New Law Allows Leeway in Herbal Claims : Health: FDA approval of labeling could still leave room for confusion, agency official says. Public is warned to be vigilant.

Prevent aging. Resist AIDS. Kill infections. Stop the spread of cancer. Slow the progress of multiple sclerosis. Relive your childhood.

These are some claims that have been made for herbal remedies by their makers.

A new federal law says they’re illegal unless the Food and Drug Administration approves them beforehand.

But the law allows some new leeway in how herbal remedies and other dietary supplements are labeled and promoted in side literature. The Dietary Supplement Health and Education Act of 1994 says supplements can bear claims about how they will affect the structure or function of the body.

Labels can say, for example, a product “boosts T-cells” or is valuable “for the proper function of the immune system” if there’s evidence to indicate it’s true.

And that worries the FDA.

“These claims do not require FDA approval,” warned Mitch Zeller, an FDA special assistant for policy. Companies are free to make the claims without providing scientific evidence.

“The law says they have to have substantiation,” Zeller said. “It just doesn’t say how much.”

The FDA argues that harm could come to a person with AIDS who, say, interprets a claim about T-cells, the disease-fighting cells important in holding AIDS at bay, to mean a supplement will improve their health.

Claims must be accompanied by a disclaimer that says the FDA has not evaluated the claim and the supplement is not intended to prevent, treat or cure disease, but confusion may still prevail, Zeller said.

“Our message to the public is: Be vigilant. Be very careful. Read the labels and check with a health professional if you have any condition you think can be treated with one of these products,” Zeller said.

The dietary supplement act became law on Oct. 25. But it will take four years to go fully into effect.

The act classifies herbal remedies, vitamins, minerals and amino acids as foods. It restrains the FDA from regulating them as heavily as food additives and drugs, which must be shown to be safe to the FDA’s satisfaction before they are marketed.

The new law says any supplement is considered safe unless the FDA proves otherwise.

That measure took two years of congressional wrangling, and more than 2 million pieces of consumer mail, springing in part from fears that the FDA might end up yanking many popular supplements from shelves over safety concerns.

“That battle was based on people’s philosophical beliefs: ‘We’re taking it. We want to continue taking it. Get out of our faces,’ ” says Roy Upton, president of the American Herbalists Guild.

The FDA may remove a dietary supplement now on the market only when the product presents a “significant or unreasonable risk of illness or injury” if used as directed.

The new law requires labels to spell out the ingredients of each supplement. For herbs, that includes which part of the plant the product is derived from. Labels must also show the amount of each ingredient. But the labeling requirements won’t be enforced until the end of 1996, Zeller said.

The law requires that a seven-member Commission on Dietary Supplement Labels be appointed by the president to provide recommendations for the regulation of product labeling.

And it’s going to be a long process, Zeller said. “They get two years to deliberate and make recommendations, and from the date we receive the recommendations, we have two years to issue any regulations changing how health claims and other claims are regulated.”