A date, not a chemistry
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The definition
A new dietary ingredient means a dietary ingredient that was not marketed in the United States before October 15, 1994. One date, and everything turns on which side of it an ingredient sits.
Which is an archival question
Not a question about the plant, its safety or its potency. A question about the American market in and before 1994, answered from records.
And for this group it is the whole question
Amanita, blue lotus, kava, kratom and mushroom extracts are all old plants and the 1994 line is about whether they were being sold here, as what, and in what form.
Form matters inside the date
An ingredient marketed in one form before the date is not automatically the same ingredient in another. Which is why the first route around the rule turns on chemical alteration.
A new dietary ingredient is not forbidden
A supplement containing one is deemed adulterated unless it meets one of two requirements. The rule is a gate rather than a wall.
Route one is the food supply
A supplement containing only ingredients present in the food supply as an article used for food, in a form in which the food has not been chemically altered.
Route two is 75 days of notice
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.
Which is a packaging deadline in disguise
75 days before introduction means 75 days before the thing is boxed and shipped. Container lead times and notification windows run in the same calendar.
And none of it is settled here
Which ingredients in this group need which route, and whether any of them clears it, is a per-ingredient determination this property does not make.
The useful thing is to know what to ask
Not is this safe, but was it marketed here before 15 October 1994, in what form, and if not which of the two routes applies.