Herbals and Dietary Supplements
15.4.15 Herbals and Dietary Supplements
Herbals and dietary supplements do not receive INNs, and they are not regulated as drugs in many countries, including the United States (as mandated by the Dietary Supplement Health and Education Act, passed in 199411).
In the United States, Congress has defined a dietary supplement as
a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, [Dietary Supplement Health and Education Act] places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.11,12
Components of dietary supplements may be pharmacologically active, so accurate and specific nomenclature is essential. As noted above, dietary supplements are often mixtures of several ingredients, and quantities of each may be proprietary. Such a mixture makes standard nomenclature policy difficult to establish. Whenever possible, a nonproprietary name should be used to refer to a dietary supplement. However, if the dietary supplement is a mixture of many components, either an abbreviation derived from the components or the proprietary name must be used. (See also 15.4.9, Combination Products.)
Metabolife 356 (Metabolife International Inc, San Diego, California) is a dietary supplement containing 19 labeled ingredients including ephedra and caffeine (hereinafter abbreviated as DSEC).
The USP Dictionary,1 Physicians’ Desk Reference for Nonprescription Drugs and Dietary Supplements,13 Physicians’ Desk Reference for Herbal Medicines,14 and The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines15 are useful resources for naming herbals and dietary supplements. If these resources do not provide the necessary information, the Web can be helpful in identifying substances as well, although of course the accuracy of the source should be considered.
Herbal medicines generally can be named according to their botanical genus and species, although the lack of regulation in some countries again makes consistent nomenclature a challenge. A review of regulation of herbal medicines worldwide has been completed by the WHO.16 Particularly in countries where botanicals are not regulated, the specific herbal and manufacturer, wherever relevant, should be included, since different manufacturing techniques result in different biological activity. According to WHO,
It is not unusual for a common name to be used for two or more different species. Unless the names of herbal plants follow an international system of plant nomenclature, the potential for confusion when exchanging information is enormous. The information attached to a name is thus crucial. As an example, because common names are often used, heliotrope (Heliotropium europaeum)—containing potent hepatotoxins—is often confused with garden heliotrope (Valeriana officinalis), which is used as a sedative and muscle relaxant. Identification of the herbal preparation by the Latin binomial system, in addition to the common name, is therefore essential.17
Thus, whenever possible, herbals derived from a specific plant should be named according to the botanical name (eg, Ginkgo biloba, Echinacea purpurea) to ensure that the correct entity is identified. When the plant itself is referred to, the genus and species may be abbreviated after being spelled out at first mention:
The main pharmacologic substances with immunostimulant activity in experimental and clinical studies are purified polysaccharides that can be extracted only in small quantity from pressed Echinacea purpurea.
Given our laboratory findings, the symptoms we have described may be attributed to an overdose of Illicium verum, contamination with Illicium anisatum, or a combination of both.
One day prior to taking Ginkgo biloba or placebo and again at the end of the 6-week double-blind period (while still taking G biloba and within 3 days of the end of the study), participants underwent neuropsychological evaluation including tests of learning, memory, attention and concentration, and expressive language.
In some cases the vernacular name is not the genus or species and should be provided as well to ensure that the reader understands which plant is intended.
Hypericum perforatum (St John’s wort) is a popular herbal product used to treat depression, but it has been implicated in drug interactions.
When referring to a specific product or formulation, as in a study, the specific proprietary name and manufacturer should be listed, because formulations vary by manufacturing technique.
Participants were randomly assigned to 1 of 2 conditions: Ginkgo biloba (Ginkoba; Boehringer Ingelheim Pharmaceuticals, Ingelheim, Germany) or placebo control (1:1 ratio).
A marketed enteric-coated preparation (Tegra; Hermes Arzneimittel GmbH, Grosshesselohe, Germany) containing 5 mg of steam-distilled garlic (Allium sativum) oil bound to a matrix of beta cyclodextrin and matching placebos, whose coating tasted like garlic, were used.
Guggulipid, which is an extract from the plant Commiphora mukul (guggul), contains numerous other substances besides the small amounts of guggulsterones purported to be the active ingredients.