Definitions

What is a dietary supplement?

According to the FDA, a dietary supplement is “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.” The FDA considers a dietary supplement to be a type of food rather than a drug. For more information about how the FDA regulates dietary supplements, visit these FDA webpages:

• Questions and Answers on Dietary Supplements
• FDA 101: Dietary Supplements

What is a drug?

The FDA defines a drug, in part, as “a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

What is an IND?

An IND is an investigational new drug. Investigators need to submit an IND application when they want to test the therapeutic or diagnostic potential of a new product in humans.

What is Generally Recognized As Safe (GRAS) status?

A substance added to conventional foods is subject to premarket approval by the FDA unless it is deemed GRAS. The FDA has procedures for submitting GRAS notifications for specific substances.

What is a new dietary ingredient (NDI)?

An NDI is an ingredient that was not marketed in the United States in a dietary supplement before October 1994. The FDA must be notified before the ingredient can be marketed in a legal dietary supplement. The FDA has a number of requirements for submitting notifications for NDIs.