With the passage of the Keafuver-Harris Amendments in 1962, all marketed drugs were investigated, including herbs, the panels evaluated them concentrated only on active ingredients. Herbal preparations were then promoted by manufacturers as food products and could only be sold if the lables did not make statements about preventing or treating a disease. Many drugs containing herbs were judged unsafe or ineffective, or lacking evidence for evaluation. Some herbs were no longer marketed, but most companies merely removed the information claiming their effects from the labels. The FDA does keep a list of herbs that are generally recognized as safe (GRAS) but this is based primarily on a food use.

According to Varro E. Tyler, professor of pharmacognosy at Purdue University, what is needed is a "rational use of phytomedicinals." ⁵ Such a system would provide effective indications for use on the label as well as standards for purity and quality in preparation. Tyler believes that access to safe and effective herbs would help with the increasing cost associated with traditional drug therapy.

Some progress has been made. In 1984 Canada banned more than 50 herbs as unsafe, and required warning labels as harmful in pregnancy in 5 others⁸ In 1978 Germany established Commission E to review the safety and use of over 1500 herbal drugs. From this panel's study of clinical trials have come about 300 monographs that are reported to be the most accurate summaries available on the safety and efficacy of herbs and phytomedicinals.⁹ Approval by Commission E, however does not mean the herb is approved for use in the United States. In 1994 the Dietary and Supplement Health and Education Act was passed. It states that herbs can be labeled with information on effects on the body's structure and function, but must state that the FDA has not reviewed them and they are not intended for use as drugs.¹⁰ However, until some agreement among the FDA, manufacturers and pharmacology experts is reached on interpretation of data, safety and efficacy issues will remain.

Safety Concerns

Issues of safety are of paramount importance to the consumer and the provider. Some of these are dosage, source and quality of purity.

Since adulteration or substitution may occur, the dosage may vary considerably from dose to dose. For example, the longer teas are steeped, the stronger the dose. Thus teas thought safe by the consumer because it is a food, must be considered a drug. One laypress story of a woman who used two tea bags of a dieter's tea and died from cardiac arrest signifies the importance of such warnings.¹¹ Another woman drank up to 10 cups of comfrey tea for stomach pains and later developed liver disease. ⁸

Many consumers grow their own herbs or use imported ones. There is no way of knowing exact amounts or quality of components. Environment, climate and conditions in which the herb is grown can cause many differences in the product, and different parts of the plant can have different effects. Thus dangers have increased, decreased, or aberrant effects exist if consumers do know what they are using. One woman thought she was drinking eucalyptus tea because she had picked the leaves, but in fact she drank a poisonous tea from oleander leaves.

Imported products may contain substances that in this country are regulated as prescribed drugs, such as digitalis. Those at particular risk, such as the elderly, may be in special danger from such products, which may interact with traditional drugs they are taking.⁹

Thus, health care providers have an obligation to elicit as exact information as possible about herbal products patients are using, the amount per dose, and amounts consumed daily, to offer the best advise for safety. Table 1 provide details on different types of herbal preparations.

Table 1 Herbal Prescriptions

Preparation Description

Bulk Herbs Raw dried material found in jars or bins; used in teas, tinctures, powdered for capsules, tablets

Oil External use only, some are fatal if ingested, used in aromatherapy

Tablets, capsules Stored and transported easily; popular in the country

Teas Hot water extracts, 3 types

Beverages, teas--steeped 1-2 minutes

Infusions - steeped 10-20 minutes

Decoctions - plant material simmered in boiling water 10-20 minutes

Tinctures Alcohol extracts; highly concentrated; come in small bottles with eyedropper caps, few drops usually used.