Any dietary ingredient that was not marketed in the United States in a dietary supplement prior to October 15, 1994 is deemed a new dietary ingredient (NDI). A new dietary ingredient must meet two requirements, as outlined in the FD&C Act:
- The dietary ingredient must have been present in the food supply and has not been chemically altered.
- There is a history of use or safety evidence. The source of evidence will include published articles, scientific literature. Other forms of evidence may be deemed acceptable by the FDA.
Upon submission of a new dietary ingredient FDA will acknowledge receiving the request within 75 days.