‘‘treat,’’ ‘‘mitigate,’’ ‘‘prevent,’’ or ‘‘diagnose’’ a spe-
cific disease. They may make the following claims:
Health claims—Statements indicating a relationship
between an ingredient in the supplement and the
reduction in the risk of developing a disease or con-
dition. (e.g., Increased intake of folic acid by preg-
nant women helps reduce the risk of neural tube
defects in their offspring.)
Nutrient content claims—Statements describing the
amount of supplement in the product and may con-
tain words such as ‘‘high in,’’ ‘‘good source of,’’ ‘‘for-
tified,’’ ‘‘enriched,’’ or ‘‘high potency.’’
Structure or function claims—Description of how the
supplement may affect organs or systems in the body
without mentioning a specific disease or condition.
(e.g., Calcium builds strong bones.) Labels with struc-
ture or function claims must also contain the words
‘‘This statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat, cure,
or prevent any disease.’’
Manufacturers of supplements are required to fol-
low federal Good Manufacturing Practices (GMPs)
that regulate sanitary and other conditions under
which these products are prepared, packaged, and
stored. These GMPs are much less stringent than
those that regulate the manufacture of conventional
drugs. They do not, for example, assure that the
amount of active ingredient in each pill or capsule of a
dietary supplement is the same. Some supplement man-
ufacturers try to assure consistency of their product by
making sure each batch contains the same amounts of
active ingredients. This type of standardization is not
required by law, and the word ‘‘standardized’’ on the
label is not an indication that the product meets any
legal requirements as to quality or consistency of
contents.
Dietary supplements in conventional medicine
Conventional medicine, also called Western or
mainstream medicine, is practiced by licensed medical
doctors (MD) and doctors of osteopathy (DO), dentists
(DDS or DMD), registered nurses (RN), licensed prac-
tical nurses (LPN), pharmacists, and similar health care
professionals. Some dietary supplements are routinely
used as an accepted part of conventional medicine. The
most common of these are vitamin and mineral supple-
ments taken in accordance with establisheddietary
reference intakes(DRIs). DRIs are a set of values for
different nutrients that indicate the daily amount of
that nutrient necessary to meet the needs of most indi-
viduals, as well as the largest amount of the nutrient
that can be consumed daily without harmful effects.
Other supplements, such as folic acid, are prescribed
for pregnant women in order to decrease the risk of
neural tube defects in their offspring. Still other supple-
ments, such as enzymes, may be given when the body
fails to produce adequate amounts of the enzyme as the
result of a genetic disorder such as cystic fibrosis. When
taken under supervision of a conventional health care
professional, dietary supplements tend to be extremely
safe.Dietary supplements in complementary and
alternative medicine
Most dietary supplements are used within a system
of complementary and alternative medicine (CAM).
Complementary medicine usestreatmentsthatarenot
part of conventional medicine to supplement conven-
tional medicine. Alternative medicine uses treatments
that are not part of conventional medicine as a complete
replacement for conventionalmedicine. Alternative med-
icine includes well-established treatment systems such as
homeopathy, traditional Chinese medicine, and Ayurve-
dic, or traditional Indian medicine, as well as newer fad-
driven treatments. Many CAM treatments have their
roots in tradition and folklore.
Herbs are some of the most common dietary sup-
plements used in CAM. Many have been used for
hundreds of years and show evidence of effectiveness.
Others are ineffective or may harm the individual
either directly or when used as a replacement for con-
ventional drugs and treatments whose effectiveness
has been proven. Vitamin and mineral supplements
used as part of conventional medicine become part of
the CAM system when they are used in mega-doses
that far exceed DRI values or when they are used to
prevent or treat a specific condition (e.g.,vitamin Cto
prevent colds). Likewise, enzymes and amino acids
that have specific uses within conventional medicine
become part of the CAM system of dietary supple-
ments when they are used in non-conventional ways or
in non-standard doses. Some dietary supplements,
such as bee pollen, are used exclusively in CAM.Precautions
It is difficult to determine whether dietary supple-
ments are safe or effective because of the way they are
regulated. Many of the studies done on supplements are
poorly designed, have a small sample size, or are spon-
sored by the manufacturer of the supplement, making
the results questionable. Natural Standard is an inde-
pendent organization that evaluates studies, scientific
evidence, and expert opinion on CAM treatments and
therapies and makes impartial judgments concerning
their safety and effectiveness. The National Center forDietary supplements