Quick answer
A new dietary ingredient (NDI) is a dietary ingredient that was not marketed in the United States in a supplement before October 15, 1994. Unless it is already in the food supply in an unaltered form, a company must give FDA its basis for expecting it to be safe at least 75 days before selling it.1,2
Key facts
- The October 15, 1994 cutoff comes from the Dietary Supplement Health and Education Act.2,3
- There is no authoritative list of ingredients sold before that date; each company must decide, and document, whether its ingredient is new.1
- A notification names the ingredient, with the Latin binomial for a botanical, its level in the product, the conditions of use and the evidence of safety.4
- FDA keeps a notification confidential for 90 days after filing, then makes it public apart from trade secrets.2,4
- No response from FDA is not a finding that the ingredient is safe.4
- A supplement that needed a notification but was sold without one is adulterated as a matter of law.1
When a notification is required
Under the law, a supplement with a new dietary ingredient is deemed adulterated unless one of two things is true. Either it contains only dietary ingredients already in the food supply as an article used for food, in a form not chemically altered, or there is a history of use or other evidence of safety and the company gave FDA the basis for its safety conclusion at least 75 days before marketing.1,2
The 75 days run from the filing date, the day FDA receives the notification. If the company later sends substantive new information, FDA can set a new filing date and the 75 days start again.4
Who files, and what goes in
Manufacturers and distributors who plan to market a new dietary ingredient, or a supplement that contains one, must file.1
- The name and complete address of the manufacturer or distributor.4
- The ingredient's name, with the Latin binomial name and its author for an herb or other botanical.4
- A description of the product: the level of the ingredient and the conditions of use on the label.4
- The history of use or other evidence of safety, with copies of any published references cited.4
- The signature of the person the company designates.4
What a notification is not
A notification is not an approval. FDA's regulation says a lack of response does not mean it found the ingredient or product safe or lawful, and FDA reminds companies that they remain responsible for the safety of the ingredients they use whether or not a notification was required.1,4
After 90 days, notifications go on public display through FDA's dockets and regulations.gov, and FDA posts a list of the notifications it has reviewed.1
Questions people ask
Does every supplement need an FDA notification?
No. Only products with a new dietary ingredient that is not already in the food supply in an unaltered form. For other supplements, firms do not have to show FDA their safety evidence before or after marketing.3
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Sources
- U.S. Food and Drug Administration. New Dietary Ingredients in Dietary Supplements: Background for Industry. Content current as of February 9, 2023. Opened 2026-10-07.
- United States Code, Title 21, Section 350b: New dietary ingredients. Legal Information Institute, Cornell Law School. Opened 2026-10-07.
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Content current as of August 27, 2026. Opened 2026-10-07.
- Code of Federal Regulations, Title 21, Section 190.6: Requirement for premarket notification. Legal Information Institute, Cornell Law School (eCFR text). Opened 2026-10-07.
This page is information, not medical advice. Talk to your doctor or pharmacist about your own situation.