Congress Reclassifies Herbal Supplements

In recent years, Congress has taken steps to acknowledge the growing interest in herbal remedies in the U.S. In 1990, Congress classified herbs as dietary supplements. Previously, the Food and Drug Administration (FDA), the federal agency responsible for regulating food and drug safety, had considered dietary supplements to include only essential nutrients, such as vitamins, minerals and proteins. The Nutrition Labeling and Education Act of 1990 expanded the term "dietary supplement" to include such substances as ginseng, fish oils and enzymes, as well.

Prior to 1994, dietary supplements were classified as food additives, and the FDA subjected them to the same regulations as foods under the 1958 Food Additive Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Under those regulations, supplement manufacturers had to prove to the FDA that their products were safe and that their labeling was truthful before their products could be marketed.

But in 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). The DSHEA amended the FD&C Act to include provisions that apply different standards to dietary supplements. Members of Congress hoped that easing dietary supplement regulations would improve public health and reduce health-care expenses.

Now, the burden of testing the safety of dietary supplements has shifted to the FDA. Supplements need not be proven safe before they are sold in health-food stores, supermarkets, pharmacies or mail-order catalogues. The FDA can restrict sales of a supplement only if it later finds the product to be unsafe. Critics say that the DSHEA tied the FDA's hands, preventing the agency from protecting consumers from useless or unsafe supplements. David Kessler, then FDA commissioner, considered the 1994 law to be a mortal blow to the FDA's regulatory powers. "Just walk into your pharmacy; it's out of control," he said, referring to the proliferation of nutritional supplements that claim positive health effects. "The agency is powerless."

The DSHEA does not allow supplement manufacturers to market their products as treatments or cures for ailments or diseases, but allows them to claim that their products support the "structure or function" of body organs or tissues. For example, a supplement can claim to help maintain cardiovascular health, but cannot claim to prevent heart attacks or strokes.

In order to make those permissible health-promoting claims, supplement manufacturers must have some evidence that their claims are truthful and not misleading. In addition, the products must carry a label that states, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." Supplements that merely claim to improve nutrition need not carry any such disclaimer.

The FDA argues that distinctions between products that claim to support bodily structures or functions and those that purport to treat or cure ailments are largely semantic. A product that claims to maintain healthy cholesterol levels could be considered a dietary supplement, while a product that claims to lower cholesterol would be considered a drug. Critics of the FDA's current regulatory policy maintain that either of those claims implies that the product can reduce the risks associated with high cholesterol, such as heart disease, yet dietary supplements are not subjected to the same rigorous testing as are pharmaceuticals making similar claims.

Because there are no regulations on the purity or maximum dosages of most supplement ingredients, herbal products vary widely in the amount of active ingredients they contain. Manufacturers may use different parts of the plant in their herbal products. Different makers of products made from the echinacea plant, for example, use the roots, leaves, flowers or some combination of plant parts. Many say that the lack of regulation leaves consumers unable to rely on the consistency of an herbal supplement from brand to brand. "The manufacturer can use what he wants," says Robert Moore, an FDA scientist. "All that's required is that it has in it what it says it has in it."

In April 1998, the FDA announced a proposal that would clarify the way dietary supplement manufacturers can promote their products as outlined by the DSHEA. While under the 1994 law supplement makers cannot claim that their products may be taken as treatments or cures for specific diseases, the new guidelines would place further restrictions on them, preventing companies from claiming that their products help relieve the symptoms of specific diseases. In addition, companies would not be able to market their products as substitutes for over-the-counter or prescription drugs. Under the guidelines, a product could not claim to reduce joint pain, for example, because that is a specific symptom of some diseases, and could not use a name like "Herbal Prozac," since that name implies that it could take the place of Prozac, a pharmaceutical antidepressant.

That proposal has not yet been finalized--the FDA will accept comments and recommendations from the public until August 1998--but critics say the proposed policy would be as ineffectual as the current standards. Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest (CSPI) in Washington, D.C., calls the proposed rules "a futile bureaucratic exercise in hairsplitting that will do little to protect consumers from misleading claims." Silverglade has called for Congress to allow the FDA to review dietary supplements before the are marketed to determine the validity of their health claims and protect consumers from false promises.

Sources

Cowley, Geoffrey. "Herbal Warning." Newsweek (May 6, 1996): 60.

Daniels, Anthony. "To Heal the Hollow Soul." National Review (July 6, 1998): 46.

Hellmich, Nanci. "Many Doubt Supplements Can Live up to the Claims." USA Today (November 25, 1997): 1A.

Krantz, Michael. "The Self-Medication Generation." Time (May 12, 1997): 72.

Okie, Susan. "With Dietary Supplements, Health Claims Needn't Wait for Science." Washington Post (November 25, 1997): A1.

Ruppel Shell, Ellen. "The Hippocratic Wars." New York Times Magazine (June 28, 1998): 34.