By Sylvia Davis
VitaDocs Public Information from the FDA

The FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Click on any of the following questions you might have about supplements to get more information.

What is a dietary supplement?

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term "dietary supplement" as 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.

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.

What is a "new dietary ingredient" in a dietary supplement?

The law defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

• a vitamin,
• a mineral,
• an herb or other botanical,
• an amino acid,
• a dietary substance for use by humans to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
• a concentrate, metabolite, constituent or extract.

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

What is the FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

Under DSHEA, a company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from the FDA before they are marketed.

Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide the FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers do not need to register themselves nor their dietary supplement products with the FDA before producing or selling them. There are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements.

However, the FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength, and composition of dietary supplements. Currently, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.