Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
This draft guidance provides information in response to frequently asked questions that the Center for Tobacco Products (CTP or we) is receiving from manufacturers and other interested stakeholders (you) on demonstrating the substantial equivalence of a new tobacco product.
In general, a tobacco product manufacturer must submit a premarket application and obtain a marketing authorization order before the manufacturer may introduce a new tobacco product into interstate commerce (section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act); 21 U.S.C. 387j).
A premarket application and a marketing authorization order under section 910(c)(1)(A)(i) is not required, however, if a manufacturer submits a substantial equivalence report under section 905(j) and obtains an order under section 910(a)(2). The report must include information demonstrating that the tobacco product is (1) substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, (2) in compliance with the requirements of the FD&C Act, including compliance with registration, listing, and tobacco product standard requirements, and (3) in compliance with section 907 (section 905(j)(1)(A)(i), (B)) of the FD&C Act.