FDA Maintains That Preparation of an NDI Notification Takes 20 Hours

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.   FDA maintained that the preparation of an NDIN imposes a minimal burden because FDA requires “only that information that the manufacturer or distributor should already have developed as the basis for its conclusion that a dietary supplement containing an NDI will reasonably be expected to be safe.”  The 20 hrs is “for extracting and summarizing the relevant information from the company’s files” and presenting it as required by FDA and does not include time for generating and collecting the information.

FDA’s estimate also does not include the burden resulting from the recently issued draft NDI guidance in which the Agency indicates that dietary supplement manufacturers must submit NDINs for virtually all their dietary supplements containing an NDI – see our previous post here.  Apparently, the burden associated with this guidance is a separate issue to be considered in the future.