This guidance provides information in response to frequently asked questions (FAQs) that the Center for Tobacco Products (CTP) is receiving from manufacturers and other interested stakeholders (you) on demonstrating the substantial equivalence (SE) of a new tobacco product. In January 2011, FDA issued guidance regarding the submission of substantial equivalence reports (SE Reports) under section 905(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 387e(j)). In September 2011, FDA issued draft guidance responding to frequently asked questions covering a range of topics on demonstrating the SE of a new tobacco product. In March 2015, FDA issued a final guidance on many of the topics in the September 2011 Draft FAQ Guidance. After carefully reviewing and considering comments submitted on the March 2015 FAQ Guidance, FDA is issuing this revised final guidance to provide further information and clarification on the topics addressed in the March 2015 FAQ Guidance.
This guidance describes FDA’s current thinking on whether and when a change to a tobacco product’s label, product quantity in the package, additives, or specifications renders that later product a “new tobacco product” subject to premarket review (whether or not the new tobacco product replaces the original tobacco product). It explains that a manufacturer may submit streamlined SE Reports for certain modifications to labels and changes to product quantity as an alternative to the more comprehensive (full) SE Reports described in the Demonstrating SE Guidance. The guidance also explains FDA’s plans and processes for review of the streamlined SE Reports. Finally, this guidance responds to several questions that have been raised about the SE process more generally.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.