The 1994 line

The two routes

On this page11

The framing sentence Route one, verbatim Which has three conditions inside it And the word "only" is doing work Route two, the notification It is notice rather than approval The 75 days are a real constraint on a launch Which is the one place this touches packaging directly Neither route is assessed here Read the statute, then ask a professional References

Unless it meets one of the following requirements. One of two, not both.

The framing sentence

"A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 342(f) of this title unless it meets one of the following requirements".

Route one, verbatim

The supplement "contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered".

Which has three conditions inside it

Present in the food supply, used as an article of food, and in a form not chemically altered. All three, and the last one is the hard one.

And the word "only" is doing work

Contains only such ingredients. One ingredient outside the description takes the whole product off this route.

Route two, the notification

A history of use or other evidence of safety, furnished to the Secretary at least 75 days before the product is introduced or delivered for introduction into interstate commerce.

It is notice rather than approval

The requirement is that the information be provided in the window. What follows from providing it is a separate matter.

The 75 days are a real constraint on a launch

Because they run before introduction, which is before the product ships. Container lead times, artwork and a notification window all land in the same quarter.

Which is the one place this touches packaging directly

Order the containers, print the labels and file the notice are three tracks with one date at the end, and the shortest of them is usually not the notice.

Neither route is assessed here

Which ingredients in this group sit where, and whether either route is open to them, is a per-ingredient determination and federal agencies have taken positions this property does not summarize.

Read the statute, then ask a professional

Both routes are quoted above so that the reading can start from the text. The determination is not a packaging decision.

References

21 U.S.C. 350b(a): "A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 342(f) of this title unless it meets one of the following requirements". The first route, (a)(1), is that the supplement "contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered". The second, (a)(2), requires a history of use or other evidence of safety furnished to the Secretary "at least 75 days before being introduced or delivered for introduction into interstate commerce". law.cornell.edu

Nothing in this property states whether any particular botanical is a lawful dietary ingredient, a new dietary ingredient, adulterated or saleable. Those are per-ingredient determinations, federal agencies have taken positions on several of the botanicals named here which this property does not summarize or characterize, and state law differs from federal law and from state to state. Dosage, preparation and effect are also outside it.

Written from 21 U.S.C. 321(ff) and 21 U.S.C. 350b and from the catalog as it stood on 19 October 2026. Nothing here says whether any particular botanical is a lawful dietary ingredient, a new dietary ingredient or saleable: those are per-ingredient determinations, federal agencies have taken positions on several of these which this property does not summarize, and state law differs. Availability and stock figures are a single snapshot rather than a trend. The shipping weight field on this shelf reaches 2,002 lb, which is a case weight in a unit field, so do not rely on it.