WASHINGTON—FDA is developing an electronic portal through which firms can notify the agency that they are introducing a new dietary ingredient (NDI) into a product. In a Federal Register notice, FDA said firms will still have the option to submit an NDI notification or so-called NDIN in a paper format.
FDA contemplates that dietary supplement firms will submit two forms, including a supplemental form that will describe the history of use or other evidence of safety establishing that the NDI is reasonably expected to be safe. Under Section 413(a) of the Federal Food, Drug, and Cosmetic Act, 75 days before the introduction into interstate commerce of an NDI into a dietary supplement, a distributor or manufacturer must notify FDA and provide the safety information previously mentioned.
FDA estimated the collection of information will affect 55 supplement distributors and manufacturers annually, requiring no more than 20 hours of work per response to meet the premarket notification requirement. FDA based its estimate of the number of respondents on notifications that it received over the past 3 years.
“FDA believes that the burden of the premarket notification requirement on industry is limited and reasonable because FDA is requesting only safety and identity information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in compliance with the FD&C Act," the agency stated in the notice.
For 60 days, FDA is seeking comment on the following topics:
(1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.