January 22, 2019

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.

© 2019 Keller and Heckman LLP

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About this Author

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney
Partner

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...

202.434.4230
Benjamin Wolf. Keller Heckmann Law Firm, Food and Drug Law Attorney
Associate

Benjamin Wolf practices in the area of food and drug law. Mr. Wolf advises food, dietary supplement, medical device, consumer product, and pharmaceutical clients regarding compliance with domestic and foreign regulations. His practice also includes providing state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers.

Prior to joining Keller and Heckman, Mr. Wolf worked for the Food and Drug Administration (FDA) as a regulatory counsel in the Center for Tobacco Products (CTP) and Office of Regulatory Affairs (ORA). In his role as a regulatory counsel, Mr. Wolf worked closely with CTP, ORA, the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) to develop and implement policies including tobacco compliance and enforcement, tobacco premarket review, medical device compliance and enforcement, device premarket, and device and combination products good manufacturing practice. This work touched upon areas including tobacco substantial equivalence (SE), premarket tobacco product applications (PMTAs), modified risk tobacco product applications (MRTPAs), investigational tobacco product applications (ITPAs), data integrity, medical device quality metrics, utilization of benefit and risk factors in determining appropriate FDA engagement for devices being marketed, laboratory developed tests (LDTs), and good manufacturing practice (GMPs) for medical devices and combination products.    

202-434-4103