Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments (Revised) *
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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.