The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as
a 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 a concentrate, metabolite, constituent, extract, or
combination of the preceding substances.
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases.
That means supplements should not make claims, such as “reduces pain”
or “treats heart disease.” Claims like these can only legitimately be
made for drugs, not dietary supplements.
Dietary supplements include such ingredients
as vitamins, minerals, herbs, amino acids, and enzymes. Dietary
supplements are marketed in forms such as tablets, capsules, softgels,
gelcaps, powders, and liquids.
Under existing law, including the Dietary
Supplement Health and Education Act passed by Congress in 1994, the FDA
can take action to remove products from the market, but the agency must
first establish that such products are adulterated.