on diet supplements

THE Food and Drug Administration is finally doing what it could and should have done nine years ago -- cracking down on dietary supplements, even though it's already too late for some consumers.

The federal regulatory agency has had the power to force manufacturers to produce clean, uncontaminated, accurately labeled supplements since the Dietary Supplement Health and Education Act was passed in 1994. Unfortunately it hasn't, and hundreds of Americans have unwittingly been hurt or died of effects caused or contributed to by the use of ephedra and other supplements.

It's happened often enough that accurate labels and purity of production are no longer enough. What we need, as the Journal of the American Medical Association said recently, is legislation requiring that supplements with so-called "biological functions" be subject to the rules and regulations "of any drug."

Such substances shouldn't be available until their efficacy and relative safety are established. Only then will we bring sanity to what students of supplemental products call "a madhouse" and FDA Commissioner Mark McClellan now admits is "a buyer beware market."

McClellan and his federal agency are finally saying "we need to make sure" that millions of Americans who take dietary supplements "are getting the products they pay for."

The herbs, extracts, etc. used in supplements are derived "naturally" from leaves, roots, rocks and animal parts and can be as powerful and dangerous as drugs the government strictly regulates. However, they're in a legal category between food and drugs, which means they're not tested for effectiveness, dangers or contents until there is reason to suspect their safety.

Not surprisingly, herbs and supplements don't always carry the amount of desired substance advertised. They're more likely to contain less than more. Half the ephedra products vary by as much as 20 percent, says University of Arkansas pharmacologist Bill Gurley.

Other tests found supplements polluted with bacteria, glass, lead, pesticides and other contaminants. Thus the FDA cave-in to labeling.

But it's not enough. Products that claim to help people lose weight, increase exercise endurance, enhance sexual function or prowess and otherwise boost biological functions need to be treated in the same way as over-the-counter and prescription drugs. They can have just as powerful -- and harmful -- an effect on the human body and therefore should submit to the same testing standards so people know what they're getting and how it might affect them.

To get it done, Congress needs to pass legislation that reverses the current burden of proof. Unlike prescription drugs, which manufacturers must prove are safe before general consumption, the 1994 law says the FDA must prove a supplement harmful. The process is backward and much more difficult to prove. It must be reversed, put the burden of proof where it belongs -- on the manufacturer.

We understand that -- in addition to legislation -- enforcement costs manpower and money at a time when they're in short supply. But lives are at stake and Americans are unwittingly being forced to play a form of deadly roulette.

A study in the New England Journal of Medicine linked 54 deaths to ephedra, an herb that speeds up the metablolism, accelerates the heart rate, raises blood pressure and constricts blood vessels, potentially damaging the cardiovascular system and making it increasingly difficult for the body to cool itself.

Tests may also show what positive effects supplements may have and which substances have healing qualities that are more myth than reality. If Congress doesn't change federal law, however, the industry will continue responding to public concern with the same disdain as Wes Siegner of the Ephedra Education Council, who dismisses concerns about the herb's safety as overblown.

That's one reason district attorneys in Alameda, Kern, Marin, Monterey, Napa, San Benito, San Francisco and Sonoma counties have joined to seek a court order to stop Cytodyne Technologies of New Jersey, makers of Xenadrine, from what they allege is false and misleading advertising that ignores the product's health risks.

It is past time to test and regulate such substances.

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