FDA Soliciting Comments on Premarket Notification Submission for a New Dietary Ingredient (NDI)

The Natural Products Association is preparing comments on the proposal.

The U.S. Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency on new dietary ingredients (NDIs). This notice solicits comments on the procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to the FDA, upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.

The FDA invites comments on these topics: whether the proposed collection of information is necessary for the proper performance of the FDA’s functions, including whether the information will have practical utility; the accuracy of the FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ways to enhance the quality, utility, and clarity of the information to be collected; and 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. The pre-publication notice is available here.

The Natural Products Association will prepare comments on the docket and anticipates more to follow from the agency with respect to guidance on the NDI submission process. The association will also solicit information from members by survey on the agency’s time burden estimations as well as other topics appearing in the docket. The association will notify members of the official comment period when the notice is published. Written or electronic comments must be submitted to the FDA by 60 days after the date of publishing the notice in the Federal Register. Please contact Daniel Fabricant, Ph.D., Natural Products Association vice president of scientific and regulatory affairs with any questions, [email protected].

Electronic comments on the collection of information can be submitted online to http://www.regulations.gov/. Written comments on the collection of information should be sent to:

Division of Dockets Management (HFA305)
Food and Drug Administration
5630 Fishers Lane
Rm. 1061
Rockville, MD 20852

Comments should be identified with the docket number FDA2008N0170. For more information, contact Jonna Capezzuto, Office of the Chief Information Officer, at (301) 827-4659.

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