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FDA Regulations - September 30th 2017
Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.

FDA Regulation & Registration Webinar

Who must register?
Every person who owns or operates any domestic establishment engaged in manufacturing regulated tobacco products must register under section 905(b) of the FD&C Act, and every registrant must file a list of its regulated tobacco products in accordance with section 905(i) of the FD&C Act.
Source (Page 4)
Who has registered so far?
Search FDA Database
How do I register?
FDA strongly encourages electronic submission. For electronic submission of such information, FDA utilizes the FDA Unified Registration and Listing System (FURLS)

Online Registration
Offline Registration

Alternatively, you may use Form FDA 3741 for Establishment Registration and Product Listing. Persons with disabilities having problems accessing the above pdf file may call 1-877-CTP-1373 for assistance.

Downloadable Form