Webinar Recording: AHPA New Dietary Ingredient (NDI) Database

Searchable database of NDI notifications submitted to FDA

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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.

About the AHPA NDI Database

AHPA's staff regularly obtains NDI notifications from FDA's Division of Dockets Management. NDI notifications are reviewed and the following information is posted on the searchable AHPA NDI Database:

  • 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 email any questions to ndi@ahpa.org.

The Botanical Safety Handbook, Second Edition includes:

  • Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
  • Information on adverse events reported in clinical trials or case reports 
  • Safety-related pharmacology and pharmacokinetics of each herb
  • Additional information on the use of herbs by pregnant or lactating women 
  • Toxicological studies and data on toxic compounds 
  • Extensive references for each entry

The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:

Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition  Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online

Member annual subscription: $95.00 
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.

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