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U.S. Department of Health and Human Services

For Industry

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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:

  1. "Has the same characteristics as the predicate tobacco product; or"
  2. "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."

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