Waxman) had limited the category of what a dietary supplement would be to tablets and capsules,” said J. B. Cordaro, president of the Council for Responsible Nutrition, a trade group representing 66 of the largest manufacturers of vitamins, minerals and other supplements.

Cordaro said this would exclude products that are used in conventional foods, such as cereal, or bar products, which is a growth area. The bill does include products that are intended for use in “powder, soft-gel or liquid form.”

Waxman said the bill would have put the burden of proof regarding unsafe products on the FDA. Beyond that, his definition of supplements was negotiable.

“We were willing to talk about it,” Waxman said. “We weren’t closing that issue out.”

Waxman predicts that Congress will still have the opportunity to act when it reconvenes in January. Any FDA regulations would not take effect until six months after being promulgated. And Waxman does not expect the FDA to adopt regulations to implement the 1990 legislation quickly because it is “mindful of the strong interest in Congress to resolve the issues.”

He said he expects to work with Richardson and others to resolve their differences when Congress reconvenes. Taking a similar stance, Richardson said: “We have to negotiate an entire package on access and claims. I know there have to be adjustments on both sides.”

Hatch, Richardson and Gallegly, meanwhile, have written Health and Human Services Secretary Donna Shalala, whose department oversees the FDA, requesting that the agency take no action until Congress concludes its deliberations. They contend that the FDA already has sufficient authority to remove any products that threaten consumer safety.

“The worst thing (they) can do is raise the temperature on this issue,” Richardson said. “They’d be tripling the amount of consumer excitement . . . I would get 300 co-sponsors.”

Jerry Kessler, executive director of the Nutritional Health Alliance, a supplement advocacy group, put out a newsletter in November asserting that Waxman has “declared war on the dietary supplement industry” and accused him of refusing “to negotiate in good faith.”

In an interview, Kessler, a retired owner of a dietary supplement company, charged that Waxman seeks to protect the pharmaceuticals industry, which contributes significantly to his campaigns, by making supplements more difficult or costly to obtain.

A recent study by Common Cause, a public interest group, found that Waxman has received a total of $45,380 in contributions from pharmaceutical interests over the past 10 years.

Waxman responded: “Many of the pharmaceutical companies own these vitamin companies, so it’s not so clear-cut. Some of my concern is that they would allow some products that are really drugs to be sold without FDA approval even though some of the pharmaceutical companies might like to avoid the FDA establishing the safety and efficacy of these products.”

He said his goal is that “the public not be deceived by the manufacturers of products that are nothing more than snake oil and that vulnerable people who are anxious about their health not have a product represented to them as curing them or being helpful to them when there’s no scientific basis.”