What is the 75-day premarket notification requirement for a new dietary ingredient?
A manufacturer or distributor must notify the FDA at least 75 days before introducing a dietary supplement that contains a new dietary ingredient (NDI) into interstate commerce. The requirement is set out in the FDA's regulations and rests on the statutory safety standard for new dietary ingredients.
The rule
Under 21 CFR § 190.6(a), the notification must be submitted at least 75 days before the NDI-containing supplement is introduced or delivered for introduction into interstate commerce. It goes to the FDA and must include the information on which the manufacturer bases its conclusion that the supplement will reasonably be expected to be safe.
The statutory basis
The regulation implements 21 U.S.C. § 350b(a), which deems a new dietary ingredient adulterated unless there is a history of use or other evidence of safety and the manufacturer or distributor submits that information to the Secretary at least 75 days before introducing the ingredient into interstate commerce.
A citation to watch
A brief might cite 21 CFR § 541.101(a) for the 75-day duty. That citation does not hold up: the cited subsection does not resolve to the notification requirement. A real-looking CFR cite is not the same as a cite that supports the claim — which is exactly what the judge checks.
How these citations were verified
Ruled 2026-06-22Every citation in the answer above was submitted to the Kingsfield judge and ruled against the primary-law corpus — Accept, Reject, or Inconclusive, per citation. These are live verdicts, not editorial. Each card shows the verbatim authority text the verdict was rendered against.
Proposition: At least 75 days before introducing a dietary supplement that contains a new dietary ingredient into interstate commerce, the manufacturer or distributor must submit a premarket notification to FDA.
“§ 190.6 Requirement for premarket notification. (a) At least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient…”
Cite found; proposition supported by the cited text.
Proposition: A new dietary ingredient is deemed adulterated unless there is a history of use or other evidence of safety, and the manufacturer submits information to the Secretary at least 75 days before introducing it into interstate commerce.
“… there is a 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…”
Cite found; proposition supported by the cited text.
Proposition: Manufacturers of dietary supplements must submit a premarket notification at least 75 days before introducing a new dietary ingredient.
Cite found, but the pinpoint does not resolve to a subsection that supports the 75-day notification duty. A real-looking citation to the wrong authority — the failure an existence check passes clean.
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Connect the Judge See the architectureThis page is legal information, not legal advice, and does not create an attorney-client relationship. Verdicts reflect the cited authority in the Kingsfield corpus as of the verification date shown above.