Herbs Affecting the Central Nervous System Varro E. Tyler LAWS AND REGULATIONS GOVERNING HERBAL MEDICINES IN THE US

LAWS AND REGULATIONS GOVERNING HERBAL MEDICINES IN THE US As a result of the existing laws and regulations, most herbal remedies (botanicals, phytomedicines) are currently marketed in the United States as dietary supplements, a food category, not as the drugs they are. This situation stems directly from the passage, in 1962, of the Kefauver–Harris Amendments to the Federal Food, Drug, and Cosmetic Act of 1938. These amendments required drugs to be proven effective prior to marketing, in addition to the purity and safety requirements already in effect. Although the law specifically exempted from this requirement all drugs marketed prior to 1938, which included almost all of the herbal remedies, the Food and Drug Administration (FDA), by a clever application of administrative law, i.e., regulations, circumvented the will of Congress. The agency declared that although sale could continue, any unproven claim of efficacy would cause the herb to be considered as misbranded which could result in confiscation. To determine efficacy of over-the-counter products, in 1972 the FDA established 17 panels to evaluate, on the basis of submitted information only, the data supporting such claims. The panels were not permitted to utilize anecdotal information, product popularity, nor did they conduct detailed literature surveys. Because proof of efficacy studies are extremely expensive—current estimates for new chemical entities range up to one-half billion dollars—a limited amount of data was submitted to the panels for the old botanical remedies for which patent protection and market exclusivity with consequent profitability were doubtful. In consequence, very few herbal remedies were approved as drugs. The few that were found acceptable included capsicum (Capsicum spp.) as a topical analgesic, slippery elm (Ulmus rubra Muhl.) as a demulcent, psyllium seed and husk (Plantago spp.) as a laxative, and distilled extract of witch hazel (Hamamelis virginiana L.) as an astringent (due to the 14% alcohol added to the final preparation). On the basis of inadequate data submission, the FDA declared peppermint (Mentha × piperita L.) to be an unsafe and ineffective digestive aid and placed other useful remedies such as the antitussive eucalyptus (Eucalyptus globulus Labill.) and the laxative prune (Prunus domestica L.) concentrate in the same category. Sales of such herbal products declined for a time but began to increase once again in the 1980s as consumers became more health conscious and displayed a significant interest in natural products. Finally in 1993, Commissioner David Kessler of the FDA threatened additional …