Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Guidance for Industry March 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2009-D-0508
• Issued by: Center for Tobacco Products

This guidance document is intended to assist owners and operators of domestic tobacco product establishments with the registration and product listing submissions required by section 905 of the Food, Drug, and Cosmetic Act (FD&C Act).  The guidance document explains, among other things:

• The statutory requirement to make establishment registration and product listing submissions;
• The definitions of terms used in the statute and this guidance;
• Who should make establishment registration and product listing submissions;
• What information to include in the submissions;
• How to submit the information;
• When to submit the information; and
• FDA’s compliance policies. 

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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
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0508.

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