Herbal Medicine and the FDA

Nowadays, herbal supplements are plentiful in the United States: over 1,500 herbs are currently marketed and carried in health food stores, supermarkets, pharmacies, department stores, and even the occasional truck stop. In addition, about one-quarter of all U.S. prescription drugs are derived from herbs. Most of these plant-derived compounds were developed as researchers investigated the truth behind the folklore of various countries where the herbs could be found (and were traditionally used). The history of botanical remedies in this country, however, has not always been so harmonious. Indeed, the use of herbs as natural medicine was almost completely suppressed little more than a decade ago.

Herbology had been the pre-eminent form of medicine in America in the 1800's. Evolving as a hybrid of European herbalism (courtesy of the Pilgrims, who carried a book on the subject over on the Mayflower) and Native American knowledge, it defined the approach taken by the most effective healers of the time. After the Civil War, however, chemist began learning how to isolate the active ingredients in plants to create new compounds, and the use of raw, whole plant herbal remedies fell out of favor. The decline of herbs in medicine eventually led to the removal of many from the United States Pharmacopoeia (USP). By 1990, only a handful remained.

Many problems occur when a natural substance is subjected to strict guidelines and criteria. The Food & Drug Administration (FDA)'s policies have often been hostile towards the herb industry for a number of reasons. It is hard to ensure consistent dosage (strength) with botanicals, as opposed to synthetic drugs. Also, whereas pharmaceuticals are designed for specific effects on the body or mind, herbs tend to work a variety of influences upon the people who take them. We also have to consider how the popularity of herbal remedies would impact upon pharmaceutical companies' profits.

After being phased out of the USP (which served as the official standard by which the FDA would approve new drugs) the last hope for herbal medicine became the over-the-counter (OTC) drug marketplace. In 1972, however, the FDA began reviewing and categorizing OTC products, judging them by safety and efficiency standards. Virtually all herbs were listed under Category II (those not recognized as safe and effective) or Category III (those whose safety and efficacy were not yet determined). As a result, botanicals were summarily removed (for the most part) as OTC active ingredients.

The conflict between the herbal industry and the FDA came to a head in 1991. New, even more restrictive regulations had been put in place, leaving the herb companies with no recourse but to seek corrective legislation. What resulted was one of the most significant changes to the Food, Drug and Cosmetic Act: the Health Freedom Act of 1992. Bill Clinton signed this into law as the Dietary Supplement Health and Education Act in 1994. It was achieved, in large part, by the massive support of average consumers. Millions called and wrote to members of Congress and urged them to support this act.

Today, the government exercises light regulations on herbs. Herb manufacturers don't have to conduct the same safety and efficacy studies that are required for other drugs. The FDA can, however, remove herbal products that it considers unsafe. Justification for such removal must be offered up in an administrative hearing. Also, herb manufacturers are prohibited, in large part, from saying that herbs can actually cure disease - nor can they print such claims on their labels.