Regulation of Botanicals in the United States

At least four regulatory classifications are now possible for botanicals in the United States:

  1. Food
  2. Dietary supplement
  3. Over the-counter (OTC) drug, and
  4. Prescription (Rx) drug.

However, most botanical products are regulated as dietary supplements according to provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Plants have, at one time, supplied virtually all cultures with food, clothing, shelter, and medicines. It is estimated that approximately 10 to 15 percent of the roughly 300,000 species of higher plants have a history of use in traditional medicine.

By contrast, only 1 percent of plant species have a history of food use (McChesney, 1995). One hundred years ago, herbs were well established as medicines in the United States. They were widely listed in the United State Pharmacopeia (USP) and prescribed by physicians.

Herbal tinctures, extracts, salves, and so forth, were the materia medica of the day. Regulation of medicines in this country began when the authority to set and enforce drug safety standards was given to the Food and Drug Administration (FDA) in 1938.

The passage of the Food, Drug, and Cosmetic Act gave the FDA the responsibility to prosecute the adulteration or misbranding of foods, drugs, and cosmetics. Herbal preparations soon gave way to single-entity chemical drugs. WorldWar II created a demand for more powerful drugs of all kinds, particularly antibiotics and trauma treatment agents.

The federal government urged drug companies, then largely botanical crude-drug houses, such as Merck, Lily, and Parke-Davis, to invest in new synthetic chemistry-based research. Single-entity chemicals were more consistent, easier to measure, and judged more specific in their therapeutic focus than botanical preparations.

In 1951, Congress passed the Durham-Humphrey Act which defined a prescription drug as any drug that because of its toxicity or other potential for harmful effect or method of use is not safe for use except under the supervision of a practitioner licensed by law to administer such a drug (Young, 1995).

Manufacturers at that time had to position their drugs as either Rx or OTC. In 1962, the Food, Drug, and Cosmetic Act was expanded to require all drugs marketed at that time to be proven both safe and effective. The FDA then issued guidelines for safety and efficacy testing requirements for new drugs.

As a result, new drugs now required the FDA’s approval before marketing. Old drugs were permitted to remain on the market as long as their ingredients and labeling remained unchanged. In 1972, the FDA began a comprehensive review of all OTC drug products to assess their safety and efficacy.

Drug ingredients found to be generally recognized as safe and effective (GRASE) were placed into Category I and approved for marketing. Those determined to be unsafe or ineffective were placed in Category II and banned from use in any OTC drug.

If safety and efficacy could not be determined due to a lack of information, then the ingredient went into Category III. With few commercial sponsors to conduct safety and efficacy studies, many botanicals, listed as possible or known ingredients in OTC products, were relegated to Category II status and some were placed in Category III.

With few herbs retaining drug status after the OTC review, the botanical industry had no other regulatory option but to offer their products as foods. In the late 1970s, the FDA began to apply the food additive provisions of the Food, Drug, and Cosmetic Act to botanicals.

Under provisions added to the Federal Food, Drug, and Cosmetic Act of 1958, food additives already on the market in 1958 were accepted without FDA review. However, substances added to the food supply after this date were required to gain FDA approval prior to marketing, unless they were considered GRAS (generally recognized as safe).

A fair number of herbs were included on a list of GRAS food additives that had been prepared by the Flavor and Extract Manufacturers Association as flavorings for alcoholic beverages. However, the FDA viewed commonly used herbs as unapproved food additives and therefore subject to FDA approval prior to marketing.

This interpretation led to a series of bitterly fought court cases and several herbs being taken off the market. Congress passed the Nutrition Labeling Education Act of 1990 (NLEA) to reform food labeling and to allow, for the first time, a new class of health claims based on disease-nutrient relationships.

For the most part, this legislation did not apply to botanicals because of the way it was written and the way it was interpreted by the FDA. With lawsuits between herbal manufacturers and the FDA commonplace, a group of leading herb companies met with Senator Orrin G.

Hatch (R-Utah) and Congressman Bill Richardson (D-New Mexico) who drafted legislation that became the Dietary Supplement Health and Education Act of 1994. This law was passed by Congress and signed into law by President Clinton on October 25, 1994. This was the first time a U.S. law defined the terms herb or botanical.