Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.