Substantial Equivalence Reports for Tobacco Products

The FD&C Act requires FDA to issue an order under section 910(c)(1)(A)(i) (order after review of a premarket application, see section 910(b) of the FD&C Act) before a new tobacco product may be commercially marketed. An order under section 910(c)(1)(A)(i) is not required, however, if a manufacturer submits a report under section 905(j)(1)(A)(i) for the new tobacco product and FDA issues an order finding that the tobacco product is (1) substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and (2) in compliance with the requirements of the FD&C Act. Manufacturers of these tobacco products may submit a report under section 905(j)(1)(A)(i) demonstrating that a new tobacco product is “substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of this Act” (section 905(j)(1)(A)(i) of the FD&C Act). The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product. (In addition to the premarket application under section 910(b) and a report under 905(j)(1)(A)(i), certain new tobacco products may use the exemption premarket pathway, see 21 CFR 1107.1.) The regulations contain requirements for the content and format of SE Reports intended to establish the substantial equivalence of a tobacco product. The regulations establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the regulation contain the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. FDA will have three forms (Form FDA 3965; Form FDA 3965a; and new Form FDA 3965b) required for use (once this revision is approved) under section 21 CFR 1107.18(a)) when submitting an SE Report to the Agency. Forms FDA 3965 and 3965b are required when submitting single and bundled SE submissions. Form FDA 3965a is for use when firms are submitting amendments and other general correspondence. Form FDA 3965b is a new form that assists industry and FDA in identifying the products that are the subject of a submission. CTP is planning a significant upgrade to the submission process for SEs, known as the CTP Portal Next Generation (CTP Portal NG), streamlining the application process for the tobacco industry.

The latest form for Substantial Equivalence Reports for Tobacco Products expires 2028-04-30 and is listed under ICR 202402-0910-004.

View the official OMB control history on Reginfo.gov.

Reporting; Substantial Equivalence (SE) Report

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