Gallegly Is Key Foe of FDA’s Vitamin Rules : Simi Valley: The GOP congressman has emerged as leader of effort to minimize new labeling requirements.

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.). Gallegly 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 of Representatives 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 by some companies that their products can do everything from cure cancer to reverse 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 maintains 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.”

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Last week, the FDA issued new rules that would require dietary supplement makers to provide hard evidence--under the same truth-in-labeling standards that apply to most foods--for any health claims they make for 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 smaller supplement manufacturers, Gallegly has become a player in a complex issue that has aroused widespread alarm among the millions of Americans who regularly take dietary supplements. Nothing else has sparked so much mail to lawmakers 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 is 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 further elaboration of his position.

The heart of the battle concerns implementation of the 1990 food-labeling law authored by Waxman that treats supplements as 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 on Dec. 15.

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

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“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.

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

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

Yet without a legislative remedy, Gallegly has warned, “those small businesses and entrepreneurs who produce dietary supplements are going to be saddled with costly and cumbersome new rules” that could prove financially insurmountable. He says he wants to see the burden of proof for fraudulent claims and product safety, or the lack thereof, placed on the FDA--not the manufacturers.

“The FDA does not prevent people from eating conventional food products that are high in calories, cholesterol, saturated fat, sodium and caffeine, so it should not attempt to impose unreasonable and unnecessary regulations on dietary supplements that many consumers want and many health professionals recommend,” Gallegly said in a Jan. 12, 1993, letter to his House colleagues.

He 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 “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.”

In addition, the bill prohibits any requirement that the manufacturer obtain approval prior to making the claim. Gallegly has subsequently become a co-sponsor of a similar bill by Rep. Richardson that gives the FDA 30 days notice before a product is marketed with a specific claim.

The FDA opposes Richardson’s proposal, which has more than 200 sponsors. Gallegly has more than 60 sponsors; all but one are Republican.

“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 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 that he hasn’t seen “any evidence of bias” by the agency against the supplement industry.

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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 Inc., a medium-sized Chatsworth vitamin company, who has met with Gallegly several times on the issue. Gallegly represented Chatsworth prior to the 1992 electoral reapportionment.

Balbert said Gallegly’s 23rd District “includes a very, very active consumer base that utilizes dietary supplements. . . . I’m sure that’s what aroused his constituency to contact him.”

Clinton Ray Miller, a Virginia-based lobbyist for the National Council for Improved Health, which represents smaller supplement manufacturers and physicians who use herbal and other alternative therapies, has also worked with Gallegly.

He said the lawmaker “has a sense of what’s the proper exercise of authority in the Food and Drug Administration.” He called Gallegly’s bill “perfect” because it would accomplish the legislative goals of those in the nutritional therapy movement.

Less enthusiastic is Ventura County’s other congressman, who comes down on the other side of the debate.

Rep. Anthony C. Beilenson (D-Woodland Hills), whose 24th District includes most of Thousand Oaks, said he supports the right of consumers to retain access to vitamins and other supplements.

But he said he also backs the powers that Congress gave the FDA to regulate the supplement industry under the 1990 food labeling act. Richardson’s bill, he said, “puts a huge burden of proof on the regulators to disprove claims these people are making, rather than the other way around.”

Faced with a torrent of calls and letters from anxious constituents who rely on supplements, Beilenson added: “The easiest thing for a member to do is to sign onto” the pro-industry proposals. “You please 8,000 people.”

But he said he has talked to supplement manufacturers in his district about the FDA’s authority under the 1990 measure and “they’re not able to show me a single item of theirs that has been, or will be, banned.”