The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.
Regulatory Impact Analysis
Federal Register: 84 FR 12740, April 2, 2019