Gallegly Wages High-Potency War Over Vitamins : Health: Legislator emerges as strong opponent of new labeling rules. He is accused of echoing industry scare tactics that FDA hopes to limit access to supplements.

Rep. Elton Gallegly, who says his total dietary supplement intake is Vitamin C when he feels a cold coming on, has become a champion of the $4-billion industry in its high-profile battle to minimize new labeling requirements.

The Simi Valley Republican has staked out a position that is even more aggressive than that of the supplement industry’s two leading congressional advocates, Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.). He has done so by sponsoring a bill that Hatch had introduced in the last Congress but has since moderated.

Without such legislation, Gallegly said in an Oct. 6 letter to Richardson, “Millions of consumers will soon be unable to obtain the vitamins, minerals, herbs, fish oils and other supplements that they have been relying on and require for their nutritional needs and their personal health.”

This kind of dire warning has been criticized by Rep. Henry A. Waxman (D-Los Angeles), a leader in the House on health issues, and the Food and Drug Administration, which oversees the dietary supplement industry.

They say Gallegly is echoing industry scare tactics that falsely accuse the FDA of seeking to limit access to vitamins, minerals and herbs. Rather, they insist that the agency is merely trying to protect consumers from fraudulent and even harmful health claims that some such products can do everything from curing cancer to reversing the aging process.

“Some ingredients marketed as dietary supplements have demonstrated serious or even life-threatening hazards,” the FDA said in a July report that the industry says overstated the problem. “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.”

Last week, the FDA issued rules that would require dietary supplement makers to provide evidence--under the same truth-in-labeling standards that apply to most foods--for any health claims about their products.

FDA Commissioner David Kessler said that in contrast to industry warnings, the rules do not take any supplements off the shelves or require a prescription for them.

“Consumers should have access to dietary supplements that are truthfully labeled and marketed,” Kessler said. “These rules enable the public to make informed choices. They will not restrict access.”

Gallegly, however, has indicated that he shares the view of many in the industry that the FDA is not to be trusted with too much regulatory authority.

In his letter to Richardson, he said: “This is an agency that has a dismal record of approving any health claims for new dietary supplement products and is biased, in the view of many in the industry, against dietary supplements or any other products for which a prescription is not required.”

Apparently spurred by the concerns of constituents and small-supplement manufacturers, Gallegly has become a player on a complex issue that has aroused widespread alarm among the millions of Americans who regularly take dietary supplements. Nothing else has sparked as much mail to legislators in recent months--much of it encouraged by vitamin makers and health food stores.

A frequent critic of what he regards as excessive regulation of business, Gallegly calls this a case of “the government thinking it’s smarter than the consumers.”

Although Gallegly is better known for his legislation to crack down on illegal immigration, he has quietly become the House’s leading Republican proponent of the dietary supplement industry.

He discussed the issue briefly in an interview in early December. But in recent weeks, he has not returned phone calls seeking elaboration of his position.

The heart of the battle concerns implementation of the 1990 food labeling law written by Waxman that treats supplements like foods. The standard set by the law is that health claims be supported by significant scientific agreement among qualified experts.

This requires manufacturers to obtain the FDA’s approval that each product meets this test before using the claim to market it.

Industry pressure, however, led to a moratorium while Congress attempted to devise regulations. Negotiations have thus far been inconclusive and the moratorium ended Dec. 15.

But the new regulations proposed by the FDA will not take effect until July 1. Pushed by pro-industry legislators, Congress is expected to refocus on the issue when it returns from its winter break later this month.

“The industry has harnessed an unusual coalition of right-wing libertarians and left-leaning New Age activists who share an interest in alternative medicine,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest, a national consumer advocacy group that strongly supports the new regulations.

“There has been a longstanding tradition in American society of resistance to traditional medicine,” Silverglade said. “It’s often been called the health freedom movement and congressman Gallegly would seem to represent that part of the debate.”

But he added, “The freedom to choose alternative medicine doesn’t mean much if it’s influenced by misleading marketing hype on dietary supplement labels.”

Gallegly introduced legislation in the last Congress written by Hatch that would give the industry far greater leeway to make health claims. Gallegly reintroduced the bill last January.

The so-called Health Freedom Act permits a manufacturer to make a claim if it is “truthful and not misleading and there is scientific evidence, whether published or unpublished, that provides a reasonable basis for such claim.”

The bill also prohibits any requirement that manufacturers obtain approval prior to making the claim. Gallegly has become a co-sponsor of a similar bill by Rep. Richardson that gives the FDA 30 days’ notice before marketing a product with a specific claim.

The FDA opposes Richardson’s plan, which has more than 200 sponsors. Gallegly has more than 60 sponsors--all but one of them Republicans.

“We think it will weaken FDA’s ability to make sure that dietary supplements are safe and properly labeled,” said Mitch Zeller, FDA special assistant for policy.

“Instead of the FDA deciding whether there’s enough science to support the claim, the companies would do so and that really turns the last 50 years of food and drug law on its head. It’s not practicable, it’s not feasible and it’s just not good public policy.”

In addition, Zeller said that under the weaker scientific standard, a company “could conceivably make a health claim relying on a preliminary study of a couple of dozen people as long as it was truthfully described, even though it is inconceivable that one study could establish the scientific validity of a relationship between a nutrient and a disease.”

In 11 years as a consumer advocate, congressional investigator and FDA employee, Zeller said, he has not seen any evidence of bias by the agency against the supplement industry.

Nevertheless, the FDA remains the enemy to many of those whose cause Gallegly has espoused.

“He is representing what the majority of his constituents want,” said Elliott Balbert, chairman of Natrol, a Chatsworth company. Gallegly represented Chatsworth prior to the 1992 reapportionment.

Balbert said that Gallegly’s 23rd District “includes a very, very active consumer base that utilizes dietary supplements. . . .”