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GUIDANCE DOCUMENT

Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments Guidance for Industry December 2017

Final

This guidance is being distributed for comment purposes only.

Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

Issued by:
Guidance Issuing Office
Center for Tobacco Products

December 2017

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. 

Due to intermittent outages of the FDA Unified Registration and Listing System (FURLS), the FDA has extended the registration and listing compliance deadline until October 12, 2017. If you continue to experience technical difficulties with FURLS, please email CTPRegistrationandListing@fda.hhs.gov.


Submit Comments

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.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)