The market

The use of herbal medicines in the United States is less widespread than in the majority of developed nations as wider distribution through pharmacies is difficult because no medical claims may be made and consumers are dependent on advice from pharmacists who, in majority of cases, have little knowledge about medicinal herbs. Also distribution of herbal products is limited to health food stores frequented by only a small proportion of the population.

Legal status

Ever since the passing of the Food, Drug and Cosmetic Act in the late 1930s the Food and Drug Administration (FDA) has regulated as drugs any products which claim to treat, cure, mitigate or prevent a disease. Thus for any herbal medicine claims to be allowed, the same procedures must be followed as for a chemical drug. Thus most natural products in the United States are regulated as foods or food additives even though many are used by consumers as folk medicines. Even for herbs ‘generally recognized as safe’ (GRAS) and related products that are not misbranded or adulterated, no claims are allowed. Natural products theoretically have GRAS status, as long as qualified experts confirm this and are not contradicted by other experts. Also the requirement of ‘common use in food’ is not only restricted to use in the United States, but applied also to herbs without a history of use in the United States. Though some better-known medicinal herbs were initially listed by the FDA for OTC status, they were dropped as the US herbal drug industry failed to submit evidence to support their use as such.

Following the ‘Proxmire Bill’ of 1976, according to a civil regulation for the Health Food Market, foods including dietary supplements are not categorized as drugs. This law kept the FDA from making monographs on dietary supplements, vitamins, minerals and herbs as has been done for several kinds of drugs.

Nutrition Labelling and Education Act (NLEA) passed by the Congress in 1990 required all food products to have nutritional labelling and the FDA was required to establish criteria for approving such health benefit labelling. Vitamins, minerals, herbs and similar nutritional substances that are consumed differently from conventional food were considered for exemption and leniency with respect to standards of evidence for their health benefits. The Dietary Supplement Health and Education Act (DSHEA) of 1994 recognized the usefulness of dietary supplements in preventing chronic diseases and helping limit long-term health care costs. Herbs and other botanicals, vitamins and minerals too now fall under the definition of a dietary supplement which is presented in a dosage form such as capsules, tablets, liquids etc. Dietary supplements do not include substances first sold as drugs and later as dietary supplements, nor do they include substances undergoing clinical studies which were not first sold as dietary supplements.