Dietary Supplements: A Background
Nutritional supplements are those items that we commonly refer to as a “dietary supplement”.
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education
Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary
ingredient" intended to supplement the diet. The "dietary ingredients" in these products may
include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes,
organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates,
and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.
They can also be in other forms, such as a bar, but if they are, information on their label must not
represent the product as a conventional food or a sole item of a meal or diet (in other words, the
“food” must be labeled as a dietary supplement). Whatever their form may be, DSHEA places
dietary supplements in a special category under the general umbrella of "foods," not drugs, and
requires that every supplement be labeled a dietary supplement 7, 10-11.
The intended use of a product guides what regulatory category the product falls under, food,
drug, or cosmetic, and thus how it will be regulated.
Intended use may be established in a number
of ways. Among them are: 1) Claims stated on the product labeling, in advertising, on the Internet,
or in other promotional materials. Certain claims may cause a product to be considered a drug, even
if the product is marketed as if it were a dietary supplement. 2) Consumer perception, which may be
established through the product's reputation. This means asking why the consumer is buying it and
what the consumer expects it to do. 3) Ingredients that may cause a product to be considered a drug
because they have a well-known (to the public and industry) therapeutic use1, 3, 6, 9.
The Nutrition Business Journal has estimated that the dietary supplement business generated
$18.8 billion dollars in 2003 (the nutrition industry as a whole is considered to be a $62 billion
dollar industry) (11, 12). The “sports nutrition and weight loss” segment is currently thought to
generate $14 billion dollars, however there is a cross over of specific types of foods or drinks into
this dollar amount as noted by the respected Nutrition Business Journal 14, 15.
Regulation of Dietary Supplements
Dietary supplements are regulated by the Food and Drug Administration (FDA) within the
confines of the 1994 Dietary Supplement Health Education Act (see
http://www.cfsan.fda.gov/list.html for more detailed information). The FDA does mandate that all
dietary supplement labels contain the following phrase “ This product is not intended to diagnose,
treat, cure, or prevent any disease”. According to the DHSEA 1994 law, dietary supplement labels