ABSTRACT
The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the
Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary
supplements and for other purposes. The DSHEA formally defined supplements and
assigned them a unique regulatory status between foods and drugs under the oversight of
FDA’s Center for Food Safety and Applied Nutrition. Before this time, dietary supple-
ments were subject to the same regulatory requirements as were other foods (1). Under
the DSHEA (2), the term dietary supplement means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following
“dietary ingredients”:
n a vitamin,
n a mineral,
n an herb or other botanical,
n an amino acid,
n a dietary substance for use by man to supplement the diet by increasing the total diet-
ary intake (e.g., enzymes or tissues from organs or glands), or
n a concentrate, metabolite, constituent, or extract.
