The Dietary Supplement Health and Education Act is a U.S. federal law enacted in 1994 that defines dietary supplements and regulates safety and effectiveness claims. It makes manufacturers responsible for the safety of these products and protects consumers from being misled about their intended purposes. The Dietary Supplement Health and Education Act treats dietary supplements as food products subject to some of the same regulations as food.
This legislation amended a food, drug, and cosmetic law to address nutritional supplements separately. The Dietary Supplement Health and Education Act led to the formation of the Office of Dietary Supplements at the U.S. National Institutes of Health to coordinate research and report findings to the federal government. It also created a commission to review labels on dietary supplements and make recommendations to improve accuracy of information available to the public.
Under the law, manufacturers of supplements, which include herbs, extracts, vitamins, and minerals, must notify the Food and Drug Administration (FDA) of any serious adverse health effects reported by consumers. The FDA is charged with investigating these reports before removing a product from the market. When a dietary supplement manufacturer makes claims about the health benefits of a product, it must be backed by scientific evidence under the Dietary Supplement Health and Education Act. The law prohibits advertising that claims supplements can cure, prevent, or treat a certain disease or disorder. Manufacturers may explain the function of the vitamin or mineral in the human body and illustrate how the product might support, maintain, or regulate those functions.
This law also changed regulations regarding labels on dietary supplements. Under the Dietary Supplement Health and Education Act, labels must contain a list of all ingredients used to make the product. These include any additives, preservatives, colors, and flavors added to the main ingredient. Labels must also include warnings if evidence points to adverse health effects in certain segments of the population, such as pregnant women.
Nutritional supplements do not need FDA approval before they are marketed and sold. The agency receives notification of any new ingredient that emerges, and statements of support that bolster the effectiveness of a supplement. The Dietary Supplement Health and Education Act requires manufacturers to notify the government by letter if they make a statement regarding the health benefits and safety of a new product. These letters become public documents available for review.