How does the Tobacco Control Act define substantial equivalence?
"Substantially equivalent" or "substantial equivalence," as defined by Section 910(a)(3)(A) of the Tobacco Control Act, refers to a product that:
- "Has the same characteristics as the predicate tobacco product; or"
- "Has different characteristics and the information submitted [in a Substantial Equivalence Report] contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under [the new tobacco product application provisions of section 910(c)] because the product does not raise different questions of public health."
- Overview of Substantial Equivalence and Exemption from Substantial Equivalence
- Overview Questions: Substantial Equivalence
- Overview Questions: Exemptions from Substantial Equivalence Requirements
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