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GUIDANCE DOCUMENT

Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised) Guidance for Industry October 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
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 (you) 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

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Questions?

Contact Point
Contact CTP
Center for Tobacco Products
Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
AskCTP@fda.hhs.gov
(9 a.m. - 4 p.m. Eastern) 1-877-CTP-1373 (1-877-287-1373)
Twitter: https://twitter.com/FDATobacco
FDA Tobacco Education Resource Library: https://digitalmedia.hhs.gov/tobacco
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