Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product). As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along with copies of all labeling (see our full summary of the registration requirement here). This registration must be renewed annually before midnight on December 31 (Eastern time) every year, and product lists must be updated bi-annually: by midnight June 30 and December 31 every year.
This means that operators of manufacturing establishments of newly deemed products (e.g., vapor, cigars, hookah, etc.) on the market as of August 8, 2016 that have made changes to their product offerings must update their product lists with FDA by tomorrow, June 30, 2018, or as soon as possible to avoid FDA enforcement (considering the likelihood that FURLS may crash, the sooner you start this process, the better). Specific examples of changes that need to be updated (in FURLS, if you used that system to register online) include (1) discontinuing products on your product list that you are no longer actively manufacturing, (2) adding new products that are now being manufactured (e.g., co-packers now manufacturing pre-August 8, 2016 products that were not on the co-packers’ initial product list), (3) adding a new manufacturing location for products already listed by another establishment, or (4) labeling changes (including rebranding) of existing products.
Note that if you are planning to update your labels to comply with FDA’s nicotine addiction warning and other labeling requirements (that go into effect on August 10, 2018) after June 30, you have until December 31, 2018 to update your product listing with the revised labels.
If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury (202.434.4230, firstname.lastname@example.org) or Ben Wolf (202.434.4103, email@example.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.