Identity and Safety of New Dietary Ingredients
New Dietary Ingredients — Identity and Safety
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the Food and Drug Administration about these ingredients. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
A dietary ingredient is any whole or part of a vitamin, mineral, herb, other botanical, amino acid or alternate dietary substance used to supplement diet. A new dietary ingredient (NDI) specifically means an ingredient that was not marketed in a dietary supplement in the United States prior to Oct. 15, 1994.
Manufacturers and distributors who wish to market dietary supplements containing new dietary ingredients (NDIs) are required to notify the Food and Drug Administration (FDA) about these ingredients under the Federal Food, Drug, and Cosmetic Act (FDCA).
Ingredient Safety
NDIs must be deemed as reasonably expected to be safe under the conditions of use recommended or posted on the label, evaluated by the FDA from the proof provided by the manufacturer or distributor. To submit a notification for a new dietary ingredient, visit FDA’s website.
Guidance
Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
Helpful Resources
New Dietary Ingredients Backgrounder for Industry
How to Submit Notifications for a New Dietary Ingredient
FR 97-24737: 1997 Final Rule — Premarket Notification for a New Dietary Ingredient
NDI Guidance Redraft
Publication of the FDA’s redraft of the NDI Guidance for industry is imminent.
Within 72 hours of the FDA’s publication of the re-draft of the NDI Guidance (Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues), NPA will hold a two-hour webinar highlighting the most important and pressing aspects of the guidance and its regulatory and scientific impact.
Where to Learn More About the NDI Notification Process
