The definition

Three elements

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Element (A), the form Element (B), not a conventional food Element (C), labeled as a dietary supplement So two of the three are about words Which makes packaging copy a classification decision And a missing supplement statement is not a formality The ingredient list sits in paragraph (1)Botanicals and extracts are both named Being in a listed category is not a permission Two tests, in order References

All three, not any one. Which is how a product can fail on its own packaging copy.

Element (A), the form

Intended for ingestion in a form described in one cross-referenced provision, or complying with another. A form requirement, and the one most people mean when they picture a supplement.

Element (B), not a conventional food

Not represented for use as a conventional food or as a sole item of a meal or the diet. A representation test, which means it is about what is said rather than what is in the jar.

Element (C), labeled as a dietary supplement

Printing, as an element of a statutory definition. The package is doing part of the defining.

So two of the three are about words

What the product is represented as, and what it is labeled as. Only the first element is about the thing itself.

Which makes packaging copy a classification decision

A powder marketed as a daily drink, a meal replacement or a food is making a statement about element (B), and it is the statement that counts rather than the intention behind it.

And a missing supplement statement is not a formality

Element (C) is not satisfied by the product being obviously a supplement. It is satisfied by the label saying so.

The ingredient list sits in paragraph (1)

Which is where the categories of dietary ingredient live: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract or combination of those.

Botanicals and extracts are both named

Which is why this group sits in the definition at all. An herb or other botanical is a listed category, and so is an extract of one.

Being in a listed category is not a permission

It establishes that an ingredient is the kind of thing the definition covers. Whether it may be used is the 1994 question.

Two tests, in order

Does the product satisfy the three elements, and does the ingredient clear the new dietary ingredient gate. The first is a packaging question and the second is not.

References

21 U.S.C. 321(ff)(2), part of the definition of dietary supplement, requiring a product that "(A)(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title; or (ii) complies with section 350(c)(1)(B)(ii) of this title; (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement". The concluding text of (ff) reads "Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement shall be deemed to be a food within the meaning of this chapter." law.cornell.edu

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

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.