s not marketed in the United States” before October 15, 1994. Dietary ingredients marketed in the United States before that date are not NDIs and do not require an NDIN.What to Include in an NDINAccording to the Final Guidance, “[a]n NDIN must contain the information, including any citation to published articles, that provides the basis on which the manufacturer or distributor of the NDI or dietary supplement (the notifier) has concluded that the dietary supplement containing the NDI will reasonably be expected to be safe[.]” If premarket notification is not submitted to the FDA, the dietary supplement containing the NDI is deemed to be adulterated under the FD&C Act; even if it is submitted, the dietary supplement is deemed adulterated “unless there is a history of use or other evidence of safety establishing that the NDI, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe[.]”The NDIN regulation at 21 C.F.R. § 190.6 requires:The name and complete address of the manufacturer or distributor;The name of the NDI that is the subject of the premarket notification (include the Latin binomial name and the author/scientist citation for botanicals);A description of the dietary supplement(s) containing the NDI. These include The level of NDI in the dietary supplement; andThe conditions of use recommended or suggested in the labelling of the dietary supplement, or if none, the ordinary conditions of use of the supplement;The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe;The signature of a person authorized by the manufacturer or distributor to sign the notification on its behalf.Who Must Submit an NDINThe Final Guidance states that “[e]ither the manufacturer or distributor of a dietary supplement that contains an NDI, or the manufact

By Riëtte van Laack –Under the law, a manufacturer of a new dietary ingredient ("NDI") or a dietary supplement containing an NDI must notify FDA of the basis for the manufacturer’s conclusion that its product “will reasonably be expected to be safe.” FDA’s regulation, 21 C.F.R. § 190.6, specifies what information an NDI notification ("NDIN") must contain.In a June 3, 2011 notice, FDA announced that, based on experience from the last three years, it estimated the annual reporting burden of NDINs to be 1100 hours, i.e., 50 NDINs with an average burden of 20 hrs per NDIN.Although FDA received several comments that its estimate was too low, it submitted its original estimate to the Office of Management and Budget.