substantial equivalence

(3) Substantially equivalent defined (A) In general In this section and section 387e(j) of this title , the term “substantially equivalent” or “substantial equivalence” means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product— (i) has the same characteristics as the predicate tobacco product; or (ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health. (B) Characteristics In subparagraph (A), the term “characteristics” means the materials, ingredients, design, composition, heating source, or other features of a tobacco product. (C) Limitation A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated.


21 USC § 387j(a)(3)

Scoping language

In this section
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