The AHPA NDI Database was designed to ease your access to and understanding of the notifications submitted to the Food and Drug Administration for new dietary ingredients (NDIs) that are used in dietary supplements. The database is a searchable platform that allows you to easily locate individual notifications by searching for key terms that include the generic and brand name of the NDI itself and the Latin name (genus) of herbal NDIs, as well as the name of the submitting firm or their counsel or other consultant or the report number assigned by FDA.

FDA is required to make NDI notifications public within 90 days of their receipt, except that trade secrets and confidential commercial information are not allowed to be disclosed. As of this date FDA has placed all or part of about 300 NDI notifications on public display at their Division of Dockets Management website: http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s0316.htm.

When using the AHPA NDI Database, you will not need to open and review lengthy or numerous documents to evaluate the status of an NDI submission. Instead, AHPA has prepared an “outcome statement” for each notification to provide a short summary of FDA’s response to the submission.

The AHPA NDI Database also provides direct links to all of the documents that make up an NDI notification, including all communications between the submitting firm and FDA and any attachments that have been made publicly available. These links are named to assist you in finding the specific documents that are needed to complete a review of any of these notifications. Confidential and copyrighted material that has not been posted at FDA’s Division of Dockets Management website, however, can not be accessed through the AHPA NDI Database.

The AHPA NDI Database is a joint project of the American Herbal Products Association (AHPA), which is responsible for its content, and NPIcenter, which provides technical support to maintain this site. Please direct any questions or comments to ndi@npicenter.com.

Federal regulations for new dietary ingredients
The Federal Food, Drug and Cosmetic Act (FFDCA) as amended by the Dietary Supplement Health and Education Act of 1994 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.” Specific regulations have been implemented by FDA at 21 CFR 190.6 to govern this NDI notification requirement.

In reviewing submitted NDI notifications, FDA does not “approve” or “disapprove” the NDI that is the subject of a notification. Instead, as a rule the Agency informs the submitting firm either that it has an objection to the notification or that it has accepted the notification for filing. When objections are recorded, these may be based on any number of identified concerns, and the Agency informs the firm that dietary supplements containing the NDI “may be adulterated” under the Act. On the other hand, in accepting a notification for filing, FDA usually states that such action does not constitute a finding that the NDI is safe.

Relevant sections of the FFDCA can be found here (PDF 15Kb). 21 CFR 190.6 can be accessed here (PDF 14KB).

[* 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.]

Additional information on NDIs
On October 20, 2004 FDA published a notice in the Federal Register in which it announced a public meeting and requested comments on its premarket notification program for new dietary ingredients. The FDA notice is available here (PDF 65Kb). AHPA submitted substantive comments to FDA on February 1, 2005 and an addendum on February 24, 2005. These can be downloaded from the links below:

Comments of AHPA to FDA’s Premarket Notification Program for New Dietary Ingredients, February 1, 2005 (PDF 3Mb)

Additional Comments of AHPA to FDA’s Premarket Notification Program for New Dietary Ingredients, February 24, 2005 (PDF 1.6Mb)

Additional comments files, September 23, 2005 (PDF 21kb)

AHPA president Michael McGuffin and General Counsel Tony Young published an in-depth review of the NDI program through its first ten years in the June 2004 edition of the Food and Drug Law Journal. The Journal has generously allowed that article to be made available and it can be accessed below.

McGuffin, M. and AL Young. 2004. Premarket notifications of new dietary ingredients – a ten-year review. FDLJ 59(2):229-244. (PDF 116Kb)