This final rule codifies the specific format and content of substantial equivalence reports for tobacco products. If the new tobacco product has some characteristics that are identical to a valid predicate, but some characteristics are not identical, the applicant may submit an SE Report and choose to certify that certain characteristics are identical (e.g., product quantity changes). The final rule will clarify when manufacturers can certify that certain characteristics are identical.
Regulatory Impact Analysis
Federal Register: 86 FR 55224, October 10, 2021