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The 1994 line

New dietary ingredient

By Dwight Davis, Founder

On this page13
New means not marketed here before a date. It does not mean recently discovered.

The definition again, because it is short

A dietary ingredient that was not marketed in the United States before October 15, 1994. That is the whole test.

So new is a market fact

Not a botanical fact, not a novelty, and not a judgment about risk. A thousand-year-old plant can be a new dietary ingredient.

And an old American ingredient is not new however exotic

Which cuts both ways and is why the records matter more than the description.

The consequence is a deeming, not a ban

A supplement containing a new dietary ingredient is deemed adulterated unless it meets one of two requirements. There are two ways through.

Form is inside the question

Marketed before the date in what form, as what, and by whom. A traditional preparation and a modern concentrated extract are not obviously the same ingredient.

Which is where the chemical alteration language bites

The first route requires a form in which the food has not been chemically altered. Extraction and concentration are exactly the processes that question is about.

For this group that is the live issue

Mushroom extract and blue lotus extract are extracts by name. Whether an extract is the pre-1994 ingredient is the determination, and it is not ours.

The burden sits with whoever introduces the product

Which is the maker, not the container supplier. We sell jars and we have no visibility into an ingredient history.

And the notification route has a clock

75 days before introduction or delivery for introduction into interstate commerce. A deadline that runs against a production calendar.

And the two halves of the test are independent

An ingredient can be old in the American market and the product can still fail the definition on its labeling, or the labeling can be perfect and the ingredient still sit behind the gate. Two tests, neither answering the other.

Which is why the order matters

Settle the ingredient question first, because it decides whether there is a product at all. The label questions are solvable at any point before printing.

Both routes are quoted on the next page

With the exact wording, because a paraphrase of either one would be doing the reader a disservice in a category this consequential.

References

21 U.S.C. 350b(d): "For purposes of this section, the term 'new dietary ingredient' means a dietary ingredient that was not marketed in the United States before October 15, 1994". law.cornell.edu
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
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.