Dietary Supplement Fact Sheet

Botanical Dietary Supplements: Background Information
 
Table of Contents

What is a botanical?

A botanical is a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent. Herbs are a subset of botanicals. Products made from botanicals that are used to maintain or improve health may be called herbal products, botanical products, or phytomedicines.

In naming botanicals, botanists use a Latin name made up of the genus and species of the plant. Under this system the botanical black cohosh is known as Actaea racemosa L., where "L" stands for Linneaus, who first described the type of plant specimen. In the Office of Dietary Supplements (ODS) fact sheets, we do not include such initials because they do not appear on most products used by consumers.

Can botanicals be dietary supplements?

To be classified as a dietary supplement, a botanical must meet the definition given below. Many botanical preparations meet the definition.

As defined by Congress in the Dietary Supplement Health and Education Act (http://www.fda.gov/opacom/laws/dshea.html#sec3), which became law in 1994, a dietary supplement is a product (other than tobacco) that
  • is intended to supplement the diet;
  • contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
  • is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
  • is labeled on the front panel as being a dietary supplement.

How are botanicals commonly sold and prepared?

Botanicals are sold in many forms: as fresh or dried products; liquid or solid extracts; and tablets, capsules, powders, and tea bags. For example, fresh ginger root is often found in the produce section of food stores; dried ginger root is sold packaged in tea bags, capsules, or tablets; and liquid preparations made from ginger root are also sold. A particular group of chemicals or a single chemical may be isolated from a botanical and sold as a dietary supplement, usually in tablet or capsule form. An example is phytoestrogens from soy products.

Common preparations include teas, decoctions, tinctures, and extracts:
  • A tea, also known as an infusion, is made by adding boiling water to fresh or dried botanicals and steeping them. The tea may be drunk either hot or cold.
  • Some roots, bark, and berries require more forceful treatment to extract their desired ingredients. They are simmered in boiling water for longer periods than teas, making a decoction, which also may be drunk hot or cold.
  • A tincture is made by soaking a botanical in a solution of alcohol and water. Tinctures are sold as liquids and are used for concentrating and preserving a botanical. They are made in different strengths that are expressed as botanical-to-extract ratios (i.e., ratios of the weight of the dried botanical to the volume or weight of the finished product).
  • An extract is made by soaking the botanical in a liquid that removes specific types of chemicals. The liquid can be used as is or evaporated to make a dry extract for use in capsules or tablets.

Are botanical dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (also known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists for standardization in the United States as it applies to botanical dietary supplements. Because of this, the term "standardization" may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.

Ideally, the chemical markers chosen for standardization would also be the compounds that are responsible for a botanical's effect in the body. In this way, each lot of the product would have a consistent health effect. However, the components responsible for the effects of most botanicals have not been identified or clearly defined. For example, the sennosides in the botanical senna are known to be responsible for the laxative effect of the plant, but many compounds may be responsible for valerian's relaxing effect.

Are botanical dietary supplements safe?

Many people believe that products labeled "natural" are safe and good for them. This is not necessarily true because the safety of a botanical depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used.

The action of botanicals range from mild to powerful (potent). A botanical with mild action may have subtle effects. Chamomile and peppermint, both mild botanicals, are usually taken as teas to aid digestion and are generally considered safe for self-administration. Some mild botanicals may have to be taken for weeks or months before their full effects are achieved. For example, valerian may be effective as a sleep aid after 14 days of use but it is rarely effective after just one dose. In contrast a powerful botanical produces a fast result. Kava, as one example, is reported to have an immediate and powerful action affecting anxiety and muscle relaxation.

The dose and form of a botanical preparation also play important roles in its safety. Teas, tinctures, and extracts have different strengths. The same amount of a botanical may be contained in a cup of tea, a few teaspoons of tincture, or an even smaller quantity of an extract. Also, different preparations vary in the relative amounts and concentrations of chemical removed from the whole botanical. For example, peppermint tea is generally considered safe to drink but peppermint oil is much more concentrated and can be toxic if used incorrectly. It is important to follow the manufacturer's suggested directions for using a botanical and not exceed the recommended dose without the advice of a health care provider.

Does a label indicate the quality of a botanical dietary supplement product?

It is difficult to determine the quality of a botanical dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.

FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.

What methods are used to evaluate the health benefits and safety of a botanical dietary supplement?

Scientists use several approaches to evaluate botanical dietary supplements for their potential health benefits and safety risks, including their history of use and laboratory studies using cell or animal studies. Studies involving people (individual case reports, observational studies, and clinical trials) can provide information that is relevant to how botanical dietary supplements are used. Researchers may conduct a systematic review to summarize and evaluate a group of clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis of data combined from many studies.

What are some additional sources of information on botanical dietary supplements?

Medical libraries are one source of information about botanical dietary supplements. Others include Web-based resources such as PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=nih) and FDA (http://www.cfsan.fda.gov/~dms/ds-info.html). For general information about dietary supplements see Dietary Supplements: Background Information (http://ods.od.nih.gov/factsheets/dietarysupplements.asp) from the Office of Dietary Supplements (ODS), available at ods.od.nih.gov.

Glossary

administration - The process of giving a person a medicine or dietary supplement by mouth, by vein, on the skin, or by another route. For example, a 14-day administration of valerian extract.
amino acid - A chemical building block of protein.
animal study - A laboratory test using animals to study the development and course of human diseases, and to test the safety and effectiveness of new treatments before they are given to humans.
black cohosh - A plant whose rhizome and root are used to relieve hot flashes and other symptoms of menopause. It is not known how black cohosh works or whether it acts like estrogen (a hormone needed to develop and maintain female sex characteristics and the growth of long bones). Historically, black cohosh has been used to treat many medical conditions. Also called black snakeroot, bugbane, bugwort, rattleroot, rattletop, rattleweed, and macrotys. Latin names: Actaea racemosa and Cimicifuga racemosa.
botanical - Having to do with plants or plant parts, or dietary supplement products made from plants.
botanist - A scientist who studies the biology of plants.
capsule - A gelatin shell containing a dose of medicine, a vitamin, or other dietary supplement.
cell - The individual unit that makes up the tissues of the body. All living things are made up of one or more cells, which are the smallest units of living structure capable of independent existence.
chamomile - The flower of this herb is used in some cultures for its calming effect, to promote sleep, and as a treatment for indigestion. It is being studied in relieving chronic pain in children with bowel disorders. Latin names: Matricaria recutita and Anthemis nobilis.
clinical trial - A type of research study that uses volunteers to test the safety and efficacy (the ability to produce a beneficial effect) of new methods of screening (checking for disease when there are no symptoms), prevention, diagnosis, or treatment of a disease. Also called a clinical study.
compound - In pharmacy, a substance that contains more than one ingredient.
constituent - A component, part, or ingredient of a larger whole. For example, valerenic acid and valepotriate are constituents of the dietary supplement valerian.
data - Facts and information.
decoction - A substance made by simmering some types of roots, bark, and berries in water to extract their desired ingredients. It is simmered for a longer time than that needed to make tea and may be drunk hot or cold.
dietary supplement - A product that is intended to supplement the diet. A dietary supplement contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their components; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is identified on the front label of the product as being a dietary supplement.
digestion - The process the body uses to break down food into simple substances for energy, growth, and cell repair.
dose - The amount of medicine or other substance taken at one time or over a specific period of time.
drug - Any substance (other than food) that is used to prevent, diagnose, treat, or relieve symptoms of a disease or abnormal condition. Also, a substance that alters mood or body function or that can be habit-forming or addictive, especially a narcotic.
extract - A substance made by soaking an herb in a liquid that removes specific types of chemicals. The liquid can be used as is or evaporated to make a concentrate or a dry extract for use in capsules or tablets.
genus - The name of a category that is part of the scientific classification of all organisms. Genus is located in the classification system after kingdom, phylum, class, order, and family and before the subclassification of species. Humans, for example, belong to the genus Homo and are identified by the scientific name Homo (genus) sapiens (species).
ginger - The root of this plant has been used in cooking and in some cultures to treat nausea, vomiting, and certain other medical conditions. It is being studied in the treatment of nausea and vomiting caused by cancer chemotherapy. Latin name: Zingiber officianale.
health care provider - A person who supplies health care services. Health care providers include individuals with professional training (including doctors, nurses, technicians, and aides).
herb - A plant used in cooking, in tea, and for medicinal purposes.
herbal - Having to do with or made from medicinal or edible plants.
kava - The root of this plant has been used in traditional medicine to relieve stress, anxiety, tension, sleeplessness, and problems of menopause. The US Food and Drug Administration advises users that products containing kava may cause severe liver damage. Also called kava kava, intoxicating pepper, rauschpfeffer, tonga, and yangona. Latin name: Piper methysticum.
label - When referring to dietary supplements, information that appears on the product container, including a descriptive name of the product stating that it is a "supplement"; the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and each dietary ingredient contained in the product. Supplements must also include directions for use, nutrition labeling in the form of a Supplement Facts panel that identifies each dietary ingredient contained in the product and the serving size, amount, and active ingredients.
laboratory study - Research done in a laboratory. A laboratory study may use cells in test tubes or animals to find out if a drug, procedure, or other treatment is likely to be safe and useful. Laboratory studies usually take place before any testing is done in humans.
laxative - A substance that moves the bowels and relieves constipation.
lot - A batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, an amount produced in a unit of time or quantity.
medicinal - Having to do with the abilities of medicine to prevent and cure.
meta-analysis - A methodical review of the results of multiple research studies. In a meta-analysis, statistical methods are used to measure the combined results of these studies and estimate an overall effect.
mineral - In nutrition, an inorganic substance found in the earth that is required to maintain health.
peppermint - A plant that has been used in traditional medicine in many parts of the world to relieve indigestion, cough, sore throat, headache, abdominal cramping, and gas. Also called brandy mint, lamb mint, and lammint. Latin name: Mentha piperita.
phytoestrogen - A weak estrogen-like substance found in some plants and plant products. Isoflavones, a type of phytoestrogen, are being studied in the prevention of osteoporosis, menopausal symptoms, and some types of cancer. Soybeans are a rich source of phytoestrogens.
phytomedicine - The use of herbs and other plants to treat disease. Also called phytotherapy.
preparation - A mixture made for medicinal use.
quality control - A system to ensure that consistency and uniformity are maintained in the manufacturing of a product.
rigorous - Accurate, precise, and without deviation from standards.
risk - The chance or probability that a harmful event will occur.
senna - A plant used in traditional Chinese medicine and Ayurvedic medicine. The leaves are used to make a stimulant laxative that increases the frequency of bowel movements and relieves constipation. It is widely used in over-the-counter laxatives. Latin name: Senna alexandrina.
sennoside - The active ingredient in senna, a plant whose leaves are used to make a stimulant laxative that increases the frequency of bowel movements and relieves constipation.
solution - A liquid in which another substance has been dissolved or mixed.
soy - A plant that produces beans used in many food products. Soy products contain isoflavones (estrogen-like substances) that are being studied in the prevention of cancer, hot flashes that occur with menopause, and osteoporosis (loss of bone density). Also called soya and soybean. Latin name: Glycine max.
species - The name of a category that is part of the scientific classification of all organisms. The category species is located in the classification system after kingdom, phylum, class, order, family and genus. Humans, for example, belong to the species sapiens and are identified by the scientific name Homo (genus) sapiens (species).
standardization - A process manufacturers may use to ensure batch-to-batch consistency of their products and to provide a measure of quality control. Dietary supplements are not required to be standardized in the United States. Some manufacturers use the term incorrectly or to mean different things and the presence of the word "standardized" on a supplement label does not necessarily indicate a level of product quality.
supplement - A nutrient that may be added to the diet to increase the intake of that nutrient. Sometimes used as a synonym of dietary supplement.
systematic review - A structured method of identifying, selecting, and analyzing appropriate research to answer a specific question.
tea - A drink made by adding boiling water to fresh or dried herbs and steeping (soaking) them. It may be drunk either hot or cold. Also called an infusion.
therapeutic - Used to treat disease and help healing take place.
tincture - A liquid made by soaking an herb in a solution of alcohol and water. It is used for concentrating and preserving an herb and may be made in different strengths that are expressed as ratios of the weight of the dried herb to the volume or weight of the finished product.
toxic - Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted health effects.
uniformity - The quality of being consistently the same and not varying or fluctuating in color, size, weight, composition, or any other physical feature.
valerian - The roots of this plant are used by some cultures as an ingredient in mild sedatives and sleep aids for nervous tension and insomnia. It is being studied in improving sleep in patients undergoing treatment for cancer. Latin name: Valeriana officinalis.
vitamin - A nutrient that the body needs in small amounts to function and maintain health. Examples are vitamins A, C, and E.
volume - The amount of space taken up by a substance; the amount of space a container can hold.

Disclaimer

Reasonable care has been taken in preparing this fact sheet and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations.

About ODS

The mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

General Safety Advisory

  • The information in this document does not replace medical advice.
  • Before taking an herb or a botanical, consult a doctor or other health care provider-especially if you have a disease or medical condition,
    take any medications, are pregnant or nursing, or are planning to have an operation.
  • Before treating a child with an herb or a botanical, consult with a doctor or other health care provider.
  • Like drugs, herbal or botanical preparations have chemical and biological activity. They may have side effects. They may interact with certain medications. These interactions can cause problems and can even be dangerous.
  • If you have any unexpected reactions to an herbal or a botanical preparation, inform your doctor or other health care provider.
Document Last Updated: 4/11/2006 2:59 PM
Office of Dietary Supplements
National Institutes of Health
Bethesda, Maryland 20892 USA
Web: http://ods.od.nih.gov
E-mail: ods@nih.gov		 National Institutes of Health Department of Health and Human Services FirstGov, Your First Click to the US Government