The American Herbal Products Association's (AHPA) New Dietary Ingredient (NDI) Database, the up-to-date compilation of all of the NDI notifications that have been submitted to the Food and Drug Administration (FDA) since the first of these was filed in August 1995, has added 27 new notifications. The database now encompasses more than 600 NDI notification submissions.
The AHPA NDI Database provides subscribers access to and understanding of notifications submitted to FDA for 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 Engredea, which provides technical support to maintain this site. The AHPA NDI Database is available via daily or annual access. AHPA members receive a substantial registration discount.
The 600-notification milestone was reached in late November 2011, when an additional set of 27 notification submissions was added to the database by AHPA staff. The most recent additions included novel herbal preparations, new chemically combined vitamin-mineral ingredients, and cutting-edge enzymes.
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.
"While it's possible to obtain NDI information by Freedom of Information Act requests, doing so is costly and tedious," said Merle Zimmermann, Ph.D., AHPA's information analyst. "AHPA's Silver Spring, Md., location allows us to easily visit FDA's offices when new NDI information is released, saving NDI Database subscribers expense and inconvenience, while providing a much quicker turnaround time between release and posting."
Of the latest notifications posted to the AHPA NDI Database, FDA did not acknowledge a number due to various issues. In several cases, FDA notified the submitter that the lack of manufacturing information provided in the submission prevented the agency from successfully reviewing it, as FDA was unable to confirm the identity of the proposed new dietary ingredient. In other cases, incorrect information, including misspellings, were cited as reasons for agency objections, as well as failures to follow established submission guidelines.
Six of these new submissions, however, were evaluated and acknowledged by FDA without substantial comment. Two of these were follow ups successfully addressing agency objections to previous filings.
AHPA continues to monitor NDI notification submissions and will add them to the NDI Database as they become available.
For more information and to subscribe, please visit the AHPA NDI Database website.
For more information on other NDI-related products and resources available from AHPA, please visit the AHPA website.
About the American Herbal Products Association
The American Herbal Products Association is the national trade association for and the voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and botanical and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products.