The AHPA NDI Database provides online access to more than 725 notifications submitted to the Food and Drug Administration (FDA) for new dietary ingredients (NDIs) that are used in dietary supplements and FDA's responses to these notifications.
AHPA's NDI Database provides a valuable resource for any company looking to develop and market new dietary ingredients in dietary supplements. The database helps companies avoid common mistakes by highlighting issues that cause FDA to object to a notification or determine the notification to be incomplete. Database users can also access notifications that were successfully filed without substantive comment by FDA.
Subscribers can browse NDI notifications and search by the NDI's generic and brand name, the Latin name (genus) of herbal NDIs, report numbers assigned by FDA and/or the name of the submitting firm, their counsel or other consultant.
The Federal Food, Drug and Cosmetic Act (FFDCA) as amended by the Dietary Supplement Health and Education Act (DSHEA) defines a "new dietary ingredient" as one that was not marketed in the United States prior to October 15, 1994. The manufacturer or distributor of an NDI, or the manufacturer or distributor of a dietary supplement that contains an NDI, has certain obligations under most circumstances* to provide information to FDA about the safety of dietary supplements containing an NDI 75 days in advance of marketing.
In order to comply with this law, companies that intend to sell an NDI or a dietary supplement that contains an NDI must first submit a notification to FDA* that includes information that is the basis for the company's conclusion that the dietary supplement will "reasonably be expected to be safe." FDA has implemented specific regulations in 21 CFR 190.6 to govern this NDI notification requirement.
This most recent round of updates brings the database to New Dietary Ingredient report 839, originally submitted to FDA in June 2014. The AHPA NDI database now has over 725 notifications available for subscriber access.
These latest notifications underscore the importance of identity and clarity in notifications. Considering the most recent six months of notifications made available by the agency, more than half of FDA responses indicated that the agency either was unable to establish the identity from the information provided in the notification, the notice was not compliant with 21 CFR 190.6, (including inadequate information about dosage, factors that characterize the conditions of use, etc.), or both.
As the only up-to-date compilation of NDI notifications, the AHPA NDI Database is a searchable platform that allows users to easily find all notifications that have been submitted for any specific ingredient or by any particular company.
Non-AHPA members can subscribe for $495 per year, and AHPA members are eligible for a member's only discount code to receive an exclusive $195/year rate.
Exceptions apply for NDIs that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered. See further details in the actual regulations.