New Dietary Ingredients and How Formula Ingredients Enter the Market

What counts as a new dietary ingredient

A dietary ingredient is a vitamin, mineral, herb or other botanical, amino acid, other dietary substance, or a concentrate, metabolite, constituent, extract or combination of these. A new dietary ingredient is one that was not marketed in the United States before October 15, 1994. [1] NCCIH puts it as safety data being required for any new ingredient not sold in a supplement before 1994. [2]

The notification is not needed if the ingredient is present in the food supply as an article used for food in a form that has not been chemically altered. [1]

What the notification contains

The regulation says the maker or distributor must submit information, including citations to published articles, on which it concluded the supplement will reasonably be expected to be safe. [3] It lists:

• The name and address of the maker or distributor.
• The name of the new ingredient, including the Latin name of any herb.
• A description of the supplement, including the level of the new ingredient and the conditions of use suggested on the label.
• The history of use or other evidence of safety.

FDA acknowledges receipt, and for 75 days after the filing date the product may not be introduced into interstate commerce. [3] FDA describes the notification as basis information the firm relies on, and says it reviews these notifications. [4][1] In October 2026 FDA announced guidance on identity and safety information for these notifications. [5]

What it does not tell you

1. Does notifying mean FDA approved the ingredient?

   FDA says it does not approve dietary supplements before they are marketed [1]

2. Is the amount in a formula limited?

   FDA says no law or regulation limits the serving size of a supplement or the amount of a dietary ingredient in a serving, beyond the maker's duty to meet safety and labeling requirements [1]

3. Has the combination of ingredients been reviewed?

   Proper evidence not found. The sources we read describe notifications for a new ingredient, not for a blend

4. Does an ingredient sold before 1994 need a notice?

   Not under this rule [1]. That does not show it is safe for you or with your medicines

5. Does the ingredient work?

   The notification covers expected safety, not benefit [3]

6. Can FDA act later?

   Yes, after sale, against adulterated or misbranded products [6]

FDA keeps a directory of ingredients with its actions and statements. It says the directory is not comprehensive and that FDA does not approve dietary supplements for safety and effectiveness. [7]

Why this matters when reading a formula

A long ingredient list can mix old, new and unusual ingredients. The rules above mean the label alone does not show that FDA reviewed each ingredient, the amount or the mix. Use the A to Z ingredient directory for evidence on single ingredients, and see label red flags for claims to treat with caution.