USA Pre-Market Notification
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market Dietary Supplement (DS) that contain “new dietary ingredients” notify the FDA about these ingredients.
Definitions - What is a new dietary ingredient?
• New Dietary Ingredient (NDI): Means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.
• A Dietary Ingredient (DI): Is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.
• Dietary Supplement (DS): Means a product intended to supplement the diet that contains one or more DI. DS is limited to products that are intended for ingestion in tablet, capsule, powder, soft gel, liquid, or other form, that are not represented as conventional food or as the sole item of a meal or of the diet, and that are labeled as dietary supplements.
Who needs to submit a notification?
You must submit a premarket notification if you are: a Manufacturer or Distributor who intends to market a new dietary ingredient; or a dietary supplement that contains a new dietary ingredient.
When must I notify FDA about a new dietary ingredient?
The manufacturer or distributor of the DI or dietary supplement should provide the FDA with information, at least 75 days before being introduced into interstate commerce.
What information must be included in the premarket notification?
You must submit the following information:
1. A description of the dietary supplement that will contain the new DI including: the quantity of the new DI in the dietary supplement; and the recommended use as suggested in the labeling of the product.
2. Submit evidence on the ingredients safety and efficacy to support the recommended use.
Important Notes
Manufacturer/distributor is responsible for determining if an ingredient is a “new dietary ingredient” and, if not, for documenting either that a DS that contained the dietary ingredient was marketed before October 15, 1994, or that the DI was marketed for use in DS before that date.
