Tobacco Products

Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

December 2016

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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Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
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Building 71, Room G335
Silver Spring, MD 20993-002

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