New Dietary Ingredient (NDI) Notification Readiness

Section 190.6(a) applies to a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered. The manufacturer or distributor of the supplement, or of the ingredient, submits the basis for concluding the supplement will reasonably be expected to be safe.

Section 190.6(b) lists the contents: name and address of the submitter; the ingredient name, including the Latin binomial and author for botanicals; the level in the supplement and its conditions of use; the history of use or other evidence of safety at those conditions, with copies of cited references and English translations; and the signature of the designated person. Build the dossier around the exact product and conditions of use you intend to sell.

Under 190.6(c), FDA acknowledges receipt and gives the filing date, which is the date FDA receives the notification. For 75 days after the filing date the supplement may not be introduced into interstate commerce.

Section 190.6(f) says that FDA not responding does not mean FDA has found the ingredient or supplement safe or not adulterated. Under 190.6(e) FDA keeps the notification confidential for 90 days after filing, then places it on public display except trade secret or confidential commercial information.

A notification covers the ingredient at the level and conditions of use described. A later formula change, a new supplier process or new label directions can take the product outside what was notified.