Botanists conservatively estimate that 250,000 species of flowering plants exist on Earth, some 85,000 plant species worldwide have been used as medicinal botanicals, and as much as 80 percent of the world's population relies on herbal or botanical medicine, according to the Geneva, Switzerland-based World Health Organization (WHO).
Botanicals are defined as fresh or dried plants, plant parts, or plants' isolated or collective chemical components, extracted in water, ethanol, or other organic solvents, plus essential oils, oleoresins, and other extractives used for flavoring, fragrance, functional health benefits, medicine, or other uses, according to eNotes.com. Some also can be classified as herbs, plants used for flavor, fragrance, or medicinal qualities, such as caraway, parsley, rosemary, sage, and thyme. Others fall under the classification of spices, piquant aromatic plant materials, usually of tropical origin, such as cloves, cinnamon, nutmeg, and pepper, used to season food. Commonly used in foods, drugs, and cosmetics, over 1,600 botanicals and their derivatives are sold in the U.S. in a special food category called "dietary supplements."
More than 250 botanicals, often in the form of concentrated extracts, are commonly added during food product manufacturing for flavor, fragrance or technical characteristics, such as coloring, thickening, or preservative activity as natural ingredient additives for many categories of food products, including baked goods, canned goods, meat products, dairy products, candy, nonalcoholic beverages, and alcoholic beverages. Many botanical ingredients have a long history of use and are generally recognized as safe (GRAS).
To enter the American market, a new ingredient not previously marketed materially in the U.S., must receive prior approval by the FDA. The manufacturer (or industry trade organization) may submit toxicological data to the FDA in support of the ingredient's safety.
In 1994 the U.S. Congress passed the Dietary Supplement Health and Education Act, which created a special food regulatory category for dietary supplements, including vitamins, minerals, herbs or other botanicals, amino acids, or other dietary substances used to supplement the diet by increasing the total dietary intake. Concentrates, metabolites, constituents, extracts, or their combinations also are included in the definition.
Dietary supplements are regulated as foods rather than as drugs despite the fact that most such products are intended to provide a health benefit. The vast majority of botanicals available on the American market, from over 1,600 plant species, are sold as dietary supplements.
Many well-known botanicals sold as dietary supplements in the U.S. also are available in other Western countries, notably Germany, where they are regulated as drugs under a special category called phytomedicines. By definition, phytomedicines include the totality of chemical constituents within a botanical or plant part rather than a single isolated chemical component. Well-known botanicals in this category are garlic, ginkgo leaf extracts, echinacea, ginseng, kava kava, saw palmetto, St. John's wort , and valerian. In European markets these botanicals are strictly regulated.