GUIDANCE DOCUMENT
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions Guidance for Industry December 2016
- Docket Number:
- FDA-2011-D-0147
- Issued by:
-
Guidance Issuing OfficeCenter 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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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
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0147.