FDA defines a dietary ingredient as a vitamin, mineral, herbal or other botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Under the regulations any dietary ingredient that was marketed in the United States in a dietary supplement prior to October 15, 1994, is permitted for use in dietary supplements today with some exceptions. Any dietary ingredient that was not marketed in the US before this time is defined as a new dietary ingredient and provides the FDA with notification of the new dietary ingredient.
In the event the ingredient is considered a new dietary ingredient the marketer must submit a premarket notification to FDA showing the ingredient will reasonably be expected to be safe under the conditions recommended or suggested in the labeling. This notification must be submitted at least 75 days before the ingredient is introduced or delivered into interstate commerce.
The regulations require the submission of an original and two (2) copies of the notification and all of its attachments. The submission must include:
Name and complete address of company filing the submission
Name of the new dietary ingredient.
A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:
level of the new dietary ingredient in the product;
conditions of use of the product; and
history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.
The signature of a person designated who is responsible for the content of the notification and can be contacted if the FDA has questions.