Part 2 of 7 parts.
The United States has seen the use of
dietary supplements steadily increase from less than 20 percent of
the population in 1970 to approximately 50 percent at the time of the
last survey in 2006. Individuals report using dietary supplements to
increase energy, maintain strength, enhance performance, maintain
health and immune system function, and prevent nutritional
deficiencies. Only 33.4 percent of individuals, however, inform
their doctors that they are taking herbal products and dietary
supplements.
Most consumers aren't aware that the
health claims on labels intended for marketing purposes may not be
accurate. Although dietary supplements are regulated by the US Food
and Drug Administration (FDA) as foods, they are regulated
differently from other foods and drugs.
Individuals who use dietary supplements
believe that these products help them retain control of their own
health. Patients typically believe that dietary supplements are not
drugs and for that reason have fewer side effects than conventional
medications.
Whether a product is classified as a
dietary supplement, conventional food, or drug depends on its
intended use. Classification as a dietary supplement is usually
determined by the information provided by the manufacturer on the
product label or in accompanying literature, although many food and
dietary supplement product labels lack these details.
The term "dietary supplement"
is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic
Act (the Act) as a product, intended to supplement the diet, that
bears or contains one or more of the following dietary ingredients:
- Vitamin;
- Mineral;
- Herb or other botanical;
- Amino acid;
- Dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
- Concentrate, metabolite, constituent, extract, or combination of any ingredient described above.
A dietary supplement is intended for
consuming as a tablet, capsule, powder, soft gel, gel cap, or liquid
form. These products are not represented for use as conventional
foods or as the sole item in a meal or diet and are labeled as
"dietary supplements." Moreover, a dietary supplement may
not contain a form or substance that is an approved drug or is
authorized for investigation as a new drug, and for which substantial
clinical investigations have been initiated and made public, unless
that article was marketed as a food or a dietary supplement prior to
its approval as a new drug or authorization as an investigational new
drug. Vitamin D is an example of a dietary supplement that may soon
begin to be marketed as a drug.
The FDA regulates dietary supplements
under a different set of rules than those covering conventional foods
and drug products (prescription and over-the-counter). Under the
Dietary Supplement Health and Education Act of 1994, the manufacturer
is responsible for ensuring that a dietary supplement is safe before
it is marketed. The FDA is responsible for taking action against any
unsafe dietary supplement after it reaches the market. Generally,
manufacturers do not need to register their products with the FDA or
get FDA approval before producing or selling dietary supplements.
However, manufacturers must make certain that product label
information is truthful and not misleading.
The FDA's post-marketing
responsibilities include monitoring safety (eg, voluntary dietary
supplement adverse event reporting) and product information, such as
labeling, claims, package inserts, and accompanying literature. The
Federal Trade Commission regulates advertising for dietary
supplements. Domestic and foreign facilities that also manufacture,
process, pack, or hold food for human or animal consumption in the
United States are required to register their facilities with the FDA.