Regulating herbal medicine

In the 19th century, many fake remedies were sold to gullible, desperate Americans. The federal government finally took action against disreputable purveyors of phony remedies by passing the Food and Drug Act of 1906. This law addressed problems of mislabeling and adulteration of plant remedies — but not safety and effectiveness.

Today, herbal remedies remain largely unregulated. The Food and Drug Administration (FDA) regulates herbal products only as dietary supplements, not drugs. This means that the FDA can recall herbal products that are shown to be harmful, but manufacturers aren't required to provide information about their products' contents or side effects or to prove their safety or efficacy. They need only provide "reasonable assurance" that the product contains no harmful ingredients.

What's more, although manufacturers can't claim a particular product cures or prevents a specific disease, they can make any other claim about the supposed benefits without providing supporting evidence. They need only add the following disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."

In essence, herbal remedies in the United States are sold on a buyer-beware basis. This highlights the importance of learning everything you can about any herbal products you plan to use.

European standards

In Europe, where millions of people use herbal and homeopathic remedies, governments and the scientific community are much more open to natural remedies, especially those with a long history of use. In Great Britain and France, traditional medicines that have been used for years with no serious side effects are approved for use under the "doctrine of reasonable certainty" when scientific evidence is lacking.

The European Economic Community has established guidelines that standardize the quality, dosage, and production of herbal remedies. These guidelines are based on the World Health Organization's Guidelines for the Assessment of Herbal Medicines, a 1991 publication that addressed concerns about the safety and effectiveness of herbal medicines.

by:
Charles W. Fetrow, Pharm.D. , Juan R. Avila, Pharm.D.