Upcoming Tobacco Product Listing Deadline: June 30
A deadline is approaching for certain manufacturers of deemed tobacco products to provide a listing of their tobacco products to FDA. The agency has undertaken efforts to educate those who could be affected by answering questions such as: What is the tobacco product listing requirement? What types of changes trigger the requirement, and when doesn’t it apply? What steps should companies take to make sure they’re in compliance?
Read on to learn about the basics of the listing requirement. Also, find a roundup of FDA resources for helping companies comply.
June 30: an important deadline for product listing
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), enacted in 2009, requires the owners and operators of domestic establishments engaged in manufacturing tobacco products to register with FDA and submit product listings. Under the deeming rule finalized in 2016, the listing requirement applies to products such as e-cigarettes and other electronic nicotine delivery systems (ENDS), cigars, pipe and hookah tobacco, nicotine gel, and dissolvable nicotine products. The act requires that certain changes to a tobacco product listing be reported to FDA twice a year: once during June and once during December.
For entities engaged in the manufacture, preparation, compounding, or processing of newly deemed finished tobacco products in the United States prior to Aug. 8, 2016, and continuing operations after Aug. 8, 2016, the deadline to provide any updated tobacco product listings is June 30, 2018. The term “finished tobacco product” refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use.
The product listing requirement pertains to updates and new listings. As outlined below, and as FDA-registered tobacco product manufacturing establishments were reminded in a recent notice from the agency, only those making certain changes are required to submit or update their product listing information. Information previously submitted to FDA should not be resubmitted.
Notably, all registered tobacco product manufacturers must update their product listing if they have made any of the following changes:
- Introduced any tobacco products for commercial distribution that were not included in a previous listing
- Discontinued manufacturing, preparation, compounding, or processing any tobacco products for commercial distribution
- Resumed manufacturing, preparation, compounding or processing any tobacco products previously listed as discontinued
- Made any required or voluntary material change to any listing information previously submitted, such as labeling or advertisement changes. A material change to labels and advertisements would include the addition of the required warnings for cigars or the required warning for covered tobacco products that will become effective Aug. 8, 2018. Please note that any material changes made after June 30, 2018, including the addition of warnings to package labels and advertisements, should be submitted by Dec. 31, 2018.
These resources from FDA contain information to help those responsible for tobacco product registration and listing.
- Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Product Establishments. This document is intended to help owners and operators of domestic product establishments with legally required submissions for registration, as well as product listing.
- Tobacco Registration and Product Listing (TRLM) Instructions Webpage. From this page, you can get to a wealth of information including video tutorials and webinars.
- User Guide for FDA’s Unified Registration and Listing System (FURLS) and Tobacco Registration and Listing Module (TRLM). FDA recommends that you submit your product listings online using the tobacco registration and listing module in FURLS. To ease the way, this guide provides simple, step-by-step instructions for setting up a new tobacco registration and product listing, viewing and updating this type of information, associating multiple product material files to multiple product listings, and using the system for other registration- and listing-related actions.
- New FDA tobacco compliance webinar: “Tobacco Product Listing Updates.”
This is the latest in a series of webinars created by FDA to help regulated industry comply with tobacco regulations—in this case, the product listing requirement.
Have additional questions?
Feel free to email FDA at: CTPRegistrationandListing@fda.hhs.gov.
Or, if you are a small business, consider these two additional options:
For more information on how to comply with FDA’s tobacco product regulations or for a list of upcoming tobacco product submission deadlines, please visit CTP’s manufacturing webpage.