that, according to the US National Institutes of
Health (NIH) Office of Dietary Supplements
- has the intention to supplement dietary intake
- contains dietary ingredients such as vitamins,
minerals, amino acids, or botanical substances,
including herbs - is taken in some form by MOUTH(such as liquid,
tablet, capsule, gel, tea, freeze-dried, or powder)
either by itself or mixed with food or water - carries clear labeling on the front of the pack-
age that identifies the product as a dietary sup-
plement
Further, dietary supplements may not make
health claims unless the US Food and Drug
Administration (FDA) approves them. Dietary
supplements are thus exempt from the rigorous
standards that medications must meet.
In the United States, there are no standards for
product ingredients or consistency for dietary sup-
plements, other than the product may not contain
substances that the law prohibits or claim to con-
tain ingredients that it does not. The term stan-
dardizedon a dietary supplement label can mean
anything the manufacturer desires, from consis-
tency in following the same recipe and balance of
ingredients in making every batch of the supple-
ment to all tablets in the same bottle are the same
color. Many manufacturers strive to produce sup-
plements that have consistent ingredients and
potency across batches though some do not.
Though reading product labels for the percentages
or measurements of included ingredients is help-
ful, health experts point out that because there are
no standards to control those measurements,
there is no way to know how accurate they are.
THE USP QUALITY STANDARD
The United States Pharmacopeia (USP) maintains
a verification program of stringent guidelines to
assure the quality of dietary supplements. Manu-
facturers whose products meet the quality guide-
lines may place the designation “USP” on
product labels. The organization’s Web site
(www.usp.org) maintains a current list of USP-
verified products.Another factor affecting the consistency of
botanical supplements manufactured from har-
vested plants (as opposed to synthesized ingredi-
ents) is the wide variation possible among the
source plants. Soil conditions, mineral content of
the water, the amounts of water and sunshine, the
part of the world where the plant grows, and
numerous other environmental factors influence
the plant’s growth and the potency of its active
ingredients. The time and method of harvest also
affects potency. As well, there may be different
species of the plant, such as GINSENG (Siberian,
Korean, Red, Panax), that have differing potencies
and characteristics. Manufacturers may blend sev-
eral species or use whatever species is available or
less expensive.Safety
There is a tendency to view herbs and botanicals
as “safe” because they are natural. However, any
substance that alters the functions of the body has
the capacity to be both helpful and harmful. Fox-
glove provides digoxin, a medication that main-
tains heart rhythm and STRENGTH in millions of
people. Foxglove also is one of the most potent
poisons; the sap residue left on the fingers after
picking its beautiful purple and white bell-like
flowers is enough to cause life-threatening
ARRHYTHMIA(disturbance of the heart’s rate and
rhythm) especially in children.
Herbal remedies, like conventional medica-
tions, can interact with each other as well as with
conventional medications. Most herbal products
available over-the-counter are mild formulas that
generally are safe when people take them accord-
ing to recommended guidelines or package
instructions. Some herbal formulas are potent
enough, or carry sufficient risk for harmful effects,
that the FDA regulates them as drugs. An example
is the “herbal Viagra” remedy YOHIMBE/YOHIMBINE,
derived from the bark of the African yohimbe
tree, which is available in the United States only
with a doctor’s prescription. It is important for
doctors to know, when considering prescription
medications, all of the remedies, including vitamin
and mineral supplements, people are taking.
See also ALTERNATIVE AND COMPLEMENTARY REME-
DIES FOR CANCER; TRADITIONALCHINESE MEDICINE.84 Alternative and Complementary Approaches