Definition of Botanicals
Table of Contents
- What is a
botanical? Can botanicals be dietary supplements?
- How are botanicals
commonly sold and prepared?
- Are botanical dietary
- Are botanical dietary
- Does a label indicate
the quality of a botanical dietary supplement product?
- What methods are used
to evaluate the health benefits and safety of a
botanical dietary supplement?
- What are some
additional sources of information on botanical dietary
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
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
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;
- 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,
- 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
- 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
Are botanical dietary
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
Does a label indicate the quality of a botanical dietary
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
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