Regulatory Reminder: Updating your U.S. Establishment Registration and Product Listing By December 31, 2018
As a reminder, the registration requirement for domestic U.S. tobacco product manufacturing establishments, including manufacturers of deemed products such as e-liquids and cigars, is a biannual obligation that requires each such establishment to “update” their Registration and Product Listing information with FDA by December 31 every year (product listing information must also be updated by June 30 every year). See Section 905(b) of the Food, Drug, and Cosmetic Act (FDCA) as amended by the Family Smoking and Tobacco Control Act, 21 U.S.C. 387e(b).
FDA strongly encourages electronic submission of establishment Registrations and Product Listings through the FDA Unified Registration and Listing System (FURLS) which can be accessed here. By December 31, 2018, all domestic manufacturers of tobacco products will need to log in to their FURLS accounts and confirm that the registration information in the system is correct (or make any necessary changes), and domestic manufacturers of deemed products who updated their product labels after June 30, 2018 to comply with the nicotine addiction warning and other labeling requirements (which became effective on August 10, 2018), will need to upload their new labels and associate them with the correct products. Domestic manufacturers who have otherwise changed the list of products they manufacture or the label or labeling, advertising, or consumer information for their products will also need to update their product list and associated information.
Although FURLS was recently updated with a more user-friendly interface, the system is notorious for running slowly and glitches during high use periods should be expected (especially if users are attempting to upload many large files). We encourage anyone who needs to update files in FURLS to develop a plan and to start updates as soon as possible ahead of the deadline.
Tobacco products that are produced in an establishment that is not registered are considered misbranded per FDCA § 903(a)(6) (21 U.S.C. 387c(a)(6)); the sale of a misbranded product is a prohibited act under FDCA § 301(a). In addition, failure to update a tobacco product list or to register a facility are violations of FDCA § 301(p) (21 U.S.C. 331(p)) and can lead to enforcement actions such as fines, seizures, or injunctions.