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.
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.
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 acknowledged 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 FFDCA. On the other hand, in acknowledging a notification for filing, FDA usually states that such action does not constitute a finding that the NDI is safe.
FDA has released a draft guidance for industry entitled "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues" which provides further insight into agency thoughts about NDI notifications. It is available on FDA's food guidance website, and can be found here.
[** 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.]