Docket Number:
FDA-2011-D-0147
Issued by:
Guidance Issuing Office
Center for Tobacco Products

This guidance provides information in response to frequently asked questions (FAQs) that the Center for Tobacco Products (CTP) has received from manufacturers and other interested stakeholders on demonstrating the substantial equivalence (SE) of a new tobacco product. Among other things, this guidance includes information on FDA’s current thinking on whether a change to the product quantity in the package renders a product “new” and thus subject to premarket review.

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All written comments should be identified with this document's docket number: FDA-2011-D-0147.

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