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Friday, August 01, 2014

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This database provides access to and understanding of notifications submitted to the Food and Drug Administration (FDA) for new dietary ingredients (NDIs) that are used in dietary supplements. It is a joint project of AHPA, which is responsible for its content, and NPI Center, part of the New Hope Supply Network, which provides technical support to maintain this site.

About the AHPA NDI Database

AHPA's staff regularly obtains NDI notifications upon their transmittal to FDA's Division of Dockets Management in Rockville, Md. These notifications are reviewed in detail and the following information is then posted on the AHPA NDI Database for each notification:

  • The Report Number* assigned by FDA

  • The name of the submitting company*

  • The name of the NDI*

  • The common* and Latin name* of the NDI if it is a botanical

  • The dosage of the NDI that the submitter recommends for use in a dietary supplement, stated per serving and per day if that information is provided

  • An "Outcome Statement" that provides a brief summary of FDA's response to the notification

  • Links to documents submitted by the notifier, and to FDA's responses

  • Links to prior submissions whenever a notification is a follow-up to an earlier notification

The database is a searchable platform so that users can easily locate the notifications they need. Each of the above details marked with an asterisk (*) is a searchable term in the database. A user can therefore easily find all of the notifications that have been submitted for any ingredient or by any company.

In addition, the "Outcome Statement" provided in the AHPA NDI Database for each notification saves users the time that would otherwise be needed to search through each notification to find FDA's reaction and response. These succinct summaries provide valuable information that assists users in understanding FDA's thinking as it processes NDI notifications.

There are currently more than 600 NDI notifications available in the AHPA NDI Database. No other resource provides such an up-to-date compilation of all of the NDI notifications that have been submitted to FDA since the first of these was filed in August 1995. Subscribers are contacted by email when new notifications are added to the AHPA NDI Database.

Disclaimer

While AHPA believes that all of the information contained on this website and in the AHPA NDI Database is accurate, any company that chooses to use this information is advised to discuss all aspects related to this subject matter with a qualified consultant, an attorney, or with appropriate FDA staff.

Questions/Contact

Please direct any technical questions, problems with login, passwords, or access to Devon Powell.

Please direct any questions about the specific posted NDI notifications or comments about this website to Merle Zimmermann.


 






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