Herbs May Not Be What You Think.

Huge numbers of Americans consume herbal products these days and most assume they are regulated by the FDA just as over-the-counter products are. It's not so. In 1994, Congress passed the Dietary Supplement Health and Education Act, which effectively removed all regulation of this $12 billion-a-year industry.

Under the current law, a manufacturer or distributor of herbal supplements, teas, or tonics doesn't need to demonstrate any real benefit of the product, just reasonable assurance that no ingredient presents a significant or unreasonable risk of illness or injury. Package labels may not promise to cure a specific disease. Thus they may not claim a product will help MS, but they can claim their product will "improve nerve conduction" or "help the immune system" without any supporting data as backup. They must, however, inform the FDA of such claims.

Food or drug?

The distinctions among health foods, herbs, and drugs are increasingly blurred, leaving many consumers with the impression that while drugs need to be handled with care, herbs are completely safe and "drug free". But the active ingredients in some herbal supplements are very powerful indeed.

No one is surprised to learn that prescription drugs can cause life-threatening side effects. But so can herbs. There have been 3 dozen deaths attributed to products containing ephedra, also known as ma huang, and over 800 reports of adverse reactions. (Florida, New York, and Nebraska, among other states, have now banned the sale of some products containing it.) There have been at least 4 deaths associated with weight-loss teas containing laxative herbs. Even the innocent-sounding licorice can cause significant rises in blood pressure.

St. John's Wort, sold as an herbal supplement, not a drug, has been reported to have active anti-depressant properties. A person already taking a prescription anti-depressant drug who adds St. John's Wort to a daily regimen runs the risk of over-medication.

Very few trials of herbal preparations have met scientific medicine's gold standard--a double-blind, placebo-controlled study. The 3 studies of St. John's Wort in progress, sponsored by the National Institutes of Health, are an exception.

The question of consistent dosage

Lack of FDA regulation leaves consumers in the dark. Even if you consult knowledgeable authorities, and know what herbal product you want to take and why, there are currently no federal standards of quality control. That means there is no real guarantee of consistent dosage or content from one lot number to the next.

The March 1999 issue of the nonprofit Consumer Union's Consumer Reports compared contents and costs of popular herbals. They found this problem over and over. For example, the active ingredient in individual samples of ginkgo biloba from the same national brand ranged from 7 to 13%.

Consumer help on the horizon

The U.S. Pharmacopoeia (USP; www. usp.org), a nonprofit organization that establishes standards of quality and purity for medicines and other healthcare products, recently identified 21 dietary supplements and herbal products that constitute over 80% of the U.S. market. USP has already published 9 monographs intended to establish standards for them. Manufacturers who voluntarily subscribe to these standards can apply the "NF" (National Formulary) designation to their product label. It's worth looking for this.

In March 1999 the FDA began requiring a "Supplement Facts" panel on the label of most products that claim to affect body structure or function. The label must say: "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."

The Council for Responsible Nutrition, an industry trade group, has developed GMPs, or good manufacturing practices, for its member companies.

Even with some quality control measures in place, consumers need to be careful. Teas and herbal supplements often make people feel they are taking positive steps to maximize their health. Wise consumers will first make sure they have all the necessary information and will consult with their physicians or other health-care professionals to avoid drug interactions or side effects.

People who have experienced a serious harmful effect or illness from using a dietary supplement can file a report with the FDA by phone or online. Contact MedWatch at 800-FDA-1088 or www.fda.gov/medwatch/

SOURCES OF INFORMATION

Books

PDR for Herbal Medicine. Medical Economics Data , 1998. 800 pp., $59.95. To order, call: 800-678-5689.

This Physician's Desk Reference lists hundreds of common herbs and botanicals with name and description, pharmacology, and clinical effects, indications contraindications, dosages, precautions, and side effects.

The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies, by Barrie R. Cassileth, PhD. W.W. Norton, 1999. 340 pp., $19.95. To order, call: 800-233-4830, or visit: www.wwnorton.com

Tyler's Honest Herbal: A Sensible Guide to the Use of Herbs and Related Remedies, by Varro E. Tyler. Haworth Press, 1999. $49.95. To order, write: 10 Alice Street, Binghamton, NY 13904-1580; call: 800-342-9678; or visit: www.haworthpressinc.com

Web sites

American Dietetic Association, www.eatright.org Information on nutrition, diets, and dietary supplements. Look under "government affairs" for food labeling issues.

Quackwatch, www.quackwatch.com Medical opinions on alternative therapies considered worthwhile, harmless, or dangerous.

U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, www.cfsan.fda.gov/~dms/supplmnt. html Information on dietary supplements which includes warnings about dangerous treatments.

Ann Palmer is director of Library Reference and Technical Services at the Society's national Information Resource Center.