Tobacco Products

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

Dec 2016

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.

 

Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002


Courier Deliveries

Page Last Updated: 12/09/2016
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