NDI (New Dietary Ingredient)

A New Dietary Ingredient (NDI) refers to a supplement ingredient introduced to the market after October 1994 that wasn’t sold in the U.S. before that date. Manufacturers must provide safety data to the FDA before marketing NDIs, demonstrating they are safe for consumption. This process helps ensure that new ingredients do not pose health risks to consumers. NDIs are used to support dietary supplements, such as vitamins, minerals, or herbs, and the regulation aims to protect public health by requiring evidence of safety prior to market entry.